Registration Dossier

Administrative data

Description of key information

The following data were obtained for the Similar Substance 01. It is expected that the Target substance will present similar skin sensitisation potential. Justification for the use of a read-across approach is

provided in Section 13 of IUCLID.

The maximization test of Magnusson and Kligman was performed on male guinea pigs to determine whether test item exhibits skin sensitization properties.

This GLP study was performed according to OECD Guideline No. 406. The study was conducted with the following test concentrations:

intradermal induction: 5%

topical induction: 50 %

first challenge: 50 and 25 %

second challenge: 50 and 25 %

formulated in sterile physiological saline solution to yield a suspension.

After the first challenge the 50 % and 25% formulations led to skin redness in 20 % and 40 % of the test animals respectively. There were no skin reactions in the control group.

After the second challenge the 50 % and 25 % formulations led to skin redness in 70 % and 45 % of the test animals, respectively. There were no skin reactions in the control group.

Therefore, the test item exhibits a definitive skin-sensitization potential under the conditions of the maximization test.

 

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the CLP Regulation (EC) no. 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 available results from the GPMT performed, the substance induces a sensitisation rate of 20 -70 % after an intradermal induction at 5 % and a challenge and a rechallenge epidermal application. This result meets the classification criterion for Skin sens. Cat. 1B “≥ 30 % responding at > 1 % intradermal induction dose” H317 1B, according to CLP Regulation (EC) no. 1272/2008.


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