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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1988
Reference Type:
publication
Title:
The Ames Salmonella/microsome mutagenicity assay
Author:
Mortelmans, K., Zeiger, E.
Year:
2000
Bibliographic source:
Mutat Res. 2000 Nov 20, 455 (1-2), 29-60

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Mortelmans, K., Zeiger, E., Ames Salmonella/microsome mutagenicity assay, Mutat Res. 2000 Nov 20, 455 (1-2), 29-60
Principles of method if other than guideline:
This review provides historical aspects of how the Ames was developed and detailed procedures for performing the test, including the design and interpretation of results.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N, N´-Diethylcarbanilide

Method

Target gene:
gene for synthesis of histidine
Species / strain
Species / strain / cell type:
other: TA100, TA1535, TA97, TA98
Additional strain / cell type characteristics:
other: histidine dependent strain
Metabolic activation:
with and without
Metabolic activation system:
Hamster, liver, s-9, aroclor 1254 (10%, 30%), Rat, liver, s-9, aroclor 1254 (10%, 30%)
Test concentrations with justification for top dose:
3, 10, 33, 100, 166, 333, 666, 1000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 2-aminoanthracene, 4-nitro-o-phenylenediamine
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar DURATION- Preincubation period: 20 min- Exposure duration: 2 daysNUMBER OF REPLICATIONS: 3DETERMINATION OF CYTOTOXICITY- Method: decrease in the number of his+ colonies, or a cleaning in the density of the background lawn, or both
Evaluation criteria:
Evaluations were made at both the individual trial and overall chemical levels.Individual trials were judged mutagenic (+), weakly mutagenic (+W), questionable (?), or nonmutagenic (-) depending on the magnitude of the increase of his+ revertants, and the shape of the dose-response. A chemical was judged mutagenic (+) or weakly mutagenic (+W) if it produced a reproducible dose-related response over the solvent control in replicate trials. A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increase in his+ revertants did not meet the criteria for a "W+" response, or if only single doses produced increases in his+ revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet criteria for a mutagenic or questionable response.

Results and discussion

Test results
Species / strain:
other: TA100, TA1535, TA97, TA98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative 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 with metabolic activationnegative without metabolic activationEthyl centarlite was found nonmutagenic under conditions of test.