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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:
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:
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:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
FDA-compound 71-41
Fine white powdered material

Test animals

Species:
mouse
Strain:
CD-1
Details on test animals 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.