Registration Dossier

Administrative data

Description of key information

In short-term to subchronic oral studies, Sorbic Acid and Potassium Sorbate were pratically non-toxic in rats and dogs at concentrations up to 10 and 2% respectively.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
6 792 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

In short-term to subchronic oral studies, Sorbic Acid and Potassium Sorbate were pratically non-toxic in rats and dogs at concentrations up to 10 and 2% respectively .Studies failed to elicit any toxic response, based on the absence of any specific abnormalities upon gross and histopathological examination of target organs.

The extrapolation from sorbic acid to potassium sorbate is considered not to be restricted in any way, since the determination of potential repeated dose toxicity is the "sorbate" anion.

Justification for classification or non-classification

According to regulation (EC) No 1272/2008, sorbic acid and potassium sorbate are not classified for STOT RE.