Registration Dossier
Registration Dossier
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EC number: 231-130-8 | CAS number: 7440-21-3
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:
- 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:
- 1 972
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
- 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
Constituent 1
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.
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