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Toxicological information

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Administrative data

Description of key information

The test article is not considered to be a sensitizer.

Key value for chemical safety assessment

Skin sensitisation

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

No information are available for the substance, but there is a study that was conducted with a substance made by the same components , but different mixture; therefore the similarity is very high. The test was conducted with international guidelines and it is GLP compliant; the purity of the substance is 94 %. In this study 15% of the animals were positive after treatment with a non irritant test substance concentration of 15 % in bi-distilled water.

Justification for selection of skin sensitisation endpoint:

The study was conducted with a substance made by the same components , but different mixture; therefore the similarity is very high. The test was conducted with international guidelines and it is GLP compliant.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) section 3.4.1.2: Skin sensitiser means a substance that will lead to an allergic response following skin contact.

The substance is capable to induce allergic reactions to 15 % of the animals. The table 3.4.4 of the CLP Regulation (EC n. 1272/2008) shows that the trigger value for classification is 30 % responding at > 1 % intradermal induction dose. The substance is below the trigger value, therefore no classification is warranted for skin sensitisation according to the CLP Regulation (EC n. 1272/2008)