Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 215-687-4 | CAS number: 1344-09-8
Endpoint summary
Administrative data
Description of key information
oral: LD50 (rat) = 3400 mg/kg bw
inhalation: LC50 (rat) > 2.06 g/m3
dermal: LD50 (rat) > 5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national standards; report with limited detail.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Cpb:Wu; Wistar random
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Not reported
- Source: The Central Institute for the Breeding of Laboratory Animals TNO, Zeist, Netherlands
- Age: Young adult
- Weight at study initiation: 196-336 g (males), 142-195 (females) - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- - Volume administered: 2.50, 3.00, 3.60, 4.32, 5.20 mL/kg
- Doses:
- 3.30, 3.96, 4.75, 5.70, 6.86 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Post dose observation: 14 days after treatment
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 400 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national standards; report with limited detail.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Cpb:Wu; Wistar Random
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: The Central Institute for Breeding of Laboratory Animals TNO, Zeist, The Netherlands.
- Age: Young adult
- Weight at study initiation: 225-300 g (males), 143-214 g (females) - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- - Volume administered: 2.5, 3.0, 3.6, 4.3, 5.2, 6.2 ml/kg
- Doses:
- 3.43, 4.11, 4.93, 5.89, 7.12, 8.49 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Post dose observation: 14 days after treatment
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 150 mg/kg bw
Referenceopen allclose all
MORTALITY:
- Time of death: Between 5 hours and 2 days after dosing
- Number of deaths at each dose:
Dose male female
3.30 0/5 1/5
3.96 0/5 2/5
4.75 1/5 1/5
5.70 2/5 1/5
6.86 5/5 5/5
CLINICAL SIGNS: Sedation, abdominal discomfort, sluggishness
and unconsciousness
NECROPSY FINDINGS: No treatment related gross alterations
MORTALITY:
- Time of death: Between 3 hours and 3 days after dosing
- Number of deaths at each dose:
Dose male female
3.43 0/5 0/5
4.11 1/5 1/5
4.93 4/5 5/5
5.89 4/5 5/5
7.12 4/5 5/5
8.49 5/5 5/5
CLINICAL SIGNS: Sedation, abdominal discomfort, sluggishness
and unconsciousness. Survivors recovered at the end of the
14-day observation period.
NECROPSY FINDINGS: No treatment related gross alterations
Additional information
Sodium silicates of varying molar ratios (MR 0.5-3.38) and varying concentrations (35-90%) have been tested in rats and mice. The majority of test results are cited as secondary literature only (Schleyer and Blumberg (1982)), but several study reports are available, although in limited detail (Potokar (1982), Spanjers and Til (1981 and 1980) Gloxhuber (1973), Gloxhuber and Potokar (1971)). Clinical symptoms observed in a dose-dependent manner consisted of sedation, abdominal discomfort, sluggishness and unconsciousness.
The acute oral toxicity of soluble silicates is generally inversely correlated to the molar ratio SiO2/Na2O. Toxicity decreases in rats with increasing molar ratio from LD50of 500 mg/kg bw for a molar ratio 0.5 to 8650 mg/kg bw for 3.38.
Limit tests were performed with potassium silicate for the inhalative and dermal exposure route. No deaths occurred. Only clinical signs caused by irritation (hunched posture, hypoactivity and erythema), which all were reversible, were observed.
Justification for classification or non-classification
The available data is conclusive but not sufficient for classification.
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.
