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EC number: 201-810-9 | CAS number: 88-21-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- Reference Type:
- other: study report
- Title:
- "Preliminary Reproduction Toxicity Screening Test of 2-Amino- 5-methylbenzenesulfonic acid by Oral Administration in Rats".
- Author:
- Ministry of Health & Welfare, Japan
- Year:
- 1 999
- Bibliographic source:
- Toxicity Testing Reports of Environmental Chemicals, vol.7 p163-171
- Reference Type:
- other: study report
- Title:
- Assessment Report for 4-AMINOTOLUENE-3-SULFONIC ACID CAS N°: 88-44-8
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report For SIAM 16 Paris, 27-30 May 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-aminotoluene-3-sulphonic acid
- EC Number:
- 201-831-3
- EC Name:
- 4-aminotoluene-3-sulphonic acid
- Cas Number:
- 88-44-8
- IUPAC Name:
- 2-amino-5-methylbenzenesulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): 4-aminotoluene-3-sulphonic acid
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 375-414 g for males, 239-266 g for females
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: sesame oil, 0.5mL/100g body weight
- Details on exposure:
- vehicle: sesame oil, 0.5mL/100g body weight
schedule: once a day by oral gavage
male: before mating 14 days, during mating 14 days, after mating 20 days;
total 48 days
pregnant female: before mating 14 days, during mating (max.) 14 days,
during gestation (about 21 days), after pregnant 3 days; total 41-46 days
not pregnant female: till 25 days after gestation; total 41-43 days
not couplated female: till 20 days after mating period; total 48 days - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: max. 14 days
- Further matings after two unsuccessful attempts: No data - Duration of treatment / exposure:
- male: 48 days, female: 41-48 days
- Frequency of treatment:
- Once a day, every day
- Duration of test:
- male: 48 days, female: 41-48 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day
Basis:
- No. of animals per sex per dose:
- 12 per sex per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: every day to all animals.
BODY WEIGHT: Yes
- Time schedule for examinations:
Male body weight: once a week, total 8 times in the 49 days
Female body weight: 1st, 8th, 15th day before mating; 0th, 7th, 14th, 21st day after copulated; 0th, 4th day after pregnant
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): in conformity with those body weights, except during mating for female.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): not checked - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: No data - Indices:
- Gestation index,Implanation index,Delivery index,Livebirth index,Viability index.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects. Remark: No dose related effects was observed on maternal toxicity
Details on maternal toxic effects:
No adversed effects was observed on maternal toxicity.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: not specified
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
- Description (incidence and severity):
- not specified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no significant differences in number of offspring or live offspring, sex ratio, the live birth index, the viability index and the body
weight. No abnormal findings related to the test substance were noted for external features, clinical signs, or on necropsy finding for the offspring. No pups with malformation were found in any group. No change in clinical signs and necropsy finding were observed in offspring.
Effect levels (fetuses)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Description (incidence and severity):
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL (No observed adversed effect level) for Developmental Toxicity and Teratogenicity is considered to be 1000 mg/kg/day.
- Executive summary:
The study was designed to investigate developmental toxicity effects of 4-aminotoluene-3-sulphonic acid on Crj: CD (SD) male and female rat by oral gavage route. Rat were treated with4-aminotoluene-3-sulphonic acid at doses of 0(vehicle), 100, 300, 1000 mg/kg/day to 12 animals per sex per dose.
There were no significant differences in number of offspring or live offspring, sex ratio, the live birth index, the viability index and the body weight. No abnormal findings related to the test substance were noted for external features, clinical signs, or on necropsy finding for the offspring. No pups with malformation were found in any group. No change in clinical signs and necropsy finding were observed in offspring.
Therefore the “No observed adverse effect level (NOAEL)” for developmental toxicity/teratogenicity was considered to be 1000 mg/kg bw/day.
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