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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:
Ames test
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 18 April, 1989 to 08 May, 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
S. Typhimurium TA102 and/or E.coli WP2 strains not included; conducted according to old version of Guideline
Justification for type of information:
Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification.

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)
Version / remarks:
the version of the OECD guideline should be specified: OECD 471 (1983).
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
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid

Method

Species / strain
Species / strain / cell type:
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 / solvent:
- Vehicle(s)/solvent(s) used: Water
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
Solvent control
Negative solvent / vehicle 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
Untreated negative controls:
yes
Remarks:
Solvent control
Negative solvent / vehicle 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
Untreated negative controls:
yes
Remarks:
Solvent control
Negative solvent / vehicle 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
Untreated negative controls:
yes
Remarks:
Solvent control
Negative solvent / vehicle 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
Untreated negative controls:
yes
Remarks:
Solvent control
Negative solvent / vehicle 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 experimental 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
Key result
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Preliminary toxicity test: Yes

Applicant's summary and conclusion

Conclusions:
Based on the results of the read across study, the test substance is not considered to be mutagenic in the presence and absence of exogenous metabolic activation.
Executive summary:

A study was conducted to determine the mutagenic potential of test substance, Coco TMAC (33% active in water), according to OECD 471 and EPA OPPTS 870.5265 Guidelines, in compliance with GLP. Using pour-plate assays, the test substance was examined for mutagenic activity in four strains of Salmonella typhimurium: TA 100, TA 1535, TA 1537 and TA 98 in the absence and in the presence of S9-mix. The test concentrations included 0, 1, 3, 10, 32 and 100 µg/plate (i.e., equivalent to 0, 0.33, 0.99, 3.3, 10.56 and 33 µg/plate). No increase in reversion to prototrophy was obtained with any of the bacterial strain at any concentration 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.Appropriate positive control chemicals (with S-9 mix where required) induced marked increases in revertant colony numbers with all strains, confirming sensitivity of the cultures and activity of the S-9 mix. Under the study conditions, the test substance was not mutagenic with and without metabolic activation (May, 1989).