Resin acids and Rosin acids, maleated, sodium salts

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

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
Proposed OECD 211 Daphnia reproduction study to fill Long-Term Toxicity to Invertebrates.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
o Rosin, fumarated (CAS No. 65997-04-8)
o Resin acids and Rosin acids, maleated, sodium salts (CAS No. 68201-60-5)
- Name of the substance for which the testing proposal will be used [if different from tested substance]
o Rosin, fumarated
o Resin acids and rosin acids, maleated, sodium salts
o Rosin, maleated
o Resin acids and Rosin acids, maleated, calcium salts
o Resin acids and Rosin acids, maleated, potassium salts

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 is a UVCB derived from wood. Rosin and rosin derivatives consists of gum rosin, wood rosin and tall oil rosin while rosin derivatives include hydrogenated rosin and polymerized rosin (also referred to as dimerized rosin or rosin oligomers).
The Diels-Alder reaction involves reaction of an α,ß-unsaturated carbonyl compound, such as maleic anhydride, maleic acid or fumaric acid, with a conjugated double bond; it therefore occurs only with resin acids such as levopimaric acid. However, even under the most favourable of reaction conditions, the majority of the resin acid molecules present in rosin remain unadducted simply because they are unable to undergo this reaction due to their structure.
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 3 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 Boar 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 Daphnia magna according to OECD TG 211 (2012). 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 211 (Daphnia magna Reproduction Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, fumarated

EC Number:

266-040-8

EC Name:

Rosin, fumarated

Cas Number:

65997-04-8

Molecular formula:

Not applicable as the substance is a UVCB

IUPAC Name:

Rosin, fumarated

Constituent 2

Reference substance name:

Resin acids and Rosin acids, maleated, sodium salts

EC Number:

269-228-8

EC Name:

Resin acids and Rosin acids, maleated, sodium salts

Cas Number:

68201-60-5

Molecular formula:

not applicable as the substance is a UVCB

IUPAC Name:

tetrasodium (1S,4R,5R,9R,10R,12R,13R,17R)-5,9-dimethyl-14,16-dioxo-19-(propan-2-yl)-15-oxapentacyclo[10.5.2.0¹,¹⁰.0⁴,⁹.0¹³,¹⁷]nonadec-18-ene-5-carboxylic acid (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthrene-1-carboxylate (1S,4R,5R,9R,10R,12R,13R,14R)-5-carboxy-5,9-dimethyl-16-(propan-2-yl)tetracyclo[10.2.2.0¹,¹⁰.0⁴,⁹]hexadec-15-ene-13,14-dicarboxylate

Test organisms

Test organisms (species):

Daphnia magna