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EC number: 689-188-9 | CAS number: 149343-84-0
- 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:
- 26 May 1993 to 2 June 1993.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion"
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Method B4 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, sodium salts
- EC Number:
- 689-188-9
- Cas Number:
- 149343-84-0
- Molecular formula:
- C32H24N12O8S4Cu to C76H56N28O32S12Cl4Na8Cu
- IUPAC Name:
- Cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, sodium salts
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identification: JPR Blue 100
Description: Blue powder
Chemical Name: Cuprate(2-),[2-[[4-chloro-6-[[2-[(29H,31H-phthalocyaninylsulphonyl)amino]ethyl]amino]-1,3,5-triazin-2-yl]amino]-1,4-benzenedisulphonato(4-)-N29,N30,N31,N32]-mono(or bis)aminosulphonyl mono (or di)sulpho derivs., sodium salts.
Lot Number: 303001
Purity: 95.2%
Major Impurities: H2o, NaCl, Na2SO4
Date Received: 30 March 1993
Container: Opaque plastic jar x 7
Storage conditions: Room temperature
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Specification
Three New Zealand White rabbits were supplied by David Percival ltd., Moston, Sandbach, Cheshire, U.K. At the start of the study the animals weighed 2.45 - 2.74 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
Husbandry
The animals were individually housed in suspended metal cages.
Free access to mains drinking water and food. (RABMA Rabbit Diet, Special Diet Services ltd., Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 18 – 23 °c and relative humidity of 51 - 65%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give continuous 12 hours light and 12 hours darkness.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".
Any other skin reactions, if present, were also recorded.
An additional observation was made on day 7 to assess the reversibility of skin reactions .
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin sites one hour after patch removal and at all treated skin sites at the 24, 48 and 72-hour observation. The erythema extended beyond all treated skin sites during this time.
Very slight oedema was noted at one treated skin site at the 24 and 48-hour observations.
Desquamation was noted at all treated skin sites seven days after treatment. - Other effects:
- Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal. The staining did not affect evaluation of skin responses.
Any other information on results incl. tables
JPR BLUE 100: ACUTE DERMAL IRRITATION TEST IN THE RABBIT
INDIVIDUAL SKIN REACTIONS
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex (Bodyweight Kg) |
Total |
||
198 Female (2.74) |
202 Male (2.45) |
203 Female (2.45) |
|||
Erythema/Eschar Formation |
1 Hour 24 Hours 48 Hours 72 Hours 7 Days |
1 STA 1 RSTA 1 RSTA 1 STA 0 DSTA |
1 STA 1 RSTA 1 RSTA 1 STA 0 DSTA |
0 STA 1 RSTA 1 RSTA 1 RSTA 0 DSTA |
(2) 2 (3) 3 (0) |
Oedema Formation |
1 Hour 24 Hours 48 Hours 72 Hours 7 Days |
0 0 0 0 0 |
0 1 1 0 0 |
0 0 0 0 0 |
(0) 1 (1) 0 (0) |
Sum of 24 and 72-Hour Readings (S) |
7 |
||||
Primary Irritation Index (S/6) |
7/6 = 1.2 |
||||
Classification |
MILD IRRITANT |
( ) = Total values not used for calculation of primary irritation index
D = desquamation
STA = light blue-coloured staining
R = reaction extends beyond treatment site
INDIVIDUAL DAILY AND INDIVIDUAL MEAN SCORES FOR DERMAL IRRITATION FOLLOWING 4-HOUR EXPOSURE REQUIRED FOR EEC LABELLING REGULATIONS
Skin Reaction |
Reading (Hours) |
Individual Scores –Rabbit Number and Sex (Bodyweight Kg) |
||
198 Female (2.74) |
202 Male (2.45) |
203 Female (2.45) |
||
Erythema/Eschar Formation |
24 48 72 |
1 1 1 |
1 1 1 |
1 1 1 |
Total |
|
3 |
3 |
3 |
Mean Score |
|
1.0 |
1.0 |
1.0 |
Oedema Formation |
24 48 72 |
0 0 0 |
1 1 0 |
0 0 0 |
Total |
|
0 |
2 |
0 |
Mean Score |
|
0.0 |
0.7 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, JPR BLUE 100, produced a primary irritation index of 1.2 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as NON IRRITANT to rabbit skin. No symbol and risk phrase are therefore required. - Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals {1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in Commission Directive 92/ 69/ EEC {which constitutes Annex V of Council Directive 67/ 548/ EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/ 548/ EEC {as adapted to technical progress by Commission Directive 91/325/EEC} .
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Desquamation was noted at all treated skin sites seven days after treatment.
The test material produced a primary irritation index of 1.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material was also classified as non-irritant according to EEC labelling regulations. No symbol and risk phrase are required.
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