Ethyl decanoate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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:

LC50

Effect level:

> 5 mg/L air

Based on:

test mat.

Exp. duration:

4 h

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 inhalation Toxicity
Ethyl decanoate	110-38-3	C10	ethanol	200.32	Liquid	No data
Ethyl undecylenate	692-86-4	C11	ethanol	212.33	liquid	Experimental result : LC50 > 5,7 mg/L
Isopropyl laurate	10233-13-3	C12	Isopropanol	242,41	Liquid	Experimental result: LC50 > 5 mg/L
Octyl octanoate	2306-88-9	C8	octanol(C8)	256,42	Liquid	no data
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	no data
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

 

All the category substance are fatty acid esters. After inhalation, it is expected that substances are hydrolyzed by lipases. Substances that are absorbed through the pulmonary alveolar membrane could enter the systemic circulation directly before joining the liver where hydrolysis basically takes place. They are expected to be metabolized in common energetic pathways or excreted.

Ethyl undecylenate and isopropyl myristate were evaluated for acute inhalation toxicity. The studies were performed, respectively, according to OECD TG 403 (limit test) and 436 methods (acute toxic class method – limit test). Rats were exposed for 4 hours in nose-only. The LD50 were defined to be higher than 5 mg/L.

 

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 inhalation 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 inhaled.

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