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Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
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:
1999
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:
2003
Bibliographic source:
SIDS Initial Assessment Report For SIAM 16 Paris, 27-30 May 2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
not specified

Test material

Constituent 1
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

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
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
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
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
male 48 days; female 41-48 days.
Premating exposure period
Male :14 days
Female :14 days
Frequency of treatment:
once a day, every day
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
Details on study design:
Duration of test : male: 48 days, female: 41-48 days.

Examinations

Parental animals: Observations and 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
Litter observations:
Pups number, sex, weight by sex in each litter, appearance were observed on 0th and 4th day. Dead pups were checked separately
Reproductive indices:
copulation index, fertility index, gestation length, number of corpora lutea or implanations, implanation index, gestation index, parturition or maternal behavior.
Offspring viability indices:
sex ratio, the live birth index, the viability index

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Description (incidence and severity):
No effects was observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No effects was observed
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No effects was observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
Description (incidence and severity):
No effects were observed

Details on results (P0)

No effects were observed in the copulation index, fertility index, gestation length, number of corpora lutea or implanations, implanation index,gestation index, parturition or maternal behavior.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Effects: No effects were observed in the copulation index, fertility index, gestation length, number of corpora lutea or implanations, implanation index,gestation index, parturition or maternal behavior.
Remarks on result:
other: not specified

Target system / organ toxicity (P0)

Critical effects observed:
not specified
System:
other: not specified

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Description (incidence and severity):
no adversed effects was observed
Mortality / viability:
no mortality observed
Description (incidence and severity):
no dose related effects was observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
no effects observed during study
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
no effects was observed
Gross pathological findings:
not specified
Histopathological findings:
not specified

Details on results (F1)

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 (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Results: F2 generation

Effect levels (F2)

Remarks on result:
not measured/tested

Overall reproductive toxicity

Reproductive effects observed:
not specified
Treatment related:
not specified

Applicant's summary and conclusion

Conclusions:
“No observed adverse effect level (NOAEL)” for reproductive toxicity was considered to be 1000 mg/kg bw/day.
Executive summary:

The study was designed to investigate one generation reproductive 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 compound related effects on copulation index, fertility index, gestation length, number of corpora lutea or implantations, implantation index, gestation index, parturition or maternal behavior. 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 reproductive toxicity was considered to be 1000 mg/kg bw/day.