Registration Dossier

Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
CARCINOGENESIS BIOASSAY OF ALLYLISOTHIOCYANATE (CAS NO. 57-06-7) IN F344/N RATS AND B6C3F1 MICE (GAVAGE STUDY)
Author:
NATIONAL TOXICOLOGY PROGRAM
Year:
1982
Bibliographic source:
NTP-81-36 NIH Publication No. 83-1790

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A 2-year carcinogenesis bioassay of food-grade allyl isothiocyanate (greater than 93% purity), a flavoring agent, was conducted by administering 12 or 25 mg/ kg allyl isothiocyanate in corn oil five times per week by gavage to groups of 50 F344/ N rats and 50 B6C3Fl mice ofeach sex for 103 weeks. Groups of 50 rats and 50 mice of each sex received corn oil alone and served as vehicle controls.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Duration of treatment / exposure:
103 weeks
Frequency of treatment:
5 times per week
Doses / concentrationsopen allclose all
Dose / conc.:
12 mg/kg bw/day (nominal)
Dose / conc.:
25 mg/kg bw/day (nominal)
No. of animals per sex per dose:
Size of Test Groups: 50 males, 50 females of each species
Doses:Rats and mice: low dose 12 mg/kg body weight allyl isothiocyanate in corn oil; high dose 25 mg/ kg body weight allyl isothiocyanate in corn oil; vehicle control: corn oil.
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
Observed twice daily for morbidity and mortality.

Results and discussion

Results of examinations

Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
Rats:Throughout the study, the mean body weights of high-dose male rats were lower than those of the controls, and during the last half of the study the mean body weights of both low-and highdose female rats were higher than those of the controls.
Mice: Throughout most of the study, mean body weights of high-dose male and female mice were higher than those of the vehicle controls.

Effect levels

open allclose all
Dose descriptor:
LOAEL
Remarks:
rats
Effect level:
12 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
histopathology: neoplastic
Dose descriptor:
NOAEL
Remarks:
mice
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
histopathology: non-neoplastic

Applicant's summary and conclusion

Conclusions:
Under the conditions of this bioassay, allyl isothiocyanate was carcinogenic for male F344/N rats, causing transitional-cell papillomas in the urinary bladder. Evidence for associating allyl isothiocyanate with subcutaneous fibrosarcomas in female F344/N rats was equivocal. Allyl isothiocyanate was not carcinogenic for B6C3FI mice of either sex.