Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide

Data source

Reference
Reference Type:
publication
Title:
Detection of carcinogens as mutagens in the Salmonella/microsome terst: Assay of 300 chemicals.
Author:
McCann, J., Choi, E., Yamasaki, E., Ames, B.N.
Year:
1975
Bibliographic source:
Proc Nat Acad Sci 1975;72(12):5135-5139.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only two bacterial strains tested.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
-Name of test material (as cited in study report):Ethyl Alcohol.
-described as 'commercial solvent'.
Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Metabolic activation:
with
Metabolic activation system:
rat liver S9
Test concentrations with justification for top dose:
Not specified for this compound but typically 10, 100, 500, 1000 microgram/plate. (10,000 known also to have been tested).
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
benzo(a)pyrene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
There were < 70 revertants per 10mg/plate tested.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Salmonella/microsome

Any other information on results incl. tables

There were < 70 revertants per 10mg/plate tested.

Applicant's summary and conclusion

Conclusions:
Interpretation of results :negative

As part of a study of the mutagenic potential of 300 chemicals, ethanol was evaluated in a bacterial reverse mutation (Ames) assay at a plate concentration of up to 10mg/plate in the presence of metabolic activation. There was no evidence of mutagenicity in either of the two strains examined (TA98, TA100). . It should be noted that only two of the normal four bacterial strains were evaluated, so the study cannot be regarded as complete or definitive.
Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide
Executive summary:

As part of a study of the mutagenic potential of 300 chemicals, ethanol was evaluated in a bacterial reverse mutation (Ames) assay at a plate concentration of up to 10mg/plate in the presence of metabolic activation. There was no evidence of mutagenicity in either of the two strains examined (TA98, TA100). . It should be noted that only two of the normal four bacterial strains were evaluated, so the study cannot be regarded as complete or definitive.

Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide