Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
7 000 mg/kg bw/day
Study duration:
chronic
Species:
mouse

Toxicity to reproduction: other studies

Description of key information

Considering the overall weight of evidence and the SCF (1999, 2003) conclusion that taurine does not demonstrate any potential for teratogenicity, supplemental taurine intake is unlikely to exert adverse effects on reproductive or developmental parameters under the intended conditions of use.

Taurine passes to the developing fetus through maternal circulation during pregnancy and to the infant via breast milk. Mammalian fetuses and infants are dependent on taurine given maternally, either via the placenta or mother's milk; it is an important link in mother-fetus or mother-infant bonding.

An extensive review of the clinical use of taurine in humans in conditions including diabetes, epilepsy, congestive heart failure, hypertension, liver disease and cystic fibrosis, concluding that “No adverse health effects attributable to taurine have been reported in more than 30 clinical investigations reported over a period of 30 years. In many cases taurine has proved medically beneficial.” (SCF, 2003)

Justification for classification or non-classification

Additional information

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