Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 274-230-7 | CAS number: 69943-66-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guideline.
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)
- GLP compliance:
- no
Test material
- Reference substance name:
- Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)
- EC Number:
- 274-230-7
- EC Name:
- Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)
- Cas Number:
- 69943-66-4
- Molecular formula:
- C32H18CrN8O14S2Na3
- IUPAC Name:
- Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Spolkem breeder of Hrace Králové.
- Weight at study initiation: above 2.5 kg.
- Housing: individually housed, in commercially metal cages (supplied by s.p. Velaz Prague), without litter and climatic control.
- Diet: standard granular commercial food for rabbits, KO-16 provided by s.p. Velaz Prague.
- Water: drinking water, ad libitum.
Cleaning and disinfection of premises menagerie were made at dates determined, according to the standard operating procedures and compliance regime measures.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C.
- Humidity: 50 ± 15 %.
- Photoperiod: 12 hrs dark / 12 hrs light, by fluorescent lamp.
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Observation period (in vivo):
- 72 hours (observations were made at 1, 24, 48 and 72 hours after installation of test material).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: water.
- Time after start of exposure: 24 hours. Areas with the loss of corneal tissue are intensely coloured and the progressive rinsing of the dye in the damaged areas require more time than the place intact.
TOOL USED TO ASSESS SCORE: 2 % sodium salt, fluorescein. Reactions after 48 hours were evaluated without fluorescein. Reactions after 72 hours were evaluated with 2 % aqueous fluorescein solution.
SCORING SYSTEM
CORNEA:
A Opacity and degree of density (most dense area scored).
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque, iris invisible: 4
B Area of cornea involved
One quarter (or less) but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
A x B x 5; Maximum possible score = 80
IRITIS:
Normal: 0
Folds above normal, congestion, swelling, circum cornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive: 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
A x 5; Maximum possible score = 10
CONJUNCTIVAE:
A Redness (refers to lids and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3
B Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4
C Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
(A + B + C) x 2; Maximum possible score = 20
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 1
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 2
- Max. score:
- 4
- Irritant / corrosive response data:
- Primary irritation score: 63.3
Degree of irritation: 4
The following effects were recorded at 1, 24, 48 and 72 hours: visual examination was found massive purulent discharge from the corner of eye, blepharospasm, chemosis coniunctivae, diffuse injection of the lids and bulbar conjunctiva, cornea in quadrant rich milky turbid-leucoma with a total loss of transparency, iris obscured with loss of reaction to light.
Any other information on results incl. tables
Reactions observed
N. animal cage | Assessment | Cornea | Iritis | Conjunctival | |||
Reaction | Area | Congestion | Swelling | Discharge | |||
1 | 1 | 1 | 4 | 2 | 2 | 3 | 3 |
24 | 2 | 4 | 1 | 2 | 3 | 3 | |
48 | 2 | 4 | 1 | 2 | 2 | 3 | |
72 | 2 | 4 | 2 | 2 | 2 | 3 | |
Mean 24, 48 and 72 hrs |
2.00 |
1.33 | 2.00 | 2.33 | |||
2 | 1 | 1 | 4 | 1 | 2 | 3 | 3 |
24 | 2 | 4 | 1 | 2 | 3 | 3 | |
48 | 2 | 4 | 1 | 2 | 2 | 3 | |
72 | 1 | 4 | 1 | 2 | 2 | 3 | |
Mean 24, 48 and 72 hrs |
1.67 |
1.00 | 2.00 | 2.33 | |||
3 | 1 | 1 | 4 | 2 | 2 | 3 | 3 |
24 | 2 | 4 | 1 | 2 | 3 | 3 | |
48 | 2 | 4 | 1 | 2 | 1 | 3 | |
72 | 2 | 4 | 1 | 1 | 2 | 2 | |
Mean 24, 48 and 72 hrs |
2.00 |
1.00 | 1.67 | 2.00 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye Irrit. 2 (H319), according to the CLP Regulation (EC 1272/2008)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Eye Irrit. 2, H319.
- Executive summary:
The skin irritation potential of the substance was determined by the skin irritation test, according to the OECD guideline 404.
0.5 g of test material were applied to intact and scarified skin of rabbits and removed after 24 hours. Observations were made for 72 hours.
The substance resulted strong irritant. Primary irritation score was stated at 63.3 and the degree of irritation as 4.
The criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline. The scoring system used for the cornea opacity and degree of density, for the iris and conjunctivae redness and chemosis is the same of that reported into the OECD, but the timing for the removal of the substance are very different (24 hours in the current study and 1 hour in the OECD). Nevertheless, because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008).
The mean values from gradings at 24, 48 and 72 hours was:
- higher than 1 in all the animals tested for corneal opacity. Nevertheless in none was equal/higher than 3.
- equal than 1 in two rabbits and 1.33 in the last one for iritis
- higher than 2 in two rabbit, for conjunctival redness.
- higher than 2 in two animals, for conjunctival chemosis
Information are not available about the reversibility of the effects recorded. A relevant aspect, that may be determinant in the assessment, is that the solid substance tested was removed after 24 hours after application, instead of 1 hour as required by the OECD guideline 405 updated version 2012. Thus, it can not be excluded that the irritation potential determined by the powder form may contribut to the reactions observed.
In conclusion, it is considered appropriate a classification as eye irritant, category 2 (H319), according to the CLP Regulation (EC 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.