Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-475-1 | CAS number: 1327-36-2
- 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
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Oral ingestion of syloid to mice and rats and its chronic toxicity and carcinogenicity.
- Author:
- Takizawa, Y. et al.
- Year:
- 1 988
- Bibliographic source:
- Acta Medica et Biologica 36(1): 27-56
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- - Group size was 10 animals/sex/dose at interim kills instead of 20 each. At terminal sacrifice 20/sex/dose as recommended. Urinanalysis not performed.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 112926-00-8
- EC Number:
- 601-214-2
- Cas Number:
- 112926-00-8
- IUPAC Name:
- 112926-00-8
- Reference substance name:
- Silica gel, cryst.-free
- IUPAC Name:
- Silica gel, cryst.-free
- Details on test material:
- - Name of test material (as cited in study report): Syloid 244, produced by Fuji Davidson Chemical Ltd.
- Physical state: fine white powder
- Analytical purity: no data
- Lot/batch No.: Lot No. JC-2108v
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Funabashifarm Animal Co. Ltd. Japan
- Age at study initiation: 3 weeks
- Weight at study initiation: 117 - 150 g (male rats); 92 - 126 g (female rats)
- Housing: 2 rats/cage
- Diet: ad libitum
- Water: tap water; ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1
- Humidity (%): 50 ± 10 %
- Photoperiod (hrs dark / hrs light): 10 hrs dark / 14 hrs light
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 103 weeks, interim kill after 6 and 12 months (10 animals each)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.25, 2.5 and 5 %
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Rats were separated according to sex, and by standard randomisation 2 rats were put in one cage. Rats were dined into dosage groups of 10 animals each.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily for survival and clinical signs
BODY WEIGHT: Yes
- Time schedule for examinations: weekly for the first 55 weeks, thereafter every two weeks
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes (weekly)
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages
from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 6, 12, and 24 months
- Parameters checked in table 9-1/9-2 were examined.
CLINICAL CHEMISTRY: yes (see Report p. 30)
- Time schedule for collection of blood: 6, 12 and 24 months
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Student´s t-analysis variance test / Chi square test of Mantel-Hanszel for survival
Fisher´s exact test and Cochran-Armitage test for trend
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- SUBSTANCE UPTAKE
The mean cumulative intake after 103 weeks was 143.46, 279.55 and 581.18 g/rat in males
and 107.25, 205,02 and 435.33 g/rat in females, respectively.
(Note: Misprint for substance uptake by males, 2.5 %, in Tab. 7: 179.55 must read 279.55 g/rat)
The average doses of the male and female 5%-groups were approx. 1800 to 2000 mg/(kg bw*d) after week 15 of the study start, while they were distinctly higher in the juvenile phase of life (comp. Report, Tab. 7 and 8).
Specific silica intake decreased over time during growth and aging in relation to the relative reduction in food intake. A reasonable average of 2000 mg/(kg bw*d) is estimated from the experimental data. This estimate relates to a mean body weight of 400 g and 300 g for males and females, respectively (see Report, Tab. 7 and 8), which agrees fairly well with the growth curves (comp. Report, Fig. 5 and 6) .
ORGAN WEIGHTS
Lower liver weights were noted from 12 to 24 months in the female 2.5 and 5 % dose groups (p =<0.01) (see Report Tab. 10-2).
HISTORICAL CONTROL DATA (if applicable): no data
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 760 - 3 000 other: mg/kg bw and day
- Sex:
- male
- Basis for effect level:
- other: Daily intake of Syloid was distinctly higher in the initial phase of the lifespan study due to the body weights of the grow up animals.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 780 - 3 210 other: mg/kg bw and day
- Sex:
- female
- Basis for effect level:
- other: Daily intake of Syloid was distinctly higher in the initial phase of the lifespan study due to the body weights of the grow up animals.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The reduced liver weights in females (approx. -7 and -15 % after 12 and 24 months, respectively, independent of the dose) are not considered to be pathologically relevant.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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.