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EC number: 938-868-6 | CAS number: -
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-11-09 to 2010-11-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well-documented GLP-Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SOP/T/22: “Acute skin irritation/corrosion study”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovak National Accreditation Service (No. G-024)
Test material
- Reference substance name:
- disodium 2-[7-(carboxylatomethyl)-4,8-dioxo-1,3-dioxa-6-aza-2-cupracyclooctan-5-yl]acetate
- EC Number:
- 938-868-6
- Cas Number:
- 666828-79-1
- Molecular formula:
- not applicable
- IUPAC Name:
- disodium 2-[7-(carboxylatomethyl)-4,8-dioxo-1,3-dioxa-6-aza-2-cupracyclooctan-5-yl]acetate
- Reference substance name:
- Copper chelate of sodium salt N[1,2 dicarboxyethyl] D,L aspartic acid
- IUPAC Name:
- Copper chelate of sodium salt N[1,2 dicarboxyethyl] D,L aspartic acid
- Reference substance name:
- Cu (II) IDHA
- IUPAC Name:
- Cu (II) IDHA
- Test material form:
- other: powdered
- Details on test material:
- - Name of test material (as cited in study report): Cu (II) IDHA
- Substance type: chelate
- Physical state: solid (odourless, blue microgranules)
- Analytical purity: the test item contains 9.82% of copper
- Lot/batch No.: 1/10, date of production: April, 2010
- Expiration date of the lot/batch: April, 2013
- Storage condition of test material: in tightly closed packed at temperature from -10°C to +30°C
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Department of National Research Institute of Animal Production, Balice near Kraków
- Age at study initiation: 9-month-old rabbit female (rabbit No 1), 8.5-month-old male (rabbit No 2) and one 8-month-old male (rabbit No 3)
- Housing: individually in metal cages (60 x 35 x 40 cm). Each cage was equipped with label containing information on number of study protocol, start and end date of experiment (written after termination), sex and animal’s number
- Diet (e.g. ad libitum): ad libitum standard granulated "LSK" fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23;
- Humidity (%): 47 – 84
- Air changes (per hr): about 16 times/h
- Photoperiod (hrs dark / hrs light): 12 / 12
Study commencement: 09.11.2010.
Experiment: from 09.11.2010. to 12.11.2010. (rabbit No 1)
from 16.11.2010. to 19.11.2010. (rabbit No 2 and No 3)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0,5 g (powdered test item)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The gauze patches were covered with PCV foil and fixed with sticking plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed using water
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- for 3 animals
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- for 3 animals
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- No irritating effects were noted.
Any other information on results incl. tables
Table 1: Summary of Cu (II) IDHA. Acute skin irritation/corrosion on rabbits | |||
Administered amount of test item | 0.5 g | ||
Number of rabbit | 1 | 2 | 3 |
Sex | female | male | male |
Mortality of animals | 0/1 | 0/1 | 0/1 |
General clinical signs | none | none | none |
Skin erythema in area of treatment | none | none | none |
Skin oedema in area of treatment | none | none | none |
Other | none | none | none |
During the entire experiment, no pathological changes were stated on treated skin of rabbits.
Table 2 - Point evaluation of acute skin irritation/corrosion on rabbits | ||||||
Acute skin irritation/corrosion on rabbits | ||||||
Cu (II) IDHA | ||||||
Rabbit No | Observation type | Evaluation after | Average after24, 48and72hours | |||
1hour | 24hours | 48hours | 72hours | |||
1 | erythema | 0 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 | |
2 | erythema | 0 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 | |
3 | erythema | 0 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 |
Body weight of animals
At the start of experiment animal No 1 weighed 3.7 kg, animal No 2 – 3.5 kg and animal No 3 – 3.6 kg.
At the end of experiment animal No 1 weighed 3.6 kg, animal No 2 – 3.5 kg and animal No 3 – 3.6 kg
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- During readings no pathological changes were stated on treated skin of rabbits. The test item Cu (II) IDHA does not irritate skin of rabbits.
- Executive summary:
A study was undertaken to investigate the skin irritation potential of Cu (II) IDHA in New Zealand White rabbits (OECD 404; Kropidło, 2010, Report No. DDR-15/10). A dose of 0.5 g then was applied to a shaved, unabraded site on one animal. The powdered test item was applied in amount of 0.5 g as a single dose (applied first to multilayered gauze patch with dimensions of 2.5 x 2.5 cm, moistened with few drops of water and then laid on prepared skin) to shaved skin of one animal (rabbit No 1) and covered with appropriate band. The area of skin surface treated with the test item was about 6 cm². The gauze patches were covered with PCV foil and fixed with sticking plaster. The rabbits trunk was covered with lignin and elastic bandage was used to make circular protecting band. After an exposure time of 4 hours, the band and gauze patches were taken off and the residual test item was removed using water. The animal was observed for 72 hours. After evaluation of treated skin, in order to confirm irritation or its lack, the test item was applied to skin of another two animals (rabbit No 2 and No 3) for 4 hours. The test sites were then evaluated in accordance with the method of Draize at 1 hour, 24, 48 and 72 hours.
General clinical observations for morbidity and mortality of all animals were performed daily during the entire experiment. Detailed clinical observations of treated skin were performed after 1, 24, 48 and 72 hours since the end of exposure. Body weight of animals was determined directly before administration on day of administration of test item (day 0) and on last day of experiment. During readings no pathological changes were stated on treated skin of rabbits. No mortality or effects on body weight were observed. The test item Cu (II) IDHA does not irritate skin of rabbits.
Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.
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