Reaction mass of glycyl-L-tyrosine hydrochloride and potassium chloride

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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)