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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
Virgin female rabbits were inseminated artificially on day 0. Beginning on day 6 the females were dosed with the test compound for 13 days. On day 29 all dams were sacrificed and examined.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): synthetic silica sodium silicoaluminate (FDA 71-45)
- Physical state: fine white powder
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
Dutch
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: Female rabbits were individually housed in mesh bottom cages in temperature and humidity-controlled quarters.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water; ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
no
Details on mating procedure:
- Impregnation procedure: artificial insemination
Duration of treatment / exposure:
exposure from day 6 to day 18 of gestation (13 days)
Frequency of treatment:
daily
Duration of test:
29 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 16, 74.3, 345 and 1600 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
undetermined
Control animals:
yes

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:
1 600 mg/kg bw/day (nominal)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

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

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
1 600 mg/kg bw/day (nominal)
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rabbits for 13 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.

Applicant's summary and conclusion