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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 5 to 7, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
only 4 strains tested
GLP compliance:
yes
Remarks:
KoreaGLP
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
3‐benzoyl‐2,6‐bis({[3‐(‐lambda5‐diazynylidene)‐4‐oxo‐3,4‐dihydronaphthalen‐1‐yl]sulfonyl}oxy)phenyl 3‐(‐lambda5‐diazynylidene)‐4‐oxo‐3,4‐dihydronaphthalene‐1‐sulfonate
Cas Number:
11562-47-8
Molecular formula:
not applicable as UVCB
IUPAC Name:
3‐benzoyl‐2,6‐bis({[3‐(‐lambda5‐diazynylidene)‐4‐oxo‐3,4‐dihydronaphthalen‐1‐yl]sulfonyl}oxy)phenyl 3‐(‐lambda5‐diazynylidene)‐4‐oxo‐3,4‐dihydronaphthalene‐1‐sulfonate
Test material form:
solid

Method

Target gene:
his-operon
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:
S9-mix
Test concentrations with justification for top dose:
experiment I: 0, 8, 40, 200, 1000, 5000 µg/plate
experiment II: 6.9,20.6, 61.7, 185.2, 555.6, 1666.7 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
furylfuramide
other: 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation) (range-finding study (Experiment 1) and main experiment (Experiment 2))

DURATION
- Exposure duration: 48 - 72 h

NUMBER OF REPLICATIONS: triplicates (experiment I), duplicate (experiment I)

DETERMINATION OF CYTOTOXICITY
- Method: revertant colony number and microscopical inspection of the bacterial background lawn

The results of both experiments (exp.1 and 2) were used for determining the mutagenic properties of the test substance.
Evaluation criteria:
Results are judged as positive if the number of colony increases with dose-response and reaches 2 times that of the control, or if there is statistically significant increase in the number of colonies in any of the tester strains.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
In the presence of S9-mix, there was significant increase in the number of revertants in strain TA 1537, which reached up to 8 times that of the control and was reproducible.

Applicant's summary and conclusion

Conclusions:
The test item was mutagenic in the bacterial reverse mutation assay.
Executive summary:

The test item was tested for its mutagenic potential in bacterial cells according to OECD 471 with four Salmonella typhimurium strains (TA 100, TA 1535, TA 1537, TA 98). The following doses were tested:


experiment I: 0, 8, 40, 200, 1000, 5000 µg/plate


experiment II: 6.9,20.6, 61.7, 185.2, 555.6, 1666.7 µg/plate


In the presence of S9-mix, there was significant increase in the number of revertants in strain TA 1537, which reached up to 8 times that of the control and was reproducible. Therefore the test item was considered to be mutagenic in bacterial cells.

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