Registration Dossier
Registration Dossier
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EC number: 203-483-8 | CAS number: 107-35-7
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive 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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- GRAS Exemption Claim for Taurine for Use in Enhanced Water Beverages
- Author:
- Ashley Roberts, Ph.D.; Senior Vice President, Food & Nutrition Group, lntertek Scientific & Regulatory Consultancy
- Year:
- 2 015
- Bibliographic source:
- GRAS Notice (GRN) No. 586; www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm
- Report date:
- 2015
- Reference Type:
- publication
- Title:
- Long-term feeding of taurine of taurine in rats.
- Author:
- Takahashi H, Kaneda S, Fukuda K, Fujihira E, Nakazawa M
- Year:
- 1 972
- Bibliographic source:
- Oyo Yakuri (Pharmacometrics) 6(3):529-534
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no information available
- GLP compliance:
- no
- 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:
- mouse
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- time of 3-generations
- Frequency of treatment:
- continuously administered
Doses / concentrations
- Dose / conc.:
- 7 000 mg/kg bw/day (actual dose received)
- Remarks:
- up to 7.0 g taurine/kg body weight/day
Results and discussion
Results: P1 (second parental generation)
Effect levels (P1)
- Dose descriptor:
- NOAEL
- Effect level:
- 7 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity (P1)
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Effect level:
- 7 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 7 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity (F2)
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No adverse developmental effects attributable to taurine were reported in a 3-generation study in which mice were continuously administered up to 7.0 g taurine/kg body weight/day.
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