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EC number: 400-920-6 | CAS number: 89857-06-7
- 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 12th to February 15th, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- EWG Directive 84/449/ EWG, Amtsblatt der Europaeischen Gemeinschaften L 251, Jahrgang 27, 19. 9. 84. B.5. Akute Toxizitaet Augenreizung/ 109.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 400-920-6
- EC Name:
- -
- Cas Number:
- 89857-06-7
- Molecular formula:
- C50 H53 N11 O14 S
- IUPAC Name:
- 5'-[2-(7-{2-[4-(2-{1'-[3-(dimethylazaniumyl)propyl]-6'-hydroxy-4'-methyl-2'-oxo-1',2'-dihydro-1λ⁵-[1,3'-bipyridin]-1-ylium-5'-yl}diazen-1-yl)phenyl]diazen-1-yl}-8-hydroxy-6-sulfonatonaphthalen-2-yl)diazen-1-yl]-6'-hydroxy-3,4'-dimethyl-2'-oxo-1',2'-dihydro-1λ⁵-[1,3'-bipyridin]-1-ylium bis(2-hydroxypropanoate)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- KFM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG CH 4474 Fuellinsdorf/ Switzerland
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: 2.6 - 7.9 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: peIIeted standard KIiba 341, Batch 3/84 rabbit maintenance diet, ad libitum
- Water: comunity tap water from Itingen, ad libitum
- Acclimation period: four days under' Iaboratory conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 10 -15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescentcIight/12 hours dark, at least 8 hours music/light period
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: A singIe dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 g per animal. - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 rabbits (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:
CORNEAL IRRITATION
Opacity: degree of density (area most dense taken for reading)
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacrous 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 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
CONJUNCTIVAL IRRITATION
Redness: (refers to palpebral 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 nictating membranes
- No swelling: 0
- Any swelling above normal (includes nictating membrane): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed: 3
- Swelling with lids more than half closed: 4
TOOL USED TO ASSESS SCORE: eye examination were made with a slit-lamp 30 SL and a Varta Cliptrix diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- IRRITATION
Test item showed a primary irritation score of 0.6 when applied to the rabbit eye mucosa.
CORROSION
No corrosion of the cornea was observed at each of the measuring intervals.
Any other information on results incl. tables
TOXIC SYMPTOMS/MORTALITY
No acute toxic symptoms were observed in the animals during the test period, and no mortality occcurred.
COLORATION
In the area of application a severe black discoloration of the cornea and conjunctivae which could be related to effects of the test article was observed.
BODY WEIGHTS
The body weight gain of all rabbits was similar.
NECROPSY
Due to the results obtained, no macroscopic organ examination was indicated.
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 substance was tested for eye irritation according to the OECD Guideline 405 (1981). A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 g per animal. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. Under the conditions of this experiment, test item was found to cause a primary irritation score of 0.6 when applied to the rabbit eye mucosa. In the area of application a severe black discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.
The mean value of the scores for each type of lesion, calculated for each animal separately, is the following:
Animal No. Sex Mean 24 -72 hours
Cornea opacity Iris Conjunctivae
redness chemosis
128 male 0 0 1 0
129 female 0 0 0.7 0
130 female 0 0 0 0In conclusion, based on test results 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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