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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A standard protocol under GLP was used and results were found to be valid by peer review prior to publication.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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:
2-ethylhexane-1,3-diol
EC Number:
202-377-9
EC Name:
2-ethylhexane-1,3-diol
Cas Number:
94-96-2
Molecular formula:
C8H18O2
IUPAC Name:
2-ethylhexane-1,3-diol
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): 2-ethyl-1,3-hexanediol (EHD)
- Molecular weight (if other than submission substance): 146.2
- Substance type: viscous liquid
- Physical state: liquid
- Analytical purity: 99.18%
- Impurities (identity and concentrations): 0.36% monbutyrate ester isomers, and < 0.10% each of other unidentified impurities.
- Stability under test conditions: stable
- Source: Union Carbide Co., Danbury, CT

Method

Target gene:
histidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium, other: TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 rat liver fraction from male Arochlor 1254-treated CD rats, obtained from Microbiological Associates (Bethesda, MD, USA).
Test concentrations with justification for top dose:
0.3, 0.9, 2.8, 9.4 and 28 µl/plate, for both conditions of metabolic activation
Vehicle / solvent:
100% ethanol
Controls
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene and 4-nitro-o-phenylenediamine
Remarks:
with and without S9 activation, respectively. Concentration was 10 µg/plate for both substances.
Details on test system and experimental conditions:
The plate incorporation method of Ames BN, McCann J and Yamasaki E, Mutation Research 31: 347, 1975, was used, with modifications according to Maron DM and Ames BN, Mutation Research, 113:173, 1983.


NUMBER OF REPLICATIONS:

NUMBER OF CELLS EVALUATED:

DETERMINATION OF CYTOTOXICITY: not reported. Cytotoxic concentrations were determined in preliminary dose-finding experiments, using triplicate plates/dose. Two of five doses were above 5000 µg/plate.
Evaluation criteria:
A dose-related increase which was at least two-fold higher than the concurrent solvent control for two consecutive doses was the evaluation criteria for a positive result.

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, other: TA 1538
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
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

2-Ethyl-1,3-hexanediol (EHD) was evaluated as negative (nongenotoxic) in the Ames assay.
Executive summary:

A bacterial reverse mutation assay was conducted on 2-ethyl-1,3-hexanediol (EHD), < 99% purity. The procedure used was according to standard protocols originally published by Ames BN, McCann J and Yamasaki E, 1975, and Maron DM and Ames BN, 1983. Five strains of Salmonella typhimurium were tested, TA 1535, TA 1537, TA 1538, TA 98 and TA 100, with and without metabolic activation (S9 rat liver fraction from male Arochlor 1254-treated CD rats, obtained from Microbiological Associates (Bethesda, MD, USA). Positive results were defined as a doubling of the background mutation rate, and positive controls were 2-aminoanthracene (10 µg/plate) without S9 and 4-nitro-o-phenylenediamine (10 µg/plate) with S9 activation. EHD was tested at concentrations up to cytotoxic levels, with and without S9 activation, with no increase in mutation rate. The substance is evaluated as nonmutagenic under conditions of this assay.