3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In order to assess the photo-allergenic potential of DL-Alpha-Tocopheryl Acetate, a photo-allergenicity test according to the CTFA Safety Testing Guidelines was carried out in 30 female (20 test and 10 control) Himalayan spotted guinea pigs (Csato and Arcelin, 1996). For the induction of sensitization the undiluted DL-Alpha-Tocopheryl Acetate was applied epicutaneously to a skin area of 8 cm2 (marked previously with 4 intra-dermal injections of Freund’s Complete Adjuvant). The test sites were then exposed to 1.8 J/cm2 UVB and 10 J/cm2 UVA irradiation. This procedure was repeated 4 times within 2 weeks of the induction phase. Control animals were treated with FCA only. Three weeks after beginning of the induction a challenge was carried out by treating the experimental animals (test and control) epicutaneously on both flanks with the test article at the concentrations of 100% (undiluted), 75%, 50% and 25% (dilutions in ethanol). Treated sites were then either exposed to 10 J/cm UVA irradiation (left flank) or remained un-irradiated (right flank). Cutaneous reactions, i.e. erythema and oedema formation were evaluated at 24, 48 and 72 hrs after the challenge exposure. Two out of 20 test animals were observed with a slight erythematous skin reaction after challenge. No consistent or significant differences were detected between the irradiated and non-irradiated test sites of the animals. The reactions were not clearly dependent on the test article concentration and most likely resulted from cutaneous hyperirritability (angry back) of the animals. No reactions were observed in the control group. Considering the above experimental data it can be concluded that DL-Alpha-Tocopheryl Acetate does not exhibit photo-allergenic potential in the guinea pig under the study conditions. It can be assumed accordingly that the risk that DL-Alpha-Tocopheryl Acetate could elicit a cutaneous photo-allergenic reaction in humans is low if any.

A Draize test with 203 human volunteers was conducted to determine the sensitising potental of DL-Alpha-Tocopheryl acetate in human. During the induction phase, subjects were exposed to 100% Vitamin E (determined as non-irritating in range finding study) ten times during 2 weeks. After a rest period of two weeks, reapplication (3 days, once daily) followed. The mean irritation index after induction phase was: 0.076/subject (n=203). None of the subjects showed a higher irritation grade than 1. No positive reactions were reported after the challenge phase (n=203).

It was concluded that under the conditions of this study, the test substance, DL-Alpha-Tocopheryl acetate is not a sensitiser in human (DSM, 1975).

Migrated from Short description of key information:
DL-Alpha -Tocopheryl acetate is not a sensitiser as tested in a photoallergic test in Guinea pigs, and with the method of Draize in 203 human volunteers.

Justification for classification or non-classification

Based on the available data, DL-Alpha-Tocopheryl acetate does not have to be classified as sensitising according to Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.