Registration Dossier
Registration Dossier
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EC number: 231-588-9 | CAS number: 7646-78-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity studies on selected organosilicon compounds: in vitro assays
- Author:
- Isquith, A., Matheson, D., and Slesinski, R.
- Year:
- 1 988
- Bibliographic source:
- Fd. Chem. Toxic. 26, 255-261
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The procedure by Clive and Spector (Mutat. Res., 31, 17-29, 1975) was modified.
Fischer’s medium for Leukemic cells of mice with 10% horse serum and sodium pyruvate and those with 20% horse serum, sodium pyruvate and 0.37% agar were used for maintaining and cloning, respectively. - GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Hydrogen chloride
- EC Number:
- 231-595-7
- EC Name:
- Hydrogen chloride
- Cas Number:
- 7647-01-0
- Molecular formula:
- ClH
- IUPAC Name:
- chloride
- Test material form:
- gas
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Mouse lymphoma cell line L5178Y TK+/-
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Without activation : Ethylmetanesulfonate 0.5 uL/mL Witht activation : Dimethylnitrosoamine 0.3 uL/mL
Results and discussion
Test results
- Key result
- Species / strain:
- other: Mouse lymphoma cell line L5178Y TK+/-
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Cytotoxic concentration: z With metabolic activation: 0.8 uL/mL (100% growth inhibition) z Without metabolic activation: ca 1.0 uL/mL (12.5% growth inhibition at 0.8 uL/mL)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: -
Applicant's summary and conclusion
- Conclusions:
- enotoxic effects (positive, negative, unconfirmed, dose-response, equivocal)z With metabolic activation: Negative z Without metabolic activation: Negative
Negative result was obtained in the systems.
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