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EC number: 433-180-8 | 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:
- 1999-02-09-1999-02-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with EEC-Guideline B5 and OECD Guidelines for testing chemicals 405 according to the good laboratory practice regulations annex of paragraph 19a, section 1 of the chemical law of July, 25, 1994.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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
- Details on test material:
- -Name of test material (as cited in study report): Reaktiv-Orange DYPR934
Constituent 1
Test animals / tissue source
- Species:
- other: Rabbit, new-zealand white albino
- Strain:
- other: CrL: KBL (NZW)
- Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Species: New Zealand albino rabbit
- Origin: Charles River Deutschland GmbH
88353 Kißlegg
- Age at study initiation: 3 healthy young adult rabbits were used
- Weight at study initiation: 3.2 - 4 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery.
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3 °C
- Relative humidity: 50 ± 20 %
- Air changes (per hr): at least 10 X
- Photoperiod (hrs dark / hrs light): 12 hours daily
-Animal identification: numbered ear tags.
Test system
- Vehicle:
- water
- Remarks:
- deionized water
- Controls:
- no
- Amount / concentration applied:
- 100 mg per eye
- Duration of treatment / exposure:
- 24 hours after administration the treated eyes were washed thoroughly with isotonic saline at approx. 37 °C.
- Observation period (in vivo):
- At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal lesions under UV light after installation 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. Since 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:
- Procedure:
About 24 hours before start 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.
100 mg Reaktlv-Orsnge DYPR 934 was administered once to the conjunctival sac of the left eye of three rabbits. In each case the untreated eyes served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
24 hours after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.
This procedure was repeated at all other designated
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: 57
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: 77
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: 200
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.11
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Remarks:
- (Chemosis of conjunctivae)
- Basis:
- animal: 57
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Irritation parameter:
- chemosis score
- Remarks:
- (Chemosis of conjunctivae)
- Basis:
- animal: 77
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Irritation parameter:
- chemosis score
- Remarks:
- (Chemosis of conjunctivae)
- Basis:
- animal: 200
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- chemosis score
- Remarks:
- (Chemosis of conjunctivae)
- Basis:
- mean
- Remarks:
- All animals
- Time point:
- other: 24-72h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity of cornea)
- Basis:
- animal: 57
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity of cornea)
- Basis:
- animal: 77
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity of cornea)
- Basis:
- animal: 200
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity of cornea)
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 57
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 77
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 200
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- Bleedings of nictitating membrane were observed in two animals.
Any other information on results incl. tables
Results:
From one hour up to 3 days after; application the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse deeper crimson red color and slight swelling up to partial eversion of lids. The irritations were attended by compound coloured eye discharge. 7 days after application the irritations were reversible.
The individual findings are given below table.
Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:
Opacity of cornea
all animals : 0.00 Iris
animal 67 :
0.00
animal 77: 0.00
animal 200 ; 0.00
Iris:
all animals: 0,00
animal 57 :
0.00
animal 77 : 0.00
animal 200 : 0.00
Redness
of conjunctiva
all
animals : 1.11
animal 57 :
1.00
animal 77 : 1.33
animal 200 : 1.00
Chemosis of conjuctiva:
all animals:0.22
animal 57:0.33
animal 77 :0.33
animal 200 : 0.00
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Conclusion:
Testing of Reaktiv-Orange DYPR 934 for primary eye irritation in the rabbit showed that the substance is slightly irritating to eye. - Executive summary:
In an eye irritation study, 100 mg of Reaktiv-Orange DYPR 934 was administered once to the conjunctival sac of the left eye of three rabbits. In each case the untreated eyes served as a control.
The aim of this study was to obtain information on ocular lesions after a single administration of Reaktiv-Orange DYPR 934 to the conjunctival sac of the eye and serves as basis for the classification and labeling.
From one hour up to 3 days after; application the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse deeper crimson red color and slight swelling up to partial eversion of lids. The irritations were attended by compound coloured eye discharge.
Additionally bleedings of nictitating membrane were observed in two animals. 7 days after application the irritations were reversible.
Testing of Reaktiv-Orange DYPR 934 for primary irritation in the rabbit eye showed that the substance would be classified as sligthly irritating to the eye.
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.
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