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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In an in vivo study according to the method described by Magnusson and Kligman, 30 male and female Pirbright White guinea pigs were used (20 animals as test group, and 10 animals as control group). During the induction procedure the test group was exposed to 1 % test substance via intradermal injection and 10% test substance via topical application. The control group was exposed to vehicle only during this procedure. All animals were challenged with 3% test compound and vehicle (CIBA 1986e).

At challenge, 0% positive responses were noted in the test and control group after 24 h and 48 hour following treatment with 3% test substance, respecitvely. Therefore, the test substance has no sensitising potential.


Migrated from Short description of key information:
not sensitising; OECD 406, CIBA 1986e

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
no data available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for sensitisation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for sensitisation under Regulation (EC) No. 1272/2008.