no guideline provided
according to EPA OPP 83-1 (Chronic Toxicity)
equivalent or similar to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: yes, the animals were dosed for 1 year and only 4 animals/dose/sex were used for the study
no guideline provided
no guideline provided
according to EPA OPPTS 870.3150 (90-Day Oral Toxicity in Nonrodents), deviations: no
according to EU Method B.27 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to EPA OPPTS 870.3150 (90-Day Oral Toxicity in Nonrodents), deviations: no
according to EU Method B.27 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to EPA OPPTS 870.3150 (90-Day Oral Toxicity in Nonrodents), deviations: no
according to EU Method B.27 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: yes, Deviations from OECD Guideline 409: - the highest dose level did not elicit any signs of toxicity - not all suggested clinical chemistry parameters were investigated  - uteri and gall bladders were not weighed
no guideline provided
no guideline provided
no guideline provided
according to, Chronic toxicity study of Fast Green FCF
no guideline provided
equivalent or similar to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: yes, (see below)
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: not applicable
according to EPA OPP 83-1 (Chronic Toxicity), deviations: yes, (see below)
no guideline provided
no guideline provided
no guideline provided
according to EPA OPP 83-1 (Chronic Toxicity)
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents)
according to EPA OPP 83-1 (Chronic Toxicity), deviations: not specified
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies), deviations: yes, -gross pathology of coagulating gland, lacrimal gland, peripheral nerve, and seminal vesicles were not examined; for additional deviations, see additional details on Materials and Methods section
according to EPA OPP 83-1 (Chronic Toxicity), deviations: no
according to OECD Guideline 452 (Chronic Toxicity Studies), deviations: no
according to EPA OPP 83-1 (Chronic Toxicity), deviations: yes, On several occasions there was only one observation per day for mortality and moribundity. Due to mistakes food consumption values for week 10 reflect 6-day consumption. Blood sampling prior to treatment (week -2) was done on non-fastened animals. Before
according to EPA OPP 83-1 (Chronic Toxicity), deviations: yes, On several occasions there was only one observation per day for mortality and moribundity. Due to mistakes food consumption values for week 10 reflect 6-day consumption. Blood sampling prior to treatment (week -2) was done on non-fastened animals. Before
according to EPA OPP 83-1 (Chronic Toxicity), deviations: yes, On several occasions there was only one observation per day for mortality and moribundity. Due to mistakes food consumption values for week 10 reflect 6-day consumption. Blood sampling prior to treatment (week -2) was done on non-fastened animals. Before
according to EPA OPP 83-1 (Chronic Toxicity), deviations: yes, On several occasions there was only one observation per day for mortality and moribundity. Due to mistakes food consumption values for week 10 reflect 6-day consumption. Blood sampling prior to treatment (week -2) was done on non-fastened animals. Before
no guideline provided
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies)
equivalent or similar to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: yes, , see below in "Principles of method if other than guideline"
no guideline provided
no guideline provided
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: yes, Urinanalysis was not performed. Homogeneity samples were analysed 2 days after mixing. No analyses of samples for week 2.
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: yes, Urinanalysis was not performed. Homogeneity samples were analysed 2 days after mixing. No analyses of samples for week 2.
no guideline provided
equivalent or similar to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to, Notification of Director-General, Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries (MAFF), Japan., deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to, Notification of Director-General, Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries (MAFF), Japan., deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
no guideline provided
no guideline provided
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, No functional observations on neurobehavioural effects were conducted.
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, No functional observations on neurobehavioural effects were conducted.
no guideline provided
according to, OECD 451 (1981)
according to, OECD 451 (1981)
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies), deviations: yes, insufficient animals used, hematology only collected at beginning and end of study, no clinical chemistry/urinalysis performed, no clinical observations provided, limited gross and histopathology performed.
equivalent or similar to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
equivalent or similar to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: no
no guideline followed OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents), deviations: yes, 14 days only
no guideline provided
no guideline provided
equivalent or similar to, OECD TG 451 (carcinogenisity study), deviations: yes, ; only 2 instead of three dose levels; no differential blood count was performed; some tissues/organs not microscopally examined; no blood smear test; body weights not recorded and/or not reported according to guideline; food consumption not reported
equivalent or similar to, OECD TG 451 (carcinogenisity study), deviations: yes, ; only 2 instead of three dose levels; no differential blood count was performed; some tissues/organs not microscopally examined; no blood smear test; body weights not recorded and/or not reported according to guideline; food consumption not reported
equivalent or similar to, OECD TG 451 (carcinogenisity study), deviations: yes, ; only 2 instead of three dose levels; no differential blood count was performed; some tissues/organs not microscopally examined; no blood smear test; body weights not recorded and/or not reported according to guideline; food consumption not reported
equivalent or similar to, EPA OPPTS 870.4300 (Combined Chronic Toxicity / Carcinogenicity), deviations: yes, current guidelines require three treatment groups plus a control group
equivalent or similar to, OECD 451 (carcinogenicity study), deviations: yes, (no 3rd dose level; in histopathology some organs recommended in OECD451 were not evaluated)
equivalent or similar to, OECD 451 (carcinogenicity study), deviations: yes, (no 3rd dose level; in histopathology some organs recommended in OECD451 were not evaluated)
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
no guideline provided
no guideline provided
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, OECD Guideline 451 (Carcinogenicity Studies), deviations: yes
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: not specified
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: not specified
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: not specified
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: not specified
no guideline provided
no guideline provided
no guideline provided
no guideline provided
according to NTP guideline
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, observations reduced to mortality, and clinical signs, body weights and gross and microscopic examinations
no guideline provided
no guideline provided
no guideline provided
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no documentation of organ weights
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no documentation of organ weights
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
no guideline provided
no guideline provided
according to, 82-1
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, Exposure period 14 days instead of 28 days. No histopathology performed
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, Exposure period 14 days instead of 28 days. No histopathology performed
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to, NTP laboratory health and safety guidelines
no guideline provided
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, -acclimatization period should have been at least 7 days and histopathology of the cervix, vagina, lacrimal gland, peripheral nerve, and skeletal muscle were not examined
according to, EPA OPP 83-2 (Carcinogenicity), deviations: no
according to, EU Method B.32 (Carcinogenicity Test), deviations: no
according to, Ministry of Agriculture, Forestry and Fisheries, Japan, 59 NohSan No. 4200, deviations: no
according to, OECD Guideline 451 (Carcinogenicity Studies), deviations: no
according to, EPA OPP 83-2 (Carcinogenicity), deviations: no
according to, EU Method B.32 (Carcinogenicity Test), deviations: no
according to, Ministry of Agriculture, Forestry and Fisheries, Japan, 59 NohSan No. 4200, deviations: no
according to, OECD Guideline 451 (Carcinogenicity Studies), deviations: no
according to, OECD 451 (Carcinogenicity Studies)
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies), deviations: yes, Analytical purity not reported. Animals housing and enviromental conditons were not reported. Only two doses tested
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to, OECD Guideline 451 (Carcinogenicity Studies), deviations: yes, yes (Only 2 dose levels used in the study instead of at least 3 dose levels)
equivalent or similar to, OECD Guideline 451 (Carcinogenicity Studies), deviations: yes, yes (Only 2 dose levels used in the study instead of at least 3 dose levels)
equivalent or similar to, OECD Guideline 451 (Carcinogenicity Studies), deviations: yes, yes (Only 2 dose levels used in the study instead of at least 3 dose levels)
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
according to, Chronic toxicity study of Fast Green FCF
no guideline provided
according to, Repeated dose carcinogenicity
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies), deviations: not specified
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, (only 2 instead of 3 dose groups, no data on food consumption; hematology and clinical chemistry examinations only at 15 mo, no urinalysis data)
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, (only 2 instead of 3 dose groups, no data on food consumption; hematology and clinical chemistry examinations only at 15 mo, no urinalysis data)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -temperature=26 to 31 °C; 7.5 hour-light period; detailed clinical observations not done once/week; morbidity and mortality not observed at least twice daily; sensory reactivity test, grip strength, and motor activity assessment not done
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -temperature=26 to 31 °C; 7.5 hour-light period; detailed clinical observations not done once/week; morbidity and mortality not observed at least twice daily; sensory reactivity test, grip strength, and motor activity assessment not done
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -temperature=26 to 31 °C; 7.5 hour-light period; detailed clinical observations not done once/week; morbidity and mortality not observed at least twice daily; sensory reactivity test, grip strength, and motor activity assessment not done
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -temperature=26 to 31 °C; 7.5 hour-light period; detailed clinical observations not done once/week; morbidity and mortality not observed at least twice daily; sensory reactivity test, grip strength, and motor activity assessment not done
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (biochemical and hematological analysis not performed or not reported, details on the frequency of exposure and time-points of observations were not reported; and no statistical analysis provided)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, , a number of end points were not examined.
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, , a number of end points were not examined.
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, , a number of end points were not examined.
according to, NTP protocol
according to, NTP protocol
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, No histopathology performed. Results of clinical observations not reported. Acclimatisation period of test animals only 4 days instead of at least 5 days.
no guideline provided
no guideline provided
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to, Ministry of Agriculture, Forestry and Fisheries, Japan, 59 NohSan No. 4200, deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to, Ministry of Agriculture, Forestry and Fisheries, Japan, 59 NohSan No. 4200, deviations: no
no guideline provided
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to EPA OPP 82-1 (90-Day Oral Toxicity)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, No information provided on food consumption, haematology, clinical chemistry, macroscopic and microscopic examinations, other than urinary, kidney and bladder effects.
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies), deviations: yes, : no ophtalomologic examination, no urinalysis, no neurobehavioural examination, no food consumption monitoring.
no guideline provided
no guideline provided
no guideline provided
no guideline provided
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, , F1 offspring was followed to adulthood with continued exposure and assessment of neurologic, immunologic, and reproductive structures and functions. In addition, F0 recovery males and 28-day recovery females was assessed.
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: no
according to, US EPA OPPTS 870.3650, deviations: no
equivalent or similar to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
equivalent or similar to, EPA OPPTS 870.3050
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: no
according to, US EPA OPPTS 870.3650, deviations: no
equivalent or similar to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
equivalent or similar to, EPA OPPTS 870.3050
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: no
according to, US EPA OPPTS 870.3650, deviations: no
equivalent or similar to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
equivalent or similar to, EPA OPPTS 870.3050
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: no
according to, EPA OPPTS 870.3650 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test), deviations: no
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: no
according to, EPA OPPTS 870.3650 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test), deviations: no
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, some tissues were not taken, thus some investigations could not be conducted. Some clinical biochemistry determinations were not conducted. Neurobehavioral examination was not conducted.
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, some tissues were not taken, thus some investigations could not be conducted. Some clinical biochemistry determinations were not conducted. Neurobehavioral examination was not conducted.
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
equivalent or similar to, OECD TG 451 (carcinogenicity study), deviations: yes, ;  only 2 instead of three dose levels; no differential blood count was performed; some tissues/organs not microscopally examined; no blood smear test; body weights not recorded and/or not reported according to guideline; food consumption not reported
equivalent or similar to, OECD TG 451 (carcinogenicity study), deviations: yes, ;  only 2 instead of three dose levels; no differential blood count was performed; some tissues/organs not microscopally examined; no blood smear test; body weights not recorded and/or not reported according to guideline; food consumption not reported
equivalent or similar to, EPA OPPTS 870.4300 (Combined Chronic Toxicity / Carcinogenicity), deviations: yes, current guidelines require three treatment groups plus a control group
equivalent or similar to, OECD 451 (Carcinogenicity study), deviations: yes, Urinalysis, haematological and clinical biochemistry measurements were not reported
equivalent or similar to, OECD 451 (carcinogenicity study), deviations: yes, (no 3rd dose level; in histopathology some organs recommended in OECD451 were not evaluated)
equivalent or similar to, OECD 451 (carcinogenicity study), deviations: yes, (no 3rd dose level; in histopathology some organs recommended in OECD451 were not evaluated)
equivalent or similar to, OECD 451 (carcinogenicity study), deviations: yes, (no 3rd dose level; in histopathology some organs recommended in OECD451 were not evaluated)
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
equivalent or similar to, OECD Guideline 451 (Carcinogenicity Studies), deviations: not specified
equivalent or similar to, EPA OPPTS 870.4300 (Combined Chronic Toxicity / Carcinogenicity), deviations: yes, current guidelines require three treatment groups; top dose in males only about 500 mg/kg kg/day
equivalent or similar to, EPA OPPTS 870.4300 (Combined Chronic Toxicity / Carcinogenicity), deviations: yes, current guidelines require three treatment groups; top dose in males only about 500 mg/kg kg/day
no guideline provided
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, OECD Guideline 451 (Carcinogenicity Studies), deviations: yes
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: not specified
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: not specified
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: not specified
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: not specified
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, , see principles
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, , see principles
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
according to EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test), deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, EPA OPP 83-5 (Combined Chronic Toxicity / Carcinogenicity), deviations: no
according to, Ministry of Agriculture, Forestry and Fisheries, Japan, 59 NohSan No. 4200, deviations: no
according to EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test), deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, EPA OPP 83-5 (Combined Chronic Toxicity / Carcinogenicity), deviations: no
according to, Ministry of Agriculture, Forestry and Fisheries, Japan, 59 NohSan No. 4200, deviations: no
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies)
no guideline provided
no guideline provided
according to, EPA OTS 798.6050 (Neurotoxicity Test), deviations: no
according to, Hydroquinone Final Test Standards and Reporting Requirements (52 FR 19865-19870, May 28, 1987), deviations: no
equivalent or similar to, OECD Guideline 424 (Neurotoxicity study in rodents), deviations: no
according to, EPA OTS 798.6050 (Neurotoxicity Test), deviations: no
according to, Hydroquinone Final Test Standards and Reporting Requirements (52 FR 19865-19870, May 28, 1987), deviations: no
equivalent or similar to, OECD Guideline 424 (Neurotoxicity study in rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, ; food consumption not recorded; some serum parameters (sodium, urea, creatinine) not analysed; some organs (testes, epididymes) not weighted; some organs/tissues (spinal cord, aorta, peripheral nerves) not histopatholically examined
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, ; food consumption not recorded; some serum parameters (sodium, urea, creatinine) not analysed; some organs (testes, epididymes) not weighted; some organs/tissues (spinal cord, aorta, peripheral nerves) not histopatholically examined
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (no information on neurotoxicity and immunotoxicity)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (no information on neurotoxicity and immunotoxicity)
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, observations reduced to mortality, and clinical signs, body weights and gross and microscopic examinations
according to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no documentation of organ weights
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no documentation of organ weights
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no documentation of organ weights
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (no post exposure period, max humidity > 70%, max Temp > 25°C, limited chemical chemistry, not all recommended organs were weighed, no post exposure group)
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
no guideline provided
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no information on the analytical examination of doses, ophthalmoscopic and neurobehavioural examination not performed
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no information on the analytical examination of doses, ophthalmoscopic and neurobehavioural examination not performed
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no information on the analytical examination of doses, ophthalmoscopic and neurobehavioural examination not performed
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no information on the analytical examination of doses, ophthalmoscopic and neurobehavioural examination not performed
no guideline provided
equivalent or similar to, OECD 424, deviations: no
equivalent or similar to, OECD 424, deviations: no
no guideline provided
no guideline provided
no guideline provided
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, No observational period of 90 days (after exposure). No ophthalmological examinations. No sensory reactivity analysis and motory assessment were conducted. Animals were not fasted before blood analysis. Some organs were not subjected  to gross necropsy.
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
according to, NTP protocol
according to, NTP protocol
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, 14 days
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, : 14 days only
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, Only bodyweight and macros-/microscopical examinations were performed.
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, Only bodyweight and macros-/microscopical examinations were performed.
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: not specified
equivalent or similar to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents), deviations: yes, (expands standard precedure by including endocrine-sensitive measurements to gain information on potential hormonal effects)
equivalent or similar to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents), deviations: yes, (expands standard precedure by including endocrine-sensitive measurements to gain information on potential hormonal effects)
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to, NTP laboratory health and safety guidelines
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: not specified
no guideline provided
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies), deviations: yes, Analytical purity not reported. Animals housing and enviromental conditons were not reported. Only two doses tested
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to, OECD Guideline 451 (Carcinogenicity Studies), deviations: yes, 40 male and female rats used in the control group instead of at least 50 animals and only 2 dose levels used in the study instead of at least 3
equivalent or similar to, OECD Guideline 451 (Carcinogenicity Studies), deviations: yes, 40 male and female rats used in the control group instead of at least 50 animals and only 2 dose levels used in the study instead of at least 3
equivalent or similar to, OECD Guideline 451 (Carcinogenicity Studies), deviations: yes, 40 male and female rats used in the control group instead of at least 50 animals and only 2 dose levels used in the study instead of at least 3
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies)
no data
no guideline provided
no guideline provided
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, animals were > 6 weeks of age when dosing commenced and the lowest dose is < 10% of highest dose for females
according to, EPA OTS 798.3320 (Combined Chronic Toxicity/Oncogenicity Studies)
according to, MAFF Guideline 59 NohSan No. 4200 Combined Chronic Toxicity/Oncogenicity Studies
according to, US-EPA FIFRA Guideline 83-5
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, animals were > 6 weeks of age when dosing commenced and the lowest dose is < 10% of highest dose for females
according to, EPA OTS 798.3320 (Combined Chronic Toxicity/Oncogenicity Studies)
according to, MAFF Guideline 59 NohSan No. 4200 Combined Chronic Toxicity/Oncogenicity Studies
according to, US-EPA FIFRA Guideline 83-5
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, animals were > 6 weeks of age when dosing commenced and the lowest dose is < 10% of highest dose for females
according to, EPA OTS 798.3320 (Combined Chronic Toxicity/Oncogenicity Studies)
according to, MAFF Guideline 59 NohSan No. 4200 Combined Chronic Toxicity/Oncogenicity Studies
according to, US-EPA FIFRA Guideline 83-5
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, animals were > 6 weeks of age when dosing commenced and the lowest dose is < 10% of highest dose for females
according to, EPA OTS 798.3320 (Combined Chronic Toxicity/Oncogenicity Studies)
according to, MAFF Guideline 59 NohSan No. 4200 Combined Chronic Toxicity/Oncogenicity Studies
according to, US-EPA FIFRA Guideline 83-5
no data
according to, Chronic toxicity study of Fast Green FCF
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies), deviations: no
equivalent or similar to OECD Guideline 452 (Chronic Toxicity Studies), deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (the low dose group was treated for 90 days; the mid- and highdose groups for 28 days. No ocular and neurobehavioural examinations included )
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (the low dose group was treated for 90 days; the mid- and highdose groups for 28 days. No ocular and neurobehavioural examinations included )
according to, “28-day Repeated Dose Toxicity Study in Mammalian Species”  Notification No. 1121002 of the Pharmaceutical and Food Safety Bureau, MHLW, No. 2 of the Manufacturing Industries Bureau, METI & No. 031121002 of the Environmental Health Department, MOE, deviations: no, The study was conducted according to guideline in effect at time of study conduct
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
no guideline provided
no guideline provided
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: not specified
no guideline provided
no guideline provided
no guideline provided
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, EC Commission directive 92/69/EEC; July 31, 1992
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, EC Commission directive 92/69/EEC; July 31, 1992
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, EC Commission directive 92/69/EEC; July 31, 1992
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, EC Commission directive 92/69/EEC; July 31, 1992
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, EC Commission directive 92/69/EEC; July 31, 1992
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, EC Commission directive 92/69/EEC; July 31, 1992
no guideline provided
no guideline provided
no guideline provided
no guideline provided
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no, including 14 day recovery
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, (no information on neuro- and immunotoxicity and endocrine activity)
according to, Guidelines for 28-Day Repeat Dose Toxicity Testing of Chemicals (Japan), deviations: not specified
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, minor deviations, e.g. no determination of bile acids
according to, Guidelines for 28-Day Repeat Dose Toxicity Testing of Chemicals (Japan), deviations: not specified
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, minor deviations, e.g. no determination of bile acids
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, japanese guideline
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, japanese guideline
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, japanese guideline
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to, Guidelines for 28-Day Repeat Dose Toxicity Test of Chemicals (Japan), deviations: no
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, Sensory reactivity to stimuli, assessment of grip strength and motor activity assessment was not conducted.
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, TG for 28-day repeat dose toxicity testing of chemicals (Japan)
according to, TG for 28-day repeat dose toxicity testing of chemicals (Japan)
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
no guideline provided
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, purity was not reported and diets were not analytically verified for concentration
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, 30 day administration and a number of end points not examined
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, No hematology and urine analysis, limited blood chemistry and histopathological examinations
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, No hematology and urine analysis, limited blood chemistry and histopathological examinations
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, : exposure period in one group is 8 weeks; diet with high level of iodine (2.2 ppm)
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, : exposure period in one group is 8 weeks; diet with high level of iodine (2.2 ppm)
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, : no complete observation battery was realised
no guideline provided
no guideline provided
according to, KANPOGYO No.700, YAKUHATSU No. 1039.61, and KIKYKU No. 1014.
according to, KANPOGYO No.700, YAKUHATSU No. 1039.61, and KIKYKU No. 1014.
according to, Kanpogyo 700, Yakuhatsu 1039, Kikyoku 1014
according to, Kanpogyo 700, Yakuhatsu 1039, Kikyoku 1014
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, no hematology, ophtalmic examination or urinalysis
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, no hematology, ophtalmic examination or urinalysis
no guideline provided
no guideline provided
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, US EPA guideline OPPTS 870.3700, August 1998, deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, US EPA guideline OPPTS 870.3700, August 1998, deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, US EPA guideline OPPTS 870.3700, August 1998, deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, US EPA guideline OPPTS 870.3700, August 1998, deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, US EPA guideline OPPTS 870.3700, August 1998, deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: no
according to, US EPA guideline OPPTS 870.3700, August 1998, deviations: no
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, 6 week test period.  Not all end points examined.
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, : 6 week test period.  Not all end points examined. Males only
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, : 6 week test period.  Not all end points examined. Males only
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, : 6 week test period.  Not all end points examined. Males only
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, : 6 week test period.  Not all end points examined.
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, (only 2 instead of 3 dose groups, no data on food consumption; hematology and clinical chemistry examinations only at 15 mo, no urinalysis data)
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, (only 2 instead of 3 dose groups, no data on food consumption; hematology and clinical chemistry examinations only at 15 mo, no urinalysis data)
equivalent or similar to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies), deviations: yes, (only 2 instead of 3 dose groups, no data on food consumption; hematology and clinical chemistry examinations only at 15 mo, no urinalysis data)
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, 9Week-study
no guideline provided
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: yes, -observations for morbidity and mortality should be inspected at least twice daily; blood urea nitrogen was not examined, sensory reactivity to stimuli of different types, assessment of grip strength, and motor activity assessment was not conducted
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -observations for morbidity and mortality should be inspected at least twice daily; blood urea nitrogen was not examined, sensory reactivity to stimuli of different types, assessment of grip strength, and motor activity assessment was not conducted
according to, FIFRA 82-1, deviations: not specified
according to, MAFF (JAPAN), deviations: not specified
no guideline provided
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, , see above in "rationale for relaibility".
no guideline provided
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -Detailed clinical observations not done once/week; morbidity and mortality not observed at least twice daily; sensory reactivity test, grip strength, motor activity assessment not performed; missing some clinical chemistry, hematology and organ weights
according to, Commission Directive 87/302/EEC (No. L133/8), deviations: not specified
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -Detailed clinical observations not done once/week; morbidity and mortality not observed at least twice daily; sensory reactivity test, grip strength, motor activity assessment not performed; missing some clinical chemistry, hematology and organ weights
according to, Commission Directive 87/302/EEC (No. L133/8), deviations: not specified
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -Detailed clinical observations not done once/week; morbidity and mortality not observed at least twice daily; sensory reactivity test, grip strength, motor activity assessment not performed; missing some clinical chemistry, hematology and organ weights
according to, Commission Directive 87/302/EEC (No. L133/8), deviations: not specified
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -Detailed clinical observations not done once/week; morbidity and mortality not observed at least twice daily; sensory reactivity test, grip strength, motor activity assessment not performed; missing some clinical chemistry, hematology and organ weights
according to, Commission Directive 87/302/EEC (No. L133/8), deviations: not specified
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, some tissues were not taken, thus some investigations could not be conducted. Some clinical biochemistry determinations were not conducted. Neurobehavioral examination was not conducted.
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, some tissues were not taken, thus some investigations could not be conducted. Some clinical biochemistry determinations were not conducted. Neurobehavioral examination was not conducted.
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, biochemical and hematological analysis not performed or not reported, details on the frequency of exposure and time-points of observations were not reported; and no statistical analysis provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, biochemical and hematological analysis not performed or not reported, details on the frequency of exposure and time-points of observations were not reported; and no statistical analysis provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, biochemical and hematological analysis not performed or not reported, details on the frequency of exposure and time-points of observations were not reported; and no statistical analysis provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, , not all currently required analysis carried out.
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, , not all currently required analysis carried out.
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, , not all currently required analysis carried out.
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, :data not provided on environmental conditions, insufficient # of animals tested, clinical observations not performed, gross and histopathology not performed on required organs, histopathology only performed on 2 animals/group.
according to, NTP protocol
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no ophtalmological examination; no examination of sensory reactivity
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no ophtalmological examination; no examination of sensory reactivity
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, no ophtalmological examination; no examination of sensory reactivity
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, -biochemical analyses, ophthalmologic examinations, and sensory reaction to stimuli test were not performed, individual details of macroscopic findings and individual body weights were not reported, and food consumption was not measured weekly
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, humidity,stability of the test substance in diet, clinical chemistry, and hematological parameters were not measuered, no ophthalmological examination or sensory reaction to stimuli was performed, and food consumption was not measured weekly
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, Mortality was recorded once a day instead of twice; ophthalmological examination not performed; platelet count not performed; some organ not examined; individual weight not reported.
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, Mortality was recorded once a day instead of twice; ophthalmological examination not performed; platelet count not performed; some organ not examined; individual weight not reported.
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
no guideline provided
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, with fertility segment
according to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, with fertility segment
no guideline provided
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to, Ministry of Agriculture Fisheries and Forestry, Japan, NohSan 3850, deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to, Ministry of Agriculture Fisheries and Forestry, Japan, NohSan 3850, deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to, Ministry of Agriculture Fisheries and Forestry, Japan, NohSan 3850, deviations: no
according to EPA OPP 82-1 (90-Day Oral Toxicity), deviations: no
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: no
according to, Ministry of Agriculture Fisheries and Forestry, Japan, NohSan 3850, deviations: no
no guideline provided
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: yes, based on the draft of enhanced guideline 407
according to, Test Guideline of the Japanese Chemical Control Act (Official Name: Law Concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances)
according to, Test Guideline of the Japanese Chemical Control Act (Official Name: Law Concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, the study exceeds the guideline by following the F1 offspring to adulthood and includes assessment of neurologic function.
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, the study exceeds the guideline by following the F1 offspring to adulthood and includes assessment of neurologic function.
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, the study exceeds the guideline by following the F1 offspring to adulthood and includes assessment of neurologic function.
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, the study exceeds the guideline by following the F1 offspring to adulthood and includes assessment of neurologic function.
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, the study exceeds the guideline by following the F1 offspring to adulthood and includes assessment of neurologic function.
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (see rationale for reliability)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (see rationale for reliability)
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, (see Principles of Method)
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, (see Principles of Method)
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, (see Principles of Method)
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, (see Principles of Method)
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, (see Principles of Method)
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, (see Principles of Method)
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, (see Principles of Method)
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, (see Principles of Method)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, no details provided on mating methods, or on housing or feeding of animals
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: no
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: no
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to, EPA OPPTS 837.3800, 1998
equivalent or similar to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, EPA OPPTS 837.3800, 1998
equivalent or similar to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, EPA OPPTS 837.3800, 1998
equivalent or similar to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, EPA OPPTS 837.3800, 1998
equivalent or similar to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, EPA OPPTS 837.3800, 1998
equivalent or similar to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to, EPA OPPTS 837.3800, 1998
equivalent or similar to, OECD Guideline 416 (Two-Generation Reproduction Toxicity Study) TG 416 Enhanced
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
according to OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes
no guideline provided
no guideline provided
no guideline provided
no guideline provided
Kankiken No. 233, Eisei No. 38, and 63 Kikyoku No 823 (November, 1988)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Kankiken No. 233, Eisei No. 38, and 63 Kikyoku No 823 (November, 1988)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Kankiken No. 233, Eisei No. 38, and 63 Kikyoku No 823 (November, 1988)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
no guideline provided
no guideline provided
no guideline provided
no guideline provided
according to EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)), deviations: no
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), deviations: no
according to, OPPTS 870.3050, deviations: no
no guideline provided
according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, no neurobehavioural examination performed; hematology and clinical chemistry only was done on males.
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
according to, OECD Guideline 421
according to, OECD Guideline 421
according to, OECD Guideline 421
according to, OECD Guideline 421
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, duration, number of animals, dosages, administration volume, hematology, clinical chemistry, organ weights, histopathologic examination, neurobehaviour
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, duration, number of animals, dosages, administration volume, hematology, clinical chemistry, organ weights, histopathologic examination, neurobehaviour
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, duration, number of animals, dosages, administration volume, hematology, clinical chemistry, organ weights, histopathologic examination, neurobehaviour
equivalent or similar to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), deviations: yes, duration, number of animals, dosages, administration volume, hematology, clinical chemistry, organ weights, histopathologic examination, neurobehaviour
no guideline provided
no guideline provided
no guideline provided
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
equivalent or similar to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
no guideline provided
equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents), deviations: yes, (no ophthalmology examination; no functional observations; limited clinical chemistry examination)
no guideline provided