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EC number: 235-113-6 | CAS number: 12069-69-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Already evaluated by the Competent Authorities for Biocides and Existing Substances Regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Copper(II) carbonate-copper(II) hydroxide (1:1)
- EC Number:
- 235-113-6
- EC Name:
- Copper(II) carbonate-copper(II) hydroxide (1:1)
- Cas Number:
- 12069-69-1
- Molecular formula:
- CuCO3.Cu(OH)2
- IUPAC Name:
- copper(II) carbonate, basic
- Details on test material:
- Batch number - not reported
Description - powder
Purity - not reported
Stability - Stable at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl.: (WI) BR - Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source - Firma Charles River Wiga, Germany
Weight at study initiation - Males weighed 220-314 g and females weighed 181-262 g.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Carboxymethylcellulose
- Details on oral exposure:
- Concentration in vehicle - 10, 15 and 20%
Total volume applied - 1.8 – 3.1 ml - Doses:
- Following a preliminary range finding test with a dose of 2000 mg/kg the final doses were 1000, 1500 and 2000 mg/kg.
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- Clinical observations were recorded after 10 minutes, 1, 2, 6, 24 hours and once daily thereafter up to Day 14 following test substance
administration. The bodyweights of test organisms were recorded immediately before treatment (Day 0) and surviving animals reweighed on Day 7
and Day 14 (termination).
Animals found dead or killed in extremis were immediately necropsied. The surviving animals were sacrificed after 14 days and gross pathological
examinations performed. - Statistics:
- The LD50 values were carried out by probit analysis.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 434 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 291 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 385 mg/kg bw
- Based on:
- test mat.
- Mortality:
- See Table 1.
- Clinical signs:
- other: Severe clinical symptoms related to CNS-symptoms, coordination, reflexes and automatic functions were observed with dose related intensity up to 9 days post administration. For further details, refer to Table 1.
- Gross pathology:
- Gross pathological examination at 14 days post administration revealed no test article dependent findings in any of the dose groups. Those
macroscopic changes observed were attributable to the sacrificing procedure or to minor variations which often occur spontaneously in rats of this
strain and age.
In contrast, severe macroscopic changes of the gastro-intestinal tract were observed in all mid and high dose animals killed in extremis or died
spontaneously. The findings are considered to be test article-related. For further details refer to Table 1 - Other findings:
- None.
Any other information on results incl. tables
Table 1. Summary of Findings for Acute Oral Toxicity |
||||
Dose mg/kg |
Number of dead / |
Time of death (range) |
Observations |
|
1000 males |
0/5 |
- |
Clinical observations included reduced activity, general reactions, body tone and skin turgor. Additional signs were piloerection, diarrhoea, paleness in skin/mucous membrane and test organisms adopted a squatting position. One animal was killed in extremis and pathological investigations determined residues of the test article in the stomach and green discolouration of the intestine. After 14 days observation period, pathological findings included a white cover on the mucous membrane of the stomach in one male and one female, foamy yellow contents in the intestine, swollen liver and spleen, pale kidneys and hydrometra in the genital system of one female. |
|
1000 females |
2/5 |
Day 7 |
||
1500 males |
4/5 |
Day 2 – Day 8 |
Clinical observations included reduced activity and general reactions. Additional signs were pilorection, diarrhoea, paleness in skin/mucous membrane and test organisms adopted a squatting position. Pathological findings of animals killed in extremis prior to test termination included marbled lung, green discoloured and swollen mucous membrane of the stomach. After 14 days, pathological findings included swollen mucous membranes in the stomach and intestine of one male and two females. One organism had an enlarged and darkened spleen. |
|
1500 females |
3/5 |
3 hours – Day 6 |
||
2000 males |
4/5 |
Day 3 – Day 9 |
Clinical observations included reduced activity, general reactions, body tone and skin turgor. Additional signs were pilorection, diarrhoea, paleness in skin/mucous membrane and test organisms adopted a squatting position. Pathological findings in animals killed in extremis included swollen mucous membranes, green discoloration and mucous membrane and corrosion in the stomach of 3 males and 3 females. Four males and three females had hyperaemic and green discolouration of the intestine. Other findings were reduced and discoloured spleen and abnormal coloured kidney. After 14 days two individuals had enlarged and dark discoloured spleen. Other pathological findings included a marbled liver and lung, enlarged and dark coloured spleen, marbled and discoloured kidney and inflated and green coloured intestine. |
|
2000 females |
3/5 |
4 hours – Day 7 |
||
LD50value |
Male – 1434 mg/kg Female – 1291 mg/kg Males and Females – 1385 mg/kg |
|||
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The resulting LD50 values were 1434, 1291 and 1385 mg/kg for males, females and both sexes combined respectively. Based on these results and according to EU directive 83/467/EEC copper carbonate should be classified as 'Harmful if Swallowed’ under Commission Directive 93/21/EC)
- Executive summary:
Materials and Methods
The aim of this study was to determine the acute oral toxicity of copper carbonate to male and female rats. The test concentrations were 1000, 1500 and 2000 mg/kg bw. During a 14-day post exposure period the test animals were assessed for clinical observations, bodyweight change and mortality. At the end of the study all animals were sacrificed and subject to pathological examination.
The study was conducted according to GLP and the following guidelines;
OECD Guidelines, No. 401. Acute Oral Toxicity (February 24, 1987).
EEC Directive 84/449/EEC. (September 19, 1984).Results and Discussions
Severe clinical symptoms were observed up to 9 days post administration. There were reduced weight gains in all test animals. Gross pathological examinations at 14 days revealed no test article dependant findings in any of the dose groups. However, all mid and high dose animals killed in extremis or died spontaneously revealed characteristic gastro-intestinal alterations, which were considered to be test article related.
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