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EC number: 231-545-4 | CAS number: 7631-86-9
- 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
- Flammability
- 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
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- 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:
- no guideline followed
- Principles of method if other than guideline:
- 4 dose levels, administered on GD 6-15 by oral gavage, examination for skeletal and external malformations on GD 17
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- Virgin adult female albino CD-1 outbred mice were ganghoused in disposable plastic cages in temperature and humidity-controlled quarters with free access to food and fresh tap water.
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Females mice were mated with young adult males, and observation of the vaginal sperm plug was considered Day 0 of gestation.
- Duration of treatment / exposure:
- GD 6-15
- Frequency of treatment:
- daily
- Duration of test:
- until GD 17
- Dose / conc.:
- 13.4 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 62.3 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 289 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 340 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 21 - 26 pregnant dams
- Control animals:
- yes, sham-exposed
- other: positive control: dosed with Aspirin (150 mg/kg bw/d)
- Maternal examinations:
- Body weights were recorded on Days 0, 6, 11, 15, and 17 of gestation. All animals were observed daily for appearance and behavior with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal.
On Day 17 all dams were subjected to Caesarean section under surgical anesthesia, and the numbers of implantation sites, resorption
sites, and live and dead fetuses were recorded. The body weights of the live pups were also recorded. The urogenital tract of each dam
was examined in detail for anatomical normality. - Fetal examinations:
- All fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses of each litter underwent detailed visceral examinations employing 10X magnification. The remaining two-thirds were cleared in potassium hydroxide (KOH), stained with alizarin red S dye and examined for skeletal defects.
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weight after 17 days was 43.6 g in average in highest dose group, against a mean body weight of 50.1 in sham controls.
- Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Changes in number of pregnant:
- no effects observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- >= 1 340 mg/kg bw/day (actual dose received)
- Basis for effect level:
- body weight and weight gain
- Abnormalities:
- not examined
- Reduction in number of live offspring:
- no effects observed
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 340 mg/kg bw/day (actual dose received)
- Sex:
- not specified
- Basis for effect level:
- reduction in number of live offspring
- external malformations
- skeletal malformations
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- skeletal: skull
- skeletal: sternum
- skeletal: rib
- skeletal: vertebra
- other: external: extremities (unspecified)
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 13.4 mg/kg bw/day (actual dose received)
- Treatment related:
- no
- Relation to maternal toxicity:
- developmental effects occurring together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- no
- Relevant for humans:
- no
- 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 abnoimmaities 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:
The developmental toxicity of Syloid 244 was evaluated in mice treated on GD 6 -15.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- 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:
- no guideline followed
- Principles of method if other than guideline:
- 4 dose levels, administered on GD 6-15 by oral gavage, examination for skeletal and external malformations on GD 20
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Virgin adult female albino rats (Wistar derived stock) were individually housed in mesh bottom cages in temperature and humidity controlled quarters with free access to food and fresh tap water.
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Females rats were mated with young adult males, and observation of the vaginal sperm plug was considered Day 0 of gestation.
- Duration of treatment / exposure:
- GD 6-15
- Frequency of treatment:
- daily
- Duration of test:
- until GD 20
- Dose / conc.:
- 13.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 62.7 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 292 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 350 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 20 - 25 pregnat rats
- Control animals:
- yes, sham-exposed
- other: positve control: dosed with Aspirin (250 mg/kg bw/d)
- Maternal examinations:
- Body weights were recorded on Days 0, 6, 11, 15, and 20 of gestation. All animals were observed daily for appearance and behavior with particular attention to food consumption and weight, in order to rule-out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal.
- Fetal examinations:
- All fetuses were examined grossly for the presence of external congenital abnormalities, One-third of the fetuses of each litter underwent detailed visceral examinations employing 10X magnification. The remaining two-thirds were cleared in potassium hydroxide (KOH), stained with alizarin red S dye and examined for skeletal defects.
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weight after 20 days was 334 g in average in highest dose group, against a mean body weight of 356 in sham controls.
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Dead fetuses:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- >= 1 350 mg/kg bw/day (nominal)
- Basis for effect level:
- body weight and weight gain
- Key result
- Abnormalities:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 350 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- external malformations
- skeletal malformations
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- skeletal: skull
- skeletal: sternum
- skeletal: rib
- skeletal: vertebra
- other: external: extremities (unspecified)
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 13.5 mg/kg bw/day (actual dose received)
- Treatment related:
- no
- Relation to maternal toxicity:
- developmental effects occurring together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- no
- Relevant for humans:
- no
- 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:
The developmental toxicity of Syloid 244 was assessed in rats treated on GD 6 -15.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- 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:
- no guideline followed
- Principles of method if other than guideline:
- 4 dose levels, administered on GD 6-18 by oral gavage, examination for skeletal and external malformations on GD 29
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rabbit
- Strain:
- Dutch
- Details on test animals or test system and environmental conditions:
- Virgin, adult Dutch belted female rabbits were individually housed in mesh bottom cages in temperature and humidity-controlled quarters with free access to food and fresh tap water.
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Each dose was inseminated artificially with 0.3 ml of diluted semen from, a proven donor buck using approximately 20 x 10^6 motile sperm.
- Duration of treatment / exposure:
- GD 6-18
- Frequency of treatment:
- daily
- Duration of test:
- until GD 29
- Dose / conc.:
- 16 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 74.3 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 345 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 600 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10 - 15 pregnat rabbits
- Control animals:
- yes, sham-exposed
- other: positve control: dosed with 6-AN (2.5 mg/kg) on GD 9
- Details on study design:
- On Day 0, each doe was given an injection of 0.4 ml of human chorionic gonadotropin (400 IU) via the margins 1 ear vein. Three hours later, each
doe was inseminated artificially with 0.3 ml of diluted semen from, a proven donor buck using approximately 20 x 10^6 motile sperm. Beginning on Day 6 and continuing daily through Day 18 the females were dosed with the indicated dosages by oral intubation. The controls were sham treated with the vehicle at a level equivalent to the group receiving the highest test dose. - Maternal examinations:
- Body weights were recorded on Days 0, 6, 12, 18, and 29 of gestation. All animals were observed daily for appearance and behavior, with particular attention to food consumption and body weight in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal.
- Fetal examinations:
- All fetuses underwent a detailed gross examination for the presence of external congenital abnommlities. The live fetuses of each litter were then placed in an incubator for 24 hours for the evaluation of neonatal survival. All surviving pups were sacrificed, and all pups examined for visceral abnormalities (by dissection) . All fetuses were then cleared in potassum hydroxide (KOH), stained with alizarin red S dye and examined for skeletal defects.
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weight after 29 days was 3.34 kg in average in highest dose group, against a mean body weight of 3.84 kg in sham controls.
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals; the highest mortality was in the lowest dose group, but not in shame control animals.
- Changes in number of pregnant:
- no effects observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- >= 1 350 mg/kg bw/day (nominal)
- Basis for effect level:
- body weight and weight gain
- Key result
- Abnormalities:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 600 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- external malformations
- skeletal malformations
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- skeletal: skull
- skeletal: sternum
- skeletal: rib
- skeletal: vertebra
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 16 mg/kg bw/day (actual dose received)
- Treatment related:
- no
- Relation to maternal toxicity:
- developmental effects occurring together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- no
- Relevant for humans:
- no
- 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:
The developmental toxicity of Syloid 244 was assessed in rabbits treated on GD 6 -18.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 4 dose levels, administered on GD 6-10 by oral gavage, examination for skeletal and external malformations on GD 14
- GLP compliance:
- not specified
- 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
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- CAS.-Nr.: 7631-86-9, Gel, Surface Area/BET [m2/g]: 349, purity > 99%
Constituent 1
Test animals
- Species:
- hamster
- Strain:
- other: golden hamsters
- Details on test animals or test system and environmental conditions:
- Virgin adult female golden hamsters from an outbred strain were individually housed in mesh bottom cages in temperature and humidity controlled quarters with free access to food and fresh tap water at all times.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Females hamsters were mated with young adult males and the appearance of motile sperm in the vaginal smear was considered Day 0 of gestation.
- Duration of treatment / exposure:
- GD 6-10
- Frequency of treatment:
- daily
- Duration of test:
- until GD 14
Doses / concentrationsopen allclose all
- Dose / conc.:
- 16 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 74.3 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 345 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 600 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 20 - 22 pregnat hamsters
- Control animals:
- yes, sham-exposed
- other: positve control: dosed with Aspirin (250 mg/kg bw/d)
Examinations
- Maternal examinations:
- Body weights were recorded on. Days 0 , 8, 10, and 14 of the gestation period. All animals were observed daily for appearance and behavior with particular attention to food consumption in order to better recognize any abnonnmlities resulting from anorexic effects in the pregnant animal.
- Fetal examinations:
- All fetuses were examined grossly for the presence of external congenital abnormalities, One third of the fetuses of each litter underwent detailed visceral examinations employing 10X magnification. The remaining two-thirds were cleared in potassium hydroxide (KOH), stained with alizarin red S dye and examined for skeletal abnormalities.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weight after 14 days was 147.6 g in average in highest dose group, against a mean body weight of 157.4 in sham controls.
Maternal developmental toxicity
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Dead fetuses:
- no effects observed
- Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- >= 1 600 mg/kg bw/day (nominal)
- Basis for effect level:
- body weight and weight gain
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Reduction in number of live offspring:
- no effects observed
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- no significant difference between treated and sham control animals
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 600 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- external malformations
- skeletal malformations
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- skeletal: skull
- skeletal: sternum
- skeletal: rib
- skeletal: vertebra
- other: external: extremities (unspecified)
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 16 mg/kg bw/day (actual dose received)
- Treatment related:
- no
- Relation to maternal toxicity:
- developmental effects occurring together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- no
- Relevant for humans:
- no
Applicant's summary and conclusion
- 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:
The developmental toxicity of Syloid 244 was assessed in hamsters treated on GD 6 -10.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.