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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
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Reason / purpose:
read-across: supporting information
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
Reason / purpose:
read-across source
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Additional strain / cell type characteristics:
other: histidine dependent
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix derived from rat liver
Test concentrations with justification for top dose:
8-5000 μg/plate
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: 2-nitrofluorene, 2-aminoanthracene, 9-aminoacridine, N-methyl-N'-nitro-N-nitrosoguanidine
Details on test system and experimental conditions:
NUMBER OF REPLICATIONS: 2
Evaluation criteria:
Increases in reversion to prototrophy.
Key result
Species / strain:
other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results: negative

The test substance is not mutagenic both in the presence and absence of S-9.
Executive summary:

An Ames Salmonella typhimurium assay was performed to assess the mutagenicity of BP 8313. Duplicate testing was performed on the strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100, both in the presence and absence of metabolic activation. Test concentrations were between 8-5000 ug/plate. Positive controls substances were benzo(a)pyrene, 2 -nitrofluorene, 2 -aminoanthracene, 9 -aminoacridine, and N-methyl-N'-nitro-N-nitrosoguanadine. Positive control cultures had significantly increased number of revertant colonies. Test substance cultures exhibited no increase in the number of revertant colonies as compared to negative controls in cultures either with or without metabolic activation. The test substance is not mutagenic.

Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

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

Method

Species / strain
Species / strain / cell type:
other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Additional strain / cell type characteristics:
other: histidine dependent
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix derived from rat liver
Test concentrations with justification for top dose:
8-5000 μg/plate
Controls
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: 2-nitrofluorene, 2-aminoanthracene, 9-aminoacridine, N-methyl-N'-nitro-N-nitrosoguanidine
Details on test system and experimental conditions:
NUMBER OF REPLICATIONS: 2
Evaluation criteria:
Increases in reversion to prototrophy.

Results and discussion

Test results
Key result
Species / strain:
other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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: negative

The test substance is not mutagenic both in the presence and absence of S-9.
Executive summary:

An Ames Salmonella typhimurium assay was performed to assess the mutagenicity of BP 8313. Duplicate testing was performed on the strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100, both in the presence and absence of metabolic activation. Test concentrations were between 8-5000 ug/plate. Positive controls substances were benzo(a)pyrene, 2 -nitrofluorene, 2 -aminoanthracene, 9 -aminoacridine, and N-methyl-N'-nitro-N-nitrosoguanadine. Positive control cultures had significantly increased number of revertant colonies. Test substance cultures exhibited no increase in the number of revertant colonies as compared to negative controls in cultures either with or without metabolic activation. The test substance is not mutagenic.