Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In Maurer, 1986, 10 week old male and female Pirbright White Guinea Pigs were exposed to TK 11638/1 (a similar material to the registered substance) in a maximisation test. The test substance was found to be sensitising according to 67/548/EEC and should therefore be classified as R43 - May cause sensitisation by skin contact. Accordingly, in line with regulation (EC) No 1272/2008, the substance should be classified as skin sensitiser Category 1 and labelled with H317: May cause an allergic skin reaction.


Migrated from Short description of key information:
The following study was submitted in support of the skin sensitisation endpoint:

Maurer (1986) TK 11638/1 Skin Sensitization Test in the Guinea Pig. Modified Maximization Test. Report Number: 86106. Report date: 1986-12-18.

The study has been performed to GLP and in line with appropriate guidelines but DBT(2-EHMA) is the test material and so has been allocated a Klimisch score of 2 on the basis that it has been used as read-across.

Justification for classification or non-classification

The test substance was found to be sensitising according to 67/548/EEC and should therefore be classified as R43 - May cause sensitisation by skin contact. Accordingly, in line with regulation (EC) No 1272/2008, the substance should be classified as skin sensitser Category 1 and labelled with H317: May cause an allergic skin reaction.