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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key 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

Principles of method if other than guideline:
Thirteen-week studies were conducted to evaluate the cumulative toxicity of allyl isothiocyanate and to determine the doses to be used in the chronic studies.
Groups of 10 rats and mice of each sex received 1.5, 3, 6, 12, or 25 mg/ kg allyl isothiocyanate by gavage 5 days per week for 13 weeks. Vehicle controls received corn oil alone.
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:
13 weeks
Doses / concentrationsopen allclose all
Dose / conc.:
1.5 mg/kg bw/day (nominal)
Remarks:
5 days per week
Dose / conc.:
3 mg/kg bw/day (nominal)
Remarks:
5 days per week
Dose / conc.:
6 mg/kg bw/day (nominal)
Remarks:
5 days per week
Dose / conc.:
12 mg/kg bw/day (nominal)
Remarks:
5 days per week
Dose / conc.:
25 mg/kg bw/day (nominal)
Remarks:
5 days per week
No. of animals per sex per dose:
Groups of F344/N rats: 10 animals/sex/group
Groups of B6C3F1 mice: 10 animals/sex/group
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
Animals were observed twice daily for mortality, morbidity and clinical signs of toxicity.
Sacrifice and pathology:
On days 92 to 96, all animals were killed and a necroscopy carried out.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed

Effect levels

open allclose all
Key result
Dose descriptor:
NOAEL
Remarks:
rats
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
gross pathology
Key result
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
gross pathology

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
No gross or microscopic lesions were seen at the highest dose level (25 mg/kg) in the 13-week study.