Reaction mass of glycyl-L-glutamine 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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted with a supporting substance, but according to EU method B.13/14 and is fully GLP-compliant. As no study for the reaction mass of Glycyl-L-glutamine and potassium chloride is available, studies conducted with the two main components L-glycyl-L-glutamine and potassium chloride (such as this) were used for read-across in order to avoid unnecessary repitition of testing. As no synergistic or antagonistic effects from either of the main components are expected, the information derived from both main components is considered to be reliable for classification of the reation mass of Glycyl-L-glutamine and potassium chloride.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid

EC Number:

700-144-0

Cas Number:

13115-71-4

Molecular formula:

C7H13N3O4

IUPAC Name:

(2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

62, 185, 556, 1667, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Migrated to IUCLID6: for TA1535 and TA 100 without S9-mix

Controls 2

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: for TA1537 without S9-mix

Controls 3

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

Migrated to IUCLID6: for TA98 without S9-mix

Controls 4

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene for all strains with S9-mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: no
- Exposure duration: 3 days

NUMBER OF REPLICATIONS: 3

Evaluation criteria:

A positive response in the assay system is taken to be a two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background spontaneous reversion rate observed with the vehicle, together with evidence of a dose-response.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

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 with metabolic activation
ambiguous without metabolic activation

The test substance did not show mutagenic activity in Salmonella typhimurium TA1535, TA1537, TA98 or TA100 (with and without S-9 mix).