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Reaction mass of Cobaltate(2-), [2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)][2-[[2-hydroxy-5-[(phenylamino)sulfonyl]phenyl]azo]-3-oxo-N-phenylbutanamidato(2-)]-, disodium and Cobaltate(3-), bis[2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)]-, trisodium and sodium bis[2-[[2-hydroxy-5-[(phenylamino)sulphonyl]phenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)
EC number: 947-257-3 | CAS number: -
- 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:
- November from the 01st to the 08th, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Yellow 235
- IUPAC Name:
- Acid Yellow 235
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 - 2.9 kg
- Housing: individually in stainless cages equipped with an automatic cleaning and drinking system.
- Diet: pelleted standard Kliba 341, Batch 10/85 rabbit maintenance diet ("KIiba" Klingentalmuehle AG, Switzerland), ad Iibitum.
- Water: community tap water from Itigen, ad libitum.
- Acclimation period: four days under test conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 55 ± 10 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: 12 hrs dark / 12 hrs artificial fluorescent Iight.
- Other: music/light period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Application volume: 0.1 g per animal
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- OBSERIVATIONS
- Viability / mortality: daily.
- Bodyweights: Day 1 and at termination of test on a Mattler PK 16 balance.
TOOL USED TO ASSESS SCORE: slit-lamp 30 SL.
OBSERVATION TIME POINTS
For each individual animal, the irritation scores for erythema and edema were recorded at 60 minutes, 24, 48 and 72 hours after administration; in addition, any lesions, a description of the degree and nature of irritation, corrosion or reversibility and any toxic effect observed were recorded.
SCORING SYSTEM
Cornea Grade
Opacity: degree of density (readings should be taken from most dense area)
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
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is positive) 1
Hemorrhage, gross destruction, or no reaction to light 2
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse,crimson colour; individual vessels not easily discernible 2
Diffuse beefy red 3
Swelling (refers to lids and/or nictating membranes)
Normal 0
Some swelling above normal 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: 2/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- 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
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Irritant / corrosive response data:
- Under the conditions of the experiment, the test item was found to cause a primary irritation score of 2.4 when applied to rabbit eye mucosa.
In the area of application a slight yellow discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article.
No corrosion effect had occurred on the skin at each measuring interval. - Other effects:
- BODY WEIGHTS
The body weight gain of all rabbits was similar.
TOXIC SYMPTOMS / MORTALITY
No acute toxic symptoms were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Animal N. / sex | Reaction | Observation at | Mean 24/48/72 hrs | |||
1 hr | 24 hrs | 48 hrs | 72 hrs | |||
295 M | Cornea opacity | 1 | 1 | 1 | 0 | 0.67 |
296 F | Cornea opacity | 1 | 1 | 1 | 1 | 1.00 |
297 F | Cornea opacity | 0 | 0 | 0 | 0 | 0.00 |
295 M | Iris | 0 | 0 | 0 | 0 | 0.00 |
296 F | Iris | 0 | 0 | 0 | 0 | 0.00 |
297 F | Iris | 0 | 0 | 0 | 0 | 0.00 |
295 M | Conjunctival redness | 2 | 1 | 1 | 1 | 1.00 |
296 F | Conjunctival redness | 2 | 2 | 1 | 1 | 1.33 |
297 F | Conjunctival redness | 2 | 1 | 0 | 0 | 0.33 |
295 M | Conjunctival chemosis | 3 | 1 | 0 | 0 | 0.33 |
296 F | Conjunctival chemosis | 2 | 1 | 0 | 0 | 0.33 |
297 F | Conjunctival chemosis | 1 | 0 | 0 | 0 | 0.00 |
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 purpose of the primary eye irritation study was to assess possible irritation potential when single doses of test item are placed in the conjunctival sac of rabbit eyes. The experiment was conducted in accordance with the method and procedures outlined into the OECD guideline 405.
Under the conditions of the experiment, the test item was found to cause a primary irritation score of 2.4 when applied to rabbit eye mucosa. In the area of application a slight yellow discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article.
No corrosion effect had occurred on the skin at each measuring interval.
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 at least 2 out of three tested animals. Thus, 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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