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Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity
Remarks:
subcutaneous
Type of information:
experimental study
Adequacy of study:
other information
Study period:
535 days
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: significant methodilogical deficiencies (i.e. only one dose, limited number of animals, pathological examinations only of the site of application, no adjustment for differences in survival, no statistics)

Data source

Reference
Reference Type:
publication
Title:
Carcinogenicity of epoxides, lactones, and peroxy compounds. IV Tumor response in epithelial and connective tissue in mice and rats
Author:
Van Duuren BL, Langseth L, Orris L, Teebor G, Nelson N, Kuschner M
Year:
1966
Bibliographic source:
J. Natl. Canc. Inst. Monogr. 37: 825-838

Materials and methods

Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
mouse
Strain:
other: ICR/Ha Swiss
Sex:
female

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
other: tricaprylin
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
535 days
Frequency of treatment:
once weekly
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
3.3 mg
Basis:
no data
No. of animals per sex per dose:
30
Control animals:
other: concurrent vehicle and no treatment

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:
Due to the methodical deficiencies of the study the results should be regarded as inconclusive.

Any other information on results incl. tables

1 fibrosarcoma was observed

median survival time was 472 days

Applicant's summary and conclusion

Conclusions:
In a s.c. carcinogenicity study with mice 1 fibrosarcoma was observed at the application site; due to the methodical deficiencies of the study the results should be regarded as inconclusive
Executive summary:

Cumene hydroperoxide was tested for its carcinogenicity in mice; the substance was applied subcutaneously once weekly for 535 days to 30 mice; 1 fibrosarcima was observed at the application site; due to the methodololical deficiencies of the study the results should be regarded as inconclusive