Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Remarks:
subcutaneous administration
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1980
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:
TOXICOLOGY OF GLUCOSINOLATES, RELATED COMPOUNDS (NITRILES, R-GOITRIN, ISOTHIOCYANATES) AND VITAMIN U FOUND IN CRUCIFERAE
Author:
K. NISHIE and M. E. DA.XENBICHLER
Year:
1980
Bibliographic source:
Fd Cosmer. To:dcol. Vol. 18. pp. 159 to 172

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Two groups of pregnant Holtzman rats received 50 or 100 mg/kg bw allyl isothiocyanate by subcutaneous administration on days 8 and 9 of gestation.
GLP compliance:
not specified
Type of method:
in vivo

Test material

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

Test animals

Species:
rat
Strain:
other: Holtzman
Sex:
female

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
other: Dissolved in either propylene glycol or distilled water
Duration of treatment / exposure:
11-12 days after treatment.
Frequency of treatment:
One dose/day was administered on day 8 and/or 9 of gestation,
Duration of test:
11-12 days after treatment.
Doses / concentrationsopen allclose all
Dose / conc.:
50 mg/kg bw/day (nominal)
Dose / conc.:
100 mg/kg bw/day (nominal)
No. of animals per sex per dose:
6 female rats/50 mg/kg bw
8 female rats/100 mg/kg bw
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
dose level:
Effect level:
100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: embryo death

Applicant's summary and conclusion

Conclusions:
Maternal toxicity was evident with the high dose. Foetuses were examined on day 20; those in the low-dose group weighted significantly less than controls, while an increased incidence of resorptions was seen in the high-dose group. No treatment-related malformation was observed.