Registration Dossier

Administrative data

Description of key information

Skin sensitising in GPMT.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

EU method B.6, analogous to OECD guideline 406.

Test substance was investigated for possible allergenic potential to the skin of 20 (10 females and 10 males) albino guinea pigs based on the guinea pig maximisation test.

The intradermal induction of sensitisation in test group was performed in the shoulder region with a 1 % dilution of test substance in physiological saline and in a 1:1 mixture of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 48 hours under occlusion with test article at 50 % in vaseline on day 6 following pretreatment on day 5 of test areas with 10 % Sodium-Lauryl-Sulfate (SLS) in vaseline. Animals of the control group were intradermally induced with physiological saline and FCA / physiological saline and epidermally induced for 48 h with vaseline only, under occlusion following pretreatment with 10 % SLS. Challenge phase was done by topical application of test substance at 50 % in vaseline on day 20 for 24 h.

No mortality occurred. Body weight of animals increased during the study. No toxic symptoms were evident in the guinea pigs of the control or test group. Positive skin reaction in 10 of 20 animals was seen, after challenge treatment with test substance.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), Annex I, Part 3, Table 3.4.3, a test substance is assigned to Category 1B based on this criteria: "≥ 30 to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose," in the guinea pig maximisation test.

50 % of animals exposed to 1 % intradermal induction dose showed response to test substance. Since this result fulfils the above criteria for classification, test substance is classified in category 1B (H317) as skin sensitiser in the CLP Regulation (EC 1272/2008).