Resin acids and Rosin acids, maleated, esters with glycerol

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Type of information:

experimental study planned

Study period:

The study will be conducted following acceptance of this testing proposal

Justification for type of information:

TEST PROPOSAL FOR ANNEX IX INFORMATION REQUIREMENTS
Proposed OECD 222 Earthworm Reproduction Test (Eisenia fetida/ Eisenia andrei) to fill Toxicity to soil macroorganisms except athropods.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
- Resin acids and rosin acids, fumarated, esters with pentaerythritol (CAS n. 94581-15-4)
- Resin acids and rosin acids, maleated, esters with pentaerythritol (CAS n. 94581-17-6)
- Name of the substance for which the testing proposal will be used [if different from tested substance]
- Resin acids and rosin acids, fumarated, esters with glycerol (Annex IX)
- Resin acids and rosin acids, fumarated, esters with pentaerythritol (Annex X)
- Rosin, fumarated, reaction products with glycerol and pentaerythritol (Annex X)
- Resin acids and rosin acids, maleated, esters with pentaerythritol (Annex IX)
- Resin acids and rosin acids, maleated, esters with glycerol (Annex VIII)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: There are no available GLP studies for long-term toxicity in terrestrial organisms.
- Available non-GLP studies: There are no relevant studies available for long-term toxicity in terrestrial organisms. - Historical human data: Not applicable to long-term toxicity testing in terrestrial organisms.
- (Q)SAR: The category members are UVCBs, and as QSAR predictions would be only derived for single constituents, QSAR would not be appropriate to assess hazard to the terrestrial environment of poorly water-soluble UVCBs. In addition, the available validated ECOSAR model does not contain earthworm data for the class ‘Rosin’.
- In vitro methods: Currently, there are no validated EU / OECD guidelines for in vitro tests that would be relevant to terrestrial toxicity.
- Weight of evidence: Since there are no reliable data on long-term toxicity studies in terrestrial species (experimental, QSAR or, based on read across), it is not possible to derive a weight of evidence for this endpoint.
- Grouping and read-across: Rosin adduct esters are formed through the reaction of an α,ß-unsaturated carbonyl compound, such as maleic anhydride, maleic acid or fumaric acid, with a conjugated double bond present in resin acids such as levopimaric acid via the by the Diels-Alder reaction.
Identification of the Diels-Alder adduct of levopimaric acid and maleic anhydride using GC-MS demonstrates that the reaction produces maleopimaric acid anhydride and the (cis-) maleopimaric tricarboxylic acid, while the Diels-Alder adduct of levopimaric acid and fumaric acid comprises fumaropimaric tricarboxylic acid (the trans-maleopimaric tricarboxylic acid) and maleopimaric acid anhydride.
It is important to ensure that these differences are characterised and that the data density is high enough to establish that all of the potential environmental hazards have been identified and that risk assessments are protective of all organisms. In order to target testing within this category to meet this objective, the category has been split into sub-categories. This way, it can be ensured that there is enough data in each subcategory to fully characterise the category as a whole. These sub-categories may, in some cases, be different for environmental and mammalian toxicity endpoints. Higher Annex Ecotoxicity studies have been proposed for at least 1 member of each of these categories if Higher Annex studies are required (i.e., it contains substances registered for at least Annex IX 100-100 TPA).
Category 4 is divided into the following sub-categories:
• Fumerated
• Maleated
The consortium has also committed to filling data gaps for lower annex studies to provide a full set of data to support the read-across approach for the higher annex studies. This is detailed in the attached testing strategy.
- Substance-tailored exposure driven testing [if applicable]: NA
- Approaches in addition to above [if applicable]: NA
- Other reasons [if applicable]: The results from long-term terrestrial testing would improve the existing data-set for category.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
No adaptations are applicable from Column 2 of Annexes VI to X as direct and indirect exposure to soil is not avoided, in addition the substances have high log Koc values, indicating high adsorptive potential to soil.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: The Earthworm Reproduction Test (Eisenia fetida/ Eisenia andrei) will be conducted according to OECD TG 222 (2016). Details on the definitive test design will be determined during the pre-tests and in the study plan phase with the consortium and the Study Director.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, fumarated, esters with pentaerythritol

EC Number:

305-514-1

EC Name:

Resin acids and Rosin acids, fumarated, esters with pentaerythritol

Cas Number:

94581-15-4

IUPAC Name:

Resin acids and Rosin acids, fumarated, esters with pentaerythritol

Constituent 2

Reference substance name:

Resin acids and Rosin acids, maleated, esters with pentaerythritol

EC Number:

305-516-2

EC Name:

Resin acids and Rosin acids, maleated, esters with pentaerythritol

Cas Number:

94581-17-6

Molecular formula:

UVCB substance

IUPAC Name:

Resin acids and Rosin acids, maleated, esters with pentaerythritol