Resin acids and Rosin acids, fumarated, esters with glycerol

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Study period:

The study will be conducted following acceptance of this testing proposal

Justification for type of information:

TESTING PROPOSAL FOR ANNEX IX AND X INFORMATION REQUIREMENTS
The proposed OECD 210 Fish Early Life Stage study to fill Long-Term Toxicity to Fish will only be conducted if the OECD 211 study data and the lower annex studies that will be commissioned show that Annex XI waivers cannot be utilised. It is accepted that some tests on fish may be required but the number and type of substances that is appropriate to test will not be clarified until the rest of the data is received and appraised.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
- Unknown until data from OECD 211 and lower annex studies is available.
- 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 aquatic Invertebrates.
- Available non-GLP studies: There are no available studies for long-term toxicity in aquatic invertebrates.
- Historical human data: Not applicable to long-term toxicity testing in aquatic invertebrates.
- (Q)SAR: The category members are UVCBs, therefore, QSAR predictions would be only derived for single constituents. It would not be appropriate to assess hazard to the aquatic environment of poorly water-soluble UVCBs using QSARs.
- In vitro methods: Currently, there are no EU / OECD guidelines for in vitro tests of relevance to aquatic toxicity.
- Weight of evidence: Since there are no reliable data on long-term toxicity studies (experimental, QSAR or based on read across) for long-term toxicity in daphnia or other aquatic species, 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]
The OECD 211 studies proposed and the additional lower annex studies to fill the data gaps are intended to provide enough data to be able to provide robust exposure assessments. These will be used to determine if long-term toxicity to fish testing is required or if the hazard and risk assessment can be completed without the use of vertebrate animals. If further data on the long-term toxicity to fish is still required then this data gap will be filled. However, at this point without the lower annex data or the data on long-term testing in invertebrates it is not clear how many (if any) fish tests will be required or which substances would be most appropriate to test.
- Approaches in addition to above [if applicable]: Not applicable
- Other reasons [if applicable]: The results from long-term aquatic testing would improve the 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:
Following the Board of Appeal Decision Column 2 can no longer be used to waive the data requirements for long-term testing in invertebrates.
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 long-term testing will be carried out using an appropriate fish species according to OECD TG 210. In addition, the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD Series on Testing and Assessment, No. 23 will be considered as the proposed test materials are UVCB substances. The long-term testing will be preceded by a range finding test where concentration levels of the definitive study will be determined.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

GLP compliance:

yes (incl. QA statement)

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

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)