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EC number: 413-090-5 | 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:
- 27 April 1993 to 25 May 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate
- EC Number:
- 413-090-5
- Cas Number:
- 189574-45-6
- Molecular formula:
- Hill formula: C24H18LixN10NayO12S4
- IUPAC Name:
- lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- See below
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test species: New Zealand albino rabbit
Strain: Chbb: NZW (SPF)
Origin: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 7950 Biberach
Number of animals: 3
Animal identification: numbered ear tags
Animal weights: 3.8 - 3.9 kg
Age of animals: about 3 - 5 months
Animal housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
Ambient temperature: 18 ± 3 °C
Relative humidity: 55 ± 20 %
Lighting time: 12 hours per day
Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad 1ibitum and hay (approx. 15 g daily)
Drinking water: deionised, chlorinated water from automatic water dispensers, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Exposure 24 hours
- Observation period (in vivo):
- 72 hours - Effects were still present in the eyes after 72 hours, further examinations were carried out after 7 days.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- About 24 hours 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 Reaktiv-Gelb F-68 072 FW was applied once to the conjunctival sac of the left eye of 3 rabbits. The untreated eyes served in each case as a control.
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein-sodium solution took place, the treated eyes were washed out thoroughly with physiological saline at approx. 37 °C.
The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded. Since effects were still present in the eyes after 72 hours, further examinations were carried out after 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- One hour up to three days p.a. the conjunctivae of all animals showed deeper crimson red up to diffuse beefy red as well as slight swellings up to obvious swellings in two animals. One hour up to one day slight swellings up to obvious swellings were noted in one animal. Additionally clear, from substance discoloured discharge as well as white viscous discharge and bleeding at the nictating membrane were observed. 7 days p.a. all irritations were reversible.
Any other information on results incl. tables
RABBIT EYE IRRITATION TEST - READINGS
ANIMAL NUMBER | SEX | EYE USED | INIT PAIN REACTION | IRRIGAT’N | ELAPSED TIME | CORNEA | IRIS | CONJUNCTIVA | |||
OPACITY | AREA | REDNESS | CHEMOSIS | DISCHARGE | |||||||
66 | F | LEFT | NONE | 24 HRS | 1.2 HRS | 0 | 0 | 0 | 3 | 2 | 2 |
1 DAY | 0 | 0 | 0 | 3 | 2 | 1 | |||||
2 DAYS | 0 | 0 | 0 | 2 | 1 | 0 | |||||
3 DAYS | 0 | 0 | 0 | 2 | 1 | 0 | |||||
7 DAYS | 0 | 0 | 0 | 0 | 0 | 0 | |||||
68 | F | LEFT | VERY SEVERE | 24 HRS | 1.1 HRS | 0 | 0 | 0 | 2 | 2 | 2 |
1 DAY | 0 | 0 | 0 | 3 | 1 | 0 | |||||
2 DAYS | 0 | 0 | 0 | 2 | 0 | 0 | |||||
3 DAYS | 0 | 0 | 0 | 2 | 0 | 0 | |||||
7 DAYS | 0 | 0 | 0 | 0 | 0 | 0 | |||||
72 | F | LEFT | NONE | 24 HRS | 1.2 DAYS | 0 | 0 | 0 | 3 | 2 | 2 |
1 DAY | 0 | 0 | 0 | 3 | 1 | 0 | |||||
2 DAYS | 0 | 0 | 0 | 2 | 1 | 0 | |||||
3 DAYS | 0 | 0 | 0 | 2 | 1 | 0 | |||||
7 DAYS | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Testing of Reaktiv-Gelb F-68 072 FW for primary eye irritation in the rabbit showed, that the substance is slightly irritating to eyes.
- Executive summary:
Testing for primary irritation in the rabbit eye provides information on ocular lesions after a single application of the test substance to the conjunctival sac of the eye and serves as a basis for classification and labelling.
The present study was conducted in compliance with EEC Directive B.5. 'Acute toxicity Eye Irritation' of the Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals, 405 "Acute Eye Irritation/Corrosion". This study was conducted in compliance with the Principles of Good Laboratory Practice (GLP).
One hour up to three days p.a. the conjunctivae of all animals showed deeper crimson red up to diffuse beefy red as well as slight swellings up to obvious swellings in two animals. One hour up to one day slight swellings up to obvious swellings were noted in one animal. Additionally clear, from substance discoloured discharge as well as white viscous discharge and bleddings at the nictating membran were observed.
7 days p.a. all irritations were reversible.
Testing of Reaktiv-Gelb F-68 072 FW for primary eye irritation in the rabbit showed, that the substance is slight irritating to eye. The substance is classified under CLP as "Eye Irritant, Cat 2", but does not fulfil the criteria for eye irritation under the Dangerous Substances Directive.
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