Registration Dossier
Registration Dossier
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EC number: 230-363-2 | CAS number: 7069-42-3
Endpoint summary
Administrative data
Description of key information
The key study was the limit oral acute study (similar to OECD guideline 401) in rats with retinyl proprionate, resulting in an LD50 > 2000 mg/kg.
Key value for chemical safety assessment
Additional information
In the chosen key study similar to OECD 401 guideline retinyl propionate (approx. 95% purity) was administered in olive oil via gavage at a dose of 2000 mg/kg bw to Wistar rats (BASF 10A0454/891109). No deaths, clinical signs of toxicity or pathological findings were noted. Consequently, the oral LD50 was > 2000 mg/kg bw in rats.
In a supportive study similar to OECD 401, oral administration via gavage of 2425, 3434 or 4850 mg/kg retinyl palmitate in peanut oil resulted in mortality, body weight loss an clinical effects, i.e. ataxia, piloerection, respiratory depression, hypomotility (DSM 1532). An LD50 = 2300 (1660 - 3200) mg/kg bw has been determined.
Similar acute toxicity has been observed in mice after oral (gavage) application of 1717, 2425, 3434 or 4850 mg/kg bw retinyl palmitate in peanut oil, resulting in mortality, body weight loss, and clinical effects, i.e. ataxia, piloerection, respiratory depression, hypomotility (DSM 1533). A lower LD50 = 1275 (385-4200) mg/kg has been determined, fulfilling the criteria according to 67/548/EEC and 1272/2008/EEC. However,
a higher variability of this value is evident compared to the LD50 value obtained in the rat study. Furthermore, mortality observed at doses close to the limit dose of 2000 mg/kg ranged from 40% to 90% for the dose group 1717 and 2525 mg/kg respectively.
Overall, on the basis of the present data, the acute toxicity of retinyl propionate is low, and the LD50 values obtained in the key and supportive study in rats represent a valid justification for the non-classification as acute oral toxicant under the criteria laid down under 67/548/EEC and 1272/2008/EEC.
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. According to UN-GHS, the test substance needs to be classified as acute oral toxicant (Category 5).
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