2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

other: Expert assessment

Adequacy of study:

key study

Study period:

May 25, 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was performed for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) based on experimental data identified for its parent acid and amine components.

Data source

Reference

Reference Type:

other: Expert assessment

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

An assessment was undertaken to determine the capacity of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) to induce chromosome aberration in mammalian cells by review of reliable experimental data identified in the literature for the parent acid and amine components; 2-ethylhexanoic acid and 2-aminoethanol.

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

EC Number:

278-031-6

EC Name:

2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

Cas Number:

74931-55-8

Molecular formula:

C10H23NO3

IUPAC Name:

2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

Test material form:

liquid

Details on test material:

- Density: 0.999 g/cm3

Results and discussion

Test results

Key result

Species / strain:

other: Rat lymphocyte cells; rat hepatocytes (RL4)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: 2-Ethylhexanoic acid and 2-aminoethanol did not induce gene mutation in bacteria with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:

An assessment was undertaken based on experimental data identified for the parent acid and amine components; 2-ethylhexanoic acid and 2-aminoethanol, of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1). The registered substance is not expected to induce structural chromosomal aberration in mammalian cells and an experimental study is not required.

Executive summary:

To fulfil Annex VIII of REACH Regulation (EC) No. 1907/2007, the capacity of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) to induce structural chromosomal aberration in mammalian cells was evaluated. No experimental data was identified for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) for structural chromosomal aberration in mammalian cells following an extensive review. Therefore, experimental data identified for the parent acid and amine components; 2-ethylhexanoic acid and 2-aminoethanol, relating to in vitro structural chromosomal aberration in mammalian cells was reviewed for the purpose of the endpoint assessment. Given that the registered substance will dissociate in the event of exposure and its acid and amine components will behave independently in water, the mutagenicity of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) is anticipated to be driven by 2-ethylhexanoic acid and 2-aminoethanol. The study results indicated that the components were negative for structural chromosomal aberration in mammalian cells with and without metabolic activation and were regarded as reliable without restriction (Klimisch score = 1) or reliable with restrictions (Klimisch score = 2). According to the activity of the two components, 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) is not expected to induce structural chromosomal aberration in mammalian cells. An experimental study is not required.