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Diss Factsheets
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EC number: 266-442-3 | CAS number: 66669-53-2
- 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
Long-term toxicity to fish
Administrative data
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- CONDITIONAL TESTING PROPOSAL ON VERTEBRATE ANIMALS
GENERAL CONSIDERATIONS
A testing proposal for Annex IX Long Term Fish is included in the dossier based on BoA decisions A-010-2018 and A-011-2018. The BoA in A-011/2018 came to the conclusion that registrants are required to propose long-term fish testing under Annex IX in any case, and that registrants may be required to perform / shall propose (under column 2) longer term fish toxicity tests that go beyond those described in Annex IX, column 1. According to the BoA, Annex IX (section 9.1, column 2) does not allow registrants to omit information on long term toxicity to fish under column 1. Rather, according to the BoA, Annex IX requires registrants to submit information on a further study than one of the three listed in Column 1 of Section 9.1.6. of Annex IX, if the chemical safety assessment indicates that it is necessary to investigate the effects of a substance on aquatic organisms beyond what any one of those three Column 1 studies would do.
No hazard towards the environment has been identified in our CSA. In conclusion, further testing is not warranted. However, a long-term fish study (OECD 210) is nevertheless proposed based on the BoA decision. As the BoA decision A-010-2018 is currently being challenged before the General Court (T-656/20), we respectfully request ECHA to suspend any decision on the testing proposal and to first await the decision of the General Court in the aforementioned case. Vertebrate studies should always be the last resort to generate information. In this regard, reference is made to Para. 132 of C-471/18 P:
“It follows from those general provisions, which are to be construed in the light of recital 47 of the REACH Regulation, according to which it is necessary to replace, reduce or refine testing on vertebrate animals’, that a registrant has, generally and therefore especially where ECHA issues it with a decision asking it to complete its registration dossier with a study involving animal testing, not simply the possibility but the obligation to generate information obtained by means other than animal testing ‘whenever possible’ and to undertake such testing ‘only as a last resort’.”
Case T-656/20 is still ongoing and the decision if long-term fish tests must always be performed is, thus, still not finally decided. In conclusion, LANXESS requests ECHA to not issue any draft decision until the BoA decision’s in case A-010-2018 is upheld by the General Court in case T-656/20, also taking animal-welfare considerations into account.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate, CAS No. 66669-53-2, EC No. 266-442-3.
- Name of the substance for which the testing proposal will be used [if different from tested substance]: the substance itself.
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Acute toxicity studies are available for fish and algae with the structural analogue 2-Phosphonobutane-1,2,4-tricarboxylic acid, CAS No. 37971-36-1, EC No. 253-733. In addition, a chronic daphnia study is available for 2-Phosphonobutane-1,2,4-tricarboxylic acid, CAS No. 37971-36-1, EC No. 253-733. A 14 d Prolonged toxicity test according to OECD 204 is also available for 2-Phosphonobutane-1,2,4-tricarboxylic acid, CAS No. 37971-36-1, EC No. 253-733. The test shows no effects on Danio rerio after 14 d up to the highest tested concentration of 1042 mg/L. However, as the test does not cover the most sensitive stage in larval development of the test species, it cannot be used to fill the data gap for a chronic fish test. There are no GLP-compliant fish early-life stage studies available on the substance itself or its structural analogue 2-Phosphonobutane-1,2,4-tricarboxylic acid, CAS No. 37971-36-1, EC No. 253-733-5.
- Available non-GLP studies: There are no non-GLP-compliant fish early-life stage studies available on the substance.
- Historical human data: Not relevant for this endpoint.
- (Q)SAR: There are no QSAR models available for this higher tier ecotoxicological endpoint that are sufficiently validated and acceptable (according to OECD Q/SAR validation criteria).
- In vitro methods: The registrant is not aware of any validated alternative tests that use in vitro methodologies that could be used to meet the standard requirement of the REACH regulation for fish early-life stage toxicity.
- Weight of evidence: No data are available for use in a weight of evidence approach.
- Grouping and read-across: Grouping and read-across approaches have been evaluated.
No studies suitable for read-across or grouping are available. 2-Phosphonobutane-1,2,4-tricarboxylic acid will dissociate in aqueous solution under pH 4-9 as indicated by the pKa values to hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate. It is reasonable to perform the testing with the tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate as the resulting data will be used to fill data gaps for the substance itself and can be used in a read-across approach for 2-phosphonatobutane-1,2,4-tricarboxylic acid. Ths substance is slightly easier to handle being available as a solid. Furthermore, it can be assumed, that using the tetrasodium salt will simplify any adjustments to the pH-value, as the salt will not react strongly acidic or basic during dissolution.
- Substance-tailored exposure driven testing [if applicable] : Not applicable
- Approaches in addition to above [if applicable] : Not applicable
- Other reasons [if applicable] : Not applicable
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:
- Please refer to first section of this testing proposal.
Additional information: Literature searches have been performed in 2020 to find valid data on long-term toxicity to fish for the registered substance. No information sufficient to cover the endpoint could be retrieved.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: not relevant.
Data source
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
- Reference substance name:
- Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate
- EC Number:
- 266-442-3
- EC Name:
- Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate
- Cas Number:
- 66669-53-2
- Molecular formula:
- C7H7Na4O9P
- IUPAC Name:
- tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate
- Details on test material:
- generic test material
Constituent 1
- Specific details on test material used for the study:
- Test material with high purity will be used
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.
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