Registration Dossier
Registration Dossier
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EC number: 203-483-8 | CAS number: 107-35-7
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Title:
- Reproduction studies of taurine - teratogenicity study in rats
- Author:
- Yamada T, Nogariya T, Nakane S, Sasajima M
- Year:
- 1 981
- Bibliographic source:
- Japan Pharmacology and Therapeutics 15: 87-98. Cited in: SCF, 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: not specified developmental toxicity study
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Taurine
- EC Number:
- 203-483-8
- EC Name:
- Taurine
- Cas Number:
- 107-35-7
- Molecular formula:
- C2H7NO3S
- IUPAC Name:
- 2-aminoethanesulfonic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- on days 7-17 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- 10 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 3 000 mg/kg bw/day (actual dose received)
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 3 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 3 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The developmental toxicity study by Yamada et al. (1981) showed no adverse effects, either prenatally or postnatally, from gavage administration of taurine at 300, 1000 or 3000 mg/kg bw/day to rats on days 7-17 of gestation.
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