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

Repeated dose toxicity: oral

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Administrative data

Endpoint:

short-term repeated dose 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 Target Substance Record

Materials and methods

Test material

Test material information

Constituent 1

Test material form:

liquid

Results and discussion

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: according to the results of available studies

Target system / organ toxicity

Critical effects observed:

no

Any other information on results incl. tables

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

ID#	CAS	Repeated dose toxicity
Fatty acids, C8-16, 2- ethylhexylesters	135800-37-2	Experimental Result : NOAEL : 1000 mg/kgbw/day
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: NOAEL: 1000 mg/kgbw/day
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-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.

 

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 repeated oral toxicity according to CLP criteria.

 

 

Applicant's summary and conclusion

Conclusions:

According to the results of the available studies for LCAE Category members, the NOAEL value was defined at 1000 mg/kg bw/day. According to the CLP criteria and the Category Members results, the registered substance was not classified for repeated dose toxicity.

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.

Two key studies were available dor repeated dose oral toxicity, and were performed on Fatty acids, C16-18, 2-ethylhexyl esters and fatty acids C8 -C16, 2 -ethylhexyl esters. On the two 28 days repeated toxicity study, rats were dosed once daily. The NOAEL was defined at 1000 mg/kg bw/day due to absence of systemic effects in this two studies.

According to the results of the available studies for LCAE Category members, the NOAEL value was defined at 1000 mg/kg bw/day. According to the CLP criteria and the Category Members results, the registered substance was not classified for STOT-RE.