Ethyl palmitate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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 on section 0 Categories and assessment report section 13 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

Test results

Key result

Species / strain:

other: S typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. Coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

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	In vitro gene mutation study in bacteria (Ames test)
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: Negative
Isopropyl palmitate	142-91-6	C16	Isopropanol	298.51	Liquid	no data
Ethyl linoleate	544-53-4	C18:2	ethanol	308,5	Liquid	Experimental result: Negative
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	no data
Isopropyl isostearate	68171-33-5	C18iso	Isopropanol	326.56	Liquid	no data

 

Several Ames test were performed according to OECD 471 guideline. This stain used bacterial strain lines as Salmonella Typhimurium and E.Coli. .These tests were performed on the isopropyl myristate and ethyl linoleate, both of these substances did not showed mutagenicity. The two substances showed structural and physic chemical similarities with the target substance the ethyl palmitate. It can be stated that the ethyl palmitate followed same mutagenic property with source substances of the category on bacteria. Hence, the ethyl palmitate was not considered as mutagenic for bacteria.

Applicant's summary and conclusion

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 mutagenic on bacteria strain.

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 structural and physic chemical similarities (fatty acids linked with esters), the toxicological profiles between the members of the category are expected to be the same on bacteria strain.

Hence, the members of the category were not considered as mutagenix for bacteria strain.