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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:
From 18 April, 1989 to 08 May, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the OECD Guideline 471 and EPA OPPTS 870.5265 as well as in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Clear, colourless liquid
Details on test material:
- Batch: 01263LA
- Description: Clear, colourless liquid, contained in a glass screw-capped bottle. It was stored at room temperature and protected from light until required. The test substance was identified as a 33% aqueous solution.

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
1, 3, 10, 32 and 100 µg/plate for both with and without S9-mix
Vehicle:
- Vehicle(s)/solvent(s) used: Water
Controlsopen allclose all
Negative controls:
yes
Remarks:
Solvent control
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Tested with TA 1535, TA 100 in the absence of S-9 mix
Negative controls:
yes
Remarks:
Solvent control
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
Tested for TA 1535 in the presence and absence of S9 mix
Negative controls:
yes
Remarks:
Solvent control
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Tested for TA 1537 in the absence of S9-mix
Negative controls:
yes
Remarks:
Solvent control
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
Tested for TA 98 in the absence of S9-mix
Negative controls:
yes
Remarks:
Solvent control
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Tested for TA 1537, TA 100 and TA 98 in the presence and absence of S9 mix
Details on test system and conditions:
METHOD OF APPLICATION: In agar (pour-plate method)

DURATION
- Incubation period: 48 h at approximately 37°C

NUMBER OF REPLICATIONS: Three

DETERMINATION OF CYTOTOXICITY
- Method: Number of revertant colonies were counted, either manually or with a Biotran II automatic colony counter. Total colonies on nutrient plates were counted in the same way. Growth of the background lawn of non-revertant cells on minimal plates were verified.

Evaluation criteria:
The number of the revertants per plate of the tester strain is compared to the control.

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:
yes
Vehicle controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Preliminary toxicity test: Yes

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

Under the test conditions, the test substance is not considered to be mutagenic in the presence and absence of exogenous metabolic activation.
Executive summary:

An OECD 471 study was conducted to determine the mutagenic potential of C12-C18 TMAC. The test substance was examined for mutagenic activity in four strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium using pour-plate assays. The studies were performed in the absence and in the presence of S9-mix. Doses for studies ranged from 1 to 100 µg/plate.No increase in reversion to prototrophy was obtained with any of the bacterial strain at any dose level either in the presence or absence of S9-mix. Further, inhibition of growth, observed as thinning of the background lawn of non-revertant cells, occurred in all strains following exposure to the test substance at 100 µg/plate. Under the test conditions, C12-C18 TMAC is not mutagenic in the presence and absence of exogenous metabolic activation (May K, 1989).