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

Acute Toxicity: inhalation

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Administrative data

Endpoint:

acute toxicity: inhalation

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

Materials and methods

Test material

Test material information

Constituent 1

Test material form:

liquid

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.7 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Any other information on results incl. tables

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

ID#	CAS	Acute inhalation Toxicity
Fatty acids, C8-16, 2- ethylhexyl esters	135800-37-2	No data
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	No data
2-Ethylhexyl oleate	26399-02-0	Experimental result: LC50 > 5.7 mg/L
2-Ethylhexyl stearate	22047-49-0	No data

 

Similar toxicokinetic behavior and toxicity profile

 

All the category substance are fatty acid esters. After inhalation, it is expected that substances are hydrolyzed by lipases. Substances that are absorbed through the pulmonary alveolar membrane could enter the systemic circulation directly before joining the liver where hydrolysis basically takes place. They are expected to be metabolized in common energetic pathways or excreted.

 

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.

 

One key study was performed in a member of the category for acute inhalation toxicity. Results showed an LD50 value greater than 5.7 mg/L (analytical).

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

One key study was performed in a member of the category for acute inhalation toxicity. Results showed an LD50 value greater than 5.7 mg/L (analytical).
 

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.

This category 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, not volatile and have high adsorption potential. They are not expected to be found in air or water compartments.  If released in surface water, the substances would probably partition from the water phase to the sediment. However these substances being readily biodegradability as measured in different screening tests, and highly sorptive as demonstrated with calculated estimations, so they will be eliminated in sewage treatment plants to a high extent. Release to surface waters and thereby exposure of sediment is therefore considered as negligible due to the elimination in sewage treatment plant. Moreover the fatty acids esters are expected to be metabolized by living organisms using common pathways, as dietary fats.

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.

One key study was performed in a member of the category for acute inhalation toxicity. Results showed an LD50 value greater than 5.7 mg/L (analytical). Hence, the target substance was not classified for acute inhalation toxicity according to CLP criteria.