2-ethylhexane-1,3-diol

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

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 results

Test results 1

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

Test results 2

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.