Registration Dossier

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

A photoallergenicity study and a photoirritancy study, both in Guinea-pigs, concluded that the test substance is neither photoallegenic nor a photoirritant.

Additional information

A phototoallergenicity test on the test material (UV-A and UV-B) was assessed according to the CTFA Safety Testing Guidelines, The Cosmetic, Toiletry and Fragrance Association, Inc , Washington, D.C. 20036; “Guidelines for EvaluatingPhotodermatitis” 1991.To this aim, the method described by Harber et al. was used (The guinea pig as an effective model for the demonstration of immunological medicated contact photosensitivity, In Animal Models in Dermatology (H.Maibach, Ed) Ch.10, Churchill Livingstone, New York 1995).

Ten guinea pig males were used as control group and 20 males as test group to assess thephotoallergenicityof the test material.

The highest non-irritating concentration used for the challenge application was 25% in ethanol according to a preliminary experiment carried out by the same testing laboratory (PhototoxicityofCepionatein guinea pigs). In addition, the concentration of 15%, 10%, 5% in ethanol were applied

Conclusion.The test article is not photoallergenic according to the test conditions.

The skin phototoxicity of the test material was determined according to theCTFA Safety Testing Guidelines, The Cosmetic, Toiletry and Fragrance Association, Inc , Washington, D.C. 20036; “ Guidelines for Evaluating Photodermatitis ” 1991. Single administration of the test material at 100%, 50%, 25% and 15% was performed on guinea pig skin of the test group on both UV-irradiated and non-irradiated test sites. The animals of the control group were treated with the vehicle alone. Animals were observed daily for 72 hours after test substance application(local and systemic effects).

No death occurred, neither local nor systemic signs were observed during the study and bodyweight changes were normal in all animal tested. No edema was observed in any of the animal tested. No positive skin reaction were observed in the animals of the control group treated with the vehicle alone and no effects were observed in the test group on the test sites treated with the test article at 25% and 15% in ethanol.

Three animals out of 10 treated with the test substance at 100% showed irritant effect on the non-irradiated test sites at the 24-hour reading. At the 48-and 72-hour reading only one animal out of ten was found positive. Therefore, a slight irritant effect of the test substance is noted which would not classify the test substance as a skin irritant as this slight irritant effect is measured at high concentrations only (50 % and 100 %) furthermore in conditions improving skin penetration facilitating skin irritation.

 

Five, three and two out of ten animals showed positive reactions on the irradiated skin sites treated with the test substance at 100% after 24, 48 and 72 hours respectively.

A slight difference in the number of animals showing positive reactions within the test group were observed art the test article concentration of 100% comparing the observation made on the non-irradiated and the irradiated skin sites. Therefore, a possible photoirritanteffect of the test substance at 100 % could not be excluded.

The reactions noted at the concentration of 50 % were comparable between the irritated and non irritated test sites and are described only as a slight irritant effect of the test substance concentration at 50 %.

In conclusion the test substance cannot be classified as a photoirritant according to the test guideline used in that study.