Registration Dossier

Administrative data

Description of key information

Not a skin sensitiser

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 sensitisation potential. Justification for the use of a read-across approach is provided in Section 13 of IUCLID.

In order to evaluate the skin sensitising potential, an in vivo guinea pig maximisation test (GPMT) was performed according to the OECD Guideline 406 (1981). A primary irritation experiment was performed in order to determine the test concentrations of the main study. In the main study, ten control animals (5 males, 5 females) were treated with the vehicle alone (petrolatum oil) and 20 treatment animals (10 males, 10 females) were treated with the test item. Treatments were firstly two inductions: (i) an intradermal injection of 0.5 % test item; followed by (ii) an epidermal application of 5 % test item. After two weeks, the animals were subjected to two epidermal challenge applications separated by 24 hours using doses of 3 % in petrolatum.

No treatment or control animals were positive for sensitisation, therefore, the sensitisation rate of the test item was found to be 0 % to guinea pigs after intradermal and epidermal induction.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Section 3.4 of the CLP Regulation (EC) No. 1272/2008, Respiratory or skin sensitisation, defines a skin sensitiser as a substance that will lead to an allergic response following skin contact.

A substance shall be classified as a skin sensitiser (Category 1) where data are not sufficient for sub-categorisation (Category 1A and Category 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test (according to 3.4.2.2.4.1).

If a guinea pig maximisation test (GPMT) is performed in order to evaluate skin sensitisation potential, a substance is classified as skin sensitiser sub-category 1B if ≥ 30 % to 60 % of test animals respond (positive) at a dose of > 0.1 % to ≤ 1 % following an intradermal induction dose.

Based on the results from the GPMT performed, no skin reactions were observed after an intradermal induction dose of > 0.1 % to ≤ 1 %. Therefore, the substance is not classified as skin sensitiser, according to the CLP Regulation (EC) No. 1272/2008.