2-ethylhexan-1-ol

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

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Deviations:

no

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexan-1-ol

EC Number:

203-234-3

EC Name:

2-ethylhexan-1-ol

Cas Number:

104-76-7

Molecular formula:

C8H18O

IUPAC Name:

2-ethylhexan-1-ol

Details on test material:

- Source: Wako Pure Chemcials Industries, Osaka,, Japan
- Purity 2-EH: 98%

Method

Species / strain

Species / strain / cell type:

other: bacteria. S. typhimurium TA98, TA100, TA1535, TA1537; TA1538; E. coli (WP2uvrA)

Additional strain / cell type characteristics:

other:

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9 mix from polychlorinated biphenyl KC 500) induced male animals

Test concentrations with justification for top dose:

0, 1, 5, 10, 50, 100, 500, 1000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: experiments w/o S9 mix: AF-2 for TA100, TA 98, WP2uvrA; ENNG for TA 1535; 9AC for TA 1537, 4NQO for TA 1538; experiments with S9 mix: B(a)P for TA 100, TA 98, TA 1537 and TA 1538, 2AA for TA 1535 and WP2uvrA

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; preincubation;

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours

SELECTION AGENT (mutation assays): histidine or tryptophan deficiency
SPINDLE INHIBITOR (cytogenetic assays): not applicable (n..a.)
STAIN (for cytogenetic assays): n.a.

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: n.a.

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: no data

OTHER EXAMINATIONS:
- Determination of polyploidy: no
- Determination of endoreplication: no

Evaluation criteria:

no data

Statistics:

no data

Results and discussion

Test results

Species / strain:

other: S. typhimurioum and E.coli

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS

ADDITIONAL INFORMATION ON CYTOTOXICITY: growth inhibition was noted in all test strains except TA1537 at 500 and 1000 µg/plate

Remarks on result:

other: other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538; E. coli (WP2 uvrA)

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Except for TA 1537 toxicity was observed at doses of 500 and 1000 µg/plate in
all tester strains.
  

Mean number of revertants:

Dose (µg/plate)	TA100		TA1535		E. coli WP uvrA		TA98
	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
0 water	149	161	28	15	32	33	29	39
0 DMSO	150	154	30	15	30	34	32	42
1	144	170	39	23	32	31	24	44
5	166	171	23	19	30	26	33	61
10	161	149	26	18	27	31	29	48
50	155	147	33	13	26	33	28	57
100	133	151	19	14	28	33	37	51
500	0*	0*	0*	0*	0*	0*	0*	0*
1000	0*	0*	0*	0*	0*	0*	0*	0*
Positive control	501	1084	1101	440	1082	359	278	809

Dose (µg/plate)	TA1537		TA1538
	-S9	+S9	-S9	+S9
0 water	16	21	21	28
0 DMSO	18	22	22	28
1	13	36	25	24
5	11	28	33	30
10	15	23	29	25
50	16	30	25	30
100	12	26	18	30
500	12	39	0*	0*
1000	16	28	0*	0*
Positive control	889	313	270	354

0* = growth inhibition

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

2-EH was not mutagenic in Salmonella typhimurium and E. coli with and without metabolic activation.

Executive summary:

The mutagenicity of 2 -EH was tested in bacterial test sytems (S. tyhimurium TA98, TA100, TA1535, TA1537, TA1538, and E. coli WP2 uvrA) according to OECD TG 471 and TG 472 both with and without metabolic activation in a dose range from 1 to 1000 µg/plate (Shimizu et al., 1985). 2 -EH did not increase the number of revertants in any of the test strains. Growth inhibition was seen at 500 and 1000 µg/plate. The negative and positive controls performed as expected. Therefore, 2 -EH was not mutagenic in baterial test systems in-vitro.