Silicic acid, aluminum magnesium salt

Developmental toxicity / teratogenicity

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 for cross-reference:

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 mice were mated with young males. Beginning on day 6 of gestation, the females were dosed orally with the test compound for 10 days. On day 17 of gestation all dams were sacrificed and examined.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum sodium salt

EC Number:

215-684-8

EC Name:

Silicic acid, aluminum sodium salt

Cas Number:

1344-00-9

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:

mouse

Strain:

CD-1

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: disposable plastic 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:

not specified

Details on mating procedure:

Virgin female mice were mated with young adult males, and observation of the vaginal sperm plug was considered day 0 of gestation.

Duration of treatment / exposure:

exposure from day 6 to day 15 of gestation (10 days)

Frequency of treatment:

daily

Duration of test:

on day 17 all dams were sacrificed

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 16, 74.3, 345, 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 mice for 10 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.