Ethyl palmitate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

See attached report for category rationale and justification

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl palmitate

EC Number:

211-064-6

EC Name:

Ethyl palmitate

Cas Number:

628-97-7

Molecular formula:

C18H36O2

IUPAC Name:

ethyl hexadecanoate

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

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	Acute oral Toxicity
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: LD50 > 2000 mg/kgbw
Isopropyl palmitate	142-91-6	C16	Isopropanol	298.51	Liquid	Experimental result: LD50 > 5000 mg/kgbw
Ethyl linoleate	544-53-4	C18:2	ethanol	308,5	Liquid	Experimental result: LD50 >2000 mg/kgbw
Ethyl oleate	111-62-6	C18:1	ethanol	310.52	Liquid	Experimental result: LD50 > 4360mg/kgbw
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: LD50 > 2000 mg/kgbw
Isopropyl isostearate	68171-33-5	C18iso	Isopropanol	326.56	Liquid	Experimental result: LD50 > 2000 mg/kgbw

 

All category members are subject to enzymatic hydrolysis by pancreatic lipases resulting in free acids and alcohol. Based on current literature, when absorbed from intestines and carried through blood stream, fatty acids are oxidized by beta-oxydationpathway in order to provide energy for cell and stored as glycerides esters in fat deposit. The alcohols are primarily metabolized in the liver.

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.

Several studies were performed in members of the category for acute oral toxicity. For acute oral toxicity studies, results showed an LD50 value greater than 2000 mg/kgbw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the results of the key studies on the source substances of the category, the LD50 value for the ethyl palmitate was defined to be higher than 2000 mg/kg bw. Hence, the target substance was not classified according to CLP regulation.

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 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.

The fatty acids linked with 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 (esters and the fatty acid chain). The toxicological profiles between the members of the category are expected to be the same.

Several reliable studies were available (GLP, accordingly to OECD 401 guideline method). The experimental studies were performed in rodents (rat and mouse) which were treated orally (gavage) by

single dose. Lethal Dose 50 (LD50 ) values were found to be greater than 2000 mg/kg bw, or 5000 mg/ kg bw in the differents test performed.

According to the results from experimental study performed on the substances of the category, the LD50 value for the Ethyl Palmitate was defined higher than 2000 mg/kg bw. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for Acute Oral Hazard.