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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 June 1993 to 6 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion"
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Method B5 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Specification
Three New Zealand White rabbits were supplied by David Percival Ltd., Maston, Sandbach, Cheshire, U.K. At the start of the study the animals weighed 2.61 - 3.09 g, and were approximately 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 a 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 19 – 23 °C and relative humidity of 58 - 66 %. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.1 ml of the test material, which was found to weigh approx imately 99 mg.
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope.
Animals showing evidence of ocular lesions were rejected and replaced.
One rabbit was initially treated. A volume of 0.1 ml of the test material, which was found to weigh approximately 99 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released.
The left eye remained untreated and was used for control purposes.
Immediately after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on application of the test material, one drop of local anaesthetic ("Ophthaine", 0.5% proxymetacaine hydrochloride, E.R. Squibb & Sons , Limited Hounslow, Middlesex, U.K.) was instilled into both eyes of these animals 1 - 2 minutes before treatment.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation, (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 ocular effects were also noted. Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 Hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation at the 24-hour observation. Minimal conjunctival redness was noted in one treated eye at the 48-hour observation.
No ocular effects were noted 72 hours after treatment. - Other effects:
- Residual test material was noted around the treated eye of all animals throughout the study.
Blue-coloured staining was noted in all treated eyes throughout the study.
Any other information on results incl. tables
JPR BLUE 100: ACUTE EYE IRRITATION TEST IN THE RABBIT
INDIVIDUAL SCORES AND INDIVIDUAL TOTAL SCORES FOR OCULAR IRRITATION
Rabbit Number and Sex (Bodyweight Kg) |
IPR = 3 |
IPR = 0 + |
IPR = 0 + |
|||||||||
151 Female (3.09) |
154 Male (2.61) |
165 Female (2.83) |
||||||||||
Time After Treatment |
1 hr |
24 hr |
48 hr |
72 hr |
1 hr |
24 hr |
48 hr |
72 hr |
0 hr |
24 hr |
48 hr |
72 hr |
CORNEA E = Degree of Opacity F = Area of Opacity |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS D |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE A = Redness B = Chemosis C = Discharge |
2S 2 2Re |
1S 1 0Re |
0S 0 0Re |
0S 0 0Re |
2S 2 3Re |
2S 1 0Re |
1S 0 0Re |
0S 0 0Re |
2S 2 2Re |
1S 1 0Re |
0S 0 0Re |
0S 0 0Re |
Score (A + B + C) x 2 |
12 |
4 |
0 |
0 |
14 |
6 |
2 |
0 |
12 |
4 |
0 |
0 |
Total Score |
12 |
4 |
0 |
0 |
14 |
6 |
2 |
0 |
12 |
4 |
0 |
0 |
Key: hr = hour(s) IPR = initial pain reaction Re = residual test material around treated eye
+ = one drop of Ophthaine instilled into each eye 1 – 2 minutes before dosing S = blue coloured staining
JPR BLUE 100: ACUTE EYE IRRITATION TEST IN THE RABBIT
INDIVIDUAL TOTAL SCORES AND GROUP MEAN SCORE FOR OCULAR IRRITATION
Rabbit Number and Sex |
Individual Total Scores At: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
151 Female 154 Male 165 Female |
12 14 12 |
4 6 4 |
0 2 0 |
0 0 0 |
Group Total |
38 |
14 |
2 |
0 |
Group Mean Score |
12.7 1 Hour |
4.7 24 Hours |
0.7 48 Hours |
0.0 72 Hours |
JPR BLUE 100: ACUTE EYE IRRITATION TEST IN THE RABBIT
INDIVIDUAL & MEAN SCORES FOR CORNEA, IRIS & CONJUNCTIVAE REQUIRED FOR EEC LABELLING REGULATIONS
Rabbit Number & Sex (Bodyweight Kg) |
Time After Treatment |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
151 Female (3.09) |
24 Hours 48 Hours 72 Hours |
0 0 0 |
0 0 0 |
1 0 0 |
1 0 0 |
Total |
|
0 |
0 |
1 |
1 |
Mean |
|
0.0 |
0.0 |
0.3 |
0.3 |
154 Male (2.61) |
24 Hours 48 Hours 72 Hours |
0 0 0 |
0 0 0 |
2 1 0 |
1 0 0 |
Total |
|
0 |
0 |
3 |
1 |
Mean |
|
0.0 |
0.0 |
1.0 |
0.3 |
165 Female (2.83) |
24 Hours 48 Hours 72 Hours |
0 0 0 |
0 0 0 |
1 0 0 |
1 0 0 |
Total |
|
0 |
0 |
1 |
1 |
Mean |
|
0.0 |
0.0 |
0.3 |
0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, JPR BLUE 100, produced a maximum group mean score of 12.7 and was classified as a MILD IRRITANT (CLASS 4 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as NON IRRITANT to the rabbit eye. 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 eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method B5 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 application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. No ocular effects were noted 72 hours after treatment.
The test material produced a maximum group mean score of 12.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the Kay and Calandra classification system.
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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