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EC number: 439-590-3 | CAS number: 12158-75-7
- 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:
- from March 13, 2001 to March 29, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 439-590-3
- EC Name:
- -
- Cas Number:
- 12158-75-7
- Molecular formula:
- Cu2H3NO6
- IUPAC Name:
- copper(2+) hydroxide nitrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- batch n°: 060248
composition of the test material: Cu=52.6% - N=5.4% - H=1.5% - O=36.8%
solubility in water: practically insoluble
expiration date of the batch: February 2002
storage conditions of test substance: ambient temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD (SD) IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- hygiene: optimal hygienic conditions
room temperature: average of 22.5°C (continuous control and recording)
relative humidity: average of 49.9% (continuous control and recording)
air exchange: 12 per hour
light: artificial light from 6 a.m. to 6 p.m.
cages: single caging in Makrolon cages type III ; wire mesh lids ; sanitation of cages once a week
bedding material: aspen wood chips, type "4 HV", autoclaved ; the bedding material was changed weekly
environmental enrichment: nibbling wood bricks and nesting material, both from the same material and source as the bedding material, were offered to the animals once a week
feed: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum (producer: Altromin GmbH, D-32761 Lage) ; exception: the feed was withdrawn the evening before the administration of the test substance and was offered again about 3 hours afterwards ; random samples of the feed are analysed for contaminants by Altromin
water: tap water from an automatic watering system, ad libitum
identification: labelling with felt-tipped pen on the tail and on the cage
acclimatisation: at least 5 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test substance was dissolved in deionised water.
The solutions were prepared freshly before administration and were administered within 10 minutes after the preparation.
A peroral administraiton was performed once in the morning by stomach intubation using a metal gavage. - Doses:
- 200 (male/female) & 2000 (male) mg per kg body weight
The dose volume was 20 mL per kg body weight. The individual dose volumes were calculating using the body weights determined at the day of administration. - No. of animals per sex per dose:
- 3 (in dose groups)
- Control animals:
- no
- Details on study design:
- Observations were performed within the periods 0-0.5, 0.5-1, 2-4 and 4-6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurence of secretions and excretions, automatic activity, changes in gait, posture and the presence of convulsions.
Body weights were determined before administration, 7 days p.a., 14 days p.a., early deaths as soon as possible after fnding. Body weight gains were calculated for each week of the study, i.e. 0-7 days p.a. and 7-14 days p.a.
Deceased animals were dissected and examined macroscopically in an attempt to identify the target organs. Surviving animals were killed by CO2-asphyxia 14 days p.a. and subjected to a necropsy including a gross pathological examination.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 1 000 mg/kg bw
- Mortality:
- 200 mg/kg b.w., males: all animals survived until the scheduled termination of the study.
200 mg/kg b.w., females: all animals survived until the scheduled termination of the study.
2000 mg/kg b.w., males: 2/3 animals died on the day of administration. - Clinical signs:
- other: Only the high dose males were affected. The findings, with an onset shortly after administration and lasing until death or to a maximum of 10 d.p.a. were: - autonomous nervous effects: piloerection - central nervous effects: sedation - signs of discomfort
- Gross pathology:
- See 'Remarks on results' section.
- Other findings:
- Necropsy findings:
Anormal findings were present only in deceased animals: swelling of the gastric and intestinal mucosa, irritation of the trachea. tracheal irritation may be due to a minimum test substance reflux, but was not expressed enough to have been cause of death.
All other animalswere normal at the necropsy 14 d.p.a.
Any other information on results incl. tables
Synopsis of the results - time of death:
dose (mg/Kg) | sex | animal n° | nb. of animals | time of death | ||
exposed | affected | deceased | ||||
200 | m | 71 - 73 | 3 | 0 | 0 | animals survived |
200 | f | 76 - 78 | 3 | 0 | 0 | animals survived |
2000 | m | 81 | 3 | 3 | 2 | between 2 and 4 hours |
82 | animal survived | |||||
83 | between 2 and 4 hours |
Body weights and body weight gains:
Dose | Animal n° |
Body weight (g) |
Body weight gain (g) |
||||
Sex | before administration | 7 days p.a. | 14 days p.a. | death | 0-7 days p.a. | 7-14 days p.a. | |
200 mg/Kg m | 71 | 209 | 293 | 338 | - | 84 | 45 |
72 | 206 | 264 | 288 | - | 58 | 24 | |
73 | 208 | 289 | 333 | - | 81 | 44 | |
mean | 208 | 282 | 320 | - | 74 | 38 | |
SD | 2 | 16 | 28 | - | 14 | 12 | |
200 mg/Kg f | 76 | 168 | 195 | 200 | - | 27 | 5 |
77 | 170 | 207 | 233 | - | 37 | 26 | |
78 | 180 | 229 | 246 | - | 49 | 17 | |
mean | 173 | 210 | 226 | - | 38 | 16 | |
SD | 6 | 17 | 24 | - | 11 | 11 | |
2000 mg/Kg m | 81 | 213 | a) | a) | - | a) | a) |
82 | 209 | 212 | 273 | - | 3 | 61 | |
83 | 221 | a) | a) | - | a) | a) | |
mean | 214 | - | - | - | - | - | |
SD | 6 | - | - | - | - | - |
a) animal died spontaneously.
Observations in life:
'low-mid-high': grade of severity was recorded (where applicable).
'-': no grade of severity applicable.
Findings | Dose (mg/Kg), sex | N° of affected animals | Observation time (p.a.) first - last | Maximum grade of severity |
Piloerection | 2000, M | 81 (a) | 0,5h - 2h (b) | - |
82 | 0,5h - 1 d | - | ||
83 (a) | 0,5h - 2h (b) | - | ||
Closed eyes | 2000, M | 81 (a) | 1h - 2h (b) | - |
83 (a) | 1h - 2h (b) | - | ||
Chromodacryorrhoea | 2000, M | 82 | 2d - 8d | low |
Anaemia, pale skin | 2000, M | 82 | 6d - 9d | - |
Hunched posture | 2000, M | 81 (a) | 2h (b) | - |
82 | 6h - 10d | - | ||
Sedation | 2000, M | 81 (a) | 1 - 2h (b) | mid |
82 | 1h - 7 d | mid | ||
83 (a) | 1 - 2h (b) | mid | ||
Normal at any time | 200, M | 71 | - | - |
72 | - | - | ||
73 | - | - | ||
200, F | 76 | - | - | |
77 | - | - | ||
78 | - | - |
(a) animal died spontaneously
(b) sign did not resolved before death
Necropsy findings:
Number of animals examined = 3 females and 6 males.
SYSTEM | Dose | Sex | N° of affected animals |
organ, finding | (mg/kg) | ||
normal | 200 | m | 71, 72, 73 |
200 | f | 76,77,78 | |
2000 | m | 82 | |
ALIMENTARY SYSTEM | |||
glandular stomach, mucosa, swelling | 2000 | m | 81 (a), 83 (a) |
intestinum, mucosa, swelling | 2000 | m | 81 (a), 83 (a) |
RESPIRATORY SYSTEM | |||
trachea, local irritation | 2000 | m | 81 (a) |
(a) animal died spontaneously.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the oral LD50 for Basic Copper Nitrate was estimated to be higher than 500 and less than 1000 mg/ Kg bw in rats.
According to the EC Regulation No. 1272/2008 and subsequent regulations, Basic Copper Nitrate is classified as acutely toxic by oral route - category 4.
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