Registration Dossier

Administrative data

Description of key information

Acute oral toxicity rat, similar to OECD guideline 401:   LD50 > 2000 mg/kg (95% retinyl propionate)
Acute oral toxicity rat, similar to OECD guideline 401: LD50 = 9560 mg/kg (50% retinyl acetate solution)

Key value for chemical safety assessment

Additional information

No data from primary sources are available on acute oral toxicity of retinol. However, reliable studies on structural analogues, i.e. retinyl-propionate and retinyl-acetate are available.

In an acute oral toxicity study, performed similar to OECD 401 guideline, no deaths, clinical signs of toxicity or pathological findings were noted after oral application of retinyl propionate (approx. 95% purity; (BASF 10A0454/891109). The oral LD50 was > 2000 mg/kg bw in rats in this well conducted limit study.

In the key study for acute oral toxicity in rats similar to OECD TG 401, Vitamin A Acetat-Mutterlaugenöl, containing approx. 50% retinyl acetate, has been tested (BASF 77/998). The LD50 was reported to be 9560 mg/kg bw for males and females.

The low acute toxicity potential of retinol on the basis of the chosen key studies on respective structural analogues are supported by poorly documented studies on retinol from secondary sources, providing acute oral toxicity LD50 of approx. 4000 mg/kg (NTP 2000), 1510 mg/kg (RTECS 1984) or 2570 mg/kg (Kamm 1987) in mice or LD50 = 2000 mg/kg (RTECS 1975) in rats.

Justification for classification or non-classification

The present data on acute oral toxicity do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and therefore, a non-classification is warranted.