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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-034-8 | CAS number: 16961-83-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published, guideline-comparable study
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of cosmetics ingredients licensed by the European Communities
- Author:
- Gocke E, King MT, Eckhardt K & Wid D
- Year:
- 1 981
- Bibliographic source:
- Mutat Res 90:91-109
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- : small group size
- GLP compliance:
- no
- Remarks:
- : older published study
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Sodium hexafluorosilicate
- IUPAC Name:
- Sodium hexafluorosilicate
- Details on test material:
- Sodium hexafluorosilicate (Fisher Scientific)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- Two exposures at 0 and 24 hours.
- Frequency of treatment:
- Animals were dosed at 0 and 24 hours.
- Post exposure period:
- Bone marrow smears were prepared at 30 hours.
Doses / concentrations
- Dose / conc.:
- 37.6 other: mg/kg bw actual
- No. of animals per sex per dose:
- 2/sex
- Control animals:
- yes
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
Any other information on results incl. tables
No deaths occurred; signs of toxicity are not reported. The proportion of micronucleated PCEs in treated animals is reported to be 2.0/1000, compared to 2.2/1000 in controls. No evidence of mutagencitity was seen under the conditions of this assay.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
No evidence of mutagencitity was seen under the conditions of this assay. - Executive summary:
The genotoxicity of sodium hexafluorosilicate was investigated in a bone marrow micronucleus assay in NMRI mice. Animals (2/sex) were administered two intraperitoneal injections of the test substance at 37.6 mg/kg bw. No evidence of genotoxicity was seen in this study.
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.
