Registration Dossier
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EC number: 201-766-0 | CAS number: 87-69-4
Endpoint summary
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.
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