Ethyl decanoate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic 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

Dose descriptor:

NOAEL

Effect level:

> 800 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

clinical signs

mortality

Target system / organ toxicity

Key result

Critical effects observed:

no

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 acid chain length	Type of  alcohol	MW	Appareance	Repeated dose 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	no data
Octyl octanoate	2306-88-9	C8	octanol(C8)	256,42	Liquid	no data
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	Experimental result: NOAEL (m,f): 1000 mg/kgbw/day
Dodecanoic hexylester	34316-64-8	C12	Hexanol(C6)	284,49	Liquid	Experimental result: NOAEL (m, f): 800 mg/kgbw/day
Ethyl linoleate	544-35-4	C18:2	ethanol	308,5	Liquid	no data
Ethyl oleate	111-62-6	C18:1	ethanol	310.52	Liquid	Experimental result: NOAEL (m,f): 5500 mg/kgbw/day
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

 

All the category substances 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 and not bioaccumulable after repeated administration.

 

Three relevant studies are available for assessment. None of these studies, performed according to OECD TG 407 and 408 methods, showed adverse effect to rats during the entire treatment period.

 

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

 

 

 

 

 

 

 

Applicant's summary and conclusion

Conclusions:

Based on the category approach and on the available experimental results, the NOAEL value applied for the category is higher than 800 mg/kg bw. Hence, the category substances did not required classification for STOT-RE in absence of adverse effects.

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.

Based on the category approach and on the available experimental results, the NOAEL value applied for the category is higher than 800 mg/kg bw. Hence, the category substances did not required classification for STOT-RE in absence of adverse effects according to CLP criteria.