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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)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication, which meets basic scientific principles

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

Principles of method if other than guideline:
Bacterial reverse mutation assay (Ames test)
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
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
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
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes 37°C without shaking
- Exposure duration: 2 days

NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including the controls; experiments were repeated

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
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: was observed at all tested concentrations, the revertant colonies were counted manually

Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test item showed no mutagenic activity in the preincubation test performed with modifications similar to Prival with (induced rat and hamster liver S9) and without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test item did not exert mutagenic activity in the reverse bacterial mutation assay (preincubation assay, also with Prival modification) with and without metabolic activation.
Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhimurium strains TA 1535, TA 1537, TA98 and TA100 with (Aroclor 1254-induced rat liver S9 mix or with Aroclor 1254-induced hamster liver S9 mix; i.e. modified Prival test) and without metabolic activation at concentrations of 100, 333, 1000, 3333 and 10000 µg/plate using the preincubation method.

The test item did not reveal any mutagenic activity under the conditions tested. The appropriate reference mutagenes showed distinct positive mutagenic effects.