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Diss Factsheets
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EC number: 946-877-1 | CAS number: -
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acid Green 025
- IUPAC Name:
- Acid Green 025
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: 12 to 16 weeks old.
- Weight at study initiation: 2.36 - 2.83 kg.
- Housing: rabbits were individually housed in suspected metal cages.
- Diet: rabbit diet, A.W. Tindall Ltd, ad libitum.
- Water: drinking water, ad libitum.
- Acclimation period: minimum 5 days.
- Health check: within 24 hours of commencement of the test both eyes of each rabbit were examined for evidence of ocular irritation or defect using an ophthalmoscope. Animals showing evidence of ocular lesions were rejected and replaced.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 20 °C
- Relative humidity: 45 - 50 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: lighting was controlled by a time switch to give 12 hours light and 12 hours of darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- test item was used as supplied
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml (weight 54 mg) of test item was placed into the right eye of each rabbit.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three animals
- Details on study design:
- TOOL USED TO ASSESS SCORE: examination was facilitated by use of a standard ophthalmoscope.
SCORING SYSTEM
Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment, according to the numerical evaluation given by 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".
Cornea
Opacity: degree of density (area most dense taken for reading)
No opacity: 0
Scattered or diffuse area of opacity (other than slight dulling of normal lustre) ditails of iris clearly visible: 1
Easily discernible translucent area, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
IRITIS
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, hemorrhage, gross destruction (any or all of these): 2
CONJUNCTIVAE
Redness (refers to lids and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal: 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
Chemosis: lids and/or nictitating membranes.
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No evidence of corneal opacity was noted during the study period. Iridial inflammation was noted in all treated eye one hour after treatment. Minimal conjunctivitis continued to be noted on day one in one treated eye; the remaining two treated eyes were normal. All treated eyes were normal on day two.
Any other information on results incl. tables
Individual and mean scores for cornea, irirs and conjuntivae
Animal | Reaction | 1 hrs | 24 hrs | 48 hrs | 72 hrs | Mean 24/48/72 hrs |
Animal 1 | Cornea | 0 | 0 | 0 | 0 | 0.0 |
Animal 2 | Cornea | 0 | 0 | 0 | 0 | 0.0 |
Animal 3 | Cornea | 0 | 0 | 0 | 0 | 0.0 |
Animal 1 | Iris | 0 | 0 | 0 | 0 | 0.0 |
Animal 2 | Iris | 1 | 0 | 0 | 0 | 0.0 |
Animal 3 | Iris | 1 | 0 | 0 | 0 | 0.0 |
Animal 1 | Conjunctival redness | 1S | 1 | 0 | 0 | 0.3 |
Animal 2 | Conjunctival redness | 1S | 0 | 0 | 0 | 0.0 |
Animal 3 | Conjunctival redness | 2S | 0 | 0 | 0 | 0.0 |
Animal 1 | Conjunctival chemosis | 1 | 0 | 0 | 0 | 0.0 |
Animal 2 | Conjunctival chemosis | 1 | 0 | 0 | 0 | 0.0 |
Animal 3 | Conjunctival chemosis | 2 | 0 | 0 | 0 | 0.0 |
S: areas of green staining
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not irritating
- Executive summary:
The eye irritation potential of the test substance was investigated according to thhe method and procedures outlined into the OECD guideline 405. 0.1 ml (weight 54 mg) of test item was placed into the right eye of each rabbit; the other eye remaining untreated, served as a control. The eyes were examined and the grade of ocular reaction was recorded at 1, 24, 48 and 72 hours. The ocular reactions were scored by the method described by 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".
No evidence of corneal opacity was noted during the study period. Iridial inflammation was noted in all treated eye one hour after treatment. Minimal conjunctivitis continued to be noted on day one in one treated eye; the remaining two treated eyes were normal. All treated eyes were normal on day two.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all the tested animals.
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