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Registration Dossier
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EC number: 701-065-4 | CAS number: -
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Circa 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards, basic data given, acceptable for assessment, although deficiencies in documentation of test design and results. Justification for read-across is warranted given the similarities in toxicity profile and physico-chemical properties for silicon dioxide and magnesium silicate.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards, basic data given, acceptable for assessment, although deficiencies in documentation of test design and results. Justification for read-across is warranted given the similarities in toxicity profile and physico-chemical properties for silicon dioxide and magnesium silicate.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- Syloid 244: CAS-Name: Silica gel, cryst.-free;
CAS-No. 112926-00-8 - Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation:
- Weight at study initiation: no data
- Fasting period before study: no
- Housing: single
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: water suspension
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No information
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: no data
- Length of cohabitation: no data
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from day 6 to day 15 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- gestation day 17: sacrifice of all dams by caesarean section
- Remarks:
- Doses / Concentrations:
0, 13.4, 62.3, 289 and 1340 mg/kg bw/d
Basis: - No. of animals per sex per dose:
- 21 - 26 pregnant dams
- Control animals:
- yes
- other: positive control dosed with Aspirin, 150 mg/kg bw/d
- Details on study design:
- - Dose selection rationale: no data
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: gestation day 0, 6, 11, 15, and 17
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 17
- Organs examined: in particular urogenital tract
- 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 resorptions: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: 1/3 per litter
- Head examinations: yes - Statistics:
- no data
- Indices:
- No data
- Historical control data:
- no data
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The administration of up to 1340 mg/kg (body weight) of the test material to pregnant mice for
10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. - Dose descriptor:
- NOAEL
- Remarks:
- (highest dose tested)
- Effect level:
- 1 340 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
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. - Dose descriptor:
- NOAEL
- Remarks:
- (highest dose tested)
- Effect level:
- 1 340 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The administration of up to 1340 mg/kg (body weight) of the test material to pregnant mice 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. - Executive summary:
A study with Syloid 244 was conducted based on OECD test guideline 414. Mice were dosed with 0, 13.4, 62.3, 289 and 1340 mg/kg bw/d.
The administration of up to 1340 mg/kg (body weight) of the test material to pregnant mice 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.
The NOAEL was determined to be 1340 mg/kg bw/day.
The administration of up to 1340 mg/kg (body weight) of the test material to pregnant mice 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.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards, basic data given, acceptable for assessment, although deficiencies in documentation of test design and results. Justification for read-across is warranted given the similarities in toxicity profile and physico-chemical properties for silicon dioxide and magnesium silicate.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- Syloid 244: CAS-Name: Silica gel, cryst.-free;
CAS-No. 112926-00-8 - Species:
- rabbit
- Strain:
- Dutch
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no
- Housing: single
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: water suspension
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No information
- Details on mating procedure:
- - Impregnation procedure: artificial insemination
- Proof of pregnancy: no data [day 0 = day of artificial insemination] - Duration of treatment / exposure:
- from day 6 to day 18 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- day 29: sacrifice of does by caesarean section
- Remarks:
- Doses / Concentrations:
0, 16.0, 74.3, 345 and 1600 mg/kg bw/d
Basis: - No. of animals per sex per dose:
- 10, 12, 11, 14, and 13 pregnant animals, respectively for 0, 16.0, 74.3, 345 and 1600 mg/kg bw/d groups
- Control animals:
- yes
- other: pos. control dosed with 6-aminonicotinamide, 2.5 mg/(kg bw *d)
- Details on study design:
- No information available
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: gestation day 0, 6, 12, 18, and 29
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: in particular urogenital tract - 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 resorptions: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: yes
- other: neonatal survival by placing the pups 24 h in an incubator before tissue examination - Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rabbits for
13 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. - Dose descriptor:
- NOAEL
- Remarks:
- (highest dose tested)
- Effect level:
- 1 600 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
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. - Dose descriptor:
- NOAEL
- Remarks:
- (highest dose tested)
- Effect level:
- 1 600 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rabbits for
13 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. - Executive summary:
A study with Syloid 244 was conducted based on OECD test guideline 414. Rabbits were dosed with 0, 16.0, 74.3, 345 and 1600 mg/kg bw/d.
The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rabbits for
13 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.
The NOAEL was determined to be 1600 mg/kg bw/day.
The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rabbits for
13 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.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards, basic data given, acceptable for assessment, although deficiencies in documentation of test design and results. Justification for read-across is warranted given the similarities in toxicity profile and physico-chemical properties for silicon dioxide and magnesium silicate.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- Syloid 244: CAS-Name: Silica gel, cryst.-free;
CAS-No. 112926-00-8 - Species:
- hamster, Syrian
- Strain:
- other: (outbred)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no
- Housing: single
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: water suspension
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No information
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: no data
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from day 6 to day 10 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- day 14: sacrifice of dams by caesarean section
- Remarks:
- Doses / Concentrations:
0, 16.0, 74.3, 345 and 1600 mg/kg bw/d
Basis: - No. of animals per sex per dose:
- 21 - 22 pregnant hamsters
- Control animals:
- yes, concurrent vehicle
- other: pos. control receiving Aspirin, 250 mg/kg bw/*d
- Details on study design:
- - Dose selection rationale: no data
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: gestation day 0, 6, 8, 10, and 14
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: no data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 14
- Organs examined: in particular urogenital tract
- 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 resorptions: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: 1/3 per litter
- Head examinations: No data - Statistics:
- no data
- Indices:
- No data
- Historical control data:
- no data
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The administration of up to 1600 mg/kg (body weight) of the test material to pregnant hamsters for
5 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. - Dose descriptor:
- NOAEL
- Remarks:
- (Maximum dose tested)
- Effect level:
- 1 600 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
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. - Dose descriptor:
- NOAEL
- Remarks:
- (maximum dose tested)
- Effect level:
- 1 600 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The administration of up to 1600 mg/kg (body weight) of the test material to pregnant hamsters for
5 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. - Executive summary:
A study with Syloid 244 was conducted based on OECD test guideline 414. Rabbits were dosed with 0, 16.0, 74.3, 345 and 1600 mg/kg bw/day.
The administration of up to 1600 mg/kg (body weight) of the test material to pregnant hamsters for
5 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.
The NOAEL was determined to be 1600 mg/kg bw/day.
The administration of up to 1600 mg/kg (body weight) of the test material to pregnant hamsters for
5 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
- Details on test material:
- Syloid 244: CAS-Name: Silica gel, cryst.-free; CAS-No. 112926-00-8
Constituent 1
- Specific details on test material used for the study:
- Syloid 244: CAS-Name: Silica gel, cryst.-free;
CAS-No. 112926-00-8
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): 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: water suspension
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No information
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: no data
- Length of cohabitation: no data
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from day 6 to day 15 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- Gestation day 20: sacrifice of all dams by caesarean section
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 13.5, 62.7, 292 and 1350 mg/kg bw/d
Basis:
- No. of animals per sex per dose:
- 20 - 25 pregnant female rats
- Control animals:
- yes, concurrent vehicle
- other: positive control dosed with Aspirin, 250 mg/(kg bw *d)
- Details on study design:
- - Dose selection rationale: no data
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: gestation day 0, 6, 11, 15, and 20
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: in particular urogenital tract
- 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 resorptions: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: 2/3 per litter
- Head examinations: yes - Statistics:
- no data
- 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:
The administration of up to 1350 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.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Remarks:
- (highest dose tested)
- Effect level:
- 1 350 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
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.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Remarks:
- (highest dose tested)
- Effect level:
- 1 350 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
The administration of up to 1350 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
- Conclusions:
- The administration of up to 1350 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. - Executive summary:
A study with Syloid 244 was conducted based on OECD test guideline 414. Rats were dosed with 0, 13.5, 62.7, 292 and 1350 mg/kg bw/d.
The administration of up to 1350 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.
The NOAEL was determined to be 1350 mg/kg bw/day
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