Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Some information in this page has been claimed confidential.

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:
guideline study with acceptable restrictions
Remarks:
Well performed GLP and OECD guideline study, but using a different set of tester strains

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Using a different set of tester stains
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Test material form:
solid: bulk

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254(R) induced rat liver S9-mix
Test concentrations with justification for top dose:
Experiment I: 0, 4, 20, 100, 500, 2500, 10000 µg/plate
Experiment II: 0, 4, 20, 100, 500, 2500, 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO

Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Na-azide, 9-aminoacridine, 2-nitrofluorene, benzo[a]pyrene, 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION:
in agar (plate incorporation)

DURATION
- Exposure duration: incubation for at least 48 to 72 hours at 37°C

NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls, two independent experiments

Evaluation criteria:
Positive:

The test compound cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or presence
of S-9 Mix.

A dose dependent effect was obtained.


Negative:

The test compound does not cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or presence
of S-9 Mix.

No dose dependent effect was obtained.
Statistics:
Arithmetic means of the counted colonies were calculated.

Results and discussion

Test results
Key result
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
incipient at 500 µg/plate without metabolic acivation
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

The test item did not cause a significant increase in the number of revertant colonies with any of the tester strains in the Salmonella typhimurium reverse mutation assay (plate incorporation test) either in the absence or presence of metabolic activation. No dose dependent effect was observed. Therefore the test item is not considered to be mutagenic under the conditions in this Salmonella typhimurium reverse mutation assay.
Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhymurium strains 1535, 1537, 98, 100 and 1538 with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0, 4, 20, 100, 500, 2500, 5000 and 10 000 µg/plate (experiment I) and concentrations of

0, 4, 20, 100, 500, 2500, 5000 µg/plate (experiment II). Each concentration was tested in triplicate. Initial Toxic effects and precipitation were evident at 500 µg/plate.

Under the conditions tested the test compound did not cause a significant increase in the number of revertant colonies and no dose dependent effect was observed. Therefore the test item is not considered mutagenic under the conditions in this Salmonella typhimurium reverse mutation assay.