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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Results of an study conducted in accordance with generally accepted scientific principles. Possible deficiencies in the reporting of the endopoint do not affect the quality of relevant results.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 422
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Commercial, purity 97.2%

Test animals

Species:
rat
Strain:
Crj: CD(SD)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration of treatment / exposure:
Male: 44 days including 14 days before mating.
Female: from 14 days before mating to day 3 of lactation.
Premating exposure period: male, 14 days; female, 14 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
30
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
150
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
750
Basis:
nominal in diet

Examinations

Maternal examinations:
All gestation animals delivered pups normally.
Fetal examinations:
The body weight of fetuses showed the favorably growths until day 4 of lactation.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
The results observed in mating, fertility and estrous cycle did not reveal any effects attributable to the administration of test substance.
Observation of delivery, all gestation animals delivered of pups normally, and there were not a treatment-related effect throughout the lactation period.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
750 mg/kg bw/day
Based on:
no data
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
The necropsy of stillborn, dead pups until day 4 of lactation and newborns at day 4 of lactation did not reveal any effects attributable to the administration of the test substance.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
750 mg/kg bw/day
Based on:
no data
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of this screening study, no test substance-related effects were observed on the general physical condition of F1 pups at any dosage level. As such, a dosage level of 750 mg/kg bw/day was considered to be the no-observed-adverse-effect level (NOAEL) for maternal and teratogenic toxicity.