Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

A recent two-generation reproduction toxicity study of Sorbic acid following oral administration to rats, carried out in 2004 according to the guidelines of the OECD 416 (2001), EC method B.35 (88/302/EEC) and IV.C.9.a. Guidelines for Reproduction Studies, FDA Redbook (2000), also showed no effects on reproduction parameters up to the highest dose of 3 000 mg/kg bw/d

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


Short description of key information:
A 2-generation reproductive toxicity study of sorbic acid via oral administration on rats and 3 teratogenecity studies, one in rabbits with sorbic acid and two in pregnat mice and rats with potassium sorbate were conducted. Collectivelly, observations showed no teratogenic effects.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
300 mg/kg bw/day
Additional information

No treatment-related maternal or developmental effects were observed at 300 mg/kg/day in rabbits administered Sorbic Acid.

No teratogenic effects have been observed in pregnant mice and rats administered Potassium Sorbate. Mice were administered Potassium Sorbate at doses of 4.6-460.0 mg/kg body weight, while the rats received doses of 3.4-340.0 mg/kg body weight. Doses were administered orally on days 6-15 of gestation. No significant effects were noted on nidation or on maternal or fetal survival in either mice or rats.

The extrapolation from sorbic acid to potassium sorbate is considered not to be restricted in any way, since the determinant of potential 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 as reproductive toxicants.