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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
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented peer-reviewed publication

Data source

Reference
Reference Type:
publication
Title:
A comparative analysis of data on the clastogenicity of 951 chemical substances tested in mammalian cell cultures
Author:
M. Ishidate Jr., M.C. Harnois and T. Sofuni
Year:
1988
Bibliographic source:
Mutation Research, 195 (1988) 151-213

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Reference substance name:
Aluminium potassium sulfate
IUPAC Name:
Aluminium potassium sulfate
Constituent 2
Chemical structure
Reference substance name:
Aluminium potassium bis(sulphate)
EC Number:
233-141-3
EC Name:
Aluminium potassium bis(sulphate)
Cas Number:
10043-67-1
Molecular formula:
Al.2H2O4S.K
IUPAC Name:
aluminium potassium bis(sulphate)

Method

Target gene:
A clonal sub-line of fibroblasts derivedfrom lung tissue (Koyama et al., 1970)
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
A clonal sub-line of fibroblasts derivedfrom lung tissue (Koyama et al., 1970)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
without
Test concentrations with justification for top dose:
1000 µg/ml = 3.9 mmol/L Aluminium potassium sulfate
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):negative without metabolic activationNOEL-48h for in vitro Mammalian Chromosome Aberration Test at Chinese hamster lung fibroblasts (V79 = 3.9 mmol/L = 1006 mg/Lfor aluminium potassium sulfate. Result: negative without metabolic activation.
Executive summary:

NOEL-48h for in vitro Mammalian Chromosome Aberration Test

at Chinese hamster lung fibroblasts (V79 = 3.9 mmol/L = 1006 mg/L for aluminium potassium sulfate.

Result: negative without metabolic activation.