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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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 bis sulphate. Result: negative

Link to relevant study records
Reference
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
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
Target gene:
A clonal sub-line of fibroblasts derivedfrom lung tissue (Koyama et al., 1970)
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
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
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'.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro and in vivo:

Based on the well documented in vitro Mammalian Aberration key study from Ishidate et al. and the other supporting and

Weight of Evidence studies the resulting NOEL-48h for in vitro Mammalian Chromosome Aberration Test at Chinese

hamster lung fibroblasts V79 is NOEL = 3.9 mmol/L = 1006 mg/L for aluminium potassium bis sulphate.

Result: negative

Based on the negative results of all available in vitro and in vivo studies the substance is not classified as genetic toxic according to regulation (EC) No. 1272/2008.


Justification for selection of genetic toxicity endpoint
Well documented study according OECD guideline 473 (In vitro Mammalian Chromosome Aberration Test)

Justification for classification or non-classification

Based on the negative results of all available in vitro and in vivo studies the substance is not classified as genetic toxic according to regulation (EC) No. 1272/2008.