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EC number: 276-123-0 | CAS number: 71873-46-6
- 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:
- From February 24th to March 06th, 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Blue 278
- IUPAC Name:
- Acid Blue 278
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland.
- Age at study initiation: 14 - 15 weeks.
- Weight at study initiation: 2.4 - 2.5 kg.
- Housing: individually in steinless steel cage, equipped with automatic cleaning and drinking system.
- Diet: pelleted standard Kilba 341, batch 93/83, rabbit maintenance diet, ad libitum.
- Water: community tap water, ad libitum.
- Acclimation period: 4 days under laboratory conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 55 ± 10 %
- Air changes: 10 - 15 air change per hour.
- Photoperiod: 12 hrs artificial light / hrs darkness.
- Other: at least 8 hours of music / light period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g per animal
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1 maes and 2 females
- Details on study design:
- TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL and a Varta Cliptrix diagnostic-lamp.
OBSERVATIONS
- Viability/mortality: daily
- Body weight: pre-treatment, day 1 and at termination of the test.
SCORING SYSTEM
The rabbits were examined 1, 24, 48, 72 hours and 7 days after application of the test compound. The ocular reactions were scored according to the OECD guideline 405.
Opacity-degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse area (other than slight dulling of normal luster) details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacros area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, 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 palpebral and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperemic (injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis: lids and/or nictating membranes
No swelling 0
Any swelling above normal (includes nictitating membranes) 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
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- Test substance showed a primary irritation score of 2.1 when applied to the rabbits eye mucosa.
In the area of application a bluish discoloration of the cornea, sclera and conjunctivae was observed within 1 hour after treatrnent. This could be related to effects of the test article
No corrosion of the cornea was observed at each of the measuring intervals..
TOXIC SYMPTOMS / MORTALITY
No acute toxic symptoms were observed in the animals during the test period and no mortality occurred.
BODY WEIGHT
The body weight gain of all rabbits was similar.
Any other information on results incl. tables
Eye irritation scores
Animal N / sex | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | Mean 24/48/72 hrs |
281 M | Cornea opacity | 0 | 1* | 1* | 0 | 0 | 0.67 |
282 F | Cornea opacity | 0 | 1* | 1* | 0 | 0 | 0.67 |
283 F | Cornea opacity | 1* | 1* | 1* | 0 | 0 | 0.67 |
281 M | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
282 F | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
283 F | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
281 M | Conjunctivae redness | 0 | 1 | 1 | 1 | 0 | 1.00 |
282 F | Conjunctivae redness | 0 | 1 | 1 | 1 | 0 | 1.00 |
283 F | Conjunctivae redness | 0 | 1 | 1 | 1 | 0 | 1.00 |
281 M | Conjunctivae chemosis | 2* | 1 | 0 | 0 | 0 | 0.33 |
282 F | Conjunctivae chemosis | 2* | 2* | 0 | 0 | 0 | 0.67 |
283 F | Conjunctivae chemosis | 2* | 1 | 0 | 0 | 0 | 0.33 |
Primary irritation score
Time point | Mean scores |
1 hr | 2.3 |
24 hrs | 3.3 |
48 hrs | 2.0 |
72 hrs | 1.0 |
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:
A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405. A single application 0.1 g of the test material was administered to the eye of three rabbits. Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.
Test substance showed a primary irritation score of 2.1 when applied to the rabbits eye mucosa. In the area of application a bluish discoloration of the cornea, sclera and conjunctivae was observed within 1 hour after treatrnent. This could be related to effects of the test article. No corrosion of the cornea was observed at each of the measuring intervals.
No acute toxic symptoms were observed in the animals during the test period and no mortality occurred. The body weight gain of all rabbits was similar.
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 of three tested animals. Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.
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