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EC number: 278-127-8 | CAS number: 75214-58-3
- 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 August 09th to September 06th, 1994
- Reliability:
- 2 (reliable with restrictions)
- 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:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24.02.1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acid Blue 193
- IUPAC Name:
- Acid Blue 193
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd Wyton, Huntingdon, England
- Age at study initiation: adult
- Weight at study initiation: the animals were weighed immediately before application of the test substance.
- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions.
- Diet: Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning.
- Water: tap water ad libitum.
- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room.
- Health check: approx. 24 hours before the test fur was shaved from the dorso-lateral area of the trunk (6x6 cm) of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healty and intact skin were used.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 1.5 °C
- Humidity: 60-80 %
- Air changes:12-15 times per hour
- Photoperiod: from 6 am to 6 pm, 12 hours artifical illumination.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- pulverized
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µl of the pulverised test substance-equivalent to approx. 34 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21days
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: treated eye was rinsed with normale saline.
- Time after start of exposure: 24 hours after instillation.
TOOL USED TO ASSESS SCORE: optical instrument (hand slit lamp) and fluorescein. Only effects persisting for more than 24 hours were included in the evaluation.
SCORING SYSTEM
For each animal the Draize scores (cornea, iris, conjunctivae, erythema and swelling and discharge) and the Mcdonald score (aqueous humor) were used. For each animal the Draize scores recorded approx. 24, 48 and 72h after application were added up. The total of these three values was divided by 3 to give the irritation index.
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: 7 days in 2/3 animals
- Irritation parameter:
- iris score
- Basis:
- animal: 2/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 7 days in 3/3 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 21 days in 2/3 animals
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 21 days in 3/3 animals
- Irritant / corrosive response data:
- Exposure of the eye to test substance caused reactions of the mucous membranes and effects of the cornea in all three animals. Additionally, in all three animals the iris was transiently affected and discharge occured. In one animal signs was fully reversible within 21 days, in the second animal corneal signs did not prove to be completely reversible within 21 days and in the third animal a slight erythema was observed on day 21. This evidence indicates that the product may be considered as "severely irritating to the eye".
Any other information on results incl. tables
Individual reactions
Animal | Reactions | Score at | Mean 24/48/72 hrs | ||||||
1 hr | 24 hrs | 48 hrs | 72 hrs | 7 d | 14 d | 21 d | |||
D11 | Corneal opacity | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1.00 |
D7 | Corneal opacity | 1 | 1 | 1 | 1 | 1* | 1+ | 1+ | 1.00 |
E8 | Corneal opacity | 1 | 1 | 1* | 1* | 0 | 0 | 0 | 1.00 |
D11 | Iris | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0.33 |
D7 | Iris | - | 1 | 1 | 1 | 0 | 1 | 0 | 1.00 |
E8 | Iris | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0.67 |
D11 | Conjunctival redness | e | 2k | 2k | 2k | 0 | 1 | 1 | 2.00 |
D7 | Conjunctival redness | e | 2 | 2k | 2k | 1 | 1 | 0 | 2.00 |
E8 | Conjunctival redness | e | 2 | 2k | 2k | 0 | 0 | 0 | 2.00 |
D11 | Conjunctival chemosis | 2v | 2 | 1 | 1 | 0 | 1 | 0 | 1.33 |
D7 | Conjunctival chemosis | 2v | 2 | 1 | 1 | 1 | 0 | 0 | 1.33 |
E8 | Conjunctival chemosis | 2v | 2 | 1 | 1 | 0 | 0 | 0 | 1.33 |
e = evaluation not possible due to colouration by test substance
k = conjunctivae and nictitating membrane: injection of blood vessels
v = conjunctivae and nictitating membrane: strong formation of vesicles
* = lower margin of cornea: vascularisation
+ = lower and upper margin of cornea: vascularisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye Dam 1 (H318), according to the CLP Regulation (EC) No 1272/2008
- Remarks:
- Migrated information
- Conclusions:
- Eye Dam 1, H318
- Executive summary:
The irritant/corrosive potential of test substance was studied on the eye of rabbit in accordance with the OECD guideline 405. After gently pulling the lower lid away from the eyeball a volume of 100 µl of the pulverised test substance-equivalent to approx. 34 mg- was placed into the conjunctival sac of one eye of each of three rabbits. 24 hours after instillation of test substance, the treated eye was rinsed with normale saline.
Exposure of the eye to test substance caused reactions on mucous membranes and effects on cornea in all three animals. Additionally in all three animals the iris was transiently affected and discharge occured. In one animal signs was fully reversible within 21 days, in the second animal corneal signs did not prove to be completely reversible within 21 days and in the third animal a slight erythema was observed on day 21. This evidence indicates that the product may be considered as "severely irritating to the eye".
Conclusion
The mean values from gradings at 24, 48 and 72 hours recorded in the study were equal to 1 for corneal opacity in all animals, lower than 1 for iritis in 2 out of three animals, equal to 2 for conjunctival redness and lower than 2 for oedema in all animals. Corneal opacity was not fully recovered within 21 days in one animals, as well as in another animal the conjunctival redness was not recovered withing 21 days.
Due to the fact that at least in one animal effects on the cornea have not fully reversed within an observation period of normally 21 days, a classification as capable to causes serious eye damage (i.e. category 1, H318), according to the CLP Regulation (EC) No 1272/2008, is applied.
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