Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters

Genetic toxicity: in vitro

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Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Materials and methods

Test material

Test material information

Constituent 1

Test material form:

liquid

Results and discussion

Test results

Key result

Species / strain:

other: TA 1535, 1537, 102, 100, 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Table 1: Results from key studies on source chemicals of the category for in vitro mutagenicity tests.

ID#	CAS	In vitro gene mutation study in bacteria (Ames test)
Fatty acids, C8-16, 2- ethylhexyl esters	135800-37-2	Experimental result: Negative
Fatty acids, coco, 2-ethylhexyl esters	92044-87-6	No data
2-Ethylhexyl palmitate	29806-73-3	No data
Fatty acids, C16-18 and C18-unsatd., 2- ethylhexyl esters	85049-37-2	No data
Fatty acids, C16-18, 2-ethylhexyl esters	91031-48-0	Experimental result: Negative
2-Ethylhexyl oleate	26399-02-0	No data
2-Ethyl hexyl stearate	22047-49-0	No data

 

Similar toxicokinetic behavior and toxicity profile

None of the tested source substances of the category were positive to Ames test (OECD TG 471). They were not mutagenic for bacteria strains.

Based on the structural similarities between source and target chemicals and their common toxicokinetic behavior, the target substance was considered as not mutagenic in in vitro system.

 

Applicant's summary and conclusion

Conclusions:

Based on the available datas for in vitro bacteria reverse mutation of the members of the category substances, nogenotoxicity was observed for both the tested substances. Hence, the registered substance 2-ethylhexyl isostearate could be considered as not mutagenic for bacteria strain using this category approach and according to the CLP criteria.

Executive summary:

According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A Read-Across Category for Long Chain Fatty Acid was performed in order to provide informations on the Isostearate Ethyl Hexyl.

This category was based on common and shared physico-chemical and structural properties as:

-       common functional group,

-       common precursors and the likehood of common impurities as well as common breakdown products via biological processes, which are chemically structurally similar, and

-       constant pattern in the changing of the potency of the properties across the category.

The fatty acids linked with 2-ethylhexyl esters have a common metabolic fate in organisms as glycolytic and fatty acid pathways after first hydrolysis step which led in breakdown products. The common toxicokinetic properties and behavior are expected due to the constant pattern (ethylhexyl esters and the fatty acid chain). The toxicological profiles between the members of the category are expected to be the same.

Several studies were performed on substances Fatty acids, C16-18, 2-ethylhexyl esters, 2-ethylhexyl oleate and Fatty acids, C8-16, 2-ethylhexyl ester in order to investigate the mutagenicity potential properties in bacteria. None of these experimental studies showed positive effect. Hence, the members of the category can be considered to have no mutagenic effects on bacteria strain.

 

Based on the structural similarities betweensource and target chemicals and their common toxicokinetic behavior, the target substance was considered as not mutagenic ini n vitro system using bacterias strain.