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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Non-skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

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

As no data on the skin sensitisation potential of target substance was available, a read across approach was followed as detailed in section 13. Experimental evidence on Similar Substance 02 was taken into account.

Skin sensitisation potential of Similar Substance 02 was assessed according to OECD guideline 406. Based on findings in the primary irritation experiments, the following concentrations were selected for the induction and challenge phase: intracutaneous induction at 5 % (w/w) in aqua dest and epicutaneous induction at 25 % (w/w) in milli-RO water; challenge at 0, 2, 5, and 10 % (w/w) in milli-RO water. Under experiment conditions, test item sensitisation rate was 0 per cent. Moreover, no symptoms of systemic toxicity and no mortality were seen; average body weight gain of experimental and control animals was similar.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), skin sensitiser is a substance that will lead to an allergic response following skin contact. In case of a guinea pig maximisation test, a response of at least 30 % of the animals, responding at > 1 % intradermal induction, is considered as positive.

Under the experimental conditions employed, 0 % of the animals of the test group showed skin reactions 24 hours upon intradermal induction with test substance at 5 % concentration; thus classification criteria were not met.