Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Justification for read-across

There are no data available for the short-term toxicity to fish and aquatic invertebrates as well as the chronic toxicity of 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3). In order to fulfil the standard information requirements set out in Annex VII and VIII, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances 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.

Aquatic toxicity

CAS

Target
90193-76-3

Source
68442-70-6

Source
119-06-2

Short term toxicity to fish

RA to CAS 119-06-2

--

LC50 (96 h) > 50 mg/L

Long term toxicity to fish

Waiving

--

--

Short term toxicity to aquatic invertebrates

RA to CAS 68442-70-6

EC0 (48 h) >= 10000 mg/L

EC50 (48 h) > 50 mg/L

Long term toxicity to aquatic invertebrates

RA to CAS 119-06-2

--

NOEC (21 d) > 10 mg/L

Toxicity to aquatic algae

EL50 (72 h)> 100%

--

EC50 (72 h) > 50 mg/L

Toxicity to microorganisms

EC50 (3 h) > 100 mg/L

--

--

 

The above mentioned substances are considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3)

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Data on the acute and chronic toxicity of 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) are not available. In the available studies on the acute toxicity of the structural analogue substance Di(tridecyl) phthalate (CAS 119-06-2) to fish and Daphnia no toxicity within the limit of water solubility was determined. In a study set up according to OECD guideline 203 with Oryzas latipes a LC50 (96 h) > 50 mg/L was determined. In a short-term toxicity study on Daphnia magna following OECD 202 an EC50 > 50 mg/L was recorded. This result is confirmed by an acute study on the acute toxicity of the analogue substance 1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters (CAS 68442-70-6). Data on the short term toxicity of 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) is only available for aquatic algae. In a study conducted according to OECD Guideline 201 no effect of the substance on Pseudokirchnerella subcapitata within the range of water solubility was determined. The toxicity of the substance to Daphnia magna was tested in a study following DIN guideline 38412/11. An EC0 >= 10000 mg/L was reported. Thus based on the available data for 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) and the results obtained for the structurally related analogue no acute toxicity of the substance to aquatic organisms is expected within the range of the water solubility.
The evaluation of the chronic toxicity is based on the results obtained for the analogue substance Di(tridecyl) phthalate (CAS 119-06-2). No effects of the substance on adult survival and reproduction were detected in a study performed in compliance with OECD 211 and a NOEC >= 10 mg/L was reported.

The results of a study on the respiration rate of activated sludge microorganisms indicate that 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) has no inhibitory effects on aquatic microorganisms (EC50 > 100 mg/L).