Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Endpoint:
carcinogenicity: dermal
Type of information:
other: publication
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary literature , no details

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1991
Reference Type:
publication
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

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

Test animals

Species:
mouse
Strain:
Swiss
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
dermal
Vehicle:
other: benzene (50%)
Details on exposure:
-application to shaved dorsal skin (0.1 ml per dose)
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
54 weeks
Frequency of treatment:
3 days/week
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
45 mg substance per application
Basis:

No. of animals per sex per dose:
30 animals
Details on study design:
no data
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
extensive skin damage
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
one squamous cell carcinoma observed
Details on results:
one squamous cell carcinoma observed. The result is attributed by authors to trace concentrations of vinylcyclohexene hydroperoxide (caused by autooxidation of 4-vinylcyclohexene); no carcinogenic effects if oxygen-free material was applied 3 times per week for life to 30 male Swiss mice)

Applicant's summary and conclusion