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Toxicological information

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Description of key information

Skin sensitising

Key value for chemical safety assessment

Skin sensitisation

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

To assess the allergenic potential of the substance in albino guinea pigs the Maximization-Test was used according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test was performed on groups of 10 male and 10 female guinea pigs.

Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were only seen after intradermal challenge application of the test substance. No difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.

One animal (male) of the test group died spontaneously 34 days after starting the experiment

The positive response during the test is ≥ 30 % responding at ≤ 0,1 % intradermal induction dose (65 %).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

SKIN SENSITIZATION

According to the CLP Regulation (EC n. 1272/2008) a substance shall be classified as Skin sensitiser Sub-category 1A if:

it showed an high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Specific criteria:

Local lymph node assay - EC3 value ≤ 2 %

Guinea pig maximisation test - ≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose

Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose

Based on animal test (Guinea pig maximisation test) results performed (65 % of positive response, responding at 0.1 % intradermal induction dose), according to the paragraph 3.4. of the CLP Regulation n. 1272/2008, the test substance is classified as Skin sensitiser Sub-category 1A (H317 may cause an allergic skin reaction).