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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
Virgin female rats were mated with young males. Beginning on day 6 of gestation, the females were dosed orally with the test compound (4 dose levels) for 10 days. On day 20 of gestation all dams were sacrificed and examined.
GLP compliance:
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, aluminum sodium salt
EC Number:
EC Name:
Silicic acid, aluminum sodium salt
Cas Number:
Molecular formula:
nSiO2*mAl2O3*zNa2O n = 2-4; m = 0.12-3.20; z = 0.11-4.5
aluminium(3+) sodium bis(oxosilanebis(olate))
Test material form:
solid: nanoform, no surface treatment
Specific details on test material used for the study:
- Name of test material (as quoted in study report): synthetic silica sodium silicoaluminate (FDA 71-45), from the study report it cannot be ascertained wether a crystalline or amorphous form was used
- Physical state: fine white powder
- Analytical purity: no data

Test animals

Details on test animals or test system and environmental conditions:
- Housing: disposable plastic cages in temperature and humidity-controlled quarters
- Diet and water: ad libitum
- Water (e.g. ad libitum): tap water; ad libitum

Administration / exposure

Route of administration:
oral: gavage
not specified
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Virgin female rats 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:
Duration of test:
on day 17 all dams were sacrificed
Doses / concentrationsopen allclose all
Dose / conc.:
16 mg/kg bw/day
Dose / conc.:
74.3 mg/kg bw/day
Dose / conc.:
345 mg/kg bw/day
Dose / conc.:
1 600 mg/kg bw/day
No. of animals per sex per dose:
not specified
Control animals:
yes, sham-exposed
Details on study design:
positive control: Asperin (250 mg/kg bw/d)


Maternal examinations:
daily for appearance, behavior and food consumption
body weights on GD 0, 6, 11, 15, 20
on GD 20: implantation sites, resorption sites, live and dead fetuses, urogenital tract
Fetal examinations:
body weight, grossly for congenital abnormalities
visceral examination in one third of animals, skeletal defects in the other two third

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

no mortality observed

Maternal developmental toxicity

Other effects:
no effects observed
Description (incidence and severity):
nidation: no clearly descernible effect

Effect levels (maternal animals)

Key result
Dose descriptor:
Effect level:
>= 1 600 mg/kg bw/day (nominal)
Basis for effect level:
other: nidation

Maternal abnormalities

not examined

Results (fetuses)

Fetal body weight changes:
not specified
Reduction in number of live offspring:
effects observed, non-treatment-related
Description (incidence and severity):
no clearly descernible effect
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
did not differ from the number occuring spontaneously in the sham-treated control
Visceral malformations:
effects observed, non-treatment-related
Description (incidence and severity):
did not differ from the number occuring spontaneously in the sham-treated control
Other effects:
effects observed, non-treatment-related

Effect levels (fetuses)

Key result
Dose descriptor:
Effect level:
>= 1 600 mg/kg bw/day (nominal)
Basis for effect level:
reduction in number of live offspring
skeletal malformations
visceral malformations

Fetal abnormalities

effects observed, non-treatment-related

Overall developmental toxicity

Key result
Developmental effects observed:

Any other information on results incl. tables

The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rats 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.

Applicant's summary and conclusion

Test item showed no maternal or developmental toxicity up to 1600 mg/kg bw/d.
Executive summary:

Female rats were orally administered Sodium silicoaluminate from GD 6 to GD 15 to examine tetratologic effects.