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Diss Factsheets
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EC number: 305-515-7 | CAS number: 94581-16-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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
- 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 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 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.
Data source
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
- 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
- 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
Constituent 1
Constituent 2
Test organisms
- Test organisms (species):
- Daphnia magna
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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