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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-505-3 | CAS number: 68259-02-9
- 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 19 October, 1992 to 09 November, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate
- EC Number:
- 269-505-3
- EC Name:
- Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate
- Cas Number:
- 68259-02-9
- Molecular formula:
- C25H19ClN10O16S5.5Na
- IUPAC Name:
- pentasodium 4-amino-6-({5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfonatophenyl}diazenyl)-3-[(2,5-disulfonatophenyl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: 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: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Animal #1 and #2: Approx. 16 weeks; Animal #3: Approx. 13 weeks
- Weight at study initiation: 2499 to 3257 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (lKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d, ad libitum.
- Water (e.g. ad libitum): Tap-water diluted with decalcified water, ad libitum.
- Acclimation period: At least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark
IN-LIFE DATES: From October 19, 1992 to November 9, 1992
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight with unit): 100 ± 1 mg/animal - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- Up to 21 d (The eyes of each animal were examined for irritation for approx. 1, 24, 48 and 72 h and 7, 14 and 21 d after instillation of the test substance).
- Number of animals or in vitro replicates:
- Three male animals
- Details on study design:
- Prior to test substance instillation, the animals were physically examined to ensure normal ocular surface integrity.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Slight blue discolouration of the cornea noted during 24, 48 and 72 h observation period.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: The conjunctival redness was difficult to score at 24, 48 and 72 h observation period, due to blue discolouration by the test substance.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Chemosis grade 2 (at 48 h) and grade 1 (at 72 h) for nictitating membrane.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Slight blue discolouration of the cornea noted during 24, 48 and 72 h observation period.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: The conjunctival redness was difficult to score at 24 and 48 observation period, due to blue discolouration by the test substance. Redness grade 2 (at 24 and 48 h) and grade 3 (at 72 h) for nictitating membrane.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Chemosis grade 1 (at 48 h) for scleral conjunctivae.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Slight blue discolouration of the cornea noted during 24, 48 and 72 h observation period.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: The conjunctival redness was difficult to score at 24 h observation period, due to blue discolouration by the test substance. Redness grade 2 (at 24 h) and grade 3 (at 48 and 72 h) for nictitating membrane.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: chemosis grade 1 (at 48 h) for nictitating membrane.
- Irritant / corrosive response data:
- Blue staining of the cornea, iris and/or conjunctivae by the test substance was noted during the study, which made scoring difficult or impossible. Ocular corrosion was not observed in any of the animals.
- Other effects:
- There were no signs of body weight variability, toxicity or mortality in any animal during the study period.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test substance was irritating to the eye.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance (of 100 % purity) in New Zealand White rabbits according to OECD Guideline 405 and EU Method B.5 in compliance with GLP.
A single dose of 100 ± 1 mg test substance was applied into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The untreated eye served as control. Without washing, eyes were scored for irritation reactions at 1, 24, 48 and 72 h and 7, 14 and 21 d post-instillation.
Blue staining of the cornea, iris and/or conjunctivae by the test substance at 24, 48 and 72 h made scoring difficult. During the study, blue staining of the fur on the head and paws was noted. Further, conjunctival redness of > 2 in 2/3 eyes was observed which had resolved within 21 d after instillation. There were no signs of body weight variability, toxicity or mortality in any animal during the study period.
Under the test conditions, the test substance was considered to be irritating to the eyes.
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.