Registration Dossier
Registration Dossier
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EC number: 232-455-8 | CAS number: 8042-47-5 A highly refined petroleum mineral oil consisting of a complex combination of hydrocarbons obtained from the intensive treatment of a petroleum fraction with sulfuric acid and oleum, or by hydrogenation, or by a combination of hydrogenation and acid treatment. Additional washing and treating steps may be included in the processing operation. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C50.
Endpoint summary
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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