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EC number: 268-974-1 | CAS number: 68155-62-4
- 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:
- February from 21st to 27th, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1986
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:
- not specified
Test material
- Reference substance name:
- Reactive Yellow 125
- IUPAC Name:
- Reactive Yellow 125
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, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 15 - 16 weeks.
- Weight at study initiation: 2.4 - 2.5 kg
- Acclimation period: 3 days.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male and 1 female
- Details on study design:
- TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL and Varta Cliptrix diagnostic-lamp.
SCORING SYSTEM
CORNEAL IRRITATION
Opacity: degree of density (densest area used for assessment)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal Iuster), details of iris clear visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
IRIDIC IRRITATION
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
CONJUNCTIVAL IRRITATION
Redness (refers to palpebral and bulbar conjunctivae, 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, lid and/on nictating membranes
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- Under the conditions of the experiment, test item was found to cause a primary irritation score of 1.3 when applied to rabbit eye mucosa. In the area of application, a slight, hardly perceptible yeIlowish-orange discolouration of the cornea and conjunctivae was observed, which could be related to effects of the test article.
No corrosion effect has occurred at each measuring intervals.
Any other information on results incl. tables
Animal N | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs |
15 M | Cornea opacity | 0 | 0 | 0 | 0 |
16 F | Cornea opacity | 0 | 0 | 1 | 0 |
15 M | Iris | 0 | 0 | 0 | 0 |
16 F | Iris | 0 | 0 | 0 | 0 |
15 M | Conjuntivae redness | 0 | 1 | 1 | 0 |
16 F | Conjuntivae redness | 1 | 1 | 1 | 0 |
15 M | Conjuntivae chemosis | 2 | 0 | 0 | 0 |
16 F | Conjuntivae chemosis | 1 | 1 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) 1272/2008
- Conclusions:
- Not eye irritating
- Executive summary:
The primary eye irritation potential of the substance was investigated according to OECD test guideline no. 405. The test item was applied undiluted, to one male and one female New Zealand White rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours.
Under the conditions of the experiment, test item was found to cause a primary irritation score of 1.3 when applied to rabbit eye mucosa. In the area of application, a slight, hardly perceptible yeIlowish-orange discolouration of the cornea and conjunctivae was observed, which could be related to effects of the test article.
No corrosion effect has occurred at each measuring intervals.
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.
Although two animals, instead of three, the results can be considered as sufficiently clear and probative to conclude that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.
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