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Toxicological information

Endpoint summary

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Description of key information

Non skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

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

A sensitization test in guinea pigs was performed to determine the contact allergenic potency of the test compound. The test was performed according to the OECD Guideline No. 406. According to the results a weak allergenic potency of the test article was observed in this test when followed the rating of allergenicity described by Magnusson B. and Kligman A.M. (1969). But according to the CLP Regulation, the results showed that test article is not a skin sensitizer.

Within the whole category, nine over fourteen registered substances covering at least one member per group (see data matrix in the Category Justification Report attached to the section 13) was tested and none of the existing tests arisen any concern for skin sensitisation.

All substances of the category were modelled with OECD Toolbox and the provisional results about sensitisation and protein binding were calculated for all members: no alerts were reported for any substance. As it can be noted, the influence of the variability in functional group is very low, more related to the variability in the polarity of the substance than on potential reactivity that can arise a concern. From a metabolic point of view, an estimation with OECD Toolbox of the dermal metabolism was also performed, in order to verify if breakdown products may be formed. Skin adsorption is considered the condition for sensitisation to express, therefore no concern for sensitisation properties can be expected for all members of the category.

 

The same was performed for the substance and a common behaviour regarding this end point within the category was observed. Based on all those considerations, the available studies on the analogous substances are representative for the substance under registration that can be considered not skin sensitizer, too. As representative supporting data, the results for 3a-MSA were considered.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.

The criteria to classify a substance as skin sensitizer, on the basis of results from test animals, are reported into the second adaptation to technical progress*: a substance in considered a skin sensitizer when:

- an adjuvant type test method for skin sensitisation is used and a response of at least 30 % of the animals is considered as positive;

- for a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive;

- a stimulation index of three or more is considered a positive response in the local lymph node assay.

Under the experimental conditions employed, 0 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.

In conclusion, the available experimental data are adequate for classification and labelling according to the CLP Regulation (EC 1272/2008), and the results show that the substance is not classified as skin sensitizer.

*Commission Regulation (EU) No 286/2011 of 10 March 2011, amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.