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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihydro-5-octylfuran-2(3H)-one
EC Number:
218-971-6
EC Name:
Dihydro-5-octylfuran-2(3H)-one
Cas Number:
2305-05-7
Molecular formula:
C12H22O2
IUPAC Name:
Dihydro-5-octylfuran-2(3H)-one

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 1537
Species / strain / cell type:
E. coli WP2
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
2-nitrofluorene
sodium azide
other: Nitrofurantoine; 4-Nitro-1,2-phenilendiammine
Details on test system and experimental conditions:
In phase A, Salmonella typhimurium TA100 was exposed to 5 different concentrations of test substance (C1-C5), prepared with a √10 dilution factor. As cytotoxicity may vary in the presence of metabolic activation systems, the test was carried out in presence and in absence of S9 (-S9; +S9). The highest concentration (C1) was 5 μl/plate, the highest allowed in the test. This solution resulted completely dissolved.
In phase B, the 5 bacteria strains were exposed to 5 different concentrations of test substance prepared with a √10 dilution factor, in presence and in absence of a metabolic activation system (-S9; +S9). The concentrations were selected according to the preliminary cytotoxicity test, including the first cytotoxic concentration: 0.16 μl/plate (C4) for testing in the absence of metabolic activation system (-S9) and 0.5 μl/plate (C3) for testing in the presence of metabolic activation system (+S9).

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion