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

Eye irritation

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Administrative data

Endpoint:

eye irritation: in vivo

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

Results

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table 1: Results from key studies on source chemicals of the category for eye irritation and corrosion tests

ID#	CAS	Eye irritation
Fatty acids, C8-16, 2- ethylhexyl esters	135800-37-2	No data
Fatty acids, coco, 2-ethylhexyl esters	92044-87-6	Experimental result: Noti rritating
2-Ethylhexyl palmitate	29806-73-3	Experimental result: Not irritating
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 Irritating
2-Ethylhexyl oleate	26399-02-0	No data
2-Ethylhexyl stearate	22047-49-0	No data

 

Similar toxicokinetic behavior and toxicity profile

In eye, some esterase enzyme could have the same ability to hydrolyze the category substances (V.H.L. Lee, 1982) into alcohol and fatty acids. They could vehicle potential irritation or corrosion effect. But, none of the source substances, which were assessed for eye irritation, showed any adverse effect on rabbit eyes as expected.

 

Based on the available key studies, the members of the category were considered as not irritating when applied on eye. Hence, the target substance was not classified for eye irritation according to CLP criteria and the category approach.

 

 

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 irritation when applied on rabbit eye. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for eye Irritation.

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 skin as hydrolysis step by esterase enzymes 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.

Experimental studies were available. These studies were performed for two category members. They are considered as reliable (GLP compliant, OECD 405 method). Rabbits were treated with the substance on the eye and observations were performed 24, 48 and 72 hours after the treatment for the first study; except in one study, observations were performed at 2, 6 and 24 hours. No ocular lesions or only slight swelling of blood vessels were observed after 1 hour post treatment which was reversible within 24 hours.

According to the results from experimental key studies performed on the substances of the LCAE Category, the source substances did not led to irritation when applied on rabbit eye as expected. Hence, according to the CLP criteria and the category approach, the registered and target substance Isostearate Ethyl hexyl was not classified for Eye Irritation.