Registration Dossier

Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from secondary literature source. However, the original data source is a United States National Toxicology Program (NTP) and quality of data source should have been guaranteed. Therefore a reliability of 2 is assigned.

Data source

Reference
Reference Type:
secondary source
Title:
Hazardous Substances Data Bank (HSDB), Alpha-Methylbenzyl Alcohol
Author:
United States National Library of Medicine
Year:
2010

Materials and methods

Principles of method if other than guideline:
Carcinogenesis was assessed in rats and mice via oral gavage for 2 years.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): alpha-methylbenzyl alcohol

- Purity: > 99%.

Test animals

Species:
other: rats and mice
Strain:
other: F344/N rats and B6C3F1 mice
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Frequency of treatment:
5 days/wk for 103 wk
Post exposure period:
No data.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
375 mg/kg
Basis:
other: nominal in vehicle
Remarks:
Doses / Concentrations:
750 mg/kg
Basis:
other: nominal in vehicle
No. of animals per sex per dose:
50
Control animals:
not specified

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:
There was some evidence of carcinogenic activity of a-methylbenzyl alcohol for male F344/N rats, as shown by increased incidences of renal tubular cell adenomas and adenomas or adenocarcinomas (combined). However there might have been problems in animal selections.

Applicant's summary and conclusion

Conclusions:
There was some evidence of carcinogenic activity of a-methylbenzyl alcohol for male F344/N rats, as shown by increased incidences of renal tubular cell adenomas and adenomas or adenocarcinomas (combined). However there might have been problems in animal selections.
No such effects were observed in female rats, or mice.
Executive summary:

NTP data. There was some evidence of carcinogenic activity of a-methylbenzyl alcohol for male F344/N rats, as shown by increased incidences of renal tubular cell adenomas and adenomas or adenocarcinomas (combined). However there might have been problems in animal selections. No such effects were observed in female rats, or mice. Data from secondary literature source. However, the original data source is a United States National Toxicology Program (NTP) and quality of data source should have been guaranteed. Therefore a reliability of 2 is assigned.