Registration Dossier
Registration Dossier
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EC number: 908-531-8 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- For this endpoint, an analysis based on the components is performed. Based on SIDS report on Sodium carbonate no in vitro mutagenicity was observed on bacteria test moreover, based on the structure no genotoxic effect are expected. Based on the SIDS report and EU-RAR about sodium hydroxide, no genotoxic effects were observed both on in vitro and in vivo tests. For Na2S, based on registration dossier data, no genotoxic effet were observed, on mammal in vitro test (Stone, 2010, Mutation at hrpt locus of mouse lymphoma L5178Y cells)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- other: HPRT mutation locus
Test material
- Reference substance name:
- Disodium sulphide
- EC Number:
- 215-211-5
- EC Name:
- Disodium sulphide
- Cas Number:
- 1313-82-2
- Molecular formula:
- Na2S
- IUPAC Name:
- disodium sulfide
- Reference substance name:
- Sodium sulfide, anhydrous
- IUPAC Name:
- Sodium sulfide, anhydrous
- Details on test material:
- - Name of test material (as cited in study report): Sodium sulfide, anhydrous
- Molecular formula (if other than submission substance): 78.04 g/mol
- Substance type: technical product
- Physical state: solid, slightly yellow granules
- Storage condition of test material: stored at 2 to 8°C in the dark, with desiccant and under nitrogen
Constituent 1
Constituent 2
Method
- Target gene:
- HPRT locus
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the sodium sulfide negative results (until 781 µg/mL), the multi-constituent is considered to not have genotoxic effects.
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.
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