Registration Dossier

Administrative data

Description of key information

Acute toxicity testing by any route (oral, inhalation, and dermal) demonstrate no evidence of toxicity. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
10 500 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
2 000 mg/kg bw

Additional information

A series of acute toxicity studies with sorbic acid were conducted either according or similar to the OECD Guidelines.

Sorbic Acid and Potassium Sorbate show a very low toxicity in rats and mice in acute oral toxicity studies. The median lethal dose (LD50) of the Sorbic Acid is 10.50±1.96 g/kg body weight in the rat, while the LD50 of the Potassium salt has been determined at 3.2-10.5 g/kg body weight in the rat.

Also an acute toxicity dermal study of sorbic acid was conducted. LD50 was determined greater than 2000 mg/kg. No animals died and no signs of toxicity were noted after 7 days.A not reliable acute inhalation (aerosol) study has also been performed in rabbits. Test animals were exposed for 2 hour (nose-only) and LD50 was determined at 7360 mg/kg (95% CI = 6690 - 8900 mg/kg bw).

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

Justification for classification or non-classification

According to criteria in Regulation (EC) No.1272/2008, sorbic acid and potassium sorbate are not classified for acute oral, inhalation or dermal toxicity, based on the observed LD50 values (acute oral toxicity: LD50 = 10500 mg/kg in rats and acute dermal toxicity: LD50 > 2000 mg/kg bw in rats). The acute inhalation study was poorly document and unreliable.