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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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.