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EC number: 208-865-8 | CAS number: 544-19-4
- 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:
- 2020-06-11 to 2020-07-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau
- Version / remarks:
- 2000
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Copper diformate
- EC Number:
- 208-865-8
- EC Name:
- Copper diformate
- Cas Number:
- 544-19-4
- Molecular formula:
- CH2O2.1/2Cu
- IUPAC Name:
- copper diformate
- Test material form:
- solid: particulate/powder
- Details on test material:
- blue in color
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan™:WIST albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Ltd
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately eight to twelve weeks
- Weight at study initiation: 156 to 176 g
- Fasting period before study: overnight prior to and approximately four hours after dosing
- Housing: in groups of one or four rats. Cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved softwood bark-free fiber bedding. Cages, food hoppers, water bottles and bedding were changed at appropriate intervals. Each cage of animals was provided with Aspen chew blocks or balls for environmental enrichment. Chew blocks or balls were provided throughout the study and were replaced when necessary. Each cage of animals was provided with a plastic shelter for environmental enrichment, which was replaced at the same time as the cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
- Method of randomisation in assigning animals to test and control groups : The animals were allocated without conscious bias to cages within the treatment groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours continuous dark
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- formulation was administered at a volume of 10 mL/kg body weight
- Doses:
- 5, 30 and 200 mg/mL (50, 300, 2000 mg/kg)
- No. of animals per sex per dose:
- Sighting investigations: 1 female per dose (2000, 50 and 300 mg/kg)
Main study: 4 females per dose (50 and 300 mg/kg) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality: at least twice daily
- Necropsy of survivors performed: Yes. All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of the brain, cecum, duodenum, heart, kidneys, small and large intestine, liver, lungs and bronchi, spleen, stomach, subcutaneous tissue and urinary bladder was recorded.
- Clinical signs including body weight: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, surviving animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). Additional observations were performed as necessary when evident toxicity was observed. The nature and severity, where appropriate, of any clinical signs and the time were recorded at each observation. The weight of each rat was recorded on Days -1 (not reported), 1 (prior to dosing), 8 and 15 or at death. Individual weekly body weight changes and group mean body weights were calculated.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
- Preliminary study:
- 2000 mg/kg: The sighting study animal dosed at 2000 mg/kg died approximately two hours after dosing.
300 mg/kg: Clinical signs observed for female 21 in the sighting study dosed at 300 mg/kg comprised piloerection, abnormal colored urine (red or brown), pallor of whole body, abnormal colored feces (black) and both eyes dull. These signs were first noted from approximately 3 hours after dosing. Recovery as judged by external app earance and behavior, was complete by Day 9.
50 mg/kg: No clinical signs were observed for animals dosed at 50 mg/kg in the sighting study or main study.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- female 22 (2000 mg/kg sighting study): The female (animal number 22) dosed at 2000 mg/kg in the sighting study died approximately two hours after dosing.
female 24 (300 mg/kg): female (animal number 24) dosed at 300 mg/kg in the main study also died approximately 3 hours after dosing
females 23, 25, 26(300 mg/kg): females (animal numbers 23, 25 and 26) dosed at 300 mg/kg in the main study were killed for welfare reasons approximately 4 hours after dosing. - Clinical signs:
- other: female 22 (2000 mg/kg): Clinical signs prior to death for female 22 (dosed at 2000 mg/kg) comprised chin rubbing, salivation, flattened posture, irregular breathing, piloerection, reduced body tone and both eyelids partially closed. These signs were obser
- Gross pathology:
- female 22 (2000 mg/kg): Macroscopic examination of this animal revealed a congestion (darkened tissue/organ) of the subcutaneous tissue, stomach, duodenum and small intestines. There were also fluid contents (blue liquid) present in the stomach, duodenum and small intestines.
females 23, 24, 25 and 26 (300 mg/kg): Macroscopic examination of these animals revealed congestion (darkened tissue/organ) of the subcutaneous tissue, liver, spleen, large intestines and cecum of all females, brain and kidneys of three females and heart of one female. Pallor of tissues/organs was observed on the kidneys of female 26 and lungs and bronchi of all females. There were also fluid contents (blue liquid) present in the stomach, duodenum and small intestines of all females and large intestines of two females. Gaseous distention was observed in the stomach of all females and lastly, a small cecum was observed in one female.
Macroscopic examination of the surviving animals at study termination on Day 15 did not reveal any abnormalities.
Any other information on results incl. tables
Mortality data:
Dose (mg/kg) |
No. of deaths |
Day* |
||||
1 |
2 to 15 |
|||||
2h |
3h |
4h |
a |
b |
||
Sighting study |
||||||
300 |
0/1F |
0 |
0 |
- |
0 |
0 |
2000 |
1/1F |
1 |
- |
- |
- |
- |
Main study |
||||||
300 |
4/4F |
0 |
1 |
3 |
- |
- |
Sighting study |
||||||
50 |
0/1F |
0 |
0 |
- |
0 |
0 |
Main study |
||||||
50 |
0/4F |
0 |
0 |
- |
0 |
0 |
* The day/time indicated is the time that the animal was found dead/killed for humane reasons
F Female
h Hour
a First observation
b Second observation
- Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of Copper Diformate was demonstrated to be between 50 and 300 mg/kg body weight.
- Executive summary:
The study was performed to assess the acute oral toxicity of Copper Diformate to the rat. Fasted female rats received a single oral gavage dose of the test item, formulated in corn oil,at the following dose levels:
Sighting investigations 1 and 2: 300 and 2000 mg/kg body weight respectively. Main study: Based on the results of the sighting investigations a further four fasted females were similarly dosed at 300 mg/kg body weight. Third sighting study: Due to the number of deaths in the main study at 300 mg/kg body weight, a further female in a third sighting study was dosed at 50 mg/kg body weight. Second main study: Based on the results of the third sighting study a further four fasted females were similarly dosed at 50 mg/kg body weight to complete the study.
No clinical signs were observed for animals dosed at 50 mg/kg in the sighting study or main study.
The acute median lethal oral dose (LD50) to rats of Copper Diformate was demonstrated to be between 50 and 300 mg/kg body weight. Copper Diformate is included in Category 3, according to the Globally Harmonised System
(GHS)
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