Registration Dossier
Registration Dossier
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EC number: 231-710-0 | CAS number: 7695-91-2
Endpoint summary
Administrative data
Description of key information
For acute toxicity, the key studies are:
- oral: limit study of BASF 1977 (similar to OECD 401, pre-GLP)
- dermal: acute toxicity test of Buser 1980 (similar to OECD 402, pre-GLP)
Key value for chemical safety assessment
Additional information
The acute toxicity of DL-Alpha-Tocopheryl acetate in animals (rodent and non-rodent) is low.
The available acute oral toxicity study in rats (BASF AG 1977) was selected as the key study. The oral LD50 was > 10000 mg/kg bw in rats in a well conducted limit study.
Relatively high LD50 values were also obtained in the supporting studies; oral LD50 values of >4000 and >2000 mg/kg bw were obtained in mice and rabbits, respectively, performed pre-GLP and similar to OECD 401 (Hane et al, 1972). In Beagle dogs the LD 50 was > 14.4 g/kg bw (BASF, 1977).
In an acute dermal toxicity test (similar to OECD 402) DL-Alpha-Tocopheryl acetate has been tested (Buser, 1980). A dermal LD50 was observed of >3000 mg/kg, since no mortality occured. The test substance causes only slight local erythemas which appear 24 - 48 hours after application. Only few animals showed signs of local abrasion.
Justification for classification or non-classification
Based on the available acute 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.
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