Registration Dossier
Registration Dossier
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EC number: 200-309-2 | CAS number: 57-06-7
Developmental toxicity / teratogenicity
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:
- 1 973
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 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
Constituent 1
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.
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