Registration Dossier
Registration Dossier
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EC number: 201-325-2 | CAS number: 81-11-8
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Data came from the SIDS dossier on CAS No. 81-11-8 that was accepted at SIAM 4 and posted on the OECD website.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD preliminary reproduction toxicity screening test
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4'-diaminostilbene-2,2'-disulphonic acid
- EC Number:
- 201-325-2
- EC Name:
- 4,4'-diaminostilbene-2,2'-disulphonic acid
- Cas Number:
- 81-11-8
- Molecular formula:
- C14H14N2O6S2
- IUPAC Name:
- 2,2'-ethene-1,2-diylbis(5-aminobenzenesulfonic acid)
- Details on test material:
- Purity of the test material was 92.02%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- males: 41 days including 14 days before mating;
females: from 14 days before mating to day 3 of lactation - Frequency of treatment:
- daily
- Duration of test:
- guideline compliant
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no data
Examinations
- Maternal examinations:
- no data
- Ovaries and uterine content:
- no data
- Fetal examinations:
- no data
- Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects: no effects
Details on maternal toxic effects: no data
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
no data
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The substance is considered not toxic to reproduction and is not teratogenic.
- Executive summary:
The substance is considered not toxic to reproduction and is not teratogenic.
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