Ethyl decanoate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

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

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:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality

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

Common name	CAS	Fatty acids chain  length	Type of  alcohol	MW	Appareance	Short-term toxicity to aquatic invertebrates
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	no data
Octyl octanoate	2306-88-9	C8	octanol(C8)	256,42	Liquid	Experimental result: EC50(48h) > 100 mg/L (nom.)
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: EC50(48h) > 0.05 mg/L (meas. limit of WS)
Dodecanoic hexylester	34316-64-8	C12	Hexanol(C6)	284,49	Liquid	no data
Ethyl linoleate	544-35-4	C18:2	ethanol	308,5	Liquid	no data
Ethyloleate	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 have low toxicity to aquatic invertebrates.

Due to their poor water solubility, these substances are difficult for aquatic testing. If undissolved test material is not properly removed from test vessels, it may cause physical effects, such as immobilization of Daphnia by getting them trapped into an oil film. These effects do not reflect real toxicity of the test substance towards the organisms. Therefore some tests on Daphnids were performed on filtrated solutions or with lower loading rates to avoid such mechanical effects. These tests show no adverse effects of the tested chemicals to Daphnia magna.

The low biodisponibility of the category substances due to their low water solubility can explain their lack of adverse effects to invertebrates in short-term ecotoxicity tests.

Target substance conclusion

Based on the experimental results obtained, the 48h-EC50 for Daphnia magna of the source substances was considered to be higher than their limits of solubility (measured, limit of water solubility). Since the limit of water solubility of Ethyl decanoate was estimated to be < 1mg/L, then the 48h-EC50 to Daphnia magna of this target substance was defined as > 1 mg/L (limit of water solubility). This estimation being extrapolated, a chronic daphnia test has been performed with Ethyl decanoate to confirm the lack of toxicity.

Validity criteria fulfilled:

yes

Conclusions:

Based on the available key studies performed on the category members, the 48h-EC50 to Daphnia magna was defined at higher than 1 mg/L (limit of water solubility) for ethyl decanoate. According to the CLP criteria, the registered substance is not classified for short-term toxicity to aquatic invertebrates.

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.

Two reliable key studies on Octyl octanoate and on isopropyl myristate are available for the assessment of acute toxicity to invertebrates.The 48h-EC50 to Daphnia magna was defined as higher than 100 mg/L (nom.) for octyl octanoate, and higher than 0.05 mg/L (its limit of solubility) for isopropyl myristate.

When tested up to their limit of solubility, it can be stated that the substances of the category have no adverse effects to Daphnia Magna exposed during 48 hours. However some physical effects on the mobility of Daphnia were demonstrated in the presence of unsoluble material.

Since the category members are expected to show the same toxicity level to aquatic organisms due to common structural and physico-chemical properties, the 48h-EC50 to Daphnia magna of Ethyl decanoate is considered as higher than its solubility limit which was estimated to < 1 mg/L.

Hence, the target substance was not classified for short-term toxicity to aquatic invertebrates

Description of key information

Based on the category approach and the available results from source substances, the target substance ethyl decanoate was considered to have an 48h-EC50 value higher than 1 mg/L (limit of water solubility). Hence, according to CLP criteria, ethyl decanoate is not classified for short term toxicity to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1 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 aquatic invertebrates

Octyl octanoate CAS 2306 -88 -9

One key study was performed according to EU guideline 92/69/EWG (1992) using Daphnia magna. Different loading rates from 1 mg/L to 100 mg/L were stirred in the test medium for about 24h. After a settling time of about 2 hours, the dissolved phase was recovered with a pipette and used to test the following nominal concentrations. 1.0, 3.0, 10, 30 and 100 mg/L for 48 hours.

The EC0 was observed at the loading rate of 1 mg/L and the EC50 and EC100 were defined to be higher than 100 mg/L. The observed mortality may be due to unsoluble fraction since the tested solutions were recovered after a short settling period and without filtration.

Isopropyl myristate CAS 110-27-0

Two experimental studies were available for assessment of the acute toxicity of ispropyl myristate to invertebrates. The key study was performed acccording to EU Method C.2. Daphnids were exposed for 48h to nominal concentrations of 100 mg/L, prepared either by direct addition of the substance followed by ultrasonic treatment, or by stirring 100 mg/L for 24h followed by filtration, or by stirring for 24 hours 3 to 5 times the saturation concentration. Mobility was analysed after 24 and 48 hours of exposure. High immobilisation of daphnia was observed when the solution prepared by direct addition of 100mg/L was tested, whereas when this solution is tested after filtration or at a lower loading rate, the 48h-EC50 is higher than 0.05 mg/L which is the limit of solubility of the tested substance. So the immobilisation of Daphnia is due to unsoluble test material in the tested solutions.

The supporting study was performed according DIN 38412, part 11. Daphnids were exposed under static conditions during 48 hours to the nominal concentrations of 0, 0.3, 1, 3, 10, 30, 100, 300 and 1000 mg/L, prepared by direct addition of the substance in presence of a vehicle and ultrasonic treatment. The EC50 (48h, nom.) was defined to be 100 mg/L and there was evidence of undissolved material in the 100 mg/L and the higher tested concentrations. Physical effects induced by unsoluble material into the tested medium are suspected.

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

Two reliable key studies on Octyl octanoate and on isopropyl myristate are available for the assessment of acute toxicity to invertebrates.The 48h-EC50 to Daphnia magna was defined as higher than 100 mg/L (nom.) for octyl octanoate, and higher than 0.05 mg/L (its limit of solubility) for isopropyl myristate.

When tested up to their limits of solubility, it can be stated that the substances of the category have no adverse effects to Daphnia Magna exposed during 48 hours. However some physical effects on the mobility of Daphnia were observed in the presence of unsoluble material.

Since the category members are expected to show the same toxicity level to aquatic organisms due to common structural and physico-chemical properties, the 48h-EC50 to Daphnia magna of Ethyl decanoate is considered as higher than its solubility limit which was estimated to < 1 mg/L.

Hence, the target substance was not classified for short-term toxicity to aquatic invertebrates