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EC number: 935-756-9 | CAS number: 1344-95-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
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- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
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- Nanomaterial pour density
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- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- For reproductive/developmental toxicity a prenatal developmental toxicity / teratogenicity study (hamster) with amorphous calcium silicates (read across with Crystalline silicic acid, calcium salt) is included. No developmental effects were observed in this study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- For reproductive/developmental toxicity a prenatal developmental toxicity / teratogenicity study (rats) with amorphous calcium silicates (read across with Crystalline silicic acid, calcium salt) is included. No developmental effects were observed in this study.
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- no gross pathological examination of the organ dams other than the urogenital tract; statistical evaluation is missing.
- GLP compliance:
- no
- Remarks:
- Study performed prior to GLP adoption
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Housing: individually in mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Oral gavage
PREPARATION OF DOSING SOLUTIONS: the substance was given as a water solution
DIET PREPARATION no data
VEHICLE
- Amount of vehicle (if gavage): 1 mL/kwg bw
The sham-exposed group received anhydrous corn oil. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: mated
-Observation of the vaginal sperm checked on Day 0 of gestation - Duration of treatment / exposure:
- Gestation Day 6 to Day 15
- Frequency of treatment:
- daily
- Duration of test:
- All dams were sacrificed after Cesarian section on gestation Day 17
- No. of animals per sex per dose:
- 21-23
- Control animals:
- yes, sham-exposed
- other: positive control aspirin (given at 250 mg/kg bw)
- Details on study design:
- - Dose selection rationale: no data
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes (appearance, behaviour)
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: Day 0, 6, 11, 15 and 17 of gestation
FOOD CONSUMPTION: Yes, daily
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 17
- Organs examined: urogenital tract examined macroscopically - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - Mortality reported: Yes
- External examinations: Yes, all per litter
- In general congenital abnormalities: Yes, all per litter
- Detailed visceral examinations: Yes, 1/3 per litter
- Skeletal examinations: Yes, 2/3 per litter
- Average fetuses weights and sex were recorded. - Statistics:
- No data
- Indices:
- Not reported
- Historical control data:
- No data
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No effects observed up to the highest dose applied. - Dose descriptor:
- NOAEL
- Effect level:
- > 1 600 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 600 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No effects observed up to the highest dose applied. - Dose descriptor:
- NOAEL
- Effect level:
- 1 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Embryotoxic / teratogenic effects:
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Oral administration by gavage of hydrated calium silicate to female Wistar rats, during gestation days 6-15, did not result to any maternal or developmental toxicity, at doses up to 1600 mg/kg bw.
- Executive summary:
In a developmental toxicity study, hydrated calcium silicate (FDA 71-4, fine white powder) was administered by gavage to groups of female pregnant Wistar rats, during gestation, from Day 6 to Day 15, at dose levels of 16, 74, 350 and 1600 mg/kg bw. Sham-exposed animals were used as negative control and aspirin was given at 150 mg/kg bw to an additional group, as a positive control. Bodyweights were recorded on Days 0, 6, 11, 15 and 17 of gestation. Clinical observations and food consumption were recorded daily. Caesarean sections were performed to all dams on Day 17, and the number of dead, live or resorbed fetuses, sex ratio and number of implantation sites were recorded. All fetuses were weighed and examined for external congenital abnormalities. One-third of the fetuses/litter was examined for visceral malformations, and the other two-thirds for skeletal malformations. The ovaries and uterine content of all dams were examined.
No adverse effect related to the treatment with hydrated calcium silicate was detected. Malformations recorded in the fetuses were comparable to sham-exposed controls. Treatment with the teratogen aspirin resulted in several malformations of the pups. Under the conditions of this test, the NOAEL for both maternal and developmental toxicity for the test item was considered to be 1600 mg/kg bw/day, the highest dose applied.
Table 1. Reproduction data
|
Dose mg/kg bw/day |
|||||
Sham-exposed |
Aspirin 250 |
16 |
74 |
350 |
1600 |
|
PREGNANCIES |
|
|||||
Total No |
21 |
25 |
21 |
21 |
20 |
22 |
Died or aborted |
0 |
0 |
1 |
0 |
0 |
0 |
To termination |
21 |
25 |
20 |
21 |
20 |
22 |
CORPORA LUTEA |
|
|||||
Total No |
271 |
284 |
324 |
269 |
283 |
292 |
Average/dam mated |
11.8 |
10.1 |
11.6 |
11.7 |
12.9 |
12.2 |
LIVE LITTERS |
|
|||||
Total No* |
21 |
21 |
20 |
21 |
20 |
21 |
IMPLANTATION SITES |
|
|||||
Total No |
214 |
249 |
234 |
216 |
230 |
251 |
Average/dam* |
10.2 |
9.96 |
11.7 |
10.3 |
11.5 |
11.4 |
RESORPTIONS |
|
|||||
Total No* |
4 |
62 |
3 |
3 |
1 |
13 |
Dams with ≥1 resorption sites |
4 |
14 |
3 |
2 |
1 |
2 |
Dams with all sites resorbed |
0 |
3 |
0 |
0 |
0 |
1 |
% partial resorptions |
19.0 |
56.0 |
15.0 |
9.52 |
5.0 |
9.09 |
% complete resorptions |
- |
12.0 |
- |
- |
- |
4.55 |
LIVE FETUSES |
|
|||||
Total No* |
210 |
175 |
231 |
212 |
229 |
238 |
Average/dam* |
10.0 |
7.0 |
11.6 |
10.1 |
11.5 |
10.8 |
Sex ratio M/F |
1.08 |
1.22 |
1.14 |
1.12 |
0.88 |
1.14 |
DEAD FETUSES |
|
|
|
|
|
|
Total No* |
- |
12 |
- |
1 |
- |
- |
Dams with ≥1 dead fetuses |
- |
7 |
- |
1 |
- |
- |
Dams with all dead fetuses |
- |
0 |
- |
0 |
- |
- |
% partial dead |
- |
28.0 |
- |
4.7 |
- |
- |
% all dead |
- |
- |
- |
- |
- |
- |
AVERAGE FETUS WEIGHT (g) |
3.77 |
2.38 |
4.04 |
4.01 |
3.90 |
4.06 |
*Includes only dams examined at termination
Table 2. Skeletal findings
|
Dose mg/kg bw/day |
|||||
Sham-exposed |
Aspirin |
16 |
74 |
350 |
1600 |
|
Live Fetuses examined |
146/21 |
127/21 |
157/20 |
149/21 |
158/20 |
166/21 |
STERNEBRAE |
|
|||||
Incomplete Oss. |
39/16 |
89/21 |
38/14 |
37/15 |
36/11 |
43/15 |
Scrambled |
|
|
|
|
|
|
Bipartite |
1/1 |
23/14 |
|
|
|
|
Fused |
|
|
|
|
|
|
Extra |
|
|
|
|
|
|
Missing |
2/2 |
119/21 |
16/5 |
2/2 |
12/6 |
10/6 |
RIBS |
|
|||||
Incomplete Oss. |
|
|
|
|
|
|
Fused/split |
|
|
|
|
|
|
Wavy |
3/1 |
10/5 |
11/7 |
11/9 |
16/5 |
5/5 |
Less than 12 |
|
|
|
|
|
|
More than 13 |
6/4 |
24/11 |
5/5 |
10/7 |
8/4 |
|
VERTEBRAE |
|
|||||
Incomplete Oss. |
|
99/20 |
4/2 |
1/1 |
5/2 |
3/2 |
Scrambled |
|
|
|
|
|
|
Fused |
|
|
|
|
|
|
Extra ctrs. Oss. |
|
|
|
|
|
|
Scoliosis |
|
|
|
|
|
|
Tail defects |
|
|
|
|
|
|
SKULL |
|
|||||
Incomplete closure |
4/2 |
53/14 |
16/8 |
3/2 |
16/12 |
25/13 |
Missing |
|
|
|
|
|
|
Extra |
|
|
|
|
|
|
EXTERMITIES |
|
|||||
Incomplete Oss. |
|
2/2 |
|
|
|
|
Missing |
|
|
|
|
|
|
Extra |
|
|
|
|
|
|
MISCELLANEOUS |
|
|||||
Hyoid; missing |
1/1 |
17/7 |
15/8 |
9/8 |
19/8 |
15/8 |
Hyoid; reduced |
9/2 |
12/5 |
23/13 |
7/4 |
21/9 |
45/13 |
-nominator: No of fetuses affected, denominator: No of litters affected
Soft tissue abnoramilites such as exncephaly. spina bifida, and umbilical hernia were seen in several pups from dams treated with the positive control aspirin. No soft tissue abnormalities were seen in the sham exposed controls or in the test item treated animals.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- no gross pathological examination of the organ dams other than the urogenital tract; statistical evaluation is missing from the report.
- GLP compliance:
- no
- Remarks:
- Study performed prior to GLP adoption
- Limit test:
- no
Test material
- Reference substance name:
- hydrated calcium silicate (amorphous)
- IUPAC Name:
- hydrated calcium silicate (amorphous)
- Reference substance name:
- Amorphous silicic acid, calcium salt
- Molecular formula:
- CaSiO3.nH2O
- IUPAC Name:
- Amorphous silicic acid, calcium salt
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FDA 71-41 (Silene EF; hydrated calcium silicate)
- Physical state: solid, fine powder
Constituent 1
Constituent 2
Test animals
- Species:
- hamster, Syrian
- Strain:
- other: outbred
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Housing: individually in mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Oral gavage
PREPARATION OF DOSING SOLUTIONS: the substance was given as a water solution
DIET PREPARATION no data
VEHICLE
- Amount of vehicle (if gavage): 1 mL/kwg bw
The sham-exposed group received anhydrous corn oil. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: mated
-Observation of the vaginal sperm checked on Day 0 of gestation - Duration of treatment / exposure:
- Gestation Day 6 to Day 10 (5 days)
- Frequency of treatment:
- daily
- Duration of test:
- All dams were sacrificed after Cesarian section on gestation Day 14
- No. of animals per sex per dose:
- 21-23
- Control animals:
- yes, sham-exposed
- other: positive control aspirin (given at 250 mg/kg bw)
- Details on study design:
- - Dose selection rationale: no data
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes (appearance, behaviour)
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: Day 0, 8, 10, and 14 of gestation
FOOD CONSUMPTION: Yes, daily
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 14
- Organs examined: urogenital tract examined macroscopically - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - Mortality reported: Yes
- External examinations: Yes, all per litter
- In general congenital abnormalities: Yes, all per litter
- Detailed visceral examinations: Yes, 1/3 per litter
- Skeletal examinations: Yes, 2/3 per litter
- Average fetuses weights and sex were recorded. - Statistics:
- No data
- Indices:
- Not reported
- Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No effects observed up to the highest dose applied.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 600 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 600 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No effects observed up to the highest dose applied.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Embryotoxic / teratogenic effects:
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1. Reproduction data
|
Dose mg/kg bw/day |
|||||
Sham-exposed |
Aspirin 250 |
16 |
74 |
350 |
1600 |
|
PREGNANCIES |
|
|||||
Total No |
21 |
23 |
21 |
22 |
19 |
21 |
Died or aborted |
0 |
0 |
1 |
0 |
0 |
0 |
To termination |
21 |
23 |
20 |
22 |
19 |
21 |
CORPORA LUTEA |
|
|||||
Total No |
330 |
345 |
297 |
319 |
289 |
291 |
Average/dam mated |
15.0 |
13.3 |
14.1 |
14.5 |
13.1 |
13.2 |
LIVE LITTERS |
|
|||||
Total No* |
21 |
22 |
20 |
22 |
19 |
21 |
IMPLANTATION SITES |
|
|||||
Total No |
267 |
273 |
232 |
256 |
229 |
250 |
Average/dam* |
12.7 |
11.9 |
11.6 |
11.6 |
12.1 |
11.9 |
RESORPTIONS |
|
|||||
Total No* |
8 |
25 |
10 |
12 |
6 |
6 |
Dams with ≥1 resorption sites |
7 |
10 |
7 |
10 |
5 |
4 |
Dams with all sites resorbed |
- |
- |
- |
- |
- |
- |
% partial resorptions |
33.3 |
43.5 |
35.0 |
45.5 |
26.3 |
19.0 |
% complete resorptions |
- |
- |
- |
- |
- |
- |
LIVE FETUSES |
|
|||||
Total No* |
259 |
237 |
221 |
242 |
221 |
243 |
Average/dam* |
12.3 |
10.3 |
11.1 |
11.0 |
11.6 |
11.6 |
Sex ratio M/F |
0.53 |
0.51 |
0.63 |
0.56 |
0.47 |
0.66 |
DEAD FETUSES |
|
|
|
|
|
|
Total No* |
- |
11 |
1 |
2 |
2 |
1 |
Dams with ≥1 dead fetuses |
- |
3 |
1 |
2 |
2 |
1 |
Dams with all dead fetuses |
- |
- |
- |
- |
- |
- |
% partial dead |
- |
13.0 |
5.0 |
9.09 |
10.5 |
4.76 |
% all dead |
- |
- |
- |
- |
- |
- |
AVERAGE FETUS WEIGHT (g) |
1.77 |
1.63 |
1.81 |
1.76 |
1.80 |
1.80 |
*Includes only dams examined at termination
Table 2. Skeletal findings
|
Dose mg/kg bw/day |
|||||
Sham-exposed |
Aspirin 250 |
16 |
74 |
350 |
1600 |
|
Live Fetuses examined |
182/21 |
165/22 |
155/20 |
169/22 |
155/19 |
175/21 |
STERNEBRAE |
|
|||||
Incomplete Oss. |
117/20 |
114/21 |
95/20 |
99/22 |
89/17 |
96/21 |
Scrambled |
|
|
|
|
|
|
Bipartite |
16/9 |
17/11 |
22/6 |
21/12 |
15/9 |
12/7 |
Fused |
|
|
1/1 |
1/1 |
|
1/1 |
Extra |
|
|
|
|
|
3/2 |
Missing |
17/10 |
29/14 |
12/7 |
20/14 |
14/7 |
14/7 |
RIBS |
|
|||||
Incomplete Oss. |
|
|
|
|
|
|
Fused/split |
|
|
|
|
|
|
Wavy |
|
|
|
|
|
|
Less than 12 |
|
|
1/1 |
|
|
|
More than 13 |
14/10 |
41/6 |
37/19 |
20/11 |
17/12 |
30/17 |
VERTEBRAE |
|
|||||
Incomplete Oss. |
|
1/1 |
|
|
1/1 |
|
Scrambled |
|
|
|
|
|
|
Fused |
|
|
|
|
|
|
Extra ctrs. Oss. |
|
|
|
|
|
|
Scoliosis |
|
|
|
|
|
|
Tail defects |
|
|
|
|
|
|
SKULL |
|
|||||
Incomplete closure |
|
|
|
|
|
|
Missing |
|
|
|
|
|
|
Extra |
|
|
|
|
|
|
EXTERMITIES |
|
|||||
Incomplete Oss. |
|
1/1 |
|
|
|
|
Missing |
|
|
|
|
|
|
Extra |
|
|
|
|
|
|
MISCELLANEOUS |
|
|||||
Hyoid; missing |
|
1/1 |
|
|
|
|
Hyoid; reduced |
1/1 |
1/1 |
|
1/1 |
1/1 |
|
-nominator: No of fetuses affected, denominator: No of litters affected
No soft tissue abnoramilites were seen in any of the animals.
Applicant's summary and conclusion
- Conclusions:
- Oral administration by gavage of hydrated calium silicate to female pregnant golden hamsters, during gestation days 6-15, did not result to any maternal or developmental toxicity, at doses up to 1600 mg/kg bw.
- Executive summary:
In a developmental toxicity study, hydrated calcium silicate (FDA 71-4, fine white powder) was administered by gavage to groups of female pregnant golden hamsters, during gestation, from Day 6 to Day 15, at dose levels of 16, 74, 350 and 1600 mg/kg bw. Sham-exposed animals were used as negative control and aspirin was given at 150 mg/kg bw to an additional group, as a positive control. Bodyweights were recorded on Days 0, 8, 10 and 14 of gestation. Clinical observations and food consumption were recorded daily. Caesarean sections were performed to all dams on Day 14, and the number of dead, live or resorbed fetuses, sex ratio and number of implantation sites were recorded. All fetuses were weighed and examined for external congenital abnormalities. One-third of the fetuses/litter was examined for visceral malformations, and the other two-thirds for skeletal malformations. The ovaries and uterine content of all dams were examined.
No adverse effect related to the treatment with hydrated calcium silicate was detected. Malformations recorded in the fetuses were comparable to sham-exposed controls. Under the conditions of this test, the NOAEL for both maternal and developmental toxicity for the test item was considered to be 1600 mg/kg bw/day, the highest dose applied.
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