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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

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

To assess the allergenic potential of the test substance (91% act. ingr.) in albino guinea pigs the Maximization test of Magnusson and Kligman was used. A pretest was performed to identify irritant test article concentrations suitable for the induction phase of the main study.In addition, a suitable non-irritant concentration of the test article, by the tropical route of administration, was identified for the challenge application. For the main study ten females were used as control group and 20 females were used as test group. The test group were treated with the following concentrations of the test item:

induction treatment: 5% given intradermal on day 0 and 25% given epidermal on day 8

challenge treatment: 25% two weeks after epidermal induction application.

No skin reactions (erythema or oedema) were observed neither after 24 hours nor after 48 hours.

Formaldehyde was used as positive control which showed 80% positive results in the treated animals after the epidermal challenge application.

Migrated from Short description of key information:
According to a Guinea Pig Maximisation Test of Magnusson and Kligman the test substance (91% act. ingr.) is not a skin-sensitiser.

Justification for selection of skin sensitisation endpoint:
Only one reliable study; this GLP-conform study is in accordance wit the OECD guideline and EU method

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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 sixth time in Regulation EC 605/2014.