Registration Dossier

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:

In a skin sensitisation study male guinea pigs were tested in irritation, induction, and challenge tests to determine if highly refined base oil is a delayed dermal sensitiser (Klimisch score = 1, ARCO 1987h). Under the conditions of this study, no significant increased response to highly refined base oil was observed at challenge treatment 2 compared to induction treatment. The response of the treatment animals was similar to the response of the challenge control group. Based on these findings, white mineral oil is not a delayed contact dermal sensitiser.

 

In a supporting study (Klimisch score = 1, ARCO, 1987i), highly refined base oils were not found to be sensitisers to guinea pigs.  In an additional supporting study (Klimisch score = 1, Stillmeadow Inc., 1991) light mineral oil was found to not be sensitising to guinea pigs.

 

Migrated from Short description of key information:

The key sensitisation study indicates that highly refined base oil is not a delayed contact dermal sensitiser in the guinea pig (OECD 406).

Justification for selection of skin sensitisation endpoint:

One of three skin sensitisation studies available.

Respiratory sensitisation

Endpoint conclusion
Additional information:

This endpoint is not a REACH requirement.

Migrated from Short description of key information:

This endpoint is not a REACH requirement.

Justification for classification or non-classification

Highly refined base oils are not considered skin sensitisers based on the information presented above. Therefore, HRBOs do not meet the criteria for classification as a dermal sensitiser under EU CLP Regulation (EC No. 1272/2008).