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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- Aug - Oct 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study tested with the source substance CAS 10043-01-3. 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- - Age of animals is not mentioned.
- 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
- Species:
- rabbit
- Strain:
- other: Hybrid Albino New-Zealand
- Details on test animals or test system 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 (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least of 1 week before the beginning of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12-hour light-dark cycle was maintained (photoperiod 7h30-19h30)
IN-LIFE DATES: From: August 25, 1987 To: August 28, 1987
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): applied as supplied, no further info
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 1, 24, 48 and 72 h
- only when severe cutaneous lesions were noted at 72 hours: observations to study possible corrosive actions at day 7 and day 14 (irreversible lesions) - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: the test article was applied with a 5 mL sterile polypropylene syringe, directly on the animal skin, on a surface of about 6 cm², and then covered with gauze pad, about 2.4 cm²
- Type of wrap if used: the test article and the gauze pad were kept in contact with the skin with a semi-occlusive patch: 10 cm wide perforated tape (Peloplast) applied on a crimped gauze bandage (Creplux) thus covering the clipped area to avoid possible irritation reactions and wrapped around the animal without blocking the respiratory and abdominal movements.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the bandages were removed and if necessary excess test article which had not penetrated was wiped away with gauze pad moistened with distilled water (or a non-irritant solvent). The animals were then returned to their individual cages.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema 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:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No other dermal irritation response was observed in any animal.
Any other information on results incl. tables
Summary of dermal lesions on clipped and intact skin (following 4-h application).
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h |
Mean score oedema 24/48/72 h |
|||||
1 |
1 |
2 |
3 |
7 |
14 |
|
|
|
||
37673 |
Erythema/ eschar Oedema |
0
0 |
0
0 |
0
0 |
0
0 |
-
- |
-
- |
|
0
|
0 |
37680 |
Erythema/ eschar Oedema |
1
0 |
0
0 |
0
0 |
0
0 |
-
- |
-
- |
|
0 |
0 |
37681 |
Erythema/ eschar Oedema |
1
0 |
0
0 |
0
0 |
0
0 |
-
- |
-
- |
|
0 |
0 |
Mean Group |
|
|
|
|
|
|
|
|
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
A primary dermal irritation study was conducted on three male Albino New Zealand rabbits using test substance aluminium sulphate as a solution. The method is according to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.
Each animal received 0.5 ml test material. A single 4 -hour, semi-occluded application of the test material to the intact skin produced immediately after patch removal very slight erythema at the test site of two animal. This effect disappeared after 24 hours after patch removal. Necrosis and ulceration were not reported.
Based on the results of the present study, it was concluded that a solution of aluminium sulfate induced practically no skin irritation, so the test material is classified as non-irritant to the skin. The slight skin effects in two animals are reversible.
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