Registration Dossier

Administrative data

Description of key information

not skin sensitising

Key value for chemical safety assessment

Skin sensitisation

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

The following data were obtained for the Similar Substance 02. It is expected that the Target substance will present similar skin sensitising profile. Justification for Read Across is given in Section 13 of IUCLID.

The substance was tested for sensitizing effect on the skin of the guinea pig in a Maximization Test based on the method of Magnusson and Kligman according to OECD Guideline 406. After the challenge application, no cutaneous reactions were observed in the animals of the control and test groups at the 24-hour and 48-hour readings.

Therefore, the test substance did not show any sensitising potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008) a skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”. A substance classified as skin sensitiser (Category 1) may be allocated to one of the two sub-categories 1A or 1B in accordance with the criteria given in Annex I, Part 3, Table 3.4.2.. If classification is based on results obtained from studies conducted in experimental animals, the test results from the LLNA, GPMT and the Buehler assay can be used directly for classification. Guidance values are presented in the CLP Regulation (EC 1272/2008) in Annex I, Part 3, Table 3.4.3 for classification in sub-category 1A and in Annex I, Part 3, Table 3.4.4 for classification in sub-category 1B.

Based on the results from the GPMT performed, the substance induces no reactions after the intradermal induction dose of 5 % and the following challenge. This result does not meet the classification criterion for Skin sens. Cat. 1B “≥ 30 % responding at > 1 % intradermal induction dose”.