Registration Dossier

Administrative data

Description of key information

No evidence of an adverse effect was seen in the dose of 3.1 g/kg bw/day  and 4.1 g/kg bw/day L(+)-tartrate for male and female rats respectively, correspond to 2.46 g/kg bw/day and 3.2 g/kg bw/day L(+)-tartaric acid for male and female rats respectively.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
2 460 mg/kg bw/day
Study duration:
chronic
Species:
rat

Additional information

NOAEL of repeated oral dose toxicity of tartaric acid is derived from the key study 004 through read across. In this study Monosodium L(+)-tartrate was fed to rats in their diet for a total of two years at levels of 25600, 42240, 60160 and 76800 ppm and no adverse effect was observed in the highest concentration of L(+)-tartrate. So it is reasonable to choose 76800 ppm tartrate, which is equal to 2460 mg/kg bw/day, as NOAEL of tartaric acid.

Furthermore, in the key study, the test material used was Monosodium L (+)-tartrate, a sodium salt of tartaric acid. It can be served as a read across study, because the basic chemical structures are the same in such two chemicals.

Justification for classification or non-classification

The DNEL of repeated oral dose toxicity of tartaric acid is 2460 mg/kg bw/day, no specific organ toxicity was found here,so non-classification will be justified.