Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 800-038-5 | CAS number: 1071838-81-7
- 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:
- 2012-12-04 to 2013-03-04
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- copper(2+) bis(carbamimidoylurea) dinitrate
- EC Number:
- 800-038-5
- Cas Number:
- 1071838-81-7
- Molecular formula:
- Cu(C2H6N4O)2 (NO3)2
- IUPAC Name:
- copper(2+) bis(carbamimidoylurea) dinitrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVERS breeder, Domaine des Oncins BP 109, 69592 L’Arbresle Cedex, FRANCE
- Weight at study initiation: 238 g (female) and 246 g (male)
- Fasting period before study: no fasting period
- Housing: polycarbonate cages (Makrolon) containing autoclaved dust-free bedding (sawdust + chips), one rat per cage
- Diet: ad libitum rat/mice Altromin 1320 (Genestil, 1 rue du mesnil, 60420 ROYAUCOURT, FRANCE)
- Water: ad libitum filtered tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 40%-70%
- Air changes (per hr): 15 to 20 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: december 4 2012 To: december 18 2012
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: A 35 cm2-gauze dressing, corresponding to the 10% of the body surface, was placed on a saran-wrap. The test item was applied uniformly as a powder over the gauze dressing area. The test item is put in contact with the skin by applying the gauze to the area stripped of the animal. The animal was wrapped with non-irritating bandage. Care was taken to ensure bandages do not interfere with respiration and to minimize interference with animal’s movements.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the site of treatment was rinsed and wiped delicately with water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 488 ± 12 mg of test item per rat
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- rats were treated with 2025 ± 30 mg/kg of body weight and with 2007 ± 10 mg/kg of body weight respectively for the male and the female.
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: on the day of treatment (D0): 30 minutes after the end of application, 2 times during the following 4 hours, and once thereafter. At D1, after removal of the bandage and rinsing of the skin, the site of treatment were observed carefully. Daily from D2 to D14 (once per day).
- Frequency of weighing: on day 0, before treatment and daily from D1 to D14.
- Necropsy of survivors performed: yes
- Necropsy observations: external examination (skin, especially the treatment site, eyes, nose), thoracic area (respiratory tracts, the trachea-bronchial lymph nodes, heart, and esophagus), Abdominal area (liver, spleen, the pancreas, the digestive tract, the adrenal glands, the kidneys, the bladder, the liver and kidneys lymphatic ganglia, the lumbar aortic lymphatic ganglia and female reproductive organs). - Statistics:
- no statistical tests
Results and discussion
- Preliminary study:
- no preliminary study
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality.
All animals were euthanized on day 14, at the end of the study. - Clinical signs:
- other: No clinical sign was observed in any of the rats during the 14 days of in-life observations.
- Gross pathology:
- No macroscopic abnormality was observed in animals except a partial growth back of the fur in 3 males and in the 5 females. In absence of control data, we could not conclude of any interaction between the fur growth and CuGUN application.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions of this study, the test item, CuGUN (lot No.40) at a dose of 2,000 mg/kg, did not cause any acute toxicity by contact with skin. Therefore, according to the regulation 1272/2008/EEC, the classification of the test item is "not classified".
- Executive summary:
The objective of this study was to evaluate the acute dermal toxicity of the test item Copper Guanylurea Nitrate (CuGUN), in rat. The study design was based on OECD Guideline No. 402.
Acute dermal toxicity was determined by a limit test at one dose level of at least 2,000 mg per kg bodyweight. Because of test item related mortality was not produced, a full study was not considered.
Method
Five males and five nulliparous and non gravid female WISTAR rats were treated with test item. Test item wasapplied as a powder to the shaven skin of the animal, on a surface corresponding to 10% of the body surface. The animal was wrapped with non-irritating bandage.The test item was left in place during 24 hours. At the end of the treatment, the bandage and all dressings were removed delicately and the site of treatment was rinsed and wiped delicately with water, to ensure elimination of potential residual test item.
Each animal was observed at least once a day for mortality, clinical signs and body weight, during 15 days. On completion of the observation period, a necropsy including macroscopic examination was realized on animals after scheduled death.
Results
Rats were treated with 2,026 ± 30 mg/kg and 2,009 ± 10 mg/kg respectively for the male and the female.
No unscheduled deaths, no clinical signs and no macroscopic changes considered to be related to the treatment of CuGUN were observed on rats treated, during the observation period.
Conclusion
Under the experimental conditions of this study, the test item, CuGUN (lot No.40) at a dose of 2,000 mg/kg, did not cause any acute toxicity by contact with skin. Therefore, according to the regulation 1272/2008/EEC, the classification of the test item is "not classified".
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.