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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1973
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:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Principles of method if other than guideline:
The teratogenic potential of allyl isothiocyanate was evaluated in mice, rats, hamsters and rabbits.
GLP compliance:
not specified

Test material

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

Test animals

Species:
other: mouse, rat.hamster, rabbit
Strain:
other: Mouse: albino CD-l - Rat: Wistar - Hamster: golden hamsters - Rabbit: Dutch-belted

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
Beginning on Day 6 and continuing daily through Day 10 (hamsters), Day 15 (mice and rats) or Day 18 (rabbits) of gestation.
Doses / concentrationsopen allclose all
Dose / conc.:
0.3 mg/kg bw/day (nominal)
Remarks:
mice
Dose / conc.:
1.3 mg/kg bw/day (nominal)
Remarks:
mice
Dose / conc.:
6 mg/kg bw/day (nominal)
Remarks:
mice
Dose / conc.:
28 mg/kg bw/day (nominal)
Remarks:
mice
Dose / conc.:
0.2 mg/kg bw/day (nominal)
Remarks:
rats, hamsters
Dose / conc.:
0.85 mg/kg bw/day (nominal)
Remarks:
rats
Dose / conc.:
4 mg/kg bw/day (nominal)
Remarks:
rats
Dose / conc.:
18.5 mg/kg bw/day (nominal)
Remarks:
rats
Dose / conc.:
1.1 mg/kg bw/day (nominal)
Remarks:
hamsters
Dose / conc.:
5.1 mg/kg bw/day (nominal)
Remarks:
hamsters
Dose / conc.:
23.8 mg/kg bw/day (nominal)
Remarks:
hamsters
Dose / conc.:
0.123 mg/kg bw/day (nominal)
Remarks:
rabbits
Dose / conc.:
0.6 mg/kg bw/day (nominal)
Remarks:
rabbits
Dose / conc.:
2.8 mg/kg bw/day (nominal)
Remarks:
rabbits
Dose / conc.:
12.3 mg/kg bw/day (nominal)
Remarks:
rabbits
No. of animals per sex per dose:
Groups of 23-25 female mice were treated for each dose.
Groups of 25 Wistar rats were treated for each dose.
Groups of25-27 golden hamsters were treated for each dose.
Groups of 11-14 Dutch-belted rabbits were treated for each dose.
Control animals:
yes
yes, sham-exposed

Examinations

Fetal examinations:
Mice: foetus were examined on day 17 for malformations.
Rats: foetus were examined on day 20 for malformations.
Hamsters: foetus were examined on day 14 for malformations.
Rabbits: foetus were delivered by ceasarean section on day 29..

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:
other: maternal effects not specified

Results (fetuses)

Effect levels (fetuses)

open allclose all
Dose descriptor:
NOAEL
Effect level:
18.5 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Remarks on result:
other: rats
Dose descriptor:
NOAEL
Effect level:
23.8
Based on:
test mat.
Sex:
not specified
Remarks on result:
other: hamster
Key result
Dose descriptor:
NOAEL
Effect level:
6
Based on:
test mat.
Sex:
not specified
Basis for effect level:
reduction in number of live offspring
Remarks on result:
other: mouse
Sex:
not specified
Remarks on result:
other: Rabbit: not determinable because effects observed at the lowest dose tested (2.8 mg/kg bw/day) were not considered to be compound-related or of toxicological significance

Fetal abnormalities

Abnormalities:
no effects observed

Overall developmental toxicity

Key result
Developmental effects observed:
yes
Lowest effective dose / conc.:
28 mg/kg bw/day
Treatment related:
yes
Relation to maternal toxicity:
developmental effects in the absence of maternal toxicity effects
Dose response relationship:
yes
Relevant for humans:
not specified

Any other information on results incl. tables

The author’s conclusion was that AITC may be fetotoxic to the mouse at doses higher than 6.0 mg/kg bw/day, without exhibiting any teratogenic potency

Applicant's summary and conclusion

Conclusions:
AITC did not show any evidence of developmental toxicity in pregnant rats, hamsters and rabbits at oral doses up to 18.5, 23.8 and 12.3 mg/kg bw/day, respectively. AITC may be fetotoxic to mice at doses higher than 6.0 mg/kg bw/day, without exhibiting any teratogenic effects.