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EC number: 205-685-1 | CAS number: 147-14-8
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When this study was performed, the OECD guideline for the LLNA did not yet exist.
Test material
- Reference substance name:
- 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
- EC Number:
- 205-685-1
- EC Name:
- 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
- Cas Number:
- 147-14-8
- Molecular formula:
- C32H16CuN8
- IUPAC Name:
- copper polyphthalocyanine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Physical state: blue powder
- Analytical purity: > 98 %
- Impurities (identity and concentrations): no data given
- Lot/batch No.: 29122
- Storage condition of test material: room temperature in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, UK
- Age at study initiation: four to seven weeks
- Weight at study initiation: 399 - 498 g
- Housing: 5 animals per suspended plastic cage with solid floor and sawdust bedding
- Diet: vitamin C enriched guinea pig diet (Harlan Teklad 9600 FD2 SQC), ad libitum
- Water: ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 +- 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D (coconut oil product)
- Concentration / amount:
- 50 % (w/v)
- Day(s)/duration:
- 48h
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- other: Alembicol D (coconut product)
- Concentration / amount:
- 7.5%
- Day(s)/duration:
- Single injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D (coconut oil product)
- Concentration / amount:
- 25 % (w/v)
- Day(s)/duration:
- 24h and 48h
- Adequacy of challenge:
- other: 50% of the highest technically achievable concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D (coconut oil product)
- Concentration / amount:
- 50%
- Day(s)/duration:
- 24h and 48h
- Adequacy of challenge:
- other: highest technically achievable concentration
- No. of animals per dose:
- 5 control animals and 10 test animals
- Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify the minimum irritant test substance concentration suitable for the induction phase and the maximum non-irritant concentration by the topical route of administration and a dilution of this for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- Site: 4 x 6 cm interscapular area
- Intradermal induction:
A clipped, 4 x 6 cm area of dorsal skin on the scapular region was prepared. 3 pairs of intradermal injections (0.1 ml/site) were conducted on day 1 into a 2 x 4 cm area within the clipped area. Injectables for the test animals were 1) Freund´s Complete Adjuvant, diluted with an equal volume of water for irrigation, 2) the test material 7.5 % (w/v) in Alembicol D and 3) the test material 7.5 % (w/v) in a 50 : 50 mixture of Freund´s Complete Adjuvant and Alembicol D.
- Epicutaneous induction:
On day 7 the same 4 x 6 cm area was clipped and the site was prepared by gentle rubbing with 0.5 ml per site of 7.5 % (w/w) sodium lauryl sulphate in petrolatum. On day 8, a 2 x 4 cm patch of Whatman No. 3 paper was saturated with ca. 0.4 ml of the test material (50 % in Alembicol D); the patch was placed over the injection sites and covered by an impermeable plastic adhesive tape which was secured by an elastic adhesive bandage, wound round the torso of the animal and fixed with an impervious plastic adhesive tape. The dressing was left in place for ca. 48 hours.
- Test groups: During the induction phase, the control animals were treated similarly to the test animals with the exception that the test substance was omitted from intradermal injections and topical applications.
B. CHALLENGE EXPOSURE
The control and test animals were challenged topically two weeks after the topical induction application (day 22), using the test material (25 and 50 % w/v in Alembicol D.
Hair were clipped on the left flank of each animal and a 2 x 2 cm patch of Whatman No. 3 paper was saturated with ca. 0.2 ml of the test material. TheWhatman papers containing 50 % w/v in Alembicol D were applied on the anterior site of the flank, the Whatman papers containing 20 % w/v in Alembicol D were applied in a similar manner on the posterior site. The patches were sealed on the flank for 24 hours under impermeable adhesive tape, secured by elastic adhesive bandage, wound round the torso of the animal and fixed with an impervious plastic adhesive tape. The challenged sites were evaluated ca. 24 and 48 h after removal of the patches.
All animals were observed daily for signs of ill health or toxicity. The body weight of each animal was recorded on day 1 of the study and following completion of the study prior to termination.
The dermal reactions resulting from challenge reaction were assessed using a numerical scoring system (Draize scores).
On completion of the study the animals were sacrificed by cervical dislocation.
The sensitivity of the guinea pig strain is checked periodically by the testing laboratory with hexyl cinnamic aldehyde (HCA), a known moderate sensitizer. - Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (HCA), periodically checkings
Results and discussion
- Positive control results:
- The following concentrations of HCA were administered: Intradermal injection 7.5 % v/v in Alembicol D; topical application as supplied (neat); challenge application as supplied (neat) and 50 % v/v in Alembicol D.
Slight to well defined dermal reactions were observed for all test animals after challenge reaction compared to no dermal reactions in the controls. The reactions in the test animals represented hypersensitivity and therefore all test animals gave positive sensitization responses.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 % (w/v) in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % (w/v) in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % (w/v) in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % (w/v) in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % (w/v) in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % (w/v) in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % (w/v) in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % (w/v) in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No deaths and no signs of ill health or toxicity were observed. The body weight of the animals increased within the normal range over the period of the study.
During the induction period, necrosis was recorded at sites receiving FCA in test animals and also in control animals. No irritation was seen in test animals at sites receiving the test material in vehicle and in control animals receiving vehicle alone after intradermal injection as well as after topical application.
After challenge, no dermal reactions were seen in either animals, all tested animals gave negative responses.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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