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Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are no sufficient data available for the acute toxicity towards fish and alge for DiPE triisononanoate triethylhexanoate (CAS No. 68443-84-5). In order to fulfil the standard information requirements set out in Annex VIII, 8.4, 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, 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, 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.

Ecotoxicological parameters for the aquatic toxicity of the target substance DiPE triisononanoate triethylhexanoate (CAS No. 68443-84-5) and the source substances are presented in the following table.

CAS

68443-84-5

84418-63-3

647028-25-9

Chemical name

DiPE triisononanoate triethylhexanoate

Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol

Dipentaerythritol (DiPE) with fatty acids, C5 and C9iso    

MW

1053.6 g/mol

1095.61 g/mol

983 - 1096

Short-term toxicity to fish


RA: CAS 647028-25-9
RA: CAS 84418-63-3

LC50 > 1000 mg/L

LL50 > 100 mg/L

Long-term toxicity to fish

Waiving: animal welfare

--

--

Short-term toxicity to aquatic invertebrates

Waiving: chronic test available

--

EL50 > 100mg/L

Long-term toxicity to aquatic invertebrates

EL50 > 100 mg/L

--

--

Toxicity to aquatic algae


RA: CAS 647028-25-9

--

EL50 > 100 mg/L

Toxicity to microorganisms

Toxicity control of biodegradation test
NOEC >=28.7 mg/L

EL10 > 50 mg/L

EC50 > 1000 mg/L

 

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information on the aquatic toxicity to fish and algae is used to predict the same endpoints for DiPE triisononanoate triethylhexanoate (CAS No. 68443-84-5).

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 DiPE triisononanoate triethylhexanoate (CAS No. 68443-84-5) and the source substance Dipentaerythritol with fatty acids, C5 and C9iso    (CAS 647028-25-9) and Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 84418-63-3) are not considered to be harmful to aquatic organisms based on the results from short-term studies with fish, aquatic invertebrates and algae.

All substances are structurally similar characterised by the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths, respectively.

Based on the structural, physico-chemical and ecotoxicological similarities, reading across between target and source substances is justified. 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 consistent pattern of results.

In all available short-term toxicity tests for the read across substances Dipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9) and Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 84418-63-3), no adverse effects occurred in the range of the water solubility of the substance (< 0.05 mg/L measured in aqua dest). A chronic reproduction test to Daphnia magna with DiPE triisononanoate triethylhexanoate (CAS No. 68443-84-5) also did not reveal any adverse effects up to the limit of water solubility.

In summary, based on this analogue approach DiPE triisononanoate triethylhexanoate (CAS No. 68443-84-5) is determined to have no adverse effects up the limit of water solubility and can thus be considered as not hazardous to the aquatic environment

The available data from suitable source substances allow for an accurate assessment of the ecotoxicity profile of the target substance DiPE triisononanoate triethylhexanoate (CAS No. 68443-84-5).