Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 910-356-7 | CAS number: -
- 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10706
- Version / remarks:
- ISO 10706:2000 — water quality — determination of long term toxicity of substances to Daphnia magna Straus (Cladocera, Crustacea). ISO/TC 147/SC5 — water qual. methods; 2000 [Switzerland, 17 pp.].
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Principles of method if other than guideline:
- The study carried out a comparative evaluation of acute and chronic toxicity of CuO nanoparticles and bulk metal oxide using Daphnia magna and Vibrio fischeri as test specimen. The chronic toxicity study on bulk CuO and Daphnia magna acc. to ISO 10706:2000, Determination of long term toxicity of substances to Daphnia magna Straus (Cladocera, Crustacea) was reported here. Results of the acute toxicity test acc. to ISO 6341 (Determination of the inhibition of the mobility of Daphnia magna Straus) were only reported in the result section.
- GLP compliance:
- not specified
- Remarks:
- Existing studies (non-GLP): acc. to REACH Annex XI section 1.1, the use of existing data may be considered as a valid justification that testing is scientifically unjustified if the conditions stipulated are met.
- Specific details on test material used for the study:
- - purchased from Vetec, Rio de Janeiro, Brazil
- purity: 99% - Analytical monitoring:
- yes
- Remarks:
- free fraction of copper ions in copper oxide suspension of 2000 mg/L
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Stock solutions of CuO bulk particles were prepared at a concentration of 4000 mg/L in ultrapure water. Stock uspensions were stored in the dark at 4 °C.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): not reported - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: D. magna Straus, 1820, Cladocera, Crustacea
- Culturing method: according to ISO 6341 and DIN 38412-30 protocols
- Culture medium: according to the guideline, M4 culture medium
- Feeding during test: yes
- Food type: algae, Scenedesmus subspicatus
- Amount: 5 × 10^6 cells per individual organism
ACCLIMATION
- Acclimation conditions (same as test or not): yes
- Type of food: algae, Scenedesmus subspicatus; green algae S. subspicatus were cultivated in CHU growth medium - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- not reported
- Test temperature:
- 20 ± 2 °C
- pH:
- not reported
- Dissolved oxygen:
- not reported
- Nominal and measured concentrations:
- Nominal test concentration range: 7.8, 15.6, 31.2, 62.5 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker, 50 mL
- Test suspension volume: 25 mL
- Renewal rate of test solution: every 48 hours
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10 (M4 medium)
- No. of vessels per positive control (replicates): 10 (copper sulfate)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 culture medium
- Culture medium different from test medium: no
- Intervals of water quality measurement: not reported
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h
- Light intensity: diffuse luminosity
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Reproduction/fecundity: daily, 21 days
- Growth: daily, 21 days
- Longevity (surviving animals): daily, 21 days
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline:
The four test dilutions used were defined according to results observed in the acute toxicity test and followed a geometric progression with a ratio of 2. The lowest test concentration for the definite test started from the concentration that had no effect on the exposed organisms over 48 h in the acute toxicity test.
- Range finding study: Concentration range was based on acute toxicity study for Daphnia magna.
- Test concentrations: range 3.6 – 2000 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- copper sulfate
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 15.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 31.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 7.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Remarks:
- parental daphnids
- Remarks on result:
- other: see overall remarks
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- < 7.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Remarks:
- parental daphnids
- Remarks on result:
- other: see overall remarks
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 62.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mortality
- Remarks:
- parental daphnids
- Details on results:
- For a summary of results, please see any other information on results.
- Behavioural abnormalities: Significant increase of the number of neonates at the two highest copper oxide concentrations and the positive control compared to the blank control. The two treatments with the highest copper oxide concentrations were the only treatments significantly different to the control (please see comment in overall remarks). The derived 21d-NOEC was 15.6 mg CuO/L, the derived 21d-LOEC was 31.2 mg CuO/L.
- Observations on body length and weight: Average growth of neonates significantly decreased with increasing test concentration (no clear dose-response relationship, please see comment in overall remarks). Significant effects could be observed at the lowest concentration: therefore, the 21d-LOEC was 7.8 mg CuO/L (please see comment in overall remarks).
- Other biological observations: morphological changes: shortening of the apical spine
- Mortality of control: no
- Derived effect concentrations of the acute immobility test with Daphnia magna were: 48h-EC50 (immobility, Daphnia magna) = 223.6 ± 9.2 mg CuO/L
- The measured free faction of copper ions (Cu 2+) for the copper oxide stock solution of 2000 mg/L was 0.37 ± 0.08 mg Cu/L. - Results with reference substance (positive control):
- Chronic exposure to copper sulfate did not have a significant effect on reproduction of Daphnia magna, i.e. no adverse effect was observed at 0.06 mg CuSO4/L. The 48h-EC50 (Daphnia magna, immobility) for copper sulfate was 0.10 ± 0.25 mg/L.
- Reported statistics and error estimates:
- Results were analyzed statistically using one-way ANOVA according to EPA 821-R-02-013. The level of significance was set to p < 0.05.
- Validity criteria fulfilled:
- yes
- Remarks:
- OECD 211
- Conclusions:
- The derived effect concentrations were: 21d-NOEC (reproduction, Daphnia magna) = 15.6 mg CuO/L (nominal), 21d-LOEC (reproduction, Daphnia magna) = 31.2 mg CuO/L (nominal), 21d-NOEC (survival, Daphnia magna) >= 62.5 mg CuO/L (nominal); measured free faction of copper ions (Cu 2+) for copper oxide stock solution of 2000 mg/L was 0.37 ± 0.08 mg Cu/L.
- Executive summary:
The study carried out a comparative evaluation of acute and chronic toxicity of CuO nanoparticles and bulk form using Daphnia magna and Vibrio fischeri. The chronic toxicity study on Daphnia magna was conducted according to ISO 10706 (similar to OECD Guideline 211), and the range of test concentrations were based on results of the acute toxicity test performed beforehand. The nominal test concentrations were 7.8, 15.6, 31.2, 62.5 mg/L copper oxide. A blank and positive control (copper sulfate, 100% bioavailable copper) were run in parallel. Analytical measurements were only performed on the bioavailable copper fraction of the stock suspension (2000 mg/L).
After 21 days of exposure, onset of birth of offspring was similar for all treatment groups including copper sulfate, indicating that copper oxide had no effect on start of reproduction. The measured effects on reproduction did not follow a typical dose-response relationship. There was a significant increase of the number of neonates relative to the blank control for copper oxide at 31.2 mg/L and copper sulfate at 0.06 mg/L. The determined 21d-NOEC for copper oxide on reproduction of Daphnia magna was 15.6 mg/L (based on increased number of offspring).
Although no significant effects on the survival of neonates (longevity) were observed during 21 days of exposure, some morphological changes were found at the end of the test, i.e. shortening of the apical spine. Effects on parental growth were observed at all test concentrations including the positive control, but without a dose-dependent pattern. The effect on growth was related to feed shortage caused by the negative effect of free copper on algae growth, which was used as feed. The effect was therefore not used as reliable endpoint for the inherent toxicity of copper oxide on Daphnia magna.
Despite shortcomings in reporting, the results of the study were considered reliable and were therefore used to evaluate adverse effects on aquatic organisms. Results of the acute toxicity test reported in Heinlaan et al. 2008 (see section 6.1.3) were comparable to effect concentrations reported here, thereby supporting the reliability of results reported by Rossetto et al. 2012.
Reference
Effect concentrations for acute toxicity during 48 hours and long-term effects on reproduction, growth and survivla of Daphnia magna exposed to CuO nano and CuO bulk particles during 21 days. Results represent the mean (n=10) ± SD.
Acute |
Chronic |
||||
EC50 (mg /L) |
Concentrations (mg/L) |
Reproduction: No. of neonates/brood |
Growth: Length (mm) |
No. of survivors |
|
CuO nano |
Control |
18 ± 2 |
5.02 ± 0.11 |
1 ± 0 |
|
0.9 |
17 ± 2 |
4.49 ±0.36+a |
1 ± 0 |
||
22 ± 0.70 |
1.9 |
18 ± 3 |
4.42 ± 0.34+ |
1 ± 0 |
|
3.9 |
18 ±7b |
4.00 ± 0.20+ |
1 ± 0 |
||
7.8 |
21 ±3⁎,a |
4.39 ± 0.37+ |
1 ± 0 |
||
CuO bulk |
Control |
18 ± 2 |
5.02 ± 0.11 |
1 ± 0 |
|
7.8 |
19 ± 2 |
4.61 ±0.44+a |
1 ± 0 |
||
223.6 ± 9.2 |
15.6 |
18 ±3b |
4.36 ± 0.39+ |
0.9 ± 0.31 |
|
31.2 |
20 ±2+a |
4.23 ± 0.41+ |
1 ± 1 |
||
62.5 |
19 ±2+a |
4.44 ± 0.46+ |
0.9 ± 0.31 |
||
CuSO4 |
Control |
18 ± 2 |
5.02 ± 0.11 |
1 ± 0 |
|
0.10 ± 0.25 |
0.06 |
21 ± 4+ |
4.27 ± 0.44 + |
1 ± 0 |
+ Values significantly different from control (p < 0.05).
a LOEC — low observed effect concentration
b NOEC — no observed effect concentration
Description of key information
21d-NOEC (Daphnia magna, reproduction) = 69 mg/L (nominal, total fraction, submission substance), corresponding to 0.028 mg/L dissolved copper (measured / extrapolated) (ISO 6341)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.028 mg/L
Additional information
A reliable key study was available for the hazard assessment of chronic toxicity to aquatic invertebrates for the submission substance reaction mass of copper oxide and manganese dioxide. The available key study was performed with copper oxide. Copper oxide was considered the hazardous constituent of the submission substance with regard to the aquatic environment. No study was available for chronic toxicity of manganese dioxide in aquatic invertebrates. As the constituent manganese dioxide was of very low water solubility and no toxicity of manganese dioxide was observed in any of the acute toxicity studies on aquatic organisms, using effect concentrations on the basis of copper oxide was considered protective (see also attached read-across report, section 13).
The key study on constituent copper oxide investigated chronic toxicity to Daphnia magna according to ISO 10706 (similar to OECD Guideline 211) (RL2, 2014). Four nominal test concentrations were used. A blank and positive control (copper sulfate, 100% bioavailable copper) were run in parallel. After 21 days of exposure, onset of birth of offspring was similar for all treatment groups including copper sulfate, which indicated that copper oxide had no effect on start of reproduction. The measured effects on reproduction did not follow a typical dose-response relationship. There was a significant increase of the number of neonates relative to the blank control. The observed effect was interpreted as the organisms' attempt to preserve the species under stressful conditions, which had been reported previously. The effect was also observed in the treatment group with copper sulfate. Although no significant effect on the survival of neonates (longevity) was observed during 21 days of exposure, some morphological changes were found at the end of the test, i.e. shortening of the apical spine. Effects on parental growth were observed at all test concentrations including the positive control, but without a dose-dependent pattern. The effect on growth was related to feed shortage caused by the negative effect of free copper on algae growth, which was used as feed. The effect was therefore not used as reliable endpoint for the inherent toxicity on Daphnia magna. In conclusion, the nominal 21d-NOEC on reproduction of Daphnia magna was 69 mg/L (based on increased number of offspring; value recalculated based on the ratio of MnO2 and CuO in the reaction mass), corresponding to 0.028 mg/L dissolved copper (value extrapolated based on measured dissolved copper fraction of 0.18% for nominal CuO concentration, see section 6.1.5, Aruoja et al. 2009).
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.