Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The information that could be retrieved from the public domain are insufficient for classification and labelling. The OECD SIDS document (Anonymous 2004) summarizes data from unpublished studies and a Japanese publication (Okada 1985).

The unpublished data cited in the OECD SIDS report describes the absence of a sensitizing potential in a GLP and OECD 406 compliant test in guinea pig with only 10 animals per dose group. This number is lower than required in the guideline, but as no animal showed a sensitizing response, this is acceptable.

In the publication by Okada, the substance caused a skin reaction in 6 of 9 animals at the 48h reading. It is not known whether the substance was stable in the solvent acetone, nor what impurities were present. As the material is irritating to skin, adequate dose selection is important but not discussed in the public data.

Migrated from Short description of key information:
Study reports are not available, therefore secondary information from published documents is summarized. The information is not consistent and in the abence of purity data and study details, it is not possible to conclude on sensitizing properties.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be not classified as sensitizing to skin 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 considered to be not classified as sensitizing to skin under Regulation (EC) No. 1272/2008.