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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The key study (Rodabaugh, 2001) is a GLP compliant study which was performed in line with standardised guidelines with a sufficient level of detail to assess the quality of the study. The skin sensitisation was determined in vivo according to the Buehler test. Under the conditions of the test none of the animals displayed a dermal reaction greater than the control in either the challenge or rechallenge, thus the test material was determined to be non-sensitising. The study was performed to a good standard and was assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch (1997).

Migrated from Short description of key information:
The potential for hydrocarbon waxes to cause skin sensitisation was determined according to a GLP compliant study (Rodabaugh, 2001) performed according to the standardised guidelines OCED 406 and EPA OPPTS 870.2600.

Justification for classification or non-classification


The guinea pig skin sensitisation study indicates that the test material is a non sensitizer and exposure does not result in any classifiable effects. Therefore the material does not require classification in line with Regulation (EC) 1272/2008.