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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 march 2012 to 6 september 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed in accordance to OECD guideline 429
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximatively 12 weeks (preliminary test) and 8 weeks (main test)
- Weight at study initiation: 18.1 to 21.6 g
- Housing: group of 2 (preliminary test) or 4 (main test) in polycarbonate cages (techniplast 1145T, 435 cm2) containing autoclaved sawdust (SICSA, Alfortville, France). Each cage contained 2 enrichments (mouse hut and cocoon). In the main test, on day 6, animals were individually housed in disposable crystal polystyrene cages.
- Diet (e.g. ad libitum): free access to SSNIFF R/M-H pelleted maintenance diet (SSNIFF Spezialdiaten GmbH, Soest, Germany)
- Water (e.g. ad libitum): ad libitum, filtered (0.22 µm) tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 2°C
- Humidity (%): 50+/-20%
- Air changes (per hr): 12 cycles/hour of filtered , non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: 25 april 2012 To: 07 may 2012
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Remarks:
- sigma batch S39776-337
- Concentration:
- 50%
- No. of animals per dose:
- 2 females per dose for the preliminary test
4 females per dose in the main test - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: homogeneous suspension to the naked eye at the concentration of 50% in propylene glycol
- Irritation potential: ear thickness measurement in a preliminary test in order to define the test item concentrations to be used in the main test. From day 1 to day 3 then on day 6, the thickness of both ears of each animal was measured and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6. On completion of the observation period, the animals were sacrificed then discarded without macroscopic post mortem examination.
- Lymph node proliferation response: five groups of mice received the test item at concentrations of 50, 25, 10, 5 or 2.5% . One negative control group received the vehicle (Propylene Glycol) under the same experimental conditions. Additionally, one positive control group received the positive control, α hexylcinnamaldehyde (HCA), at 25% in a mixture acetone/olive oil (4/1; v/v) under the same experimental conditions.
From day 1 to day 3 then on day 6, the thickness of the left ear of each animal was measured, except in animals of the positive control group, and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6.
After 2 days of resting, on day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3H-TdR). Approximately 5 hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3H-TdR.
The results were expressed as disintegrations per minute (dpm) per group and as dpm/node. The obtained values were used to calculate Stimulation Indices (SI). Stimulation indices (SI) = dpm per node of the treated group/dpm per node of the vehicle control group
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: auricular lymph node cell (ALNC) proliferation assay
- Criteria used to consider a positive response: SI> or = to 3 for a dose group with consideration of a dose-response relationship
TREATMENT PREPARATION AND ADMINISTRATION:
test item was administered as a homogeneous suspension in the vehicle. The test item was mixed under magnetic agitation with the required quantity of vehicle.
Mice received the test item, by topical route to the dorsal surface of both ears on days 1, 2 and 3 at concentrations of 50, 25, 10, 5 or 2.5% under a dose-volume of 25 µL. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- EC3 value (theorical concentration resulting in a SI value of 3) was determined by linear interpolation of points on the dose-response relation ship curve, immediately above and below the 3-fold threshold.
Results and discussion
- Positive control results:
- the threshold positive value of 3 for the SI was reached in the positive control group (SI=13.00). the experiment was considered valid
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: a dose-related increase in the SI was recorded and the threshold positive value of 3 was exceeded at concentrations >5% test item: 2.5% ->SI=1.30; 5% ->SI=2.78; 10%->SI=6.53; 25%->SI=10.40; 50%-> SI=8.12 EC3 value is equal to 5.3%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control: 116.50 dpm per node test item: 2.5% ->151.75 dpm/node; 5% ->324.38 dpm/node; 10%->760.63 dpm/node; 25%->1212.00 dpm/node; 50%-> 946.13 dpm/node positive control HCA 25%: 1514.75 dpm/node
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- Concentration 2.5 %
- Key result
- Parameter:
- SI
- Value:
- 2.78
- Test group / Remarks:
- Concentration 5 %
- Key result
- Parameter:
- SI
- Value:
- 6.53
- Test group / Remarks:
- Concentration 10 %
- Key result
- Parameter:
- SI
- Value:
- 10.4
- Test group / Remarks:
- Concentration 25 %
- Key result
- Parameter:
- SI
- Value:
- 8.12
- Test group / Remarks:
- Concentration 50 %
Any other information on results incl. tables
Clinical history:
All animals of the preliminary test: no clinical signs and final sacrifice at day 6.
All animals of the main test: no clinical signs and final sacrifice at day 6.
Cutaneous reactions:
all animals of the main test treated by test item at 2.5%, 5%, 10% or 25%: no cutaneous reaction
animals treated by test item at 50%: blue discoloration of one ear (3 mice) at day 2 and dryness of the skin (2 mice) at day 6.
Ear thickness measurement (%):
groups | 3 | 4 | 5 | 6 | 7 | 8 |
percentage of ear thickness increase at day 2 compared to day 1 | 6.19 | 2.00 | 3.06 | 2.06 | 3.06 | 1.98 |
percentage of ear thickness increase at day 2 compared to day 1 | 3.09 | 4.00 | 6.12 | 4.12 | 8.16 | 5.94 |
percentage of ear thickness increase at day 2 compared to day 1 | 3.09 | 3.00 | 4.08 | 6.19 | 5.10 | 8.91 |
Body weight and body weight change (g) Mean+/-SD:
groups | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
day 1 | 22.2 +/-1.1 | 21.2 +/-1.3 | 19.8 +/-0.7 | 20.4 +/-0.6 | 20.4 +/-0.7 | 19.2 +/-0.6 | 20.4 +/-1.0 | 19.4 +/-0.6 | 19.2 +/-1.1 |
day 6 | 22.1 +/-0.5 | 23.1 +/-1.1 | 19.4 +/-0.6 | 20.5 +/-0.2 | 20.0 +/-1.0 | 19.2 +/-0.7 | 20.0 +/-1.1 | 19.6 +/-1.1 | 19.8 +/-0.9 |
day6 -day1 | -0.1 +/-0.6 | 1.9 +/-0.1 | -0.4 +/-0.3 | 0.1 +/-0.5 | -0.4 +/-0.4 | -0.1 +/-0.4 | -0.4 +/-0.4 | 0.1 +/-0.6 | 0.6 +/-0.5 |
dpm, SI and irritation level results summary
groups | treatment and concentrations | number of nodes par group | dpm per group | dpm per node | stimulation index (SI) | irritation level |
3 | negative control vehicle | 8 | 932 | 116.5 | ||
4 | test item 2.5% | 8 | 1214 | 151.75 | 1.30 | I |
5 | test item 5% | 8 | 2595 | 324.38 | 2.78 | I |
6 | test item 10% | 8 | 6085 | 760.63 | 6.53 | I |
7 | test item 25% | 8 | 9696 | 1212.00 | 10.40 | I |
8 | test item 50% | 8 | 7569 | 946.13 | 8.12 | I |
9 | positive control HCA 25% | 8 | 12118 | 1514.75 | 13.00 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to EC3 value obtained, the test item should be considered as a moderate sensitizer.
The classification of the test item should be R43 (directive 67/548/EEC) and H317 (regulation 1272/2008/EEC) - Executive summary:
The objective of this study was to evaluate the potential of the test item, Copper Guanylurea Nitrate, to induce delayed contact hypersensitivity using the murine Local Lymph Node Assay (LLNA).
The study was based on theOECD Guideline No. 429 "Skin Sensitisation: Local Lymph Node Assay", 22nd July 2010 and on the Commission Regulation (EC) No. 440/2008, B.42, 30 May 2008.
Methods
To assess the irritant potential of the test item (through ear thickness measurement), a preliminary test was first performed in order to define the test item concentrations to be used in the main test. Two groups of two female mice received the test item, by topical route to the dorsal surface of both ears (one concentration per ear) on days 1, 2 and 3 at concentrations of 50, 25, 10 or 5% under a dose-volume of 25 µL.From day 1 to day 3 then on day 6, the thicknessof both ears of each animal was measured and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recordedonce during the acclimation period, and thenon days 1 and 6.On completion of the observation period, the animals were sacrificedthen discarded without macroscopicpost‑mortemexamination. In the main test, five groups of four female mice received the test item by topical routeto the dorsal surface of both earson days 1, 2 and 3at concentrations of50, 25, 10, 5 or 2.5% under a dose-volume of 25 µL. One negative control group of four females received the vehicle (Propylene Glycol) under the same experimental conditions. Additionally, one positive control group of four females received the positive control, α‑hexylcinnamaldehyde (HCA), at 25%in a mixture acetone/olive oil (4/1; v/v)under the same experimental conditions. From day 1 to day 3 then on day 6, the thicknessof the left ear of each animal was measured, except in animals of the positive control group, and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recordedonce during the acclimation period, and thenon days 1 and 6. After 2 days of resting, on day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3H-TdR). Approximately 5 hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of3H-TdR.
The results were expressed as disintegrations per minute (dpm) per group and as dpm/node. The obtained values were used to calculate Stimulation Indices (SI).
Results
Mortality and clinical signs
No unscheduled deaths and no clinical signs were observed during the observation period.
Local irritation
A blue discoloration of the ears was observed on day 3 only in 3/4 females treated at the concentration of 50%. Dryness of ear skin and scabs were noted in 2/4 animals of the same group on day 6 only.
No notable increase in ear thickness was observed at any tested concentrations.
Proliferation assay
The SI of the positive control was >3; this experiment was therefore considered valid.
A dose-related increase in the SI was recorded and the threshold positive value of 3 was exceeded at concentrations > 5%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity.
The EC3value is equal to 5.3%.
Conclusion
Under the experimental conditions of this study, the test item, Copper Guanylurea Nitrate, induced delayed contact hypersensitivity in the murine Local Lymph Node Assay.
Therefore, the classification of the test item should be the following: R43 (Directive 67/548/EEC) and H317 (Regulation 1272/2008/EEC). According to the EC3value obtained, the test item should be considered as a moderate sensitizer.
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