Brightener 0503E

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:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

study performed as plate incorporation test (experiment I) and as pre-incubation test (experiment II);

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Method

Target gene:

TA 1537: his C 3076; rfa-; uvrB-
TA 98: his D 3052; rfa-; uvrB-; R-factor
TA 1535: his G 46, rfa-; uvrB-;
TA100: his G 46; rfa-; uvrB-, R-factor
WP2 uvrA: trp-. uvrA-

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

from rat liver S9

Test concentrations with justification for top dose:

Pre-experiment/ experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate;
experiment II: 33, 100, 333, 1000, 2500 and 5000 µg/plate

Vehicle / solvent:

deionised water

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA

Positive control substance:

other: 2-aminoanthracene

Remarks:

with activation

Controls 2

Positive controls:

yes

Remarks:

TA 1535, TA 100

Positive control substance:

sodium azide

Remarks:

without activation

Controls 3

Positive controls:

yes

Remarks:

TA 1537, TA 98

Positive control substance:

other: 4-nitro-o-phenylene-diamine

Controls 4

Positive controls:

yes

Remarks:

WP2 uvrA

Positive control substance:

methylmethanesulfonate

Remarks:

without activation

Details on test system and experimental conditions:

DURATION
- Preincubation period: 60 min at 37°C
- Exposure duration: 48 h at 37°C

Results and discussion

Test results

Test results 1

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:

cytotoxicity

Remarks:

>5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>5000 µg/plate

Vehicle controls validity:

valid

Untreated negative 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

During the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, Leucophor 0503 E is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay with and without metabolic activation.

Executive summary:

During the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test item is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay with and without metabolic activation.