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

Skin sensitisation

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Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read Across Category Target Substance Endpoint Record

Materials and methods

Test material

Test material information

Constituent 1

Test material form:

liquid

Results and discussion

In vivo (non-LLNA)

Results

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Table 1: Results from key studies on source chemicals of the category for Repeated oral dose toxicity tests

ID#	CAS	Skinsensitisation
Fatty acids, C8-16, 2- ethylhexylesters	135800-37-2	Experimental result: Not sensitising
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- ethylhexylesters	85049-37-2	No data
Fatty acids, C16-18, 2-ethylhexyl esters	91031-48-0	Experimental result: Not sensitising
2-Ethylhexyloleate	26399-02-0	No data
2-Ethylhexylstearate	22047-49-0	No data

 

Similar toxicokinetic behavior and toxicity profile

 

All category members are subject to enzymatic hydrolysis by pancreatic lipases resulting in free acids and alcohol. Based on current literature, when absorbed from intestines and carried through blood stream, fatty acids are oxidized by beta-oxydationpathway in order to provide energy for cell and stored as glycerides esters in fat deposit. The alcohols are primarily metabolized in the liver.

 

Hence, it can be stated that the members of the category have the same toxicity due to the same metabolic pathways when absorbed in the organisms.

 

Based on the available key studies, the members of the category were considered as not sensitizing. Hence, based on the structural similarity between source chemicals and target chemical of the category and their similar toxicokineti cbehavior, the target substance was considered as not sensitizing.

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the results from experimental study performed on the substances of the LCAE Category, the category substances did not led to sensisation when treated on animals. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for skin sensitisation.

Executive summary:

This category approach is based on similar chemical properties as long fatty chain (C8 to C18) linked to 2-ethylhexyl esters.  The members of the category are poorly soluble in water. They are not expected to be found in water compartiments.  If released in surfaces water, the substances would probably partition from the water phase to the sediment. These substances in water are readily biodregadable. Due to the fatty acids property, they are expected to be metabolized by common pathways, as dietary fats. Members of the category are readily biodegradable and are expected to be rapidly eliminated from the environment.

This 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 possible 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.

According to the close structural similarities in physico-chemical, toxicological, ecotoxicological properties, the substances can be considered as a category group according to Regulation (EC) NO. 1907/2006, Annex XI, 1.5.

Several experimental studies were available as Guinea pigs maximization tests which were performed on Fatty acids, C16-18, 2-ethylhexyl esters and Fatty acids, C8-16, 2-ethylhexyl esters. In the GPMT studies, induction and challenge application with each test substance did not led to skin irritation and hypersensitivity. According to the negative response to these tests, no hypersensitivity after dermal exposure was observed. Hence, the members of the category were considered as not sensitizing.

According to the results from experimental study performed on the substances of the LCAE Category, the category substances did not led to sensitisation when treated on animals. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for skin sensitisation.