Registration Dossier

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: Study submitted in the ELINCS notification dossier.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100 mg/kg/day
Basis:
no data
Remarks:
Doses / Concentrations:
300 mg/kg/day
Basis:
no data
Remarks:
Doses / Concentrations:
1000 mg/kg/day
Basis:
no data
No. of animals per sex per dose:
25
Control animals:
yes, concurrent no treatment

Results and discussion

Results: maternal animals

Maternal developmental toxicity

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

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Increase of mean weight of the litter in all the treated groups.
cleft palate in 3 fetuses of the group 4. 2 in the group 3 and 1 case of agnathy.
No abnormality in the soft tissues or in skeletton.
Higher ossification rate in the treated animals of groups 3 and 4 (statistically significant).
Higher incidence of malformed vertebrae (C1) in the fetuses of groups 3 and 4.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day
Basis for effect level:
other: embryotoxicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

The observed effects are statisticaly significant however their incidence are in the range of the historical controls.

Applicant's summary and conclusion

Executive summary:

A teratogenicity study has been performed according to the OECD guideline 414.

The substance has been administered to Wistar rat by gavage at 100, 300 or 1000 mg/kg/day.

The NOAEL for the dams is 1000 mg/kg/day and the NOAEL for the fetuses is 100 mg/kg/day.

The effects were higher mean weight of the litter, abnormalities (cleft palate, agnathy, abnormality of the C1 vertebra) and higher ossification rate.

These effects are statistically significant but the incidence is within the historical control range.