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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report, comparable to guideline study.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Hydrated Calcium Silicate (Silene EF)
IUPAC Name:
Hydrated Calcium Silicate (Silene EF)
Details on test material:
FDA-compound 71-41
Fine white powdered material

Test animals

Species:
mouse
Strain:
CD-1
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: adult
- Weight at study initiation: 28-32 g
- Fasting period before study: no data
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): fresh tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled temperature
- Humidity (%): controlled humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:

VEHICLE
- Justification for use and choice of vehicle (if other than water): water
- Concentration in vehicle: various
- Amount of vehicle (if gavage): 1 ml/kg bw
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:


- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy
Duration of treatment / exposure:
day 6 to day 15 of gestation
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
16, 74, 350, 1600 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
16 mg/kg: 27; 74 mg/kg: 26; 350 mg/kg: 29; 1600 mg/kg: 29 animals
Control animals:
yes, sham-exposed
Details on study design:
- Other: Positive controls treated with 150 mg/kg Aspirin

Examinations

Maternal examinations:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 6, 11, 15 and 17 of gestation

FOOD CONSUMPTION AND COMPOUND INTAKE : Yes (observations, no calculations)

POST-MORTEM EXAMINATIONS: No data
- Sacrifice on gestation day 17

Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No
- Number of late resorptions: Yes
- Other:
Fetal examinations:
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: 2/3 per litter

Results and discussion

Results: maternal animals

Maternal developmental toxicity

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

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 600 mg/kg bw/day
Basis for effect level:
other: developmental toxicity
Dose descriptor:
NOAEL
Effect level:
1 600 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

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

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Maternal exposure of mice to Ca-silicate during days 6-15 of pregnancy did not cause any signs of teratogenicity or maternal toxicity even at the highest dose of 1600 mg/kg bw.
Executive summary:

The teratogenic effects of Ca-silicate were studied in mice (Food and Drug Research Laboratories 1972). Maternal exposure of mice to Ca-silicate during days 6-15 of pregnancy did not cause any signs of teratogenicity or maternal toxicity even at the highest dose of 1600 mg/kg bw.