Registration Dossier
Registration Dossier
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EC number: 233-279-4 | CAS number: 10102-90-6
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
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- Key result
- Remarks on result:
- other: Individual NOEC/(L(E) C10 values range between 4 µg Cu/L (Cerodaphnia dubia) to 188 µg Cu/L (Daphnia magna reproduction).
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- High quality chronic single-species NOEC/(L(E)C10 values are available for 13 freshwater invertebrate species. A chronic Biotic Ligand Model (BLM) was developed for D. magna and validated for 4 additional species. The NOECs and results of the BLM are carried forward to the risk characterisation.
High quality chronic single-species NOEC/(L(E)C10 values are available for 18 marine invertebrate species. The observed effects are related to the organic carbon content of the test waters. The NOECs and organic carbon relationships are carried forward to the risk characterisation.
Reference
Description of key information
High quality chronic single-species NOEC/(L(E)C10 values are available for 13 freshwater invertebrate species. A chronic Biotic Ligand Model (BLM) was developed for D. magna and validated for 4 additional species. The NOECs and results of the BLM are carried forward to the risk characterisation.
High quality chronic single-species NOEC/(L(E)C10 values are available for 18 marine invertebrate species. The observed effects are related to the organic carbon content of the test waters. The NOECs and organic carbon relationships are carried forward to the risk characterisation.
Key value for chemical safety assessment
Additional information
Data are available on a number of substances containing inorganic copper and read-across is justified on the basis that for the purposes of assessing the ecotoxicology of Copper (II) pyrophosphate (copper(2+) diphosphate) the chemical species of interest is copper. As such studies referring to soluble copper ions from any source are considered to be directly relevant to Copper (II) pyrophosphate. Copper (II) pyrophosphate is considered to contribute to copper toxicity in the environment and as such the data assessment and risk assessment focusses on the copper ion as the phosphate ion is not considered to be toxic.
NOECs for freshwater invertebrates:
High quality chronic NOEC/(L(E)C10 values are available for 13 species: 1 rotifer species (Brachionus calyciflorus), 3 insect species (Clistoronia magnifica, Chironomus riparius, Paratanytarsus parthenogeneticus), 4 mollusc species (Juga plicifera, Campeloma decisum, Villosa iris, Dreissenia polymorpha), 5 crustacean species (Ceriodaphnia dubia, Daphnia magna, Daphnia pulex, Hyalella Azteca, Gammarus pulex). Individual NOEC/(L(E) C10 values range between 4 µg Cu/L (Cerodaphnia dubia) to 188 µg Cu/L (Daphnia magna reproduction).
The NOECs are used to derive “species geo-metric mean” NOEC values for each endpoint and the most sensitive endpoint for each of the 13 species of invertebrates retained as "species-mean" NOEC value. These "species mean" NOEC values range from 6.0 µg/L Cu for the snail Juga plicifera (mortality; 1 test value) to 50.3 µg/L Cu amphipod Hyalella azteca (mortality) and are carried forward for the PNEC derivation.
20 NOECs are available for standard species, with internationally agreed protocols. For these species, the "species mean" NOECs are derived (C. dubia (13.1 µg Cu/L), D. magna (12.6 µg Cu/L) and 14.5 (D. pulex)) and these are used for Classification and Labelling purposes.
Large intra-species variability is observed in NOEC/L(E)C10 values. Effects data from Daphnia magna were used to develop a chronic invertebrate BLM (De Schamphelaere et al., 2004). The capacity of the BLM for predicting copper toxicity to other invertebrate species was demonstrated from copper toxicity studies with Brachionus calyciflorus (De Schamphelaere 2006), Lampilis siliquoide (Kunz et al., 2006), Hyridella depressa (Marckish et al, 2003) and Hyalella azteca (Borgman et al.,2006).
The database contains a paper demonstrating that dietary copper exposure does not affect the capacity of the BLM to predict toxicity to D. magna.
Research related to copper acclimation and deficiency (Bossuyt et al, 2004) demonstrated that after 3 generations of acclimation, the optimal concentration ranges (from energy reserves and number of offspring) remained constant between 1 and 35 µg Cu/L. Below 1 µg Cu/L (a concentration often used as background copper concentration in the ecotoxicity media), copper deficiency was clearly observed.
NOECs for marine water invertebrates:
32 high quality NOEC/L(E)C10 were retained for 18 different individual species belonging to different taxonomic groups: 6 mollusc species (Mytilus edulis, Prototheca staminea, Crassostrea gigas, Mercenaria mercenaria, Mytilus galloprovincialis, Placopecten magellanicus), one annelid species (Neanthes arenaceodentata), 3 decapod (crustacean) species (Pandalus danae, Penaeus mergulensis, Penaeus monodon), 3 copepod (crustacean) species (Eurytemora affinis, Tisbe battagliai, Tisbe furcata), one arthropod (crustacean) species (Artemia franciscana), one echinoderm species (Paracentrotus lividus), and 3 cnidaria species (Acropora tenuis, Goniastrea aspera, Lobophytum compactum).
Reliable species-NOEC/L(E)C10 values (µg Cu/L) are calculated for the most sensitive endpoints for 18 species. The species-specific NOEC values range from 5.9 µg Cu/L for bivalve Mytilus galloprovincialis to 145 µg Cu/L for the crustacean Penaeus monodon and were carried forward to the marine PNEC derivation.
The observed NOEC/L(E)C10 values are influenced by the dissolved organic carbon content of the test media. A relation between the observed NOEC and organic carbon content was established for Mytillus edulis. Its applicability to other invertebrate species was demonstrated for Crassostreas gigas and Paracentrotus lividus, Dendraster exentricus and Strogolocentrus purpuratus, and Mytilus galloprovincialis (Arnold et al, 2008 and 2010, Hall 2010 and Brooks 2006).
Additional information:
A voluntary risk assessment report of copper and copper compounds has been submitted to the European Chemicals Agency by the European Copper Institute (June 2008). This report is based on the industry initiative to perform a voluntary risk assessment on a substance according to the mechanisms of the implementation of the Existing Substance Regulation (EEC) No 793/93 (ESR). The procedure was agreed by the 11thJoint Meeting of the Competent Authorities for the Implementation of Directive 67/548/EEC and ESR Regulation. Italy has been acting as a reviewing Member State for the substance and the risk assessment report has been reviewed by the Technical Committee on New and Existing Substances (TC NES) according to standard operational procedures of the Committee.
In accordance with the above mentioned European copper risk assessment, the environmental hazard assessment is based on tests carried out with soluble copper species. Studies reporting quantitative dose responses of Cu(II) ions, delivered from soluble copper compounds to aquatic organisms are used for this assessment.
The data presented are considered to be adequate and reliable for the purpose of defining an appropriate classification for the ecotoxicity of Copper (II) pyrophosphate in accordance with Regulation (EC) No.1272/2008 (EU CLP).
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