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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
Study period:
year of publication: 1987
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Salmonella Mutagenicity Test: III. Results From the Testing of 255 Chemicals
Author:
Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W
Year:
1987
Bibliographic source:
Environmental Mutagenesis 9 (Suppl. 9): 1-110
Report Date:
1987
Reference Type:
publication
Title:
Salmonella Mutagenicity Test Results for 250 chemicals
Author:
Haworth S, Lawlor T, Mortelmans K, Speck W, Zeiger W
Year:
1983
Bibliographic source:
Environmental Mutagenesis (Suppl. 1): 3-142
Report Date:
1983

Materials and methods

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:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat or hamster liver S9 mix
Test concentrations with justification for top dose:
100, 333, 1000, 3333, 10000 µg/plate
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: sodium azide (TA 1535, TA 100), 9-aminoacridine (TA 1537), 4-nitro-o-phenylenediamine (TA98)
Remarks:
without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
with metabolic activation
Evaluation criteria:
An individual trial was judged as:
- mutagenic: if dose-related increase over the corresponding solvent control was seen
- weakly mutagenic: if low-level dose response
- questionable: if dose-related increase was judged to be insufficiently high to be called weakly mutagenic or only a single dose was elevated or a non -dose-related increase was seen

A chemical was judged mutagenic, if it produced a reproducible, dose-related increase in revertants over the corresponding solvent control in replicate trials.

Results and discussion

Test results
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
Untreated negative controls validity:
not examined
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