Ethylene di(acetate)

Endpoint summary

Additional information

There are no data available for the endpoint Toxicity to microorganisms for ethylene diacetate (CAS 111-55-7). In order to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

 

The ecotoxicological parameters for the aquatic environment of the target substance ethylene diacetate (CAS 111-55-7) and the source substance 2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate (CAS 111-21-7) are presented in the following table.

	Target substance	Source substance
CAS	111-55-7	111-21-7
Chemical Name	ethylene diacetate	2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate
MW	146.14	234.25
Water solubility	171.1 g/L	> 1000 mg/L
Type of glycol	Ethylene glycol	Triethylene glycol
Type of carboxylic acid	Acetic acid	Acetic acid
Short-term toxicity to fish	LC50 (96 h): 40.45 mg/L LC50 (96 h): 90 mg/L LC50 (96 h): 78 mg/L	LC50 (96 h): 185 mg/L
Long-term toxicity to fish	Exposure based adaptation	--
Short-term toxicity to aquatic invertebrates	EC50 (48 h): > 116.3 mg/L	EC50 (48 h): > 100 mg/L
Long-term toxicity to aquatic invertebrates	Exposure based adaptation	--
Toxicity to aquatic algae	ErC50 (72 h): > 119.86 mg/L NOErC (72 h): ≥ 119.86 mg/L	ErC50 (72 h): > 100 mg/L NOErC (72 h): ≥ 100 mg/L
Toxicity to microorganisms	RA: CAS 111-21-7	NOEC (28 d): ≥ 100 mg/L

Lack of data for a given endpoint is indicated by “--“.

 

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for ethylene diacetate. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5, grouping and read-across, the target substance ethylene diacetate (CAS 111-55-7) and the source substance 2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate (CAS 111-21-7) are considered to be of low toxicity to aquatic organisms based on the results from short-term studies with fish, aquatic invertebrates and algae. The available studies with aquatic algae investigated the chronic toxicity of the target and the source substance as well. Both substances are structurally similar. The difference between both substances is the alcohol component. Ethylene glycol is the alcohol component of the target substance, whereas triethylene glycol is the alcohol component for the source substance, both diesterified with acetic acid. Ethylene glycol and triethylene glycol are both of low, comparable toxicity to aquatic organisms in acute and chronic studies (OECD, 2004a, b). Based on the structural, physico-chemical and ecotoxicological similarities, it is justified to use the read-across substance. As it can be seen in the data matrix including all relevant available ecotoxicological data, none of the substances lie out of the ecotoxicological profile, showing a comparable pattern of results. Data on toxicity to microorganisms in the OECD SIDS for ethylene glycol and triethylene glycol show that triethylene glycol shows a lower IC50 (16 h) based on the cell multiplication of Pseudomonas putida (> 10000 mg/L for ethylene glycol and 320 mg/L for triethylene glycol) (OECD, 2004a, b). Therefore, it is considered justified to cover the endpoint “Toxicity to microorganisms” by read-across from the source substance which probably represents a worst case for this endpoint. Moreover, the target and the source substance are characterized by a similar profile in relevantphysico-chemical properties like log Kow, log Koc and water solubility implying a similar environmental behaviour and distribution.

Short-term studies investigating the toxicity of ethylene diacetate to aquatic organisms from three different trophic levels are available. The results from the acute studies show that ethylene diacetate has a low toxicity to aquatic organisms. Ethylene diacetate did not cause any effects on the growth of aquatic algae (ErC50 (72 h): > 119.86 mg/L) and the mobility of Daphnia magna (EC50 (48 h): > 116.3 mg/L). Fish turned out to be the most sensitive organism with a LC50 (96 h) of 40.45 mg/L. Long-term toxicity testing with fish and aquatic invertebrates was not deemed necessary. The environmental exposure assessment for ethylene diacetate according to Annex XI, Section 3 of Regulation (EC) No 1907/2006 indicates no risk for the aquatic compartment (all RCR < 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information). Based on the results from a biodegradation study with the source substance 2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate it can be concluded that ethylene diacetate is not expected to exhibit effects on the microorganism community in sewage treatment plants and inhibition of the subsequent degradation process is not expected (NOEC (28 d) ≥ 100 mg/L). In conclusion, the target substance ethylene diacetate is of low toxicity to aquatic organisms. As it can be seen in the data matrix of the analogue justification in IUCLID Section 13, all reliable ecotoxicological data from the target and the source substance support the read-across for the endpoint toxicity to microorganisms by showing a consistent pattern of results.