Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline 471. GLP study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : Ultramarine Blue, C.I. Pigment Blue 29
- Material at sunlight until use, kept at room temperature away from heat and moisture

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
-Identity of media: Center of Japanese Baioatsusi
Species / strain / cell type:
E. coli WP2 uvr A
Details on mammalian cell type (if applicable):
-Identity of media: Center of Japanese Baioatsusi
Metabolic activation:
with and without
Metabolic activation system:
S9 from rat liver
Test concentrations with justification for top dose:
Test material dose:
0.50 - 1.50 - 5.00 - 15.00 - 50.00 mg/mL (313, 625, 1250, 2500, 5000 µg/plate)
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
water for injection
True negative controls:
no
Positive controls:
yes
Remarks:
without metabolic activation
Positive control substance:
other: 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide
Remarks:
TA 100, WP2 uvrA- 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide: 0.01 µg/plate
Negative solvent / vehicle controls:
yes
Remarks:
water for injection
True negative controls:
no
Positive controls:
yes
Remarks:
without metabolic activation
Positive control substance:
other: 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide
Remarks:
TA 98- 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide: 0.1 µg/plate
Negative solvent / vehicle controls:
yes
Remarks:
water for injection
True negative controls:
no
Positive controls:
yes
Remarks:
without metabolic activation
Positive control substance:
sodium azide
Remarks:
TA 1535- sodium azide: 0.5µg/plate
Negative solvent / vehicle controls:
yes
Remarks:
water for injection
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA 1537- 9-aminoacridine: 80µg/plate

Migrated to IUCLID6: without metabolic activation
Negative solvent / vehicle controls:
yes
Remarks:
water for injection
True negative controls:
no
Positive controls:
yes
Remarks:
with metabolic activation
Positive control substance:
other: 2-Aminoanthracene
Remarks:
TA 100 - 2-Aminoanthracene: 1µg/plate
Negative solvent / vehicle controls:
yes
Remarks:
water for injection
True negative controls:
no
Positive controls:
yes
Remarks:
with metabolic activation
Positive control substance:
other: 2-Aminoanthracene
Remarks:
TA 1535, TA 1537- 2-Aminoanthracene: 2µg/plate
Negative solvent / vehicle controls:
yes
Remarks:
water for injection
True negative controls:
no
Positive controls:
yes
Remarks:
with metabolic activation
Positive control substance:
other: 2-Aminoanthracene
Remarks:
WP2 uvrA- 2-Aminoanthracene: 10 µg/plate
Negative solvent / vehicle controls:
yes
Remarks:
water for injection
True negative controls:
no
Positive controls:
yes
Remarks:
with metabolic activation
Positive control substance:
other: 2-Aminoanthracene
Remarks:
TA 98- 2-Aminoanthracene: 0.5 µg/plate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium made of minimal glucose agar
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

Results and discussion

Test resultsopen allclose all
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
Species / strain:
E. coli WP2 uvr A
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

The result was that the test material is not mutagenic.
Executive summary:

The aim of the test was to assess the potential of test material to induce a point mutation at the histidine-requiring gene locus in strains of Salmonella typhimurium and E.coli.

The test procedure used was the OECD guideline 471.

Test material doses were: 0.50 - 1.50 - 5.00 - 15.00 - 50.00 mg/mL

The result was that the test material is not mutagenic.