Registration Dossier
Registration Dossier
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EC number: 290-580-3 | CAS number: 90193-76-3
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 |
Source |
Source |
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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