Registration Dossier

Administrative data

Description of key information

Based on the results of read across GPMT, the test substance is not considered to be a skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A study was conducted to determine the skin sensitization potential of the read across substance, mono- and di- C12 PSE, K+, according to OECD Guideline 406 (guinea-pig maximisation test), in compliance with GLP. The test was performed in 15 (10 test and 4 control) female albino Dunkin Hartley guinea pigs. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 1% dilution of the test substance in purified water in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 h under occlusion with the test substance at 75% in purified water one week after the intradermal induction. The animals of the control group were intradermally induced with purified water under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test substance at 10% in purified water and purified water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 h after removal of the dressing. No toxic signs were evident in the guinea pigs of the control or test group. No deaths occurred. No skin effect/reaction was observed in the control and test group after challenge treatment with the test substance at 10% in purified water. Based on the results of the read across study, the test substance was considered to be not sensitizing to guinea-pig skin (Giannini, 2008).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the read across study, the test substance does not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC) criteria.


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