Registration Dossier

Toxicological information

Additional toxicological data

Currently viewing:

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:
1998
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
Name:
Unnamed
Type:
Constituent
Test material form:
other: Oily liquid

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.