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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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation 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): Cupric hydroxide
- Composition of test material, percentage of components: 85.9% copper dihydroxide
- Lot/batch No.: 0215913294
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were housed individually and acclimatised prior to dosing.
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Test atmospheres were generated with a NBS dust aerosol generator. The gravimetric test concentrations were determined by dividing the total weight of the test substance collected on a glass fibre filter by the volume of air sampled. The nominal test concentration was calculated by dividing the total weight of the test substance used by the total volume of air passing through the chamber during exposure. The MMAD and the particle size distribution were calculated from two samples taken during exposure with an ITP 7 L/minute cascade impactor. Refer to Table 1. Chamber environmental conditions were monitored during the exposure.
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0.13, 0.30, 0.61 and 2.61 mg/L (time weighted average gravimetric concentrations, 2.61 mg/L was maximum practical).
- No. of animals per sex per dose:
- Groups of five male and five female rats.
- Control animals:
- no
- Details on study design:
- Animals were observed for reaction to treatment during exposure (Day 1) and daily for 14 days following exposure. Mortality was recorded twice daily. Body weights were recorded prior to exposure and after 7 days (Day 8) and 14 days (Day 15). Gross pathological examinations were performed on decedents and animals surviving for 14 days.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 0.5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 0.61 mg/L air
- Based on:
- test mat.
- 95% CL:
- 0.05 - 1.17
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.56 mg/L air
- 95% CL:
- 0.2 - 0.92
- Exp. duration:
- 4 h
- Mortality:
- There were no mortalities at 0.13 and 0.30 mg/L. At 0.61 mg/L, all males and four females died and at 2.61 mg/L, all animals died. All deaths occurred on the day of exposure. Refer to Table 2.
- Clinical signs:
- other: Clinical symptoms after exposure were recorded in all surviving animals. The most notable signs were dark material around the face, urine stains, swollen eyelids, lacrimation, salivation, rough haircoat, decreased activity, breathing abnormalities and de
- Body weight:
- Body weight loss was recorded in one female treated at 0.13 mg/L in the second week after treatment and body weight loss or reduced weight gain was recorded in females treated at 0.30 mg/L. Other surviving animals gained weight during the study.
- Gross pathology:
- At necropsy, the animals which died showed fluid/mucoid contents in the digestive tract, congested meningeal vessels in the brain and mottled lungs.
- Other findings:
- None.
Any other information on results incl. tables
Table 2. Summary of Mortalities
Gravimetric concentration |
Males |
Females |
||
Mortality |
Time of death |
Mortality |
Time of death |
|
0.13 |
0/5 |
- |
0/5 |
- |
0.30 |
0/5 |
- |
0/5 |
- |
0.61 |
5/5 |
Day 1 |
4/5 |
Day 1 |
2.61 |
5/5 |
Day 1 |
5/5 |
Day 1 |
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute inhalation LC50 (4 hour) of copper dihydroxide in the rat was 0.50 mg/L for males (95% confidence interval could not be determined due to lack of partial mortality level), 0.61 mg/L for females (with 95% confidence limits of 0.05 to 1.17 mg/L) and 0.56 mg/L for the sexes combined (with 95% confidence limits of 0.20 to 0.92 mg/L).
Classification according to Directive 67/548/EEC: Toxic (T). R23, Toxic by inhalation.
Classification according to CLP/GHS: Acute Tox. 2, H330: Fatal if inhaled. - Executive summary:
A GLP-compliant acute inhalation toxicity test was conducted in accordance with US EPA 81-3 without significant deviation. Test atmospheres of copper dihydroxide were generated with a NBS dust aerosol generator. Sprague-Dawley rats were housed individually and acclimatised prior to dosing. Groups of five male and five female rats were exposed to an aerosol atmosphere of the test substance at 0.13, 0.30, 0.61 and 2.61 mg/L (time weighted average gravimetric concentrations, 2.61 mg/L was maximum practical) for four hours using a whole body exposure system. The gravimetric test concentrations were determined by dividing the total weight of the test substance collected on a glass fibre filter by the volume of air sampled. The nominal test concentration was calculated by dividing the total weight of the test substance used by the total volume of air passing through the chamber during exposure. The MMAD and the particle size distribution were calculated from two samples taken during exposure with an ITP 7 L/minute cascade impactor. Chamber environmental conditions were monitored during the exposure. Animals were observed for reaction to treatment during exposure (Day 1) and daily for 14 days following exposure. Mortality was recorded twice daily. Body weights were recorded prior to exposure and after 7 days (Day 8) and 14 days (Day 15). Gross pathological examinations were performed on decedents and animals surviving for 14 days.
There were no mortalities at 0.13 and 0.30 mg/L. At 0.61 mg/L, all males and four females died and at 2.61 mg/L, all animals died. All deaths occurred on the day of exposure. Clinical symptoms after exposure were recorded in all surviving animals. The most notable signs were dark material around the face, urine stains, swollen eyelids, lacrimation, salivation, rough haircoat, decreased activity, breathing abnormalities and decreased defecation. All survivors recovered from these signs by the end of the observation period. Body weight loss was recorded in one female treated at 0.13 mg/L in the second week after treatment and body weight loss or reduced weight gain was recorded in females treated at 0.30 mg/L. Other surviving animals gained weight during the study. At necropsy, the animals which died showed fluid/mucoid contents in the digestive tract, congested meningeal vessels in the brain and mottled lungs.
The acute inhalation LC50 (4‑hour) of copper dihydroxide in the rat was 0.50 mg/L for males (95% confidence interval could not be determined due to lack of partial mortality level), 0.61 mg/L for females (with 95% confidence limits of 0.05 to 1.17 mg/L) and 0.56 mg/L for the sexes combined (with 95% confidence limits of 0.20 to 0.92 mg/L). Copper dihydroxide is classified as Acute Tox. 2, H330: Fatal if inhaled.
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