Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication meeting basic scientific principles

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Evaluation of Di-(2-EthylhexyI)phthalate and Its Major Metabolites in the Ames Test and L5178Y Mouse Lymphoma Mutagenicity Assay

Author:

Kirby, P.E. et al.

Year:

1983

Bibliographic source:

Environmental Mutagenesis 5, 657-663

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

duplicates instead of triplicates, no data on cytotoxicity in main experiment

Principles of method if other than guideline:

The Salmonella/mammalian microsome plate incorporation assay was conducted according to the procedures described by Ames et al. [1975] using strains TA- 98, TA-100, TA-1535, TA-1537, and TA-1538.

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:

- Name of test material (as cited in study report): 2-Ethylhexanol
- CAS No. of test material (as cited in study report): 104-76-7
- Analytical purity: 99.7% (GC)
- Impurities (identity and concentrations): 0.3% 2-Ethyl-4-methyl pentanol
- Source: purchased from Union Carbide Corporation

Method

Target gene:

His operon

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced liver microsomes prepared from male Sprague-Dawley rats

Test concentrations with justification for top dose:

0, 0.01, 0.05, 0.25, 0.5 and 1.0 µL/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO at 50 µL/plate

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene at 1 μg/plate without metabolic activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO at 50 µL/plate

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

Migrated to IUCLID6: at 10.0 μg/plate for TA-98 and TA-1538

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO at 50 µL/plate

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 1,3-propane sulfone at 0.04 μl/plate for TA-100; and TA-1535

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO at 50 µL/plate

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: at 75.0 μg/plate for TA-1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation);

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: Duplicates (positive controls in triplicates)

DETERMINATION OF CYTOTOXICITY
- Method: background growth

All control and test plates were incubated at 37°C for 48 hours.
Plates were checked for appearance of normal background growth and revertant colonies were counted.
All assays were run with duplicate plates with and without Aroclor 1254-induced liver microsomes prepared from male Sprague-Dawley rats.

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: only data from preliminaryt testing reported (see below)

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Preliminary toxicity studies using Salmonella typhimurium tester strain TA-100 indicated that 2-ethylhexanol was cytotoxic at concentrations greater than 1 µL/plate.

Any other information on results incl. tables

Table 1: Summary of Ames test results

	Maximum number of revertants
	solvent control		positive control		treatment (at dose level [µL/plate])
Strain	With S9	Without S9	With S9	Without S9	With S9	Without S9
TA 98	43	23	727	778	38 (0.25)	28 (0.01)
TA 100	124	141	903	800	144 (0.05)	159 (0.25)
TA 1535	15	34	104	1035	17 (0.25)	35 (0.25)
TA 1537	12	9	59	1835	11 (0.01)	10 (0.05)
TA 1538	17	8	448	1545	23 (1.0)	10 (0.5)

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative