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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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).