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EC number: 243-815-9 | CAS number: 20427-59-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Copper dihydroxide
- EC Number:
- 243-815-9
- EC Name:
- Copper dihydroxide
- Cas Number:
- 20427-59-2
- Molecular formula:
- CuH4O2
- IUPAC Name:
- copper(2+) dihydroxide
- Details on test material:
- - Name of test material (as cited in study report): Copper hydroxide.
- Lot/batch No.: Not stated.
- Content of copper and content of copper hydroxide: Not stated.
- Storage condition of test material: The test substance was stored at ambient temperature in a dark place.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl.: (WI) BR - Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, 8741 Sulzfeld, Sandhofer Weg 7.
- Age at study initiation: Not stated.
- Weight at study initiation: Males 247 - 289 g. Females 188 - 228 g.
- Fasting period before study: 16 hours.
- Housing: During acclimation groups of 5 animals were kept in Makrolon Type III cages. During the experiment single animals were kept in Makrolon Type II cages.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: Not less than 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 2°C.
- Humidity (%): 50 - 85%.
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionised water.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The test substance was used as a 20% solution in deionised water.
MAXIMUM DOSE VOLUME APPLIED: Not stated. - Doses:
- 250, 500, 1000, 1500 mg/kg, based on a range-finding study.
- No. of animals per sex per dose:
- 5 males and 5 females per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Animals were observed frequently on the day of dosing and then once daily for the 14 day post-dosing period. Animals were weighed prior to administration, after 7 days (on day 8), after 14 days (on day 15) or at death.
- Necropsy of survivors performed: Yes. Animals were examined for macroscopic organ changes in the cranial cavity, thoracic cavity and abdominal cavity.
- Other examinations performed: Mortalities, clinical signs, body weights. - Statistics:
- Calculation of the oral LD50 with Probit Analysis according to Finney.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 878 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 582 - 3 025
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 657 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 763 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 527 - 1 272
- Mortality:
- There was one female mortality at 250 mg/kg bw. At higher doses, the frequency of mortality increased and four males and all females died at 1500 mg/kg bw. The majority of deaths occurred on day 1. Refer to Table 1.
- Clinical signs:
- other: There was a variety of clinical signs recorded including apathy, slight tremors, spasms or cramps, impaired co-ordination, reduced reflex reaction, cyanosis and pallor of the mucosa, reduced respiratory rate and reduced body temperature. The symptoms app
- Gross pathology:
- No gross findings were recorded in surviving animals. In animals that died during the study residues in the digestive tract and reddening or haemorrhage of the digestive tract mucosa were recorded.
- Other findings:
- None reported.
Any other information on results incl. tables
Table 1: Summary of mortalities following acute oral administration of copper hydroxide to rats
Dose (mg/kg bw) |
Males |
Females |
||
Mortality |
Time of death |
Mortality |
Time of death |
|
250 |
0/5 |
-- |
1/5 |
day 2 |
500 |
1/5 |
Day 1 |
2/5 |
Day 1 (2) |
1000 |
3/5 |
Day 1 (2); Day 2 |
1/5 |
Day 1 |
1500 |
4/5 |
Day 1 (4) |
5/5 |
Day 1 (5) |
Figures in parenthesis are the number that died on the day specified, if more than one.
Table 2: Summary of body weights following acute oral administration of copper hydroxide to rats
Dose (mg/kg bw) |
Mean weight start (g) |
n |
Mean weight 7 days (g) |
Mean weight end (g) |
n |
250 |
231.9 |
10 |
267.7 |
299.4 |
9 |
500 |
246.2 |
10 |
276.9 |
309.3 |
7 |
1000 |
234.7 |
10 |
253.6 |
287.4 |
5 |
1500 |
228.5 |
10 |
278.0 |
297.0 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 (calculated by probit analysis) of copper dihydroxide to the rat was 878 mg/kg bw for males (95% confidence limits 582 - 3025 mg/kg bw), 657 mg/kg bw for females and 763 mg/kg bw for the sexes combined (95% confidence limits 527 - 1272 mg/kg bw).
Classification according to Directive 67/548/EEC: Harmful (Xn). R22, Harmful if swallowed.
Classification according to CLP/GHS: Acute Tox. 4, H302: Harmful if swallowed. - Executive summary:
A GLP-compliant acute oral toxicity study was carried out in rats according to OECD Guideline 410 without deviation. Copper dihydroxide was administered in deionised water by oral gavage to groups of 5 male and 5 female rats at doses of 250, 500, 1000 and 1500 mg/kg bw. Animals were observed frequently on the day of dosing and then once daily for the 14 day post-dosing period. Animals were weighed prior to treatment and after 7 days (Day 8) and 14 days (Day 15). All animals were subjected to necropsy.
Adverse findings included one female mortality at 250 mg/kg bw. At higher doses, the frequency of mortality increased and four males and all females died at 1500 mg/kg bw. The majority of deaths occurred on day 1. Clinical signs related to treatment included apathy, tremors, spasms/cramps, impaired co-ordination, reduced reflex reaction, cyanosis and mucosal pallor, reduced respiratory rate and body temperature. Symptoms appeared about 20 minutes after dosing and persisted in some animals until day 4. Bodyweight gain in surviving animals was as expected. There were no gross necropsy findings in surviving animals. Those which died during the study showed reddening and haemorrhage of digestive tract mucosa.
The acute oral LD50 of copper hydroxide was determined to be 878 mg/kg bw for males (95% confidence limits 582 - 3025 mg/kg bw), 657 mg/kg bw for females and 763 mg/kg bw for the sexes combined (95% confidence limites 527 - 1272 mg/kg bw). Copper dihydroxide is classified as Acute Tox. 4, H302: Harmful if swallowed.
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