Ethyl decanoate

Endpoint summary

Description of key information

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 and the target substance did not required classification for STOT-RE in absence of adverse effects according to CLP criteria.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

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.

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

Key result

Critical effects observed:

no

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. 

 

 

 

 

 

 

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

800 mg/kg bw/day

Study duration:

subchronic

Species:

rat

System:

other: no effect

Organ:

not specified

Additional information

This category groups covers esters (including ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol) linked to fatty acids chain satured and unsatured (C8 to C18). This category includes monoconstituent substances and UVCB substances varying fatty acid chain length and based on the alcohol sources. This category group was made in order to provide sufficient information for physico-chemical, environmental, ecotoxicological and toxicological caracterisation of ethyl decanoate (CAS 110-38-3). This approach covers these endpoints including skin irritation, eye irritation, and in vitro gene mutation study in bacteria for which some data on the target substance of the category are available.

This category includes:

-       Target substance:

o       Ethyl decanoate (CAS 110-38-3)

-       Source substances:

o       Ethyl undecylenate (CAS 692-86-4)

o       Isopropyl laurate (CAS 10233-13-3)

o       Octyl octanoate (CAS 2306-88-9)

o       Isopropyl myristate (CAS 110-27-0)

o       Dodecanoic hexyl ester (CAS 34316-64-8)

o       Ethyl linoleate (CAS 544-35-4)

o       Ethyl oçleate (CAS 111-62-6)

o       2-Ethylhexyl laurate (CAS 20292-08-4)

o       Fatty acids, coco, 2-ethylhexyl esters (CAS 92044-87-6)

Summary of available studies for oral repated dose toxicity

Isopropyl myristate CAS 110 -27 -0

The first key study was performed with the isopropyl myristate using rats according to the OECD 407 Guideline. The animals were exposed once a day for 28 days at 100, 500 and 1000 mg/kg bw/day in corn oil by gavage. No death or adverse effects were observed. The NOAEL was defined to be higher than 1000 mg/kg bw/day.

Ethyl oleate 111 -62 -6

Another repeated dose toxicity study was available for ethyl oleate equivalent to OECD TG 408 guideline method. Sprague-Dawley rats were treated orally with test item in food, which is provided ad libitum during 91 days. The doses applied were 2.0, 3.9 and 6.1 g/kg bw/day (females) and 1.8, 3.6, 5.5 g/kg bw/day (males). No adverse effects were related to treatment during and after the treatment period. Hence the NOAEL was defined at the high dose level, 5500 mg/kg bw/day.

Dodecanoic ethylhexyl esters CAS 34316 -64 -8

The third reliable and relevant study was performed on the dodecanoic ethylhexyl esters, according to OECD TG 408 method. Rats were exposed during 90 days to the substance in food at 10.000 ppm (corresponding to 800 mg/kg bw/day). No adverse effect was observed during the treatment period. Hence, the NOAEL was defined to be higher than 800 mg/kg bw/day. Based on the category approach, the NOAEL of 800 mg/kg bw/day is applied to the target substance.

Justification for classification or non-classification

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.