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Diss Factsheets
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EC number: 252-667-4 | CAS number: 35674-65-8
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted in a contract research organization according to internationally accepted technical guidelines then at force, but without QA-statement. The study is scientifically valid and, despite limited documentation, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- 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
- Age at study initiation: adults
- Weight at study initiation: 2.5-3.0 kg
- Housing: individual cages
- Diet: standard laboratory diet for rabbits ( Altromin, Lage, Germany). The animals were starved for 16 hours prior to application.
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g of the test material was applied into the conjunctival pouch of one eye per rabbit. The contralateral eye remained untreated to serve as a control.
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- - Readings of eye alterations were made after 1, 2, 4, and 24 hours and daily thereafter up to 7 days after administration.
- Grades attained at 24, 48 and 72 hours after administration were included in the mean gradings of ocular lesions used for eye irritation/corrosion classification. - Number of animals or in vitro replicates:
- 8
- Details on study design:
- Before and after the test the eyes of all animals were examained with fluorescin (2%) under UV light. After weighing (16 hours starved) 0.1 g of the substance was applicated into the conjunctival pouch of the left eye. The right one stayed untreated and served as control.
REMOVAL OF TEST SUBSTANCE
The test material was not removed.
SCORING SYSTEM:
Eye lesions were scored according to the system of Draize:
1. Cornea
- Degree of opacity:
Score 0: No opacity (nor loss of brilliancy or lustre)
Score 1: Presence of an irritated area of diffused or disseminated appearance, details of the iris clearly visible
Score 2: Presence of a translucid, irritated area easily identifiable, details of the iris slightly obscured
Score 3: Presence of an opalescent, irritated area, details of the iris visible, outline of the pupil can scarcely be observed
Score 4: Presence of opacity making the iris invisible
- Area of opacity:
Score 1: 1/4 (or less), but not zero
Score 2: Between 1/4 and 1/2
Score 3: Between 1/2 and 3/4
Score 4: From 3/4 to the whole area
2. Iris
Score 0: Normal
Score 1: Clearly more plicate than normal, congestion, swelling circumcorneal injection (one or several of these characteristics), iris still reacting to light (a slow reaction is a positive reaction)
Score 2: No reaction to light, haemorrhage, significant "destruction" (one, several or all of these characteristics)
3. Conjunctiva
- Reddening of the palpebral conjunvtiva:
Score 0: Vessels normal
Score 1: Vessels clearly more injected than normal
Score 2: Bright red colour, more diffuse, vessels difficult to distinguish
Score 3: Diffuse blood red colour
- Chemosis:
Score 0: No swelling
Score 1: Slight swelling, including the nictitating membrane
Score 2: Pronounced swelling, with inversion of the eyelid
Score 3: Swelling with eyelids half closed
Score 4: Swelling with eyelid closed more than half-way or completely closed
- Lacrimation:
Score 0: Absence
Score 1: Slight lacrimation (do not take into account slight secretions normally in the inside corner)
Score 2: Lacrimation with moistening of the eyelids and hairs around the eyelids
Score 3: Lacrimation with moistening of the eyelids and heirs on wide areas around the eye
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 8 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: Area of opacity
- Basis:
- mean
- Remarks:
- over 8 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 8 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over 8 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 8 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: lacrimation score
- Basis:
- mean
- Remarks:
- over 8 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- Up to 4 hours after the application, the treated conjunctiva of all animals showed very slightly redness, chemosis and secretion (score 1). After 24 hours post application, no irritations have been observed at all.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results and according to the EC criteria for classification and labelling (REGULATION (EC) 1272/2008, the test material does not have to be classified and has no obligatory labelling requirement as irritating to 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.
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