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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Though formally as secondary source not assignable, the study is considered reliable: the original report (not available) is from Kligman (1977) who was involved in the development of such tests, and an appropriate conceptual design and quality assurance can be assumed.

As it is laid down in the CLP regulation (Regulation (EC) 1272/2008 Annex I,, a substance shall be classified as skin sensitiser "if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons".

This is not the case: only one out of 25 volunteers reacted, and this subject reacted to further test items, indicating a high sensitivity.

Therefore the submission substance has not to be classified with respect to skin sensitisation.

Migrated from Short description of key information:
One subject out of 25 volunteers showed sensitisation. This person reacted to a total of three test items within this test (IUCLID, 2000).

Justification for selection of skin sensitisation endpoint:
Maximisation test with 25 volunteers, one positive reaction (Data reported in chapter 7.10.4).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information, the submission substance has not to be classified as skin sensitiser according to CLP (Regulation (EC) No 1272/2008) and DSD-DPD (Council Directive 67/548/EEC). No information is available with respect to respiratory sensitisation.