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EC number: 243-815-9 | CAS number: 20427-59-2
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The available study was conducted prior to the date on whch the LLNA became the method of choice.
Test material
- Reference substance name:
- Copper dihydroxide
- EC Number:
- 243-815-9
- EC Name:
- Copper dihydroxide
- Cas Number:
- 20427-59-2
- Molecular formula:
- CuH4O2
- IUPAC Name:
- copper(2+) dihydroxide
- Details on test material:
- - Name of test material (as cited in study report): URA-08740-F-O-WP (chemical name copper hydroxide).
- Composition of test material, percentage of components: Not stated.
- Lot/batch No.: 250592
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Firma Winkelmann, Versuchstierzucht, Gartenstr. 27, W-4799 Borchen.
- Age at study initiation: Not stated.
- Weight at study initiation: Males 377 - 500 grams. Females 337 - 487 grams.
- Housing: Collective housing up to a maximum of 5 animals per cage (Macrolon type IV).
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C.
- Humidity (%): 30 - 70%.
- Air changes (per hr): Not stated.
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: aqua ad injectabilia and petrolatum
- Concentration / amount:
- Refer to details on study design.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua ad injectabilia and petrolatum
- Concentration / amount:
- Refer to details on study design.
- No. of animals per dose:
- Refer to details on study design.
- Details on study design:
- RANGE FINDING TESTS:
Intradermal Injection: The test article was diluted with aqua ad inject. and Freund's complete adjuvant (FCA) to give a final concentration of 5 %. Since this highest permissible concentration produced moderate irritation and ulceration, lower concentrations were tested. Six animals were employed for the concentration tested, skin reactions were recorded 48 h after treatment.
Dermal Application: The test article was incorporated in petrolatum to provide a final concentration of 50 % (w/w). A closed patch exposure was effected by means of an occlusive bandage. Two animals were employed and skin reactions were recorded 48 h post application.
MAIN STUDY:
The main study was performed on 20 test animals (10 male, 10 female) and 20 control animals (10 male, 10 female). The concentrations used were selected on the basis of the pilot study.
A. INDUCTION EXPOSURE
First stage - an area of 4 x 6 cm over the shoulders was clipped short with electric clippers and cleaned with 70 % (v/v) ethanol. Three pairs of intradermal injections were then made symmetrically in two rows on either side of the spine:
Test group:
1. 0.1 ml FCA 50 % (w/w) diluted in aqua ad inject.
2. 0.1 ml test article diluted in aqua ad inject, (final concentration: 0.1 %) .
3. 0.1 ml test article diluted in FCA/aqua ad inject, (final concentration: 0.1 %).
Control group:
1. 0.1 ml FCA 50 % (w/w) diluted in aqua ad inject.
2. 0.1 rnl aqua ad inject. (undiluted).
3. 0.1 ml aqua ad inject, 50 % (w/w) diluted in FCA.
Second stage - 7 days after the intradermal injections the dermal application was initiated. Because the test article was non-irritating at the highest permissible concentration in the pilot study, the area was reclipped and pretreated with 10 % sodium lauryl sulfate (SLS) in petrolatum 24 hours before application of the test article at a concentration of 50 % in petrolatum. The test article was spread in a thick layer [to saturation] over a 4 x 5 cm patch (filter paper). The latter was firmly secured over the previous injection sites by an occlusive dressing for 48 h. Control animals received a patch loaded with the vehicle alone.
B. CHALLENGE EXPOSURE
Both control and test animals were subjected to a challenge exposure 14 days after the second stage of induction. The challenge test was performed on a 5 x 5 cm clipped and shaved area on each flank. The maximal non-irritating concentration of the test article (50 % in petrolatum) was applied to the left flank and the vehicle to the right using the patch technique described for the range finding test. In each case the duration of exposure was 24 h under an occlusive dressing. 24 and 48 h after patch removal, allergic responses were evaluated on a numerical scale according to Draize. - Challenge controls:
- Refer to details on study design.
- Positive control substance(s):
- no
- Remarks:
- The reaction to the positive control substances 2,4 dinitrochlorobenzene (extreme sensitizer) and benzocaine (moderate sensirizer) is tested periodically.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Any other information on results incl. tables
Range Finding Test:
Intradermal:
5 %, 1 % and 0.5 %: Moderate irritation with test article-dependent discoloration of the partly indurated injection sites was observed.
0.25 %: Moderate irritation was observed.
0.10 %: No specific findings were observed.
Dermal:
No skin reactions were observed.
Main Study:
No skin reactions were observed in the main study in any of the 20 test animals (refer to Table 1) or 20 control animals (refer to Table 2).
The sensitisation rate at 24 hours was 0%.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No skin reactions were observed in the main study in any of the test or control animals (sensitisation rate at 24 hours 0%).
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified. - Executive summary:
A GLP-compliant test was carried out in accordance with the requirements of guideline OECD 406 (guinea-pig maximisation test) without significant deviation. Groups of 20 test and 20 control animals were used. Following induction exposure to copper dihydroxide or the vehicle, the animals were subjected two weeks later to a challenge exposure with the test article. Sensitisation responses to the challenge procedure were evaluated 24 and 48 hours after the end of the exposure period.
No skin reactions were observed in the main study in any of the test animals or control animals (sensitisation rate at 24 hours 0%). On this basis, copper dihydroxide is not classified as a skin sensitiser.
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