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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test substance revealed positive results in LLNA (EC3: 0.3%).

 

In a GPMT the outcome was considered to be ambiguous, due to the high rate of positive reactions in the negative control animals. Nevertheless the test substance caused 100% positive reactions in the dose group. Accordingly these results are not contradictory to the outcome of the LLNA.

 

Based on these data test substance was considered to be a skin sensitizer.


Migrated from Short description of key information:
OECD 429 LLNA (KEY_429_2004_NOTOX_415788): positive
OECD 406 GPMT (NON-KEY_406_2001_NOTOX_327577): ambiguous

Justification for classification or non-classification

Positive results in a LLNA and ambiguous but not contradictory findings in a GPMT meet criteria for classification according to 67/548/EEC (2.2 DSD-DPD) or REGULATION (EC) No 1272/2008 (2.1 GHS). Therefore classification as R43 May cause sensitization by skin contact or Skin Sensitisation Category 1 (H317: May cause an allergic skin reaction) is warranted.