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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from March 13, 2001 to April 10, 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 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute 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 21.6°C (continuous control and recording)
relative humidity: average of 62.4% (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) ; 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
- Type of coverage:
- semiocclusive
- Vehicle:
- other: soaked with deionised water
- Details on dermal exposure:
- Hair of the dorsal trunk was clipped with an electrical hair clipper one day before the application of the test substance. The test site was located on the median dorsal thoracal region.
A dermal administration was performed once by spreading the test substance on an area of about 10% of the estimated body surface. An area of 5 cm x 6 cm was labelled in a relaxed animal. This area, when stretched for administration, gives an application site of about 50 cm².
A cellulose patch with the calculated amount of the test substance, spread over an area of approximately 5 cm x 6 cm and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape. Patch and tape were covered semi-occlusively by a dressing.
At the end of the exposure period, the dressing, the tape and the patch were removed. Residual test substance was wopped off using a cellulose tissue. - Duration of exposure:
- 24 hours
- Doses:
- 2000 (male/female) mg 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:
- 5 (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.
Results and discussion
- Preliminary study:
- In a range finding study 3 groups of one male and one female each were dosed with 400 or 894 or 2000 mg per kg body weight. All animals survived until 7d.p.a. Therefore a limit test with one dose of 2000 mg per kg body weight was performed.
Both animals, dosed with 2000 mg/kg body weight in the preliminary test, were included into the main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: All animals were affected. The findings in life were: - signs of discomfort: chromodacryorrhoea - other effects: staining of the skin at the application site ; This discoloration is directly attributed to a staining property of the test substance ans is n
- Gross pathology:
- See 'Remarks on results' section.
- Other findings:
- Necropsy findings:
No abnormal findings were made post mortem.
Any other information on results incl. tables
Synopsis of the results:
Main study:
Sex | Animal n° | Dose (mg/Kg) | Number of animals | ||
exposed | affected | deceased | |||
m | 321-325 | 2000 | 5 | 5 | 0 |
f | 326-330 | 2000 | 5 | 5 | 0 |
Range finding study:
Sex | Animal n° | Dose (mg/Kg) | Number of animals | ||
exposed | affected | deceased | |||
m | 301 | 400 | 1 | 1 | 0 |
f | 306 | 400 | 1 | 1 | 0 |
m | 311 | 894 | 1 | 1 | 0 |
f | 316 | 894 | 1 | 1 | 0 |
m | 321 | 2000 | 1 | 1 | 0 |
f | 326 | 2000 | 1 | 1 | 0 |
Body weight and body weight gain:
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. | |
200o mg/Kg m | 321 | 294 | 322 | 356 | - | 28 | 34 |
322 | 271 | 317 | 369 | - | 46 | 52 | |
323 | 278 | 330 | 378 | - | 52 | 48 | |
324 | 292 | 332 | 380 | - | 40 | 48 | |
325 | 293 | 347 | 391 | - | 54 | 44 | |
mean | 286 | 330 | 375 | - | 44 | 45 | |
SD | 10 | 11 | 13 | - | 10 | 7 | |
2000 mg/Kg m | 326 | 253 | 254 | 279 | - | 1 | 25 |
327 | 231 | 234 | 246 | - | 3 | 12 | |
328 | 236 | 239 | 245 | - | 3 | 6 | |
329 | 228 | 230 | 248 | - | 2 | 18 | |
330 | 234 | 252 | 261 | - | 18 | 9 | |
mean | 236 | 242 | 256 | - | 5 | 14 | |
SD | 10 | 11 | 14 | - | 7 | 8 |
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 |
Chromodacryorrhoea | 2000, M | 321 | 6h - 1d | low |
2000, F | 327 | 0,5h - 6h | low | |
Test substance related stain of skin | 2000, M | 321 | 1d - 3d | - |
322 | 1d - 3d | - | ||
323 | 1d - 4d | - | ||
324 | 1d - 3d | - | ||
325 | 1d - 4d | - | ||
2000, F | 326 | 1d - 4d | - | |
327 | 1d - 3d | - | ||
328 | 1d - 2d | - | ||
329 | 1d - 3d | - | ||
330 | 1d - 2d | - |
Necropsy findings:
Number of animals examined: 5 males and 5 females
SYSTEM | Dose | Sex | N° of affected animals |
organ, finding | (mg/kg) | ||
normal | 2000 | m | 321, 322, 323, 324, 325 |
2000 | f | 326, 327, 328, 329, 330 |
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 dermal LD50 for Basic Copper Nitrate was estimated to be higher than 2000 mg/ Kg bw in rats.
According to the EC Regulation No. 1272/2008 and subsequent regulations, Basic Copper Nitrate is not classified as acutely toxic by dermal route.
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