Allyl isothiocyanate

Carcinogenicity

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

Test material information

Constituent 1

Reference substance name:

Allyl isothiocyanate

EC Number:

200-309-2

EC Name:

Allyl isothiocyanate

Cas Number:

57-06-7

Molecular formula:

C4H5NS

IUPAC Name:

3-isothiocyanatoprop-1-ene

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 / concentrations

Doses / concentrations 1

Dose / conc.:

12 mg/kg bw/day (nominal)

Doses / concentrations 2

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

1

Dose descriptor:

LOAEL

Remarks:

rats

Effect level:

12 mg/kg bw/day (nominal)

Based on:

test mat.

Basis for effect level:

histopathology: neoplastic

2

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.