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EC number: 432-550-6 | CAS number: 243858-01-7
- 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 August 24, 1999 to September 14, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only one animal was tested. As the persistent discolouration of the conjunctivae requested a classification according to EU Directive 67/548/EEC, no further animals were tested.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 432-550-6
- EC Name:
- -
- Cas Number:
- 243858-01-7
- Molecular formula:
- Hill formula: C25H22FN7Na4O16S5 CAS formula: C25H26FN7O16S5.4Na
- IUPAC Name:
- tetrasodium 2-({4-fluoro-6-[methyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-5-hydroxy-6-[2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Orange F97-0318
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Charles River Deutschland GmbH, 88353 Kisslegg.
- Body weight at treatment: 3.0 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Ssniff K-H (V2333), ad libitum and hay (i.e., approximately 15 g daily)
- Water: Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Numbered ear tags
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: August 24, 1999 to September 14, 1999
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 , 72 h and after 7, 14 d and 21 d following administration of the test substance.
- Number of animals or in vitro replicates:
- 1 female
- Details on study design:
- TEST PROCEDURE
About 24 h before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
100 mg test substance was administered once to the conjunctival sac of the left eye of one rabbit. In each case the untreated eye served as a control. 24 h after administration the treated eye was washed out thoroughly with isotonic saline at approximately 37ºC. The eye was also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.
The eye was examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7, 14 and 21 d, the eye was further examined for corneal lesions under UV light after instillation of one drop of a 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded when apparent. Since effects were still present in the eye after 72 h, further examinations were carried out after 7, 14 and 21 d.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - From 1 h up to 1 d after application the conjunctiva of the animal showed definitely injected blood vessels up to a diffuse crimson red color and swelling with the lid being half closed.
- The irritations were attended by clear substance coloured eye discharge.
- 2 d after application the irritations were reversed.
- Additionally, nictitating membrane, conjunctiva and sclera were discolored orange from 1 h up to the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the substance caused orange discoloration of the conjunctiva, nictitating membrane and sclera of one rabbit eye until end of the study period. Reddening of the conjunctiva was seen after substance application but this cleared within two days.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance in one New Zealand albino female rabbit according to OECD Guideline 405 and EU Method B.5, in compliance with GLP.
A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of the animal. The treated eye was washed out 24 h after administration. The untreated eye served as a control.
The conjunctiva, nictitating membrane and sclera were discolored orange by the test substance up to the end of the study. The conjunctiva showed definitely injected blood vessels up to a diffuse crimson red color and swelling with the lid being half closed, accompanied by clear substance coloured eye discharge on the day of substance administration. Based on the individual scores after 24, 48 and 72 h, the mean score was 0 for opacity of the cornea, iris and chemosis of the conjunctiva. The score was 0.33 for redness of the conjunctiva.
Under the test conditions, the substance caused orange discoloration of the conjunctiva, nictitating membrane and sclera of one rabbit eye until end of the study period. Reddening of the conjunctiva was seen after substance application but this cleared within two days.
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