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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 1537
Species / strain / cell type:
S. typhimurium TA 97
Species / strain / cell type:
S. typhimurium TA 98
Metabolic activation system:
S9
Test concentrations with justification for top dose:
concentrations for all test strains: 100, 333, 1000, 3333, 10000 μg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 2-Aminoantracene, 4-nitro-o-phenyl- enediamine
Details on test system and experimental conditions:
S9 in the S9 mixture (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver).

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Concentration denotes the the percentage of S9 in the S9 mixture (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) that was added to cultures.

Strain: TA100

S9 Activation

S9 Species

Concentration

No Activation

N/A

N/A

30% RLI

Rat

30%

30% HLI

Hamster

30%

10% RLI

Rat

10%

10% HLI

Hamster

10%

Strain: TA1535

S9 Activation

S9 Species

Concentration

No Activation

N/A

N/A

30% RLI

Rat

30%

30% HLI

Hamster

30%

10% RLI

Rat

10%

10% HLI

Hamster

10%

Strain: TA97

S9 Activation

S9 Species

Concentration

No Activation

N/A

N/A

30% RLI

Rat

30%

30% HLI

Hamster

30%

10% RLI

Rat

10%

10% HLI

Hamster

10%

Strain: TA98

S9 Activation

S9 Species

Concentration

No Activation

N/A

N/A

30% RLI

Rat

30%

30% HLI

Hamster

30%

10% RLI

Rat

10%

10% HLI

Hamster

10%

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the test substance is not mutagenic in the Salmonella typhimurium strains TA 97a, TA 98, TA 100 and TA 1535 in absence and presence of metabolic activation.
Executive summary:

A study was conducted to determine the mutagenic potential of the test substance according to Bacterial Reverse Mutation Test. The test substance was examined using four strains of Salmonella typhimurium (TA 97a, TA 98, TA 100 and TA 1535). The test was performed in the presence and absence of S9-mix (Sprague-Dawley rat or Syrian hamster liver S9-mix induced by Aroclor 1254). 5 concentrations were used for all test strains: 100, 333, 1000, 3333 and 10000 μg/plate. Positive and negative controls were included in the study. No significant increase of the number of revertant colonies could be observed at any of the treatment concentrations. Under the study conditions, the test substance was not mutagenic in the Salmonella typhimurium strains TA 97a, TA 98, TA1 00 and TA 1535 in absence and presence of metabolic activation (NTP, 1985).