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EC number: 296-473-8 | CAS number: 92704-41-1 The product of high temperature calcination (above 450°C (842°F)) of naturally occurring kaolin, a hydrated aluminum silicate, resulting in the evolution of water and the formation of new substances depending upon the calcination temperatures employed.
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 17 - 20 Nov 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance kaolin (CAS 1332-58-7). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Kaolin
- EC Number:
- 310-194-1
- EC Name:
- Kaolin
- Cas Number:
- 1332-58-7
- IUPAC Name:
- 1332-58-7
- Details on test material:
- - Name of test material (as cited in study report): Surround (R) WP Crop Protectant
- PSL Reference number E01110-1D
- Physical state / appearance: white powder
- Composition of test material, percentage of components: kaolin - 95%, others - 5%
- Lot/batch No.: Lot #02140
- Expiration date of the lot/batch: not applicable
- Stability: Test substance is expected to be stable for the duration of testing
- Storage condition of test material: at room temperature
- Other: solubility: insoluble
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: young adult
- Housing: singly housed in suspended stainless steel caging with mesh floors (which conform to the size recommendations in the Guide for the Care and Use of Laboratory Animals DHEW (NIH)
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: 14 days
- Contaminants: Analyses of the food and water are conducted at least once a year
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The second eye of each rabbit remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (0.04 - 0.05 g) - Duration of treatment / exposure:
- without washing-off
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- The test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance.
Ocular irritation was evaluated at 1, 24, 48 and 72 hours post-instillation.
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not removed
SCORING SYSTEM:
Ocular scoring: in accordance with Draize (Draize et al., 1944); the fluorescein dye evaluation procedure was used at 24 hours to verify the absence of corneal damage (Scale for Scoring Ocular Lesions)
Classification of eye scores: the time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra (1962).
TOOL USED TO ASSESS SCORE: high-intensity white light (Mag light), fluorescein (Blak-Ray Lamp compact 4-watt UV Lamp)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2 and #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- One hour following test substance instillation, all three treated eyes exhibited slight conjunctivitis. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 48 hours.
- Other effects:
- All animals appeared active and healthy. Apart from the eye irritation, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
Any other information on results incl. tables
Table 1: Individual scores for ocular irritation
|
Rabbit No. 1 (female) |
Rabbit No. 2 (male) |
Rabbit No. 3 (female) |
|||||||||
time post- installation [hours] |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae Redness |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Conjunctivae Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae Discharge |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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