Ethyl decanoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl decanoate

EC Number:

203-761-9

EC Name:

Ethyl decanoate

Cas Number:

110-38-3

Molecular formula:

C12H24O2

IUPAC Name:

ethyl decanoate

Test material form:

liquid

Results and discussion

In vivo (non-LLNA)

Results

Key result

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Table 1: Results from available key studies on the source substances of the category

Common name	CAS	Fatty acid chain length	Type of  alcohol	MW	Appareance	Skin sensitisation
Ethyl decanoate	110-38-3	C10	ethanol	200.32	Liquid	No data
Ethylundecylenate	692-86-4	C11	ethanol	212.33	liquid	No data
Isopropyllaurate	10233-13-3	C12	Isopropanol	242,41	Liquid	no data
Octyloctanoate	2306-88-9	C8	octanol(C8)	256,42	Liquid	no data
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: Not sensitising
Dodecanoic hexylester	34316-64-8	C12	Hexanol(C6)	284,49	Liquid	no data
Ethyl linoleate	544-35-4	C18:2	ethanol	308,5	Liquid	no data
Ethyl oleate	111-62-6	C18:1	ethanol	310.52	Liquid	no data
2-ethylhexyl laurate	20292-08-4	C12	2-Ethyl-Hexanol	312,53	Liquid	no data
Fatty acids, coco, 2-ethylhexyl esters	92044-87-6	C12-14	2-ethylhexanol	312.53 – 340.60	liquid	No data

 

The physico-chemical properties of the category members are similar or follow a regular pattern over the category. The patterns observed depend on the fatty acid and alcohol chain length. Molecular weight of the category members ranges from 200.32 g/mol (ethyl decanoate, target substance) to 340.6 g/mol (fatty acids, coco, 2-ethylhexyl esters). The physical appearance is related to the chain length of the fatty acid and the saturation or unsaturation. These substances are all liquids.

Based on the available study, th isopropyl myristate was not sensitizing. This result is in consistent with skin irritation studies performed, and the expected low toxicity of the category substances.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the available study, isopropyl myristate was not sensitizing. This result is in consistent with skin irritation studies performed, and the expected low toxicity of the category substances.

Executive summary:

According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A read-across category for short chain fatty acid was performed in order to provide informations on ethyl decanoate CAS 110-38-3.

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 category substances are fatty acid esters covering chain length C8 to C18 satured or unsatured linked to alcohol including ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol. These substances showed similar physico-chemical properties as very low solubility in water, not volatile, ready biodegradable and high log Kow. The substances are expected to have same toxicity behavior according to the common structural and physico-chemical similarities. Indeed, they are expected to be hydrolyzed in same way when applied dermally.

As expected, none of the sensitisation tests performed showed adverse effect. Hence, the category substances are not classified for acute dermal hazard according to CLP criteria.