Registration Dossier

Toxicological information

Toxicity to reproduction

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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:
2015
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:
1972
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

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:
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.