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Toxicological information

Genetic toxicity: in vitro

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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study which meets basic scientific principles, adequate for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: II. Results From the Testing of 270 Chemicals
Author:
Mortelmans K. et al.
Year:
1986
Bibliographic source:
Environ. Mutagenesis, 8, Suppl.7,|1-119, (1986)
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Method: other: after Haworth, S. et al.: Environ. Mutagen. 5, Suppl. 1, 3-142
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: TA1535, TA1537 or TA97, TA98, TA100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat and hamster metabolic activation
Test concentrations with justification for top dose:
up to 10 mg/plate, no further data available
Vehicle / solvent:
Distilled water
Controlsopen allclose all
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA1535 and TA100
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylenediamine
Remarks:
TA98
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA97 and TA1537
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
all strains
Details on test system and experimental conditions:
Type: Ames test
Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Species / strain:
other: TA1535, TA1537 or TA97, TA98, TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks:
but testes up to limit concentrations
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA1535, TA1537, TA97, TA98, TA100

Applicant's summary and conclusion