Ethyl decanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute 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 "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

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

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

Common name	CAS	Fatty acids chain length	Type of alcohol	MW	Appareance	Acute oral Toxicity
Ethyl decanoate	110-38-3	C10	ethanol	200.32	Liquid	No data
Ethyl undecylenate	692-86-4	C11	ethanol	212.33	liquid	No data
Isopropyl laurate	10233-13-3	C12	Isopropanol	242,41	Liquid	Experimental result: LD50 > 5000 mg/kgbw
Octyl octanoate	2306-88-9	C8	octanol(C8)	256,42	Liquid	Experimental result: LD50 > 5000 mg/kgbw
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: LD50 > 2000 mg/kg bw
Dodecanoic hexyl ester	34316-64-8	C12	Hexanol(C6)	284,49	Liquid	Experimental result: LD50 > 4300 mg/kg bw
Ethyl linoleate	544-35-4	C18:2	ethanol	308,5	Liquid	Experimental result: LD50 >2000 mg/kgbw
Ethyl oleate	111-62-6	C18:1	ethanol	310.52	Liquid	Experimental result: LD50 > 4360mg/kgbw
2-ethylhexyl laurate	20292-08-4	C12	2 -ethylhexanol	312,53	Liquid	Experimental result: LD50 > 2000 mg/kgbw
Fatty acids, coco, 2-ethylhexyl esters	92044-87-6	C12-14	2-ethylhexanol	312.53 – 340.60	liquid	Experimental result: LD50 > 2000 mg/kgbw

 

All the category substance are fatty acid esters. After oral ingestion, it is expected that substances are hydrolyzed by pancreatic lipases. The degradation products are free fatty acids and free alcohol which could be distributed in organism through systemic circulation. They are expected to be metabolized in common energetic pathways or excreted.

All the substances were evaluated for potential acute oral toxicity (expect the target substance and ethyl undecylenate). These experimental studies were performed according to or equivalent to OECD TG 401. Rats or mice were used as model. The LD50 oral were determined as higher than 2000 mg/kg bw to 5000 mg/kg bw.

 

These experimental studies are consistent with the low toxicity expected for these substances. 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the available experimental studies performed on the source substances of the category, none of these showed adverse effect for acute oral toxicity on rodents. Hence, no classification is required for category substances according to REACh regulation and the category approach.

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 metabolized or excreted in same way when orally administered in organism.

As expected, none of the acute oral toxicity test performed showed adverse effect. Hence, the category substances are not classified for acute oral hasard according to CLP criteria.