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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Acceptably documented study which meets basic scientific principles Ethyl Alcohol is both reagents used in the manufacture, as well as decomposition products of xanthates. Therefore, the health effects of Ethyl Alcohol need to be considered in the assessment of potassium ethyl xanthate.

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
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

Constituent 1
Chemical structure
Reference substance name:
Ethanol
EC Number:
200-578-6
EC Name:
Ethanol
Cas Number:
64-17-5
Molecular formula:
C2H6O
IUPAC Name:
ethanol
Constituent 2
Reference substance name:
Ethyl Alcohol
IUPAC Name:
Ethyl Alcohol
Test material form:
other: liquid
Details on test material:
Ethyl Alcohol is both reagents used in the manufacture, as well as decomposition products of xanthates.
-Name of test material (as cited in study report):Ethyl Alcohol.Therefore, the health effects of Ethyl Alcohol need to be considered in the assessment of potassium ethyl xanthate.
-described as 'commercial solvent'.

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 (migrated information):
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.
Ethyl Alcohol is both reagents used in the manufacture, as well as decomposition products of xanthates. Therefore, the health effects of Ethyl Alcohol need to be considered in the assessment of potassium ethyl xanthate.
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.

Ethyl Alcohol is both reagents used in the manufacture, as well as decomposition products of xanthates. Therefore, the health effects of Ethyl Alcohol need to be considered in the assessment of potassium ethyl xanthate.