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EC number: 215-477-2 | CAS number: 1327-41-9
- 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:
- April 1996 - May 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Information on substance identity and composition is lacking. Batch No. is given, guideline 405 is followed and study is performed according to GLP.
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:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : age of animals is not mentioned
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Aqualenc E
- Physical state: yellow liquid
- Analytical purity: no CoA
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: Composition does not add up to 100%: Al2O3 = 17.00%
- Lot/batch No.: TDE-95-299, received November 14, 1995
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other:
Alkalinity (OH/(3*Al)) = 37.1%
pH = 0.4
Density = 1.35-1.39 g/cm3 at 20°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, France
- Age at study initiation: no data
- Weight at study initiation: on the day of treatment 2.3 ± 0.1 kg
- Housing: Individual housing
- Diet (e.g. ad libitum): free access to pelleted diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: April 25, 1996 To: May 16, 1996
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml into the left eye
- Concentration (if solution): test article was used in its original form
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- single application into the left eye (the lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye served as control). The eyes were not rinsed
- Observation period (in vivo):
- - approximately 1 hour and 24, 48 and 72 hours after administration
- when there is persistent ocular irritation after 72 hours the observation period is extended to a maximum of 21 days (until day 22) - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not rinsed
- Time after start of exposure: not applicable
SCORING SYSTEM: see below (Table 7.3.2/1)
TOOL USED TO ASSESS SCORE:
- Cornea: 2 drops of 0.5% sodium fluorescein solution; direct examination or, if necessary, with an Ultra-Violet lamp
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:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- No ocular corrosion mentioned.
- Other effects:
- - One animal was killed on day 12. This animal showed also white spots on the conjunctivae, alopecia around the eye and neovascularisation.
- The two other animals also showed alopecia and neovascularisation.
Any other information on results incl. tables
Table 7.3.2/2: Summary of ocular lesions:
Anim. No. |
Effect |
Hours |
Days after application |
Mean score cornea Days 1/2/3 |
Mean score iritis Days 1/2/3
|
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
|||||
1 |
1 |
2 |
3 |
7 |
14 |
21 |
||||||
01 |
Cornea Iris Redness Chemosis |
0 0 0 2 |
1 1 3 3 |
1 1 3 2 |
1 1 3 2 |
1 1 3 1 |
1 1 2 1 |
1 0 0 0 |
1 |
1 |
3 |
2.33 |
02 |
Cornea Iris Redness Chemosis |
0 0 0 2 |
1 1 2 3 |
2 1 2 3 |
2 1 2 3 |
3 1 2 3 |
- - - - |
- - - - |
1.67 |
1 |
2 |
3 |
03 |
Cornea Iris Redness Chemosis |
0 0 0 2 |
2 0 3 3 |
2 1 3 2 |
1 1 3 2 |
1 1 3 2 |
0 0 0 1 |
/ / / / |
1.67 |
0.67 |
3 |
2.33 |
Mean all anim. |
|
|
|
|
|
|
|
|
1.45 |
0.89 |
2.67 |
2.55 |
- Animal killed
/ Ocular examination not performed on day 21, because effects were gone on day 19
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, it was concluded that the test compound, Aqualenc E, induced a severe eye irritation. The eye effects weren’t completely reversible within 21 days. Furthermore, one animal was killed due to severe eye effects. Therefore, the product is classified in Category 1 (H318: causes serious eye damage) according to the CLP Regulation (1272/2008) and the GHS.
- Executive summary:
In an eye irritation study performed according to OECD test guideline No. 405 and in compliance with GLP, 0.1 ml of Aqualenc E (17% Al2O3) was instilled into the conjunctival sac of one eye of three New Zealand white rabbits. The other eye of each rabbit served as control. Eyes were examined at 1, 24, 48 and 72 hours and 21 days following treatment and grading according to Draize scale.
Individual mean scores at 24, 48 and 72 h after exposure were 1, 1.67, 1.67 for corneal lesions, 1, 1, 0.67 for Iris lesions, 3, 2, 3 for conjunctival redness and 2.33, 3, 2.33 for chemosis respectively. The eye effects weren’t completely reversible within 21 days. Furthermore, one animal was killed due to severe eye effects. Therefore, the product causes irreversible effects on the eye.
Under the test conditions, Aluminium hydroxide chloride, low basicity is classified in Category 1 according to the CLP Regulation (1272/2008) and the GHS.
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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