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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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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, hydrogenated, methyl esters (CAS No. 8050-15-5)
- Resin acids and rosin acids, esters with triethylene glycol (CAS No. 8050-25-7)
- Resin acids and rosin acids, esters with pentaerythritol (CAS No. 8050-26-8)
- Resin acids and rosin acids, polymerized, esters with pentaerythritol (CAS No. 65997-12-8)
- Name of the substance for which the testing proposal will be used [if different from tested substance]
- Resin acids and rosin acids, hydrogenated, methyl esters (CAS No: 8050-15-5)
- Resin acids and rosin acids, methyl esters (CAS No: 68186-14-1)
- Resin acids and Rosin acids, esters with diethylene glycol (CAS No: 68153-38-8)
- Resin acids and rosin acids, esters with triethylene glycol (CAS No: 8050-25-7)
- Resin acids and Rosin acids, hydrogenated, esters with triethylene glycol (CAS No: 68648-53-3)
- Resin acids and Rosin acids, esters with glycerol (CAS No: 8050-31-5)
- Resin acids and rosin acids, hydrogenated, esters with glycerol (CAS No: 65997-13-9)
- Resin acids and rosin acids, esters with pentaerythritol (CAS No: 8050-26-8)
- Resin acids and rosin acids. hydrogenated, esters with pentaerythritol (CAS No: 64365-17-9)
- Resin acids and Rosin acids, esters with trimethylolpropane (CAS No: 84776-83-0)
- Resin acids and Rosin acids, polymerized, esters with glycerol (CAS No: 68475-37-6)
- Resin acids and Rosin acids, polymerized, esters with pentaerythritol (CAS No: 65997-12-8)
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:
The category of Rosin Esters consists of rosin which has been esterified with alcohols, typically methanol, ethylene glycol, diethylene glycol, triethylene glycol, glycerol and pentaerythritol. Resin acids are the predominant components of rosin (>85%) and, due to the acid functionality, the primary species for esterification reaction. Resin acids are composed of three skeletal classes of tricyclic carboxylic acids which share similar structure but vary in the position and number of the double bonds, alkyl side and methyl groups. Hydrogenated rosin is implicitly included in the definition of rosin as is disproportionated rosin which is a combination of hydrogenated and dehydrogenated rosin naturally produced when rosin is heated.
Due to the UVCB nature of the acids, the combination of multiple examples to form di-, tri- and tetra-esters can result in each individual species being present at very low level (<10%).
The category therefore also includes the hydrogenated rosin forms of these substances. Due to the reactivity of resin acids, dimers can be manufactured. These rosin dimers are also known as oligomers or by the trivial name of polymerised rosin.
As each member of this category is a UVCB, the resin acid components will vary in type and proportion.
The number of ester bonds that can be formed is driven by the alcohol. Methanol can form mono- esters, ethylene glycol, diethylene glycol and triethylene glycol can form mono- and di- esters, glycerol can form mono-, di- and tri-esters and pentaerythritol can form mono-, di-, tri- and tetra- esters. In each case, the esterification reaction results in a UVCB containing esters with varying numbers of ester bonds formed by the reaction of the various resin acids with the alcohol.
All substances in the category contain ester constituents with different levels of esterification and non-esterified resin acids. Properties of Category 2 substances change in a consistent manner depending on the level of esterification.
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 2 is divided into the following sub-categories:
• Resin and Rosin Acids with Methyl Esters (Simple Esters)
• Resin and Rosin Acids with Diethylene Glycol and Triethylene Glycol (Linear Esters)
• Resin and Rosin Acids with Glycerol, Pentaerythritol and Trimethylolpropane (Bulky Esters)
• Resin and Rosin Acids with Polymerised Esters (Bulky Esters)
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

Constituent 1
Reference substance name:
Resin acids and Rosin acids, hydrogenated, Me esters
EC Number:
232-476-2
EC Name:
Resin acids and Rosin acids, hydrogenated, Me esters
Cas Number:
8050-15-5
Molecular formula:
Not applicable for UVCB constituents
IUPAC Name:
Resin acids and Rosin acids, hydrogenated, Me esters
Constituent 2
Reference substance name:
Resin acids and Rosin acids, esters with triethylene glycol
EC Number:
232-478-3
EC Name:
Resin acids and Rosin acids, esters with triethylene glycol
Cas Number:
8050-25-7
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
IUPAC Name:
Resin acids and rosin acids, esters with triethylene glycol
Constituent 3
Reference substance name:
Resin acids and Rosin acids, esters with pentaerythritol
EC Number:
232-479-9
EC Name:
Resin acids and Rosin acids, esters with pentaerythritol
Cas Number:
8050-26-8
Molecular formula:
Not relevant for a UVCB
IUPAC Name:
Ester of rosin with pentaerythritol, consisting of mainly tetra-esters and tri-esters, as the reactor is charged with a 4:1 stoichiometric ratio of reactants (rosin and pentaerythritol), and reacted until a low ‘acid value’ is achieved, indicating that most of the –COOH groups of the parent rosin have been esterified.
Constituent 4
Reference substance name:
Pentaerythritol esters of rosin oligomers
Cas Number:
65997-12-8
Molecular formula:
not applicable as it is a UVCB substance
IUPAC Name:
Pentaerythritol esters of rosin oligomers

Test organisms

Test organisms (species):
Daphnia magna

Results and discussion

Applicant's summary and conclusion

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