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EC number: 231-159-6 | CAS number: 7440-50-8
- 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: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- coated copper flakes
- IUPAC Name:
- coated copper flakes
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): Copper powder KU 7600 Standard Material
- Analytical purity: 98%
- Lot/batch No.: 11G0015
- Expiration date of the lot/batch: May 2012
- Storage condition of test material: Cool and dry in a tightly sealed container.
- Particle size distribution: d(0.1) = 4.49 µm, d(0.5) = 10.78 µm (median), d(0.9) = 21.42 µm
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Research Models and Services Germany GmbH. Sandhofer Weg 7, 97633 Sulzfeld, Germany.
- Age at study initiation: Males, approximately 7 weeks. Females, approximately 9 weeks.
- Weight at study initiation: Males, 238 - 262 g. Females, 231 - 245 g.
- Fasting period before study: Feeding was discontinued 16 hours before exposure.
- Housing: Granulated textured wood was used as bedding material for the cages. During the 14-day observation period, the animals were kept by sex in groups of 3 animals in MAKROLON cages (tpe III plus).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12 hrs dak/12 hrs light.
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Dynamic nose-only inhalation apparatus (RHEMA-LABORTECHNIK, 65719 Hofheim/Taunus, Germany).
- Exposure chamber volume: 40L
- Method of holding animals in test chamber: Animals were held in pyrex tubes at the edge of the chamber in a radial position.
- Source and rate of air: The generator was fed with compressed air (5.0 bar) taken from the surrounding laboratory atmosphere. Air changes 22.5 times per hour.
- Method of conditioning air: Air was filtered using an in-line disposable gas filter.
- System of generating particulates/aerosols: The dust of the test material was generated using a rotating brust dust generator (RBG 1000, PALAS GmbH, Partikel und Lasermesstechnik, 76229 Karlsruhe, Germany).
- Method of particle size determination: Particle size distribution was determined during the exposure period using a cascade impactor.
- Treatment of exhaust air: The exhaust air was drawn through gas wash-bottles.
- Temperature, humidity, pressure in air chamber: The temperature during the exposure period was in the range 21.3 - 21.9°C. Humidity was in the range 60.3 - 64.2%. A positive aire pressure was maintained within the exposure apparatus.. Air flow at the entrance was 900 L/h. Air flow at the exis was 800 L/h.
TEST ATMOSPHERE
- Brief description of analytical method used: The dust inhalation in the inhalation chamber was measured gravimetrically witha n air sample filter and pump controlled by a rotameter. Dust samples were taken once every hour during the exposure. A probe was placed close to the animals' noses and air was drawn through the air sample filter at a constant rate of 5L/minute for 1 minute. The filters were weighed befor and after sampling
- Samples taken from breathing zone: yes.
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: See Table 1.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The MMAD was 3.477 µm (1.24 or 5.11 mg/L). The GSD of the MMADs were calculated as 2.61 or 2.77 (1.24 or 5.11 mg/L).
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: A nominal limit concentration of 5 mg/L was chosen. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetrically determined
- Duration of exposure:
- 4 h
- Concentrations:
- Gravimetrically determined concentrations (with SD) of 1.24 (±0.03) and 5.11 (±0.02) mg Copper powder KU 7600 Standard Material/L air.
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Clinical examinations were made at least once daily until all symptoms subsided, thereafter each working day. Observations on deaths were made at least once daily. Individual weight were determined once during acclimatisation, before exposure on day 1, on days 2, 4, 8 and 15.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight, lung weight.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.11 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: There was no evidence of respiratory tract irritation
- Mortality:
- none
- Clinical signs:
- other: A 4-hour inhalation exposure to Copper powder KU 7600 Standard Material at concentrations of 1.24 or 5.11 mg/L air revealed concentration-related slight to moderate ataxia, slight to moderate tremor and slight to moderate dyspnoea (reduced frequency of re
- Body weight:
- One of three females treated with the low concentration showed a reduced body weight gain at the end of the study compared to the start value (+2.9%). The two other females showed weight gains of +7.1% and +10.0%.
Two of three females treated with the high concentration showed a reduced body weight gain at the end of the study compared to the start value (+2.5% and +3.3%). The remaining female showed a weight gain of +6.1%. - Gross pathology:
- Dark or slight grey-stained discoloured lungs were observed in two males at the dose level of 1.24 mg/L or in one male and 1 female at the dose level of 5.11 mg/L.
- Other findings:
- There was no evidence of respiratory tract irritation
Any other information on results incl. tables
Results are summarized in table 2 (attached)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the 4-hour inhalation LC50 of Copper powder KU 7600 Standard Material is >5.11 mg/L air. No evidence of respiratory tract irritation could be observed. The test material is not classified as dangerous. The LOAEC of 1.24 mg/L was used for deriving a short trom inhalation DNEL
- Executive summary:
A GLP-compliant acute inhalation test was carried out in the Sprague-Dawley rats in accordance with OECD Guideline 436. Groups of 3 males and 3 females were exposed for 4 hours to a dry aerosol of Copper powder KU 7600 Standard Material at gravimetrically determined concentrations of 1.24±0.03 and 5.11±0.02 mg /L air using a dynamic nose-only exposure chamber. The aerosol was generated with the aid of a dry, rotating brush dust generator. The MMAD of particles in the animals’ breathing zone was 3.477 µm. GSDs of the MMADs were 2.61 (1.24 mg/L) or 2.77 (5.11 mg/L).
No mortalities were observed at either exposure concentration. One of three females from the low concentration group and two of three females from the high concentration group showed reduced body weight gain at the end of the study. A 4-hour inhalation exposure to Copper powder KU 7600 Standard Material at concentrations of 1.24 or 5.11 mg/L air revealed concentration-related slight to moderate ataxia, slight to moderate tremor and slight to moderate dyspnoea (reduced frequency of respiration with increased volume) on test day 1 immediately after end of exposure until 3 hours or until test day 4 in all animals, respectively (3 of 3 male and 3 of 3 female animals, each). In addition, reduced motility was observed in all animals at 5.11 mg/L air 2 to 4 days after exposure. Dark or slight grey-stained discoloured lungs were observed in two males from the 1.24 mg/L group and in one male and one female from the 5.11 mg/L exposure group.
The 4-hour inhalation LC50 of Copper powder KU 7600 Standard Material is >5.11 mg/L air. No evidence of respiratory tract irritation could be observed. On this basis the test material is unclassified with regard to acute inhalation toxicity.
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