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EC number: 443-940-0 | 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:
- From Jul. 02, 2002 to Aug. 29, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study was conducted according to EU Method B.5. OECD Guideline 405 and OPPTS 870.2400 in compliance with GLP. This study was carried out on one rabbit only, as the classification according to Directive 67/548/EEC states that the irreversible discoloration of the eye leads to a classification as R41. As the number of animals is not sufficient according to the guidelines if the substance does not cause damage to eyes, another study for eye irritation was added as read-across for this endpoint. This substance is structurally very similar to the registered substance and showed the same effect on eyes. The classification according to Council Directive 67/548/EEC and according to Regulation (EC) No 1272/2008 differs due to changes in the criteria for eye irritation in the new CLP regulation. The substance was classifies as "Xi Risk phrases: R41" due to persistent (21 days) discoloration of the nictitating membrane of one rabbit. In the new CLP regulation, the criteria to serious eye damage was reversed to "discoloration of the cornea", hence, this dye substance has no longer to be classified to be hazardeous to eyes according to REGULATION (EC) No 1272/2008.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kiβlegg
- Weight at study initiation: 3.79 kg
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: Aug. 06, 2002 To: Aug. 27, 2002
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 72 h. Since effects were still present in the treated eye after 72 h, further examinations were carried out after 7, 14 and 21 d.
- Number of animals or in vitro replicates:
- 1 rabbit
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h
SCORING SYSTEM: Lesions in cornea, iris or conjunctivae were graded numerically "Scale for scoring ocular reactions"
TOOL USED TO ASSESS SCORE: 0.01 % fluorescein-sodium solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (116)
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no corneal score observed
- Remarks on result:
- other: -
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (116)
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no iris score observed
- Remarks on result:
- other: -
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- (116)
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: (after 4 d)
- Remarks on result:
- other: -
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (116)
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: (after 7 d)
- Remarks on result:
- other: -
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Remarks:
- (116)
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: (after 1 d)
- Remarks on result:
- other: -
- Irritant / corrosive response data:
- - 1 h after administration the conjunctiva of the animal showed slight swelling (including nictitating membrane) and some blood vessels were definitely hyperaemic (injected). Additionally, serous discharge discolored by the test compound with moistening of the lids and hairs just adjacent to the lids was noted.
- 24 h up to 48 h after administration the conjunctiva of the animal still showed some blood vessels which were definitely hyperaemic (injected).
- 72 h after administration a slight swelling of the conjunctiva was observed again. 24 h up to 21d after administration the nictitating membrane was discoloured by the test compound. This discoloration was not reversible, the study was terminated at Day 21 after administration. - Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Council Directive 67/548/EEC: Under the test conditions, the test substance showed potential risk of serious damage to the rabbit eye due to the persistent discoloration of the eye.
Regulation (EC) No 1272/2008: not irritating
The classification according to Council Directive 67/548/EEC and according to Regulation (EC) No 1272/2008 differs due to changes in the criteria for eye irritation in the new CLP regulation. The substance was classifies as "Xi Risk phrases: R41" due to persistent (21 days) discoloration of the nictitating membrane of one rabbit. In the new CLP regulation, the criteria to serious eye damage was reversed to "discoloration of the cornea", hence, this dye substance has no longer to be classified to be hazardeous to eyes according to REGULATION (EC) No 1272/2008.
- Executive summary:
A study was conducted to assess the eye irritation potential of test substance to the rabbit eye according to EU Method B.5., OECD Guideline 405 and OPPTS 870.2400 in compliance with GLP.
One animal received 100 mg of an undiluted test substance into conjunctival sac of the left eye. The other eyes served as untreated control. 24 h after the administration the eyes were washed thoroughly with isotonic saline at 37 °C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.
The eyes were 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 eyes were further examined for cornea/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 (Scale for scoring ocular reactions). All other changes or toxic effects were recorded when apparent.
One hour after administration the conjunctiva of the animal showed slight swelling (including nictitating membrane) and some blood vessels were definitely hyperaemic (injected). Additionally, serous discharge discolored by the test compound with moistening of the lids and hairs just adjacent to the lids was noted. 24 h up to 48 h after administration the conjunctiva of the animal still showed some blood vessels which were definitely hyperaemic (injected). 72 h after administration a slight swelling of the conjunctiva was observed again. 24 h up to 21d after administration the nictitating membrane was discolored by the test compound. This discoloration was not reversible and the study was terminated at Day 21 after administration.
Under the test conditions, the test substance showed potential risk of serious damage to the rabbit eye due to the persistent discoloration of the eye according to Council Directive 67/548/EEC.
With the new CLP regulation (Regulation (EC) No 1272/2008), the susbtance has to be evaluated as not irritating to eyes.
The classification according to Council Directive 67/548/EEC and according to Regulation (EC) No 1272/2008 differs due to changes in the criteria for eye irritation in the new CLP regulation. The substance was classifies as "Xi Risk phrases: R41" due to persistent (21 days) discoloration of the nictitating membrane of one rabbit. In the new CLP regulation, the criteria to serious eye damage was reversed to "discoloration of the cornea", hence, this dye substance has no longer to be classified to be hazardeous to eyes according to REGULATION (EC) No 1272/2008.
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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