Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 4 strains used instead of 5 as required by the respective guideline

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only 4 strains were used instead of 5
Principles of method if other than guideline:
Preincubation assay as described by Haworth et al (1983): Environ Mutagen 5[Suppl 1], 3-142
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium chloride
EC Number:
231-211-8
EC Name:
Potassium chloride
Cas Number:
7447-40-7
Molecular formula:
ClK
IUPAC Name:
potassium chloride
Details on test material:
purity 99.99 %

Method

Target gene:
not mentioned in the publication
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA100, TA1535, TA1537
Additional strain / cell type characteristics:
other: no details described
Metabolic activation:
with and without
Metabolic activation system:
S9-liver fractions of male Sprague-Dawley rats and male Syrian hamsters induced with Aroclor 1254
Test concentrations with justification for top dose:
0.000, 100.000, 333.000, 1000.000, 3333.000, 10000.000 µg/plate
Vehicle / solvent:
destilled water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: sodium azide, 4-nitro-o-phenylene diamine, 9-aminoacridine, 2-aminoanthracene
Details on test system and experimental conditions:
IUCLID4 Type: Ames test
Evaluation criteria:
positive response: dose-related reproducible increase in the number of revertants over background even if the increase was less than twofold
questionable response: absense of a clear-cut dose-reated increase of revertants or when the response was not reproducible
negative response: when no increase in the number of revertants was elicited by the chemical
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

In a Salmonella Test using TA100, TA1538, TA1537 and TA98 , doses of KCl betwen 0 and 10000 mg/plate were tested with and without metabolic activation. No significant increases in mutation frequencies were noted (Mortelmans 1986)