Ethyl palmitate

Eye irritation

Administrative data

Endpoint:

eye 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 (Section 0 and section 13)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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	Eye irritation
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

 

 In eye, some esterase enzyme could have the same ability to hydrolyze the category substances (V.H.L. Lee, 1982) into alcohol and fatty acids. They could vehicle potential irritation or corrosion effect. 

No experimental study was available for the target substance the Ethyl palmitate. However, Five key experimental in vivo studies were performed for eye irritation assessment. These studies were performed in vivo on rabbits or guinea pigs according to OECD 405 guideline method. 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 the properties, it can be stated that the target substance followed the same health effect for eye irritation. Hence, the ethyl palmitate was considered as not irritant to eye.

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 eye 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.

In eye, some esterase enzyme could have the same ability to hydrolyze the category substances (V.H.L. Lee, 1982) into alcohol and fatty acids. They could vehicle potential irritation or corrosion effect. But, none of the source substances, which were assessed for eye irritation, showed any adverse effect on rabbit eyes as expected.

Based on the available studies on the source substances and according to physico-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.