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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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Equivalent to guideline study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Salmonella mutagenicity tests: V. Results from the testing of 311 chemicals
Author:
Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K
Year:
1992
Bibliographic source:
Environ Mol Mutagen 19: 2-141
Reference Type:
other: database
Title:
Acetone, CAS Number: 67-64-1, Study type: Salmonella, Study ID: 230717
Author:
National Toxicology Program (NTP)
Year:
1986
Bibliographic source:
http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetone
EC Number:
200-662-2
EC Name:
Acetone
Cas Number:
67-64-1
Molecular formula:
C3H6O
IUPAC Name:
propan-2-one
Details on test material:
- Name of test material (as cited in study report): acetone
- Analytical purity: > 99%

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 97, TA 98, TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced hamster liver S-9 mix and Aroclor 1254-induced rat liver S-9 mix; S-9 concentrations were 10% and 30% except for strain TA 1537 with 30% only
Test concentrations with justification for top dose:
0, 100, 333, 1000, 3333, 10,000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation in suspension in capped tubes to prevent evaporation

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days

SELECTION AGENT (mutation assays): histidine inpendency

NUMBER OF REPLICATIONS: triplicate plus repeat experiment

DETERMINATION OF CYTOTOXICITY
- Method: decrease of his+ colonies or clearing in the density of the background lawn or both

POSITIVE CONTROLS
- without metabolic activation: sodium azide for TA 1535 and TA 100, 9-aminoacridine for TA 97 and TA 1537, 4-nitro-o-phenylenediamine for TA98 and TA 1538
- with metabolic activation: 2-aminoanthracene
Evaluation criteria:
mutagenic or weakly mutagenic response: reproducible, dose-related response over solvent control
questionable response: results of inidvidual trials not reproducible, no dose-related response, only single doses producing increases in revertants

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 97
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with
Genotoxicity:
ambiguous
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: 10% and 30% hamster liver S-9 and 10% rat liver S-9 as activation system
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Overview on test results

 Strain  metabolic activation              Overall result
   no  10% hamster S-9   30% hamster S-9   10% rat S-9   30% rat S-9  
 TA 1535  -  -  -  -  -  -
 TA 1537  -  no data  -  no data  -  -
 TA 97  -  -  -  -  questionable a  -
 TA 98  -  -  -  -  -  -
 TA 100  -  -  -  -  -  -

 a mean revertants at 0, 100, 333, 1000, 3333, 10,000 µg/plate: 127, 174, 168, 177, 177, 173

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

There was no evidence of a genotoxic potential of acetone in the Salmonella typhimurium reverse mutation assay with and without metabolic activation up to a concentration of 10 mg/plate.
Executive summary:

The genotoxic potential of acetone was investigated in Salmonella typhimurium strains TA 1535, TA 1537, TA 97, TA 98 and TA 100 with and without metabolic activation in concentrations ranging from 100 to 10,000 µg/plate with a test protocol comparable to OECD guideline 471. Test results were negative except for a questionable result (constant increase of revertant rate above vehicle control over the whole concentration range tested) with the strain TA 97 in the assays with metabolic activation with 30 % rat liver S-9. In contrast, all other tests with TA 97 and with metabolic activation with 10 % or 30 % hamster liver S-9 or 10 % rat liver S-9 were unequivocally negative. In summary, there was no evidence of a genotoxic potential of acetone in the Salmonella typhimurium reverse mutation assay with and without metabolic activation up to a concentration of 10 mg/plate.