Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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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.
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: Pathology review
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This review article is classified reliable with restrictions. This report is a comparitive pathology review.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Granulomas in the liver of humans and Fischer rats associated with the ingestion of mineral hydrocarbon, a comparison.
- Author:
- Fleming, K. A. Zimmerman H. and Shubik, P.
- Year:
- 1 998
- Bibliographic source:
- Regulatory Toxicology and Pathology 27 , 75-81
Materials and methods
- Type of study / information:
- Type: other: Comparison of histopathological changes in F-344 rats, Sprague-Dawley rats and humans
- Principles of method if other than guideline:
- No information provided
- GLP compliance:
- not specified
Test material
- Reference substance name:
- White oil
- IUPAC Name:
- White oil
- Test material form:
- other: Oily liquid
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- It was concluded that the majority, if not all, of the lesions seen in the F-344 rat were of no significance for humans.
- Executive summary:
In this comparative pathology review, the authors examined the microscopic effects that occurred in F-344 rats following oral ingestion of white mineral oils and compared them with the findings in Sprague-Dawley rats and with the lesions reported in man following prolonged ingestion of large quantities of mineral oil.
The comparison revealed that the response in the F-344 rat was in contrast to that in the Sprague-Dawley since at comparable dose levels no lesions were observed in the Sprague-Dawley rat. The authors also concluded that the lesion observed in humans (lipogranulomas) following ingestion of mineral oil was different to that seen in F-344 rats.
It was concluded that the majority, if not all, of the lesions seen in the F-344 rat were of no significance for humans.
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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