Registration Dossier

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:
1981
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

Constituent 1
Chemical structure
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

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.