Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are no data available on the aquatic toxicity of 2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate (CAS 93803 -89 -5). In order to fulfil the standard information requirements set out in Annex VII - IX, 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.

Ecotoxicological parameters for the aquatic toxicity of the target substance 2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate (CAS 93803 -89 -5) and the source substances are presented in the following table.

 

Target

Source 1

CAS

93803 -89-5

131459-39-7

Chemical Name

2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate.

3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid

MW

697.04

472.62 - 697.04

Fatty acid chain length

C9iso

C5-C6

Alcohol

dipentaerythritol

dipentaerythritol

Short-term toxicity to fish

RA: CAS 131459-39-7

EL50 > 100 mg/L

Long-term toxicity to fish

Waiving based on Chemical Safety Assessment

--

Short-term toxicity to aquatic invertebrates

RA: CAS 131459-39-7

EL50 > 1000mg/L

Long-term toxicity to aquatic invertebrates

--

--

Toxicity to aquatic algae

RA: CAS 131459-39-7

EL50 > 100 mg/L

Toxicity to microorganisms

NOEC (14 d) ≥ 29.1 mg/L
RA: CAS 131459-39-7

EC50 > 1000 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 forPE tetraester with isononanoic acid.

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 2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate (CAS 93803-89-5) and the source substance 3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid (CAS 131459-39-7) are not considered to be harmful to aquatic organisms based on the results from short-term studies with fish, aquatic invertebrates and algae.

The target and the source substance are structurally similar characterised by thesame alcohol component (pentaerythritol) and similar fatty acid chain lengths, respectively.

Based on the structural, physico-chemical and ecotoxicological similarities, reading across between target and source substance 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.

One acute toxicity study to fish according to internationally accepted guidelines for the source substances 3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid (CAS 131459-39-7) is available.The substance consist of the same alcohol component (pentaerythritol) and similar fatty acid chain lengths (C9iso for the target substance compared to C5-6 for the source substances, respectively).No effects were observed up to the limit of water solubility.

One acute toxicity study to invertebrates according to internationally accepted guidelines for the source substances 3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid (CAS 131459-39-7) is available.The substance consist of the same alcohol component (pentaerythritol) and similar fatty acid chain lengths (C9iso for the target substance compared to C5-6 for the source substances, respectively).No effects were observed up to the limit of water solubility.

One toxicity study to algae according to internationally accepted guidelines for the source substances 3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid (CAS 131459 -39 -7) is available. No effects were observed up to the limit of water solubility.

The toxicity to microorganisms was investigated using the ready biodegradability study of the target substance. Additionally, a read across approach with the structurally similar source substance 3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid (CAS 131459-39-7) was conducted. Based on the results and the structural and profile similarity of the substances, it can be concluded that no effect on the STP microorganism community and the subsequent degradation process in sewage treatment plants is anticipated.

According to the “Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3” (ECHA, 2012), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish. Therefore, no long-term testing on fish is proposed.

In conclusion, no effects on aquatic organisms were observed in the available studies for any of the three trophic levels (fish, daphnia, algae) up to the limit of water solubility.

The available data from a suitable source substance allow for an accurate assessment of the ecotoxicity profile of the target substance 2,2 -bis[[(1 -oxoisononyl)oxy]methyl]-1,3 -propanediyl diisononanoate.