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EC number: 261-638-5 | CAS number: 59160-79-1
- 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:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- [[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper
- EC Number:
- 261-638-5
- EC Name:
- [[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper
- Cas Number:
- 59160-79-1
- Molecular formula:
- C59 H31 Cu N11 O6
- IUPAC Name:
- [[2,2',2''-[(29H,31H-phthalocyanine-C,C,C-triyl-kN29,kN30,kN31,kN32)tris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)]-copper
- Test material form:
- solid: nanoform
- Details on test material:
- BET: 17.5 m2/g
TEM (min. Feret): 46.2 nm (D50)
Constituent 1
- Specific details on test material used for the study:
- - Substance type: blue solid
- Physical state: solid
- Analytical purity: concentration ≥ 97%
- Purity test date: 2014
- Lot/batch No.: 120001P040
- Expiration date of the lot/batch: Unlimited stability
- Stability under test conditions: stable
- Storage condition of test material: At room temperature, protect against humidity, dry storage
- Other: Identifier in report: CAS 59160-79-1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 17.8 - 20.5 g
- Housing: all animals in one group were housed in a cage together as a group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45 – 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2015-06-05 To 2014-07-01
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 2, 5 and 10% (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: standard H-Methylthymidine incorporation
- Criteria used to consider a positive response: SI > 3
TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by topical (epidermal) application to the dorsal surface
of each ear. The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (diameter 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- SI = 13.7%
The periodic positive control experiment was performed in April 2014
Positive control substance: α-Hexylcinnamaldehyde; Vehicle: acetone:olive oil (4+1 v/v)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- (2%)
- Value:
- 0.69
- Parameter:
- SI
- Remarks:
- (5%)
- Value:
- 0.95
- Parameter:
- SI
- Remarks:
- (10%)
- Value:
- 1.24
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table
Any other information on results incl. tables
Table 1: Lymph Node Cell Counts after Sacrifice
Test item concentration % (w/w) |
Animal No. |
Lymph Node Cell Count x10E06 per animal |
Mean Lymph Node Cell Count x10E06 per animal |
SD | Index (Value Test Group versus Value Control |
Vehicle Control (PG) | 1 | 7.65 | 8.4 | 1.4 | 1.00 |
2 | 7.99 | ||||
3 | 9.45 | ||||
4 | 10.18 | ||||
5 | 6.61 | ||||
2 | 6 | 6.84 | 6.9 | 1.3 | 0.82 |
7 | 6.42 | ||||
8 | 5.01 | ||||
9 | 8.30 | ||||
10 | 7.86 | ||||
5 | 11 | 8.67 | 7.1 | 2.4 | 0.85 |
12 | 7.99 | ||||
13 | 8.56 | ||||
14 | 7.29 | ||||
15 | 2.95 | ||||
10 | 16 | 7.45 | 9.2 | 1.6 | 1.10 |
17 | 10.13 | ||||
18 | 7.65 | ||||
19 | 10.91 | ||||
20 | 10.00 |
Table 2: Lymph Node Weights after Sacrifice
Test item concentration % (w/w) |
Animal No. |
Lymph Node weight mg per animal |
Mean Lymph Node weight (mg) | SD | Index (Value Test Group versus Value Control |
Vehicle Control (PG) | 1 | 4.67 | 4.7 | 0.5 | 1.0 |
2 | 4.47 | ||||
3 | 5.09 | ||||
4 | 5.30 | ||||
5 | 4.09 | ||||
2 | 6 | 4.39 | 4.3 | 0.5 | 0.9 |
7 | 4.41 | ||||
8 | 3.39 | ||||
9 | 4.46 | ||||
10 | 4.75 | ||||
5 | 11 | 4.92 | 3.9 | 1.3 | 0.83 |
12 | 4.72 | ||||
13 | 4.25 | ||||
14 | 4.11 | ||||
15 | 1.63 | ||||
10 | 16 | 4.19 | 5.4 | 0.9 | 1.14 |
17 | 6.41 | ||||
18 | 4.88 | ||||
19 | 6.27 | ||||
20 | 5.22 |
Table 3: Ear Weights after Sacrifice
Test item concentration % (w/w) |
Animal No. |
Ear weight mg per animal |
Mean Ear weight (mg) | SD | Index (Value Test Group versus Value Control) |
Vehicle Control (PG) | 1 | 23.74 | 24.4 | 0.9 | 1.00 |
2 | 24.87 | ||||
3 | 25.81 | ||||
4 | 23.78 | ||||
5 | 23.95 | ||||
2.0% | 6 | 23.89 | 23.2 | 0.6 | 0.95 |
7 | 22.44 | ||||
8 | 23.60 | ||||
9 | 23.09 | ||||
10 | 22.80 | ||||
5% | 11 | 23.29 | 25.6 | 2.5 | 1.05 |
12 | 24.89 | ||||
13 | 29.90 | ||||
14 | 25.25 | ||||
15 | 24.81 | ||||
10% | 16 | 27.50 | 27.1 | 0.8 | 1.11 |
17 | 26.10 | ||||
18 | 28.34 | ||||
19 | 26.87 | ||||
20 | 26.85 |
No signs of systemic toxicity or local skin irritation were observed during the study period. A possible erythema of the ear skin could not be evaluated due to the inherent colour of the test item.
The body weight of the animals, recordedprior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.
A statistically significant increase in ear weights was observed in the high dose group in comparison to the vehicle control group (p<0.05). Furthermore, for BALB/c mice, a cut-off value of 1.1 for the ear weight index was reported for a positive response regarding ear skin irritation (see Ref. 9). The index determined for the test item treated high dose group slightly exceeded this threshold (index of 1.11). However, this was considered to be not biologically relevant, as the observed increase did not exceedthe threshold value of 25% for excessive local skin irritation mentioned in OECD guideline 429. Nevertheless, the increased ear weights indicated an irritant property of the test item.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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