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EC number: 224-460-9 | CAS number: 4368-56-3
- 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 May 26 to August 15, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 224-460-9
- EC Name:
- Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 4368-56-3
- Molecular formula:
- C20H219N2O5S.Na
- IUPAC Name:
- sodium 4-(4-acetamidophenyl-1-amino)-1-amino-9,10-dioxoanthracene-2-sulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Association of Breeders of Hradec Kralove.
- Weight at study initiation: above 2.5 Kg.
- Housing: animals were housed individually in metal cages without bedding with automatic air-condition.
- Diet: standard commercially manufactured feed mixture TM-Rabbit, ad libitum.
- Water: drinking water according to CSN 757111 ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 50 ± 15%
- Photoperiod: 12 hrs cycle dark/light
- Other: fluorescent light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (g): 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours after instillation of the sample.
- Number of animals or in vitro replicates:
- 3 animals (males and females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was flushed with water.
- Time after start of exposure: 24 hrs.
TOOL USED TO ASSESS SCORE:
- Clinical examination of the left eye was performed by the use of ophthalmoscope Heine BETA 200 at intervals of 1, 24, 48 and 72 hours after instillation of the sample.
- At 24 hours, the damage of the corneal tissue was evaluated by the use of a 2% acqueous solution of fluorescein sodium salt.
- At 48 hours was the damage was evaluated without fluorescein.
- At 72 hours was the damage was evaluated by the use of a 2% acqueous solution of fluorescein sodium salt.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- After 1 hour after application of the substance the following clinical signs are observed:
- Medial canthus: in rabbits, no. 1, no. 2 and no. 3 mucopurulent discharge, blepharospasm, narrowing of rima palpebrarum are observed.
- Bulbar and palpebral conjunctiva: rabbits, no. 1, no. 2 and no. 3 didn't show any signs of conjunctivitis. Swelling with partial lid inversion and chemosis is observed.
- Cornea: in rabbits, no. 1 and no. 2 opacity of cornea was observed; iris is not discernible. In rabbit, no. 3 the area is easily discernible translucent; details of iris slightly obscured
- Iris: in rabbits, no. 1, no. 2 and no. 3 there is total loss of light reaction.
After 24 hours after application of the substance the following clinical signs are observed:
- Medial canthus: in rabbits no. 1 and no. 3 mucopurulent medium discharge, blepharospasm and narrowing of rima palpebrarum. In rabbit, no. 2 large mucopurulent discharge, blepharospasm and narrowing of rima palpebrarum ae observed.
- Bulbar and palpebral conjunctiva: in rabbits, no. 1 no. 2 and no. 3 it is observed diffuse,crimson colour; individual vessels are not easily discernible. Difficult to evaluate the weak swelling
- Cornea: rabbits, no. 1, no. 2 and no. 3 diffuse areas of opacity; details of iris clearly visible
- Iris: rabbits, no. 1, no. 2 and no. 3 corresponded to physiological norms, without macroscopic pathomorfological changes
After 48 hours after application of the substance the following clinical signs are observed:
- Medial canthus: in rabbits, no. 1 and no. 3 there is central mucopurulent discharge, blepharospasm and narrowing of rima palpebrarum. Rabbit no. 2 shows a large mucopurulent discharge, blepharospasm and rima palpebrarum narrowing
- Bulbar and palpebral conjunctiva: in rabbits, no. 1, no. 2 and no. 3 it is observed diffuse,crimson colour; individual vessels are not easily discernible
- Cornea: in rabbits, no. 1 and no. 2 diffuse area of opacity, but details of iris are clearly visible. In rabbit, no. 3 cornea has a smooth, shiny appearance without macroscopic pathomorfologival changes.
- Iris: rabbits, no. 1, no. 2 and no. 3 corresponded to physiological norms, without macroscopic pathomorfological changes
After 72 hours after application of the substance the following clinical signs are observed:
- Medial canthus: in rabbits, no. 1 and no. 3 weak mucopurulent discharge. In rabbit no. 2 there is large mucopurulent discharge.
- Bulbar and palpebral conjunctiva: in rabbits, no. 1, no. 2 and no. 3 is observed diffuse,crimson colour; individual vessels are not easily discernible. Rabbit no.2 showed swelling with partial eversion of eye lid
- Cornea: in rabbits, no. 1 and No. 2 diffuse area of opacity, but details of iris are clearly visible
- Iris: rabbits, no. 1, no. 2 and no. 3 corresponded to physiological norms, without macroscopic pathomorfological changes
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The test substance is irritating to eyes
- Executive summary:
The substance was tested for Eye Irritation according to the OECD Guideline 405. The test substance (0.1 g) was placed as it is, in the conjuctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lids were then held together for some seconds. The right eye was left untreated, and it served for control. For the assessement of eye irritation (in cornea, iris, conjuctivae) Three New Zealand white rabbits were used.
The eyes were evaluated and examined for any signs of occular lesions at 1, 24 ,48, 72 hours following test substance application. For the grading of the occular responses the harmonised scoring system as described in the OECD Guideline 405 was used. The response was calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material. The corneal opacity in at least 2 of 3 tested animals (animal #1 and animal #2) was equal to 1 and the conjuctival redness was equal to 2 in all the three animals.
The test substance is classified as Irritating to eyes (Category 2) according to the CLP Regulation (EC) No. 1272/2008.
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