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

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

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 Endpoint Specific Report

Materials and methods

Test type:

standard acute method

Test material

Test material information

Constituent 1

Test material form:

liquid

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

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

ID#	CAS	Acute oralToxicity
Fatty acids, C8-16, 2- ethylhexylesters	135800-37-2	Experimental result: LD50 > 2000 mg/kgbw
Fatty acids, coco, 2-ethylhexyl esters	92044-87-6	Experimental result: LD50 > 2000 mg/kgbw
2-Ethylhexyl palmitate	29806-73-3	No data
Fatty acids, C16-18 and C18-unsatd., 2- ethylhexylesters	85049-37-2	Experimental result: LD50 > 17,200 mg/kgbw Reliability 4
Fatty acids, C16-18, 2-ethylhexyl esters	91031-48-0	LD50 > 4300 mg/kgbw
2-Ethylhexyloleate	26399-02-0	Experimental result: LD50 > 5000 mg/kgbw
2-Ethylhexylstearate	22047-49-0	Experimental result: LD50 > 4300 mg/kgbw

 

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-oxydation pathway 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.

 

Several studies were performed in members of the category for acute oral toxicity. For acute oral toxicity studies, results showed an LD50 value greater than 2000 mg/kgbw.

 

 

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 LD50 value for the Isostearate Ethyl Hexyl was defined higher than 2000 mg/kg bw. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for Acute Oral Hazard (or Category 5 according to GHS 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 reliable studies were available (GLP, accordingly to OECD 401 guideline method). The experimental studies were performed in rodents (rat and mouse) which were treated orally (gavage) by single dose. Lethal Dose 50 (LD50 ) values were found to be greater than 2000 mg/kg bw, or 4300 mg/kg bw and 10 0000 mg/kg bw in the differents test performed.

According to the results from experimental study performed on the substances of the LCAE Category, the LD50 value for the Isostearate Ethyl Hexyl was defined higher than 2000 mg/kg bw. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for Acute Oral Hazard (or Category 5 according to GHS criteria).