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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

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

No information on the "skin sensitisation" potential of the Target Substance is available. However data on a similar substance (Similar Substance 01) has been taken into account for the assessment. More details on the substance similarity are reported in section 13.

In a dermal sensitization study, the test substance (80 % act. ingr.) was tested in male and female Pirbright guinea pigs by using the Guinea Pig Maximisation Test of Magnusson and Kligman (induction treatment: 5 % given intradermal on day 0, 50 % given epidermal on day 8; epidermal challenge treatment: 30 % on day 21). Body weights were not affected by treatment. Under the experimental conditions employed, 25 % of the animals of the test group showed skin reactions (erythema and/or edema) 24 hours after removing dressing. On the basis of the results the test material (80 % act. intgr.) is considered to be not skin-sensitising.

Justification for classification or non-classification

Based on the Classification, Labelling, and Packaging Regulation (EC) No 1272/2008,the available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the test substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.