Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Justification for grouping of substances and read-across

There are no valid data available on the acute toxicity to fish, chronic toxicity towards aquatic invertebrates and toxicity towards algae and aquatic microorganisms of Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9). In order to fulfill the standard information requirements set out in Annex VIII, Section 8.5.2, in accordance with Annex XI, Section 1.5 of Regulation (EC) No 1907/2006, read-across from structurally similar substances is 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 physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity, the substances Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane (CAS No. 68002-78-8), Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with trimethylolpropane (EC# 931-531-4 (formerly CAS 85005-23-8) and Fatty acids, C14-18 and C16-18 unsatd., triesters with trimethylolpropane (CAS No. 68002-79-9) are selected as reference substances for the assessment of chronic toxicity towards aquatic invertebrates and acute toxicity towards fish, algae and aquatic microorganisms. The read-across is based on structural similarity as all chemicals are polyol fatty acid ester with trimethyl propane as common alcohol component. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Overview of aquatic toxicity for the target substance Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9) and the source substances is presented in the following table.

 

Target substance (a)

Source substance (b)

Source substance

Source substance

CAS No.

92113-48-9

68002-78-8

EC# 931-531-4
(formerly CAS 85005-23-8)

68002-79-9

Chemical name

Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol

Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane

Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with trimethylolpropane

Fatty acids, C14-18 and C16-18 unsatd., triesters with trimethylolpropane

Short term toxicity to fish

RA: CAS 85005-23-8

Experimental result:

LL50 (96h) >102 mg/L

Experimental result:

LC50 (96h) > 100 mg/L

--

Long term toxicity to fish

Data waiving

--

--

--

Short term toxicity to aquatic invertebrates

Experimental result: EC50 > 100 mg/L

Experimental result:

EL50 (48h) >106 mg/L

Experimental result:

EL50 (96h) > 100 mg/L (RL3)

Experimental result:

EC50 (48h) >1000 mg/L

Long term toxicity to invertebrates

RA: CAS 68002-78-8

Experimental result:

NOELR >= 110 mg/

--

--

Toxicity to aquatic algae

RA: CAS 68002-79-9

Experimental result:

EL50 (72h) >110 mg/L

--

Experimental result:

EL50 (72h) >100 mg/L

Toxicity to microorganisms

RA: CAS 85005-23-8

--

Experimental result:

EL50 (16 h) > 10000 mg/L (nom.)

--

(a) The substance subject to the REACh Phase-in registration deadline of 31 May 2013 is indicated in bold font. Only for this substance a full set of experimental results and/or read-across is given.

(b) Reference (read-across) substance(s) are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.

Discussion:

Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol , (CAS No. 92113-48-9) is assumed to be not harmful to aquatic organisms based on the results from short-term studies of different trophic levels (fish, daphnia, algae).

Aquatic organisms did not show any effects up to the limit of the water solubility in a short-term test with Daphnia magna. In addition, one test result from a short-term fish test with Cyprinus carpio for the read across substance Fatty acids, C14 -18 and C18 -unsatd., branched and linear, esters with trimethylolpropane (CAS No. 85005-23-8) determined no toxicity to fish (NOEC (96h) = 100 mg/L) as well. For algal growth inhibition a test on Desmodesmus subspicatus with the read across substance Fatty acids, C14-18 and C16-18 unsatd., triesters with trimethylolpropane, (CAS No. 68002-79-9) reveals a similar result (EL50 (72h) > 100 mg/L).

Equal observations can be reported for microorganisms, as no effects on growth were observed after 16 h (EL50/ EL10 > 10000 mg/L) in a cell multiplication inhibition test with Pseudomonas putida for a read across substance (Fatty acids, C14 -18 and C18 -unsatd., branched and linear, esters with trimethylolpropane (CAS No. 85005-23-8)). In addition, the test item can assumed to be not inhibitory on activated sludge microorganisms, since degradation of 56% within 14 days were observed in an OECD 301F test (see chapter 5.2.1 of this technical dossier). Therefore, a disturbance in the biodegradation process of a sewage treatment plant is not anticipated.

A chronic toxicity study towards aquatic invertebrates of the read across substance Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS No. 68002-78-8) revealed a NOELR = 0.11 g/L. Thus toxic effects C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS No. 68002-78-8) were not observed within the limit of water solubility (WS < 0.05 mg/L). Due to the structural similarities with the target substance this result is also applicable for Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9).