Ethyl decanoate

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

Justification for type of information:

See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Table 1: Results from available key studies on the source substances of the category

Common name	CAS	Fatty acid chain length	Type of alcohol	MW	Appareance	Short-term toxicity to fish
Ethyl decanoate	110-38-3	C10	ethanol	200.32	Liquid	No data
Ethyl undecylenate	692-86-4	C11	ethanol	212.33	liquid	No data
Isopropyl laurate	10233-13-3	C12	Isopropanol	242,41	Liquid	Experimental result: LC0(96h) = 1000 mg/L (nom.)
Octyl octanoate	2306-88-9	C8	octanol(C8)	256,42	Liquid	no data
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: LC50(96h) > 1000 mg/L (nom.)
Dodecanoic hexyl ester	34316-64-8	C12	Hexanol(C6)	284,49	Liquid	Experimental result: LC50(96h) = 2200mg/L (nom.)
Ethyl linoleate	544-35-4	C18:2	ethanol	308,5	Liquid	no data
Ethyl oleate	111-62-6	C18:1	ethanol	310.52	Liquid	no data
2-ethylhexyl laurate	20292-08-4	C12	2-Ethyl-Hexanol	312,53	Liquid	no data
Fatty acids, coco, 2-ethylhexyl esters	92044-87-6	C12-14	2-ethylhexanol	312.53 – 340.60	liquid	No data

 

Similar ecotoxicity profile

Based on the experimental data, the category members show no toxicity to aquatic fish organisms. Additionally, the exposure concentrations of the aquatic organisms are expected to be low due to the low water solubility, and in both short and long-term aquatic toxicity studies, no effect occurred up to the water solubility limit.

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

Conclusion on the target substance

Three experimental studies were available for fish toxicity assessment of source substances. Isopropyl laurate, isopropyl myristate and dodecanoic hexyl ester were assessed for their acute toxicity to fish, according to OECD TG 203, EPA 660/3-75-009 and ISO 7346 -1 guidelines. Onchorhynchus mykiss, Lepomis macrochirus and Danio rerio, which are freshwater fishes, were tested. The 96h-LC50 values were evaluated at higher than 1000 mg/L (nom.) or equal to 2200 mg/L (nom). Based on the structural similarities of the substances of the category, the 96h-LC50 of ethyl decanoate was defined to be higher than 1000 mg/L (nom.).

 

Validity criteria fulfilled:

yes

Conclusions:

Based on the available key studies performed on the category members, the 96h-LC50 to freshwater fish was defined at higher than 1000 mg/L (nom.) for ethyl decanoate. According to the CLP criteria, the registered substance is 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 was performed in order to provide informations on ethyl decanoate CAS 110-38-3.

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.

Three reliable key studies on Isopropyl laurate, isopropyl myristate and dodecanoic hexyl ester are available for the assessment of acute toxicity to fish. The Lethal Concentration (LC50) was determined as greater than 1000 mg/L (nom.) for 96 hours of exposure. The lack of adverse effects to fish of the tested category substances, can be explained by the combined factors of their low  bioavailability in the aquatic medium, due to their low water solubility, and their ease and quick metabolization in fish. Indeed fatty acids esters are known to be fully metabolized in many aquatic organisms in order to provide energetic resources or to be stored as fat deposit.

Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance Ethyl decanoate was considered to be higher than 1000 mg/L(nom.). The target substance was not Classified for Short-Term Toxicity to Fish.

Description of key information

Based on the available studies performed on the category members, the 96h-LC50 to fish was defined to be higher than 1000 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:

1 000 mg/L

Additional information

Justification and rationale of the category approach for Ethyl decanoate

This category group covers fatty acid chains linked to alcohols via an ester function. It includes mono-constituent substances and UVCB substances with varying fatty acid chain lengths from C8 to C18-unsaturated and alcohol types (including ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol). This category group was made in order to provide sufficient information for physico-chemical, environmental, ecotoxicological and toxicological characterization of ethyl decanoate (CAS 110-38-3). Some data on the target substance of the category are available.

This category includes:

-       Target substance:

o       Ethyl decanoate (CAS 110-38-3)

-       Source substances:

o       Ethyl undecylenate (CAS 692-86-4)

o       Isopropyl laurate (CAS 10233-13-3)

o       Octyl octanoate (CAS 2306-88-9)

o       Isopropyl myristate (CAS 110-27-0)

o       Dodecanoic hexyl ester (CAS 34316-64-8)

o       Ethyl linoleate (CAS 544-35-4)

o       Ethyl oleate (CAS 111-62-6)

o       2-Ethylhexyl laurate (CAS 20292-08-4)

o       Fatty acids, coco, 2-ethylhexyl esters (CAS 92044-87-6)

Summary of available studies for short term toxicity to fish

Isopropyl laurate CAS 10233 -13 -3

One key study is avalaible. The experimental study was performed according to OECD TG 403 method using Oncorhyncus mykiss (rainbow trout). Fishes were exposed to the test substance at 0, 62.5, 125, 250, 500 and 1000 mg/L during 96 hours. No mortality or adverse effect was observed. Hence, the LC50 value was defined as higher than 1000 mg/L (nom.).

Isopropyl myristate CAS 110-27-0

Two studies were performed on the isopropyl myristate in order to assess the potential acute toxicity to fish. The key study was performed according to the EPA 660/3 -75 -009 (Methods for acute toxicity tests with fish, macroinvertebrates and amphibians) and GLP compliance. Bluegill (Lepomis Macrochirus)were exposed to test substance during 96 hours under static condition at 21 -23°C. They were exposed to 0, 78, 130, 220, 360, 600 and 1000 mg/L. Mortality and sublethal effects were assessed after 24, 48, 72 and 96 h. No mortality was observed during the exposure period, hence, the LC50 was defined to be higher than 1000 mg/L (nom.). The supporting study was performed on the carp (Cyprinus Carpio). Fishes were exposed during 48 hours under static conditions to 0 and 1000 mg/L of test substance. No mortality was observed until the end of exposure duration, the LC50 was defined to be higher than 1000 mg/L (nom.).

Dodecanoic hexyl ester CAS 34316 -64 -8

One key study is available for the source substance dodecanoic hexyl ester. The experimental study was performed according to ISO 7346/2 method using Danio rerio. Fishes were exposed to 0, 100, 300, 700, 1000, 3000 and 10000 mg/L during 96 hours. At the end of exposure period, 100% of fishes died at high dose group, 70% at 3000 mg/L. The LC50 was defined to be 2200 mg/L (nom.).

Conclusion

According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A read-across category was performed in order to provide informations on ethyl decanoate CAS 110-38-3.

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.

Three reliable key studies on Isopropyl laurate, isopropyl myristate and dodecanoic hexyl ester are available for the assessment of acute toxicity to fish. The Lethal Concentration (LC50) was determined as greater than 1000 mg/L (nom.) for 96 hours of exposure. The lack of adverse effects to fish of the tested category substances, can be explained by the combined factors of their low bioavailability in the aquatic medium, due to their low water solubility, and their ease and quick metabolization in fish. Indeed fatty acids esters are known to be fully metabolized in many aquatic organisms in order to provide energetic resources or to be stored as fat deposit.

Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance Ethyl decanoate was considered to be higher than 1000 mg/L(nom.). The target substance was Not Classified for Short-Term Toxicity to Fish.