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EC number: 914-920-3 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- Sept - October 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study with acceptable deviations (no analytical purity reported)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity not reported
- Principles of method if other than guideline:
- - no observations after 3 days
- no initial and confirmatory test - GLP compliance:
- yes
Test material
- Reference substance name:
- Aluminium sulphate
- EC Number:
- 233-135-0
- EC Name:
- Aluminium sulphate
- Cas Number:
- 10043-01-3
- Molecular formula:
- Al.3/2H2O4S
- IUPAC Name:
- Aluminium sulphate
- Reference substance name:
- aluminium sulfate
- IUPAC Name:
- aluminium sulfate
- Details on test material:
- - Name of test material (as cited in study report): Sulfate d'aluminium en solution
- Physical state: viscous colorless liquid
- Analytical purity: not reported
- Composition of test material, percentage of components: composition does not add up to 100%: see Confidential details on test material.
- Lot/batch No.: ref. 10-13-14-7-87, received on August 11, 1987
- Storage condition of test material: minimum 19°C
- Other: pH 2.3
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Hybrid Albino New-Zealand rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Cleon, France
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: Individual housing, with perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 1 week before the beginning of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: September 1, 1987 To: September 4, 1987
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
-
SCORING SYSTEM: Draize score system
TOOL USED TO ASSESS SCORE: direct ophthalmoscopy
- cornea, iris and pupil: Heine's ophthalmoscope
- iris: direct lighting (using an electric torch)
- cornea: 2% fluorescein (excess rinsed away with approximately 20 ml tap water) and ultra-violet lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 days
- Irritant / corrosive response data:
- The application of the test material to the right eye of the rabbit produced redness of the conjunctivae. Furthermore, moderate chemosis and iridial congestion were observed amongst all three animals during the first 48 to 72 hours. Translucency of the cornea up to one-quarter was also apparent in one rabbit at the onehourexamination.
Any other information on results incl. tables
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 |
||||||
37688 |
Cornea Iris Redness Chemosis |
0 1 2 2 |
0 1 2 2 |
0 1 2 1 |
0 1 1 1 |
- - - - |
- - - - |
0 |
1 |
1.67 |
1.33 |
37851 |
Cornea Iris Redness Chemosis |
2 1 2 1 |
0 1 2 1 |
0 1 1 1 |
0 1 0 1 |
- - - - |
- - - - |
0 |
1 |
1 |
1 |
37884 |
Cornea Iris Redness Chemosis |
0 1 2 2 |
0 1 2 2 |
0 1 2 2 |
0 1 2 2 |
- - - - |
- - - - |
0 |
1 |
2 |
2 |
Mean all anim. |
|
|
|
|
|
|
|
0 |
1 |
1.56 |
1.44 |
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Eye irrit 2, H319
DSD: Xi, R36 - Executive summary:
A study was conducted to assess the irritancy potential of a solution of aluminium sulfate to the eye of three New Zealand Albino rabbits. The study was performed according to OECD Guideline 405 (Acute Eye Irritation/Corrosion) and also according to Good Laboratory Practice Standards.
A single application of 0.1 mL of the test material to the right eye of the rabbit produced redness of the conjunctivae. Furthermore, moderate chemosis and iridial congestion were observed amongst all three animals during the first 48 to 72 hours. Translucency of the cornea up to one-quarter was also apparent in one rabbit at the onehourexamination.
Based on the results of the present study, it was concluded that the test compound, Aluminium sulphate as a solution, induced a moderate eye irritation. It is not known whether reversibility of the eye effects would occur, as the observation period is only up to 3 days after application. Practically no decrease of the effects is seen after 3 days. It seems, however, that reversibility will occur within 21 days so the test material is classified as irritant (Eye ) to the skin according to OECD-GHS.
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