Ethyl palmitate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose 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 document in section 0 Category or section 13 Assessment report for justification and rationale of the category approach.

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

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: overall observations

Target system / organ toxicity

Critical effects observed:

no

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	Repeated dose toxicity
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: NOAEL (m,f): 1000 mg/kg bw/day
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	Experimental result: NOAEL (m,f): 5500 mg/kg bw/day
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	no data
Isopropyl isostearate	68171-33-5	C18iso	Isopropanol	326.56	Liquid	no data

 

 

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-oxydation pathwayin 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 on source substances of the category:

-Isopropyl myristate

-Ethyl oleate

 

Two studies were performed in vivo on rats according to OECD 407 guideline method for repeated short term oral exposure toxicity. None of these studies showed adverse effect or mortality. Hence the target substance ethyl palmitate was not classified for STOT-RE.

Applicant's summary and conclusion

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.

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 in organism.

Based on the available studies on the source substances for repeated dose toxicity assessment, none of these susbtances induced mortality or adverse effect when administered 5 days per week. According to physic-chemical similarities betsween source substances and target substance, it can be stated that the ethyl palmitate showed same toxicological profile. Hence, no classification for STOT-RE was made for the ethyl palmitate according to CLP criteria.