Ethyl palmitate

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-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: Category approach

Justification for type of information:

See attached report in Section 0 "Categories" or Section 13 "Assessment reports" for justification and rationale of the category approach

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

reproduction

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

Common name	CAS	Fatty acid chain length	Type of alcohol	MW	Appareance	Long-term toxicity to aquatic invertebrates
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result:NOEC(21d) ≥ 100 mg/L (nom., filt.)
Isopropyl palmitate	142-91-6	C16	Isopropanol	298.51	Liquid	no data
Ethyl linoleate	544-53-4	C18:2	ethanol	308,5	Liquid	no data
Ethyl oleate	111-62-6	C18:1	ethanol	310.52	Liquid	no data
Fatty acids, C16-18, butyl esters	85408-76-0	C16-18	Butanol	312.53 – 340.58	Paste	no data
Fatty acids, C16-18 and C18-unsatured, isobutyl esters	84988-79-4	C16-18, C18:1	Isobutanol	312.53 – 340.58	Liquid	Experimental result: NOELR (21d)>= 100 mg/L (nom., WAF)
Isopropyl isostearate	68171-33-5	C18iso	Isopropanol	326.56	Liquid	no data

Similar ecotoxicity profile

Based on the experimental data, the category members show no chronic toxicity to aquatic invertebrates. No adverse effects on the reproduction was observed for the two tested source substances and their 21d-NOEC was determined as ≥ 100 mg/L (nominal, WAF filtrated).

The exposure concentrations of aquatic organisms to category members are expected to be low due to the very low water solubility. The combined factors of the low biodisponibility of these substances due to their low water solubility, with their potential metabolisation can explain the lack of adverse effects on aquatic invertebrates in long-term ecotoxicity tests.

 

Conclusion on target substance

Based on the results obtained on the category members, the 21d-NOEC on Daphnia magna reproduction for the target substance "Ethyl Palmitate" was defined as ≥ 100 mg/L (nominal., filtrated). 

Validity criteria fulfilled:

yes

Conclusions:

Based on the category approach and the available studies, the 21d-NOEC (No Observed Effect Level) of Ethyl Palmitate on Daphnia magna reproduction was defined as ≥ 100 mg/L (nominal, filtered).
The registered substance was Not Classified for long-term Toxicity to 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 the Ethyl Palmitate.

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.

None of the long-term toxicity tests to aquatic invertebrates performed on the source substances of the category (isopropyl myristate and Fatty acids C16 -18, C18 unsat. isobutyl esters) has shown adverse effect up to the highest concentration tested. These results confirm the lack of toxicity to Daphnia magna observed in acute tests on the category members. Since Ethyl palmitate is surrounded by the two substances tested in chronic assays and based on the category approach, the target substance Ethyl Palmitate was not classified for long-term toxicity to aquatic invertebrates according to CLP criteria and its 21d-NOEC on Daphnia reproduction was determined ≥ 100 mg/L (nominal, WAF filtrated).

Description of key information

Based on the available experimental studies on the source substances and the category approach, the target substance Ethyl palmitate was considered to induce no adverse effect on the reproduction of Daphnia Magna. The 21d-NOEC was defined as ≥ 100 mg/L (nominal., WAF filtrated).

The target substance was not classified for long-term toxicity to aquatic invertebrates according to CLP criteria..

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

Justification and rationale of the category approach for Ethyl palmitate

The category group covers alcohol linked to fatty acid chains unsatured and satured, via an ester function. This category includes mono-constituent chemicals and UVCB substances with varying acid chain lengths (from C14 to C18) and alcohol types (ethanol, isopropanol, butanol and isobutanol). This approach was performed in order to provide sufficient information for physicalchemical, ecotoxicological and toxicological characterizations of ethyl palmitate. Based on structural and physical-chemical similarities, available experimental studies from source chemicals could be used for the target substance, ethyl palmitate.

This category group includes:

- Isopropyl myristate CAS 110-27-0

- Isopropyl palmitate CAS 142-91-6

- Ethyl linoleate CAS 544 -35 -4

- Ethyl oleate CAS 111-62-6

- Fatty acids, C16-18, butyl esters CAS 85408-76-0

- Fatty acids, C16-18 and C18-unsatured, isobutyl esters CAS 84988-79-4

- Isopropyl isostearate CAS 68171-33-5

- Target substance : Ethyl palmitate CAS 628 -97 -7

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 experimental studies for chronic toxicity to aquatic invertebrates

Isopropyl myristate CAS 110-27-0

One key study was performed according to OECD 202 part II with Isopropyl myristate. Daphnia magna was exposed during 21 days to nominal concentrations 0, 1 and 100 mg/L under semi-static conditions. No adverse effect on the reproduction and on the mortality of daphnids was observed. The 21d-NOEC of Isopropyl myristate on Daphnids reproduction was defined as ≥ 100 mg/L (nominal, WAF filtered).

Fatty acids, C16 -18 and C18 -unsatured isobutyl esters CAS 84988 -79 -4

One chronic study on invertebrates is available for Fatty acids, C16-18 and C18-unsaturated isobutyl esters. This key study was performed according to OECD guideline 202 part II and GLP. The test organism Daphnia magna was exposed to the test substance in a semi-static system for 21 days, at the loadings of 1 and 100 mg/L. The test solutions were prepared as water accommodated fractions (WAF) followed by a step of filtration. At 1 mg/L no mortality and no significant effect on reproduction was observed. At 100 mg/L reproduction was significantly increased compared to the control. Thus, the test substance had no adverse effects on reproduction at the tested concentrations, and the 21d-NOELR is reported to be ≥ 100 mg/L (nominal, WAF filtered).

Conclusion on the target substance

According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, a Read-Across Category for "Long Chain Fatty Acid (from C14 to C18) and short chain alcohol esters (from C2 to C4) " was performed in order to provide information on Ethyl Palmitate.

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 key and reliable studies were performed according to OECD 202 part II with Isopropyl myristate and Fatty acids, C16-C18 and C18-unsatured, isobutyl esters. No toxicity was observed for both sources substances on the reproduction of daphnids exposed to the soluble fraction of the highest tested concentration 100 mg/L. The 21d-NOEC on reproduction was defined as ≥ 100 mg/L (nominal; WAF filtrated) for the category members, since the variability of the fatty acids chain lenght from C14 to C18 is covered through these two studies.

Based on the available results and the category approach, the target substance Ethyl Palmitate can be considered as not toxic to Daphnia magna during chronic exposure. The 21d-NOEC on reproduction of Ethyl palmitate was defined as ≥ 100 mg/L (nominal; WAF filtrated) taking into account its structure, molecular weight and fatty acids chain length compared to those of the tested substances.

Hence, Ethyl palmitate was not classified for chronic toxicity to aquatic invertebrates.