Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

QSAR prediction was done on the registered substance (as constituent 1) and the outcome of QSAR dyes R&C version 5.2, SKIN SENSITIZATION QSAR MODEL (2018) is that there is no skin sensitization potential and no alerts.

There are two studies on Similar Substance 01 available. Both of them were performed according to Guideline OECD 406 and were GLP compliant. In the study of Hagemann (1993) the test material used for testing was "roh trocken" meaning "crude" and gave the result to be sensitising at the tested concentration. The sample tested had a content of 91% of actives substance meaning a purity of 27%.

In a more recent study done by Arcelin (1995) the test material is described as "purified" and didn't show sensitising properties.When purified, a higher % than 27% of the previous sample tested by Hagemann should be considered even though there is no information available on its sample composition. Therefore the purity of the substance intended for registration (target compound) which has a purity around 77% based on a 83% of active substance,  has in fact a similarity closer to material tested by Arcelin (1995) than to material tested by Hagemann (1993).

There is also one study done with humans in 1972, Shelansky (1972). This is a human repeated insult patch test and the tested material Similar substance 01 gave a negative result on sensitisation when tested at 4% in 200 individuals covering a wide range of ages. The human patch test does not give any information concerning classification.

It leads to the conclusion that the sensitisation properties of the substance could be concentration dependant as well as could be the result of contained impurities.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

This endpoint is not an information requirement of Annex IX of REACH Regulation.

Justification for classification or non-classification

According to the CLP Regulation n. 1272/2008, a substance shall be classified as skin sensitiser (Category 1) where data are not sufficient for sub- categorisation (1A and 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).

Based on the results and QSAR evaluation, according to the paragraph 3.4. of the CLP Regulation n. 1272/2008, the substance is non-classified as a skin sensitizer.