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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 266-658-8 | CAS number: 67352-37-8
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From November 18 to 25, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The complete read across justification is detailed in section 13. Source study has reliability 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Solvent Orange 062 (Na and H)
- IUPAC Name:
- Solvent Orange 062 (Na and H)
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 4414 Fuellinsdorf / Switzerland
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: animals were caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet: pelleted standard Kliba 23/341/1, rabbit maintenance diet defined for acceptaeble contaminant level, ad libitum
- Water: tap water, ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours cycle dark/light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g to the left eye of each animal - Duration of treatment / exposure:
- single application into conjunctival sac
- Observation period (in vivo):
- 1, 24, 48, 72 hours after treatment.
- Number of animals or in vitro replicates:
- 3 rabbits (1 male and 2 females)
- Details on study design:
- SCORING SYSTEM: Draize J.H. 1959
Cornea opacity and degree of density (most dense area scored)
0 no opacity
1 scattered or diffuse area, details of iris clearly visible
2 easily discernible translucent areas, details of iris slightly obscured
3 opalescent areas, no details of iris visible, siz eof pupils barely discernible
4 opaque, iris invisible
Iris
0 normal
1 folds above normal, congestion, swelling, circumcornea injection (nay or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, hemorrage, gross destruction (any or all of these)
Conjunctivae redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
0 vessels normal
1 vessels definitely injected above normal
2 more diffuse, deeper crimson red, individual vessels not easily discernible
3 diffuse beefy red
Conjuctivae chemosis
0 no swelling
1 any swelling above normal (includes nictitating membrane)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half closed
4 swelling with lids about half to completely closed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no eye reaction observed
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: no eye reaction observed
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- other: no eye reaction observed
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no eye reaction observed
- Remarks on result:
- other: not rinsed
- Other effects:
- No discoloration of the cornea and conjunctivae was observed in the rabbits during the entire test period, which could be related to compound effects.
No acute toxicological signs were observed in the rabbits during the test period.
Any other information on results incl. tables
Upon sacrifice, no macroscopical organ examination was indicated, due to the results obtained.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- Under test conditions, test substance was found to cause no irritation when applied to the rabbit eye mucosa.
- Executive summary:
Method
The substance was evaluated for eye irritation/corrosion according to the OECD guideline 405. Test substance was applied to the left eye of each animal and the eye was not rinsed. The right eye served as control.Reactions were scored 1 hour, 24, 48 and 72 hours after application.
Results
Under test conditions, the substance was found to cause no irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctiva which could be related to compound effect was observed. No corrosion effect was observed at each of the measuring intervals.
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.