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Toxicological information

Genetic toxicity: in vitro

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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:
1988
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

Constituent 1
Chemical structure
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

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.