Ethyl palmitate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 justification and rationale of the category approach

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

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

In vivo

Results

Remarks on result:

no indication of irritation

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	Skin irritation or skin corrosion
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: Not  irritating
Isopropyl palmitate	142-91-6	C16	Isopropanol	298.51	Liquid	Experimental result: Not  irritating
Ethyl linoleate	544-53-4	C18:2	ethanol	308,5	Liquid	Experimental result: Not  irritating
Ethyl oleate	111-62-6	C18:1	ethanol	310.52	Liquid	Experimental result: Not  irritating
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	Experimental result: Not  irritating

 

According to the current literature, esterase enzymes were present into the skin of different mammalian species (as human, rodents orminpigs). These enzymes, as carboxylesterase, hydrolyzed different substrates as xenobiotic or different ester as fatty acids esters (C. Jewell, 2007; J.J.Prusakiewicz, 2006). Based on this principle, when applied on skin, the source and the target substances are expected to be substrates of these carboxylesterase. They are hydrolyzed into fatty acids and alcohols. In the case that the products of hydrolysis could across the dermal barrier to reach systemic system, they have the same behavior as oral ingestion. The potential toxicity should bebringby these hydrolyzed products.

They are expected to be metabolized in common energetic pathways or excreted.

No experimental study was available for the target substance the Ethyl palmitate. However, several experimental in vivo studies were performed for skin irritation assessment. None of these studies showed irritation properties. The source substances and the target substance are structurally similar and showed common physic-chemical properties. Based on these properties, it can be stated that the target substance followed the same health effect for skin irritation. Hence, the ethyl palmitate was considered as not irritant to skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the category approach and according to the results of the available studies of the source substances, the target substance was considered to be not irritant. Hence, the ethyl palmitate was not classified for skin irritation.

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.

Based on the available studies on the source substances for skin irritation assessment, none of these susbtances showed adverse effect when applied dermally on rabbit and guinea pigs skin. 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 was made for the ethyl palmitate for skin irritation.