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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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: Category Approach

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 10 000 mg/L

Sublethal observations / clinical signs:

Table 1: Results of the key study of each source substances of the category

Name of the substance	CAS	Fatty acids chain length	Type of alcohol	MW	Appareance	Short-term toxicity to fish
Fatty acids, C8-16, 2- ethylhexyl esters	135800-37-2	C8-16	2-ethylhexanol	256.42 – 368.65	Liquid	Experimental result: LC50(96h) > 10000 mg/L(nom.)
Fatty acids, coco, 2-ethylhexyl esters	92044-87-6	C12-14	2-ethylhexanol	312.53 – 340.60	liquid	No data
2-Ethylhexyl palmitate	29806-73-3	C16	2-ethylhexanol	368.65	Liquid	No data
Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters	85049-37-2	C16-18, C18:1	2-ethylhexanol	368.65 – 396.7	Liquid	Experimental result: LC50(96h) > 10000 mg/L (nom.)
Fatty acids, C16-18, 2-ethylhexyl esters	91031-48-0	C16-18	2-ethylhexanol	368.65 - 396.7	Liquid	No data
2-Ethylhexyloleate	26399-02-0	C18:1	2-ethylhexanol	394.67	Liquid	No data
2-Ethylhexylstearate	22047-49-0	C18	2-ethylhexanol	396.7	Liquid	No data

 

Similar ecotoxicity profile

Based on the experimental data, the category members have low toxicity to aquatic fish organisms.

Additionally, the exposure concentrations of aquatic organisms are expected to be low due to the very low water solubility. In both short and long term studies, no effect occurred up to the water solubility limit.

These substances are also expected to be metabolized in the aquatic organisms; they are first hydrolyzed by lipases (Mattson andVolpenhein, 1972) resulting in free fatty acid and alcohols, which are absorbed from the intestine into blood stream. Fatty acids are either metabolized via Beta-oxidation pathway in order to generate energy for cell or reconstituted glyceride esters stored in the fat depots in the body. 2-ethylhexanolis primarily metabolized in the liver. Consequently, the combined factors of lowbiodisponibilityof these substances due to their low water solubility, with their easy and fullmetabolisation, can explain the lack of adverse effects to fish in short-term tests.

 

Target substance conclusion

Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance "Isostearate2 -ethyl hexyl" was considered to be higher than 10000 mg/L(nom.).

Validity criteria fulfilled:

yes

Conclusions:

Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance "Isostearate 2 -ethyl hexyl" was considered to be higher than 10000 mg/L(nom.). The target substance was Not Classified for Short Term Toxicity to Fish.

Executive summary:

According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A Read-Across Category for "Long Chain Fatty Acid, 2-ethylhexyl esters" was performed in order to provide informations on Isostearate 2-Ethylhexyl .

This category was based on common and shared properties as:

-   common functional group,

-   common precursors and the likelihood of common impurities resulting from common process of manufacturing,

-   chemically structurally similar breakdown products obtained via the same biological processes into the organisms, and

-   constant pattern in the changing of the potency of the properties across the category.

Two reliable key studies are available for the assessment of toxicity to fish of Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) and Fatty acids, C16-18 and C18-unsatured, 2-ethylhexyl esters (CAS 85049-37-2). Lethal Concentration (LC50) was determined greater than 10000 mg/L for 96 hours of exposure. These studies covered C8 to C18 and C18 unsaturated ethylhexyl esters. Considering the molecular weight and the chain length, this LC50 value could be attributed to all the members of the category which are within the covered range. Furthermore, the bioavailability of the category members in the water is expected to be low due to low water solubility. Additionnaly, fatty acids esters are known to be fastly metabolized as energetic source in organisms. Consequently the combined factors of low biodisponibility with their ease and full metabolisation can explain the lack of adverse effects of the category members to fish.

Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance "Isostearate 2 -ethylhexyl" was considered to be higher than 10000 mg/L(nom.). The target substance was Not Classified for Short-Term Toxicity to Fish.

Description of key information

Based on the available key studies performed on the category members, the 96h-LC50 to Zebra fish was defined higher than 10000 mg/L.

According to the CLP criteria, the registered substance is not classified for short-term toxicity to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

10 000 mg/L

Additional information

Justification and rationale of the category approach for the Isostearate, 2-ethyl hexyl :

This category group covers 2-ethyl hexyl esters linked with fatty acid chains (C8 to C18) unsatured and satured. This category includes monoconstituent substances and UVCB substances with varying fatty acid chain length and based on the same alcohol source (2-ethylhexanol). This category was made in order to provide sufficient information for physicochemical, ecotoxicological and toxicological caracterisation of the Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters (CAS No 85186-76-1).

The category group includes:

- Fatty acids, C8-16, 2-ethylhexyl esters (CAS No 135800-37-2)

- Fatty acids, coco, 2-ethylhexyl esters (CAS No 92044-87-6)

- 2-Ethyl hexyl palmitate (29806-73-3)

- Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS No 85049-37-2)

- Fatty acids, C16-18, 2-ethylhexyl esters (CAS No 91031-48-0)

- 2-Ethylhexyl oleate (CAS No 26399-02-0)

- 2-Ethyl hexyl stearate (CAS No 22047-49-0)

Target substance for Category Approach : Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters (CAS No 85186-76-1)

In accordance with article 13 (1) of Regulation (EC) No. 1907.2006, “information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, environmental fate and ecotoxicity, information shall be generated whenever possible by means other than vertebrate animal tests which includes the use of information from structurally related substances (grouping or read across)”. Therefore, the available experimental data were collected and evaluated according to Annex XI requirements.

Summary of available studies on source substances for short-term toxicity to fish

Fatty acids, C8-C16, 2-ethylhexyl esters CAS No 135800-37-2

Two studies are available and considered as reliable.

The key study was performed according to EU Method C.1 and to GLP compliance. The test substance was brought directly into the fish bassins and then treated with ultraturrax. Zebra fish (Danio Rerio) was used and exposed for 96 hours at 1000, 3000 and 10000 mg/L. With increasing test substance concentrations an increasing turbidity of the test solutions was observed. No mortalities was observed at any concentration and observation time. The LC50 was defined higher than 10000 mg/L.

The second study, considered as a supporting study, was performed according to OECD guideline 203 and GLP compliance. Scrophthalmus Maximus was used and exposed in semi-static system to 0, 320, 1000, 3200 and 5600 mg/mL (nominal) for 96 hours. No mortality was observed. The LL50 was defined as higher 5600 mg/L. This supporting study demonstrates the lack of adverse effect of the tested substance also to marine fish.

Fatty acid, C16-18 and C18-unsatd., 2-ethylhexyl esters CAS No 85049 -37 -2

Two studies were performed with the Fatty acid, C16 -18 and C18 -unsatd., 2 -ethylhexyl esters on short-term toxicity to fish.

The key study was conducted on Danio rerio according to OECD 203 with the selected nominal concentrations of 1000, 3000 and 10000 mg/L (Richterich 2001). The test substance was mixed into the dilution water by ultraturax without further preparation. No effects were observed up to the highest test concentration and a LC50(96h) > 10000 mg/L was stated.

In a supporting study with Danio rerio, a limit test was performed according to OECD 203, and an LC50(96h) >100 mg/L was reported (Van der Kerken 1995).

Conclusion

According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A Read-Across Category for "Long Chain Fatty Acid, 2-ethylhexyl esters" was performed in order to provide informations on Isostearate 2-Ethylhexyl .

This category was based on common and shared properties as:

-   common functional group,

-   common precursors and the likelihood of common impurities resulting from common process of manufacturing,

-   chemically structurally similar breakdown products obtained via the same biological processes into the organisms, and

-   constant pattern in the changing of the potency of the properties across the category.

Two reliable key studies are available for the assessment of toxicity to fish of Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) and Fatty acids, C16-18 and C18-unsatured, 2-ethylhexyl esters (CAS 85049-37-2). Lethal Concentration (LC50) was determined greater than 10000 mg/L for 96 hours of exposure. These studies covered C8 to C18 and C18 unsaturated ethylhexyl esters. Considering the molecular weight and the chain length, this LC50 value could be attributed to all the members of the category which are within the covered range. Furthermore, the bioavailability of the category members in the water is expected to be low due to low water solubility. Additionnaly, fatty acids esters are known to be fastly metabolized as energetic source in organisms.Consequently the combined factors of low biodisponibility with their ease and full metabolisation can explain the lack of adverse effects of the category members to fish.

Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance "Isostearate 2 -ethylhexyl" was considered to be higher than 10000 mg/L(nom.). The target substance was Not Classified for Short-Term Toxicity to Fish.