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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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.