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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test (OECD 471): negative in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA with and without metabolic activation

Chromosome aberration test (OECD 473): negative in human lymphocytes with and without metabolic activation

Gene mutation in mammalian cells (OECD 476): negative in mouse lymphoma cells (L5178Y) with and without metabolic activation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for read-across

There are substance-specific data available in regard to genetic toxicity in bacteria for Decyl 2-Ethylhexanoate (CAS 93777-46-9). However, no measured/experimental data for genetic toxicity are available for Decyl 2-Ethylhexanoate (CAS 93777-46-9) in regard to clastogenicity or mutagenicity in mammalian cells. To fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.4, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.

According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.

 

For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).

 

As no reliable measured/experimental data are available on clastogenicity and genetic toxicity in mammalian cells, read-across to reliable data on the analogue substance 2-Ethylhexyl oleate (CAS 26399-02-0) was conducted.

 

Genetic toxicity in bacteria (Ames)

CAS93777-46-9

The in vitro genetic toxicity of Decyl 2-Ethylhexanoate (CAS 93777-46-9) was assessed in a bacterial reverse mutation assay (Ames test) according to GLP criteria and OECD 471 (Spruth, 2015). The mutagenic potential of the test substance was assessed inS. typhimuriumtester strains including TA 98, 100, 1535 and 1537 and WP2 uvr A bacterial cells at concentrations up to 5000 µg/plate in 2 independent experiments, including the plate incorporation and preincubation method. Precipitates were visible in the plate incorporation test starting at a concentration of 512 µg/plate (TA 100 and WP2 uvr A) and 1600 µg/plate (TA 98, 1535 and 1537). In the preincubation test, precipitates occurred at the highest dose tested (all strains). The test substance did not exhibit mutagenic properties in the absence or presence of metabolic activation. Cytotoxicity was observed starting at 1600 µg/plate in all S. typhimurium strains, except of TA 98, where it was observed at 5000 µg/plate only (preincubation test, without metabolic activation). In TA 1537 it additionally occurred starting at 1600 µg/plate (with metabolic activation) and in the plate incorporation test at 52 and 1600 µg/plate (without metabolic activation) and at 52 µg/plate (with metabolic activation). The vehicle and positive controls were valid and lay within the range of historical control data, proving validity of the assay. Based on the results of the conducted study, Decyl 2-Ethylhexanoate (CAS 93777-46-9) is not considered to exhibit mutagenic properties in bacterial cells.

 

Genetic toxicity (cytogenicity) in mammalian cells in vitro

CAS26399-02-0

An in vitro mammalian chromosome aberration test was performed with 2-Ethylhexyl oleate in primary human lymphocytes according to OECD Guideline 473 and GLP (Buskens, 2010). Duplicate cultures of human lymphocytes were evaluated for chromosome aberrations in the presence and absence of metabolic activation (rat liver S9-mix). In the first experiment cells were incubated with test substance concentrations of 3, 10 and 33 µg/mL in ethanol for 3 hours with and without metabolic activation. In the second experiment cells were incubated with 3, 10 and 33 µg/mL for 24 hours followed by 24 hours expression time and 48 hours following 48 hours expression time without S9. 33 µg/mL was chosen as maximum dose due to limited solubility of the test substance. Mitomycin C and Cyclophosphamide were used as positive control substances. Evaluation of 100 well-spread metaphase cells from each culture for structural chromosomal aberrations revealed no increase in the frequency of chromosome aberrations and polyploid cells at any dose level in comparison to the negative controls. The test material demonstrated only modest cytotoxicity. Vehicle (solvent) controls had frequencies of cells with aberrations within the range expected for normal human lymphocytes. Positive control materials induced statistically significant increases in the frequency of cells with aberrations indicating the satisfactory performance of the test and of the activity of the metabolizing system. The test material did not induce a statistically significant increase in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolizing system in either of two separate experiments. The test material was therefore considered to be non-clastogenic to human lymphocytes in vitro.

 

Genetic toxicity (mutagenicity) in mammalian cells in vitro

CAS26399-02-0

An in vitro Mammalian Cell Gene Mutation Assay according to OECD Guideline 476 and under GLP was performed with 2-Ethylhexyl Oleate in mouse lymphoma L5178Y cells (Verspeek-Rip, 2010). Two independent experiments (with 3 or 24 hours of exposure) were performed in the absence and presence of S9-mix with test substance concentrations up to 100μg/mL dissolved in ethanol. Precipitation was seen at 100 µg/mL and higher. Cyclophosphamide and Methylmethanesulfonate were used as positive controls with and without S9 mix, respectively. Positive and negative controls were valid and in range of historical control data. No significant increase in mutation frequency occurred in any of the test conditions, indicating that 2-Ethylhexyl oleate is not mutagenic in the mammalian cells in vitro.

Conclusion on genetic toxicity

The available data do not provide evidence that Decyl 2-Ethylhexanoate or the structural analogue substances exhibit mutagenic or clastogenic properties in bacteria or mammalian cells. Therefore, no potential for genetic toxicity is expected for Decyl 2-Ethylhexanoate (CAS 93777-46-9).

Justification for classification or non-classification

Based on the available data on the genetic properties of the target substance and structural analogues, the available data on genetic toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.