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EC number: 233-135-0 | CAS number: 10043-01-3
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 5 to 29 March 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP guideline study well conducted.
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:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 005
- Cas Number:
- 16828-12-9
- Molecular formula:
- Al2 (SO4)3, 14 H2O
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): ALUM - 17
- Physical state: white powder
- Storage condition of test material: room temperature
- Receiving date: 19 January 1990
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: twelve to sixteen weeks old.
- Weight at study initiation: 2.73 Kg.
- Housing: suspended metal cage.
- Diet (e.g. ad libitum): Rabbit diet, Preston Farmers Limited.
- Water (e.g. ad libitum): drinking water.
- Acclimation period: five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 59-63%
- Air changes (per hr): 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light.
IN-LIFE DATES: no data.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- single application (the eyelids were gently held together for one second). The other eye, remaining untreated, serves as a control.
- Observation period (in vivo):
- 1, 24 and 48 hours following treatment.
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
- Time after start of exposure: not applicable.
SCORING SYSTEM: Draize scale.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The animal was sacrificed for humane reasons following the 48 hour period of observation. Sloughing of the cornea was observed both at 24 and 48 hours.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The animal was sacrificed for humane reasons following the 48 hour period of observation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The animal was sacrificed for humane reasons following the 48 hour period of observation. White appearance of the nictitating membrane was observed both at 24 and 48 hours. Sloughing of the nictitating and conjunctival membranes were observed at 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The animal was sacrificed for humane reasons following the 48 hour period of observation
- Irritant / corrosive response data:
- - A dulling of the normal lustre of the corneal surface was noted one hour after treatment. Diffuse corneal opacity was noted at the 24 and 48-hour observations.
- Iridial inflammation was noted one hour after treatment and at the 24 and 48-hour observations;
- Moderate conjunctival irritation was noted one hour after treatment and at the 24 and 48-hour observations.
- Other adverse ocular effects noted were sloughing of the cornea at the 24 and 48 - hour observations, pale appearance of the nictitating membrane one hour after treatment, white appearance of the nictitating membrane at the 24 and 48- hour observations and sloughing of the nictitating and conjunctival membranes at the 48-hour observation. The animal was killed for humane reasons following the 48-hour observation. - Other effects:
- None.
Any other information on results incl. tables
Table 7.3.2/1: Mean irritant/corrosive response data of one treated animal at each observation time up to removal from the test:
Anim. No. |
Effect |
Hours |
Days after application |
Mean score cornea Days 1/2 |
Mean score iritis Days 1/2
|
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
||
1 |
1 |
2 |
|
||||||
80 Female |
Cornea
Iris
Redness
Chemosis |
4 (d)
1
2 (Pa)
3 |
2 (sl)
1
2 (W)
3 |
2 (sl)
1
2 (SL W) 3 |
2
|
1 |
2 |
3 |
D : dulling of the normal lustre of the corneal surface
Sl : sloughing of the cornea
Pa : pale appearance of the nictitating membrane
W : white appearance of the nictitating membrane
SL : sloughing of the nictitating and conjunctival membranes
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the test conditions of this study, the test substance causes serious damage to eyes as corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed. Therefore, ALUM-17 (17% Al2O3) was classified in category 1 for eye damage according to Regulation (EC) N° 1272 -2008 (CLP) and to GHS.
- Executive summary:
In an eye irritation study performed similarly to the OECD test guideline No. 405 and according to GLP compliance, 0.1 g of ALUM-17 as powder was instilled into the conjunctival sac of one eye of only one female New Zealand rabbit. The other eye remained untreated served as control. Eyes were examined at 1, 24 and 48 hours following treatment and grading according to Draize scale.
A dulling of the normal lustre of the corneal surface was noted one hour after treatment following to a diffuse corneal opacity noted at 24 and 48-hours observations. Iridial inflammation and moderate conjunctival irritation were observed at 1, 24 and 48-hours observations. Other adverse effects included sloughing of the cornea up to 48 hours, pale appearance of the nictitating membrane one hour after treatment followed by white appearance of the nictitating membrane at 24 and 48-hour observations and sloughing of the nictitating and conjunctival membranes at 48-hours observation.The animal was sacrificed for humane reasons following the 48 hour period of observation.
Under the test conditions of this study, corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed and considered as serious ocular effects. Therefore, ALUM-17 was classified in category 1 for eye damage according to Regulation (EC) N° 1272 -2008 (CLP) and to GHS.
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