Registration Dossier

Administrative data

Description of key information

The key study was the limit oral acute study (OECD guideline 401) in rats with structural analogue retinyl propionate, resulting in an LD 50> 2000 mg/kg bw. 

Key value for chemical safety assessment

Additional information

The acute toxicity of retinyl-palmitate in animals is low, based on the data of structural analogue retinyl-propionate. The available acute oral toxicity study upon oral application of retinyl propionate (approx. 95% purity) was selected as the key study (performed according OECD 401 guideline, BASF 10A0454/891109

). The oral LD50 was > 2000 mg/kg bw in rats in this well conducted limit study.

In an acute oral toxicity study in rats, available as short summary from a secondary source, a LD50 = 7910 mg/kg has been given for retinyl-palmitate (Kamm 1987).

Based on the lower bioavailability after dermal application (compared to the oral application) and the LD50 value obtained after oral administration, no acute dermal toxicity is to be expected, and an acute toxicity study via the dermal route is scientifically not required and not in line with animal welfare requirements.

 

In light of the present data from acute oral toxicity studies, and the fact, that inhalative exposure is not considered to be the major route of exposure, an acute toxicity study via the inhalative route is scientifically not required and is not in line with animal welfare requirements.

Justification for classification or non-classification

Based on the available acute oral toxicity data, classification is not needed for acute toxicity according to directive 67/548/EEC and EU classification, labelling and packaging of substances and mixtures (CLP) regulation (EC) No. 1272/2008.