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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:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from study report

Data source

Reference
Reference Type:
other: study report
Title:
Study Type: Genetic Toxicology Bacterial Mutagenicity
Author:
National Institute of Environmental Health Sciences
Year:
2016
Bibliographic source:
NTP Study ID: A02552

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as per below mentioned
Principles of method if other than guideline:
Gene mutation assay was conducted to test the potential of test substance.
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl formate
EC Number:
203-721-0
EC Name:
Ethyl formate
Cas Number:
109-94-4
Molecular formula:
C3H6O2
IUPAC Name:
ethyl formate
Details on test material:
Details on test material
- Name of test material (as cited in study report): Ethyl formate
- Molecular formula (if other than submission substance): C3-H6-O2
- Molecular weight (if other than submission substance): 74.0784
- Substance type: Organic
- Physical state: Liquid
Purity
- Impurities (identity and concentrations):

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: Salmonella strains TA 100 and TA 98
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
10% RLI
Test concentrations with justification for top dose:
0, 1000,2500, 5000,7500, 10000µg/plate
Vehicle / solvent:
Dimethyl Sulfoxide
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; preincubation
Evaluation criteria:
No. of revertants
Statistics:
No data available

Results and discussion

Test results
Species / strain:
S. typhimurium, other: Salmonella typhimurium strains TA-100 and TA-98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
Test substace was considered to be non mutagenic in salmonella strains TA 100 and TA 98 with and without activation.
Executive summary:

Mutagenecity potential of test substance was determined in bacterial strain by AMES assay. The test substance was exposed to salmonella strains TA98 and TA 100 with and without metabolic activation at concentrations of 0,1000,2500, 5000, 7500, 10000, µg/plate. No mutagenic effects were observed in the study both in the presence and absence of metabolic activation. Based on the results obtained the test substance was considered to be non mutagenic with and without activation. Hence the substance cannot be classified as gene mutant in vitro.