Registration Dossier

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information
The FDA report, teratologic evaluation of FDA 71 -55, includes 4 key studies carried out in different species investigating the developmental toxicity/teratogenicity. No teratogenic effect was found in these studies.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
181 mg/kg bw/day
Additional information

The FDA report, teratologic evaluation of FDA 71 -55, summarised studies of the teratogenicity of tartaric acid in different species: mouse, rat, hamster and rabbit, using prenatal developmental toxicity test. It is found that administrations of the highest dosage, 274 mg/kg bw in mice, 181 mg/kg bw in rats, 225 mg/kg bw in hamsters and 215 mg/kg bw in rabbits, did not generate any teratogenic effects on tested animals. So these dose levels could be set as NOAELs in each individual test. In order to guarantee safety, also considering that the toxicokinetics of tartaric acid in rat is well studied, NOAEL of rat is chosen as the dose descriptor starting point for further calculation.

Justification for classification or non-classification

non-classification