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EC number: 215-582-3 | CAS number: 1333-22-8
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental phase: 07 February 2002 to 28 February 2002. Report issue: 12 June 2002.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral 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:
- Tetracopper hexahydroxide sulphate
- EC Number:
- 215-582-3
- EC Name:
- Tetracopper hexahydroxide sulphate
- Cas Number:
- 1333-22-8
- Molecular formula:
- Cu4H6O10S
- IUPAC Name:
- tetracopper(2+) hexahydroxide sulfate
- Test material form:
- solid: bulk
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: Male and female Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rats were supplied by Charles River (UK) Ltd, Margate, Kent, UK.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Approximately eight weeks old
- Weight at study initiation: At least 200g
- Fasting period before study: Overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: provided ad libitum (except for immediately prior to and after dosing)
- Water: provided ad libitum (except for immediately prior to and after dosing)
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
- Environmental enrichment: The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml for 2000 mg/kg dose and 200 mg/ml for 200 mg/kg dose.
- Amount of vehicle (if gavage): 10 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
- Doses:
- 2000 mg/kg and 200 mg/kg
- No. of animals per sex per dose:
- 2000 mg/kg: 3 female
200 mg/kg: 3 female and 3 male - Control animals:
- no
- Statistics:
- None
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Animals treated with 2000 mg/kg were found dead during the day of dosing or one day after dosing. No deaths were noted in animals treated with 200 mg/kg.
- Clinical signs:
- other: Signs of systemic toxicity noted in females were hunched posture, pilo-erection and diarrhoea. Additional signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were lethargy, decreased respiratory rate, laboured respiration and
- Gross pathology:
- Abnormalities noted at necropsy of animals that died during the study were haemorrhagic or abnormally red lungs, dark liver, dark kidneys, blue liquid present in the stomach, epithelial sloughing of the gastric mucosa and non-glandular region of the stomach and haemorrhagic small intestine. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl:CD® (SD) IGS BR) strain rat was estimated to be in the range of 300 - 500 mg/kg bodyweight.
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test material. The method used was designed to meet the requirements of the following guidelines:
• OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute ToxicClass Method" (adopted 22 March 1996)
• Commission Directive 96/54/EC Method B1 tris Acute Oral Toxicity (Oral - Acute ToxicClass Method)
Method
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. Based on the results from this dose level further groups of fasted animals were treated at a dose level of 200 mg/kg bodyweight. Dosing was performed sequentially. The test material was administered orally as a dispersion in 0.5% carboxy methyl cellulose.
Results
Animals treated with 2000 mg/kg were found dead during the day of dosing or one day after dosing. No deaths were noted in animals treated with 200 mg/kg.
Signs of systemic toxicity noted in females were hunched posture, pilo-erection and diarrhoea. Additional signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were lethargy, decreased respiratory rate, laboured respiration and ataxia. One female treated with 2000 mg/kg was found comatose four hours after dosing. All females treated with 200 mg/kg recovered one day after dosing. No signs of systemic toxicity were noted in males treated with 200 mg/kg.
Bodyweight. The surviving animals showed expected gains in bodyweight.
Conclusion
The acute median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl:CD® (SD) IGS BR) strain rat was estimated to be in the range of 300 - 500 mg/kg bodyweight.
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