Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Not skin sensitizer

Key value for chemical safety assessment

Skin sensitisation

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

No tests are available on the substance in itself, nevertheless the skin sensitisation potential of the target substance was assessed by means of the Read Across approach. The complete Justification for the Read Across is detailed at section 13.

Two tests were proposed in order to complete the assessment:

 

The selected key study [Huntsman Textile Effects GmbH, 1979] was conducted according to the AFDO Method on the Similar Substance 02. Under the test condition no animal showed positive reaction, therefore under the test condition the substance is considered as non sensitizer for skin.

Even the second study was conducted on the Similar Substance 02, reported as supporting study [Huntsman Textile Effects GmbH, 1979], and showed no positive reaction on the tested animals.

 

The key study was chosen due to the purity of the test item higher than the one of the supporting study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) 3.4.1.2 Skin sensitiser means a substance that will lead to an allergic response following skin contact. The experiment conducted in read across clearly shows that the substance is not capable to produce positive reactions after treatment with the test substance and no toxic symptoms were recorded.

Basred on the experimental results the test article is considered a non sensitizer and no classification is warranted.