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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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Endpoint summary
Administrative data
Description of key information
Skin irritation
-Based on the results of the study of Lansdown AB.1973, it was concluded that Aluminum sulphate, anhydrous induced no skin irritation, so the test material is classified as non-irritant to the skin according to EU.
No epidermal and pathological changes and dermal reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw
-Based on the results of the Toxicology lab report T-4874 regarding primary dermal and eye irritation of aluminum sulfate it was concluded that Aluminum sulphate induced no skin irritation, so the test material is classified as non-irritant to the skin according to OECD-GHS.
Eye irritation
-Based on the results of Toxicology lab report T-4874 regarding primary dermal and eye irritation of aluminum sulfate, it was concluded that the test compound, Aluminum sulfate hydrate, 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 7 days after application. It seems, however, that reversibility will occur within 21 days so the test material is classified as moderately irritant to the skin according to EU.
-Based on the results of the study of Grekhova TD,et al 1994 , it was concluded that the test compound, Aluminum sulfate, induced a moderate eye irritation. Instillation of aluminum sulfate into the eye results in conjunctivitis and purulent ophthalmitis. Aluminum sulfate and coagulants afflict the nervous system, liver and heart.
Respiratory irritation.
-Based on the results of the study of Ichinose et al.2008 it was concluded that the test compound Aluminum sulfate, (the result was read across from aluminium oxide ) do not induced a Respiratory irritation. No signs of irritation of respiratory tract and Nasal effects were observed in rats as reddish nasal discharge.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Three difference species of animals (mice, rabbit and white pigs) were used in an in vivo experiment to determine whether repeated, non-occlusive exposures to solutions or suspensions of different aluminium salts led to irritative effects on the skin. Skin samples were examined both macroscopically, microscopically in stained thin –section and histochemical techniques were employed to characterize the interaction of the aluminium with skin components.
- GLP compliance:
- not specified
- Species:
- other: 5 mice, 3 rabbits and 2 pigs
- Strain:
- other: mice: female, TF1 strain of the Carworth Farm Stock of albino mice; rabbits: New Zealand white strain from Norfolk Rabbits Ltd., Attleborough, Norfolk; pigs: large white stain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Mice: female, TF1 strain of the Carworth Farm Stock of albino mice. The mice used were randomly selected and aged about 8 weeks.
Rabbits: New Zealand white strain from Norfolk Rabbits Ltd., Attleborough, Norfolk. The rabbits were aged about 6 months at the start of the experiment.
Pigs: large white strain. The pigs were aged about 6 months at the start of the experiment.
-Environmental/Housing conditions
.The animals were maintained on a strict daily routine of 18h light/6 hours dark - Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- Concentrations:
In experiment 1, aluminium chloride (anhydrous) was applied at concentrations of 2.5, 5, 10 and 25% w/v and aluminium chlorhydrate at concentrations of 10 and 25% w/v to mice.
In experiment 2, aluminium chloride, aluminium nitrate, aluminium sulphate, aluminium chlorhydrate, aluminium hydroxide and aluminium basic acetate were applied at concentrations of 10% w/v to groups of 5 mice, 3 rabbits and 2 pigs. Aluminium chlorhydrate was also tested at a concentration of 25%.
Volume:
0.5 mL was applied daily to a 2 cm² area on the backs of the mice and rabbits. 1.0 mL was applied daily to a 4 cm² area of the pigs’ skin. - Duration of treatment / exposure:
- 5 days; (5 daily applications).
- Observation period:
- The animals were killed 24 hours after the final treatment. The mice were killed by cervical dislocation and the rabbits and pigs by an overdose of pentabarbital (Nembutal).
- Number of animals:
- 5 mice, 3 rabbits and 2 pigs
- Details on study design:
- TEST SITE
- Area of exposure: the test solutions were applied and then spread out using clean glass rods to cover areas of 2cm2 of skin for mice and rabbits and 4cm2 for pigs.
- Type of wrap if used: the test areas were not covered.
For microscopic examination (fluorescence microscopy and ordinary light microscopy), samples of treated skin were fixed in 70% ethanol for at least 18h, embedded in paraffin wax and sectioned at 5-7μm for staining with haematoxylin and eosin. Morin (dye) was used to determine the presence of aluminium (Pearse, 1960); the congo red/thioflavine T technique (Jarrett et al., 1959) was used for epidermal keratins, the DDD technique (Barrnett & Seligman, 1952) for protein-bound sulphydryl groups and Baker’s method (1944) was used for examining epidermal phospholipids.
The pH of the test solutions were measured although details of the measurement method were not provided.
Additional informations to the control animals:
A negative control group received applications of distilled water.
Previous studies were referenced as evidence for the lack of irritative effects of the 0.2% Tween-80 vehicle used for the aluminium hydroxide and the basic aluminium acetate.
A series of “hydrochloric acid” control groups (5 mice per group) received administrations of dilute solutions of hydrochloric acid with pH values of 2.2, 3.0 and 4.0.
Another series of control groups (5 mice per group) received administrations of solutions of Universal buffer with pH of 2.5, 3.1, 3.4 or 4.0. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 5 days
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: No epidermal and pathological changes and dermal reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw
- Irritant / corrosive response data:
- No epidermal and pathological changes and dermal reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information No epidermal and pathological changes and dermal reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the present study, it was concluded that Aluminum sulphate, anhydrous induced no skin irritation, so the test material is classified as non-irritant to the skin according to EU.
No epidermal and pathological changes and dermal reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw - Executive summary:
The responses of mouse, rabbit and pig skin to topically applied solutions of six aluminium salts (aluminium chloride, aluminium nitrate,aluminium sulphate,aluminium hydroxide, aluminium acetate and aluminium chlorhydrate) have been studied in relation to their pH and the deposition of aluminium in the stratum corneum.
Epidermal changes consisting of hyperplasia, microabscess formation, dermal inflammatory cell infiltration and occasionally ulceration were evident in all three species treated with aluminium chloride (10%) and nitrate (10%),but not with aluminium sulphate (10%),hydroxide (10%), acetate (10%) or chlorhydrate (10 and 25%).
In skins showing pathological changes, a high degree of aluminium deposition was present in the stratum corneum and the keratin was histochemically abnormal. It contained an unusually high concentration of protein-bound sulphydryl groups and phospholipid, and fluoresced differently to normal with the congo red technique.
Reference
The results were adequately described and informative due to the use of macroscopic and microscopic techniques, and also histochemical methods to characterize the changes that had taken place at a molecular level.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable with restrictions. Well-presented study, with relevant measurement of chemical concentrations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS: Healthy New Zealand white rabbits weighing 2.5-3.0 kg
Rabbits are purchased from laboratory animal supplier. - Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- 0.5 mg/m3.
- Duration of treatment / exposure:
- 21 days.
- Observation period (in vivo):
- 21 days.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- METHOD FOLLOWED: Determination of irritant/corrosive effects were examined using rabbits, according to OECD 405.
DEVIATIONS FROM GUIDELINE: no deviations reported
STATISTICAL METHODS: DRAIZE score system was used
METHOD OF CALCULATION: not described
ANALYTICAL METHODS: not applied
TEST ANIMALS: Rabbits - Strain: HC:NZW
- Sex: not described -
- Age: adults
- Weight at study initiation: not described
- Number of animals: 6
- Controls: other eye
ADMINISTRATION/EXPOSURE
- Preparation of test substance: Pulverized powder
- Amount of substance instilled: 0.5 mg/m3.
- Vehicle: not described
- Postexposure period: 21 days
- exposure : 24 hours
EXAMINATIONS - Ophtalmoscopic examination: yes
- Scoring system: DRAIZE system
- Observation period: 21 days
- Tool used to assess score: optical instrument (hand slit lamp) - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 1.3 - 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Category 2B (mildly irritating to eyes)
- Irritant / corrosive response data:
- Instillation of aluminum sulfate into the eye results in conjunctivitis and purulent ophthalmitis. Aluminum sulfate and coagulants afflict the nervous system, liver and heart. The recommended MAC in the air of workplace for aluminum sulfate, is equal to 0.5 mg/m3.
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Instillation of aluminum sulfate into the eye results in conjunctivitis and purulent ophthalmitis. Aluminum sulfate and coagulants afflict the nervous system, liver and heart. The recommended MAC in the air of workplace for aluminum sulfate, is equal to 0.5 mg/m3.
- Executive summary:
Aluminum sulfate, potash alum, ammonium alum, purified and unpurified nephelinic coagulant are assigned to the 3rd jeopardy class (moderately dangerous chemicals), sodium alum-to the 4th jeopardy class (slightly dangerous chemicals) at the single exposure. Local irritation of rabbit's skin was not revealed, but instillation into the eye results in conjunctivitis and purulent ophthalmitis. Aluminum sulfate and coagulants afflict the nervous system, liver and heart. The recommended MAC in the air of workplace for aluminum sulfate, potash alum, sodium alum and coagulants based on them is equal to 0.5 mg/m3.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
-Based on the results of the study of Lansdown AB.1973, it was concluded that Aluminum sulphate, anhydrous induced no skin irritation, so the test material is classified as non-irritant to the skin according to EU.
No epidermal and pathological changes and dermal reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw
-Based on the results of the Toxicology lab report T-4874 regarding primary dermal and eye irritation of aluminum sulfate it was concluded that Aluminum sulphate induced no skin irritation, so the test material is classified as non-irritant to the skin according to OECD-GHS.
Eye irritation
-Based on the results of Toxicology lab report T-4874 regarding primary dermal and eye irritation of aluminum sulfate, it was concluded that the test compound, Aluminum sulfate hydrate, 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 7 days after application. It seems, however, that reversibility will occur within 21 days so the test material is classified as moderately irritant to the skin according to EU.
-Based on the results of the study of Grekhova TD,et al 1994 , it was concluded that the test compound, Aluminum sulfate, induced a moderate eye irritation.Instillation of aluminum sulfate into the eye results in conjunctivitis and purulent ophthalmitis. Aluminum sulfate and coagulants afflict the nervous system, liver and heart.
Respiratory irritation.
-Based on the results of the study ofIchinose et al.2008 it was concluded that the test compound Aluminum sulfate,(the result was read across fromaluminium oxide) do not induced aRespiratory irritation.No signs of irritation of respiratory tract and Nasal effects were observed in rats as reddish nasal discharge.
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
Based on the hazard assessment of aluminium sulphate in section 2.1 and 2.2.in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Skin Corrosivity C R35 Causes severe burns R34 Causes burns Skin Irritation Xi R38 Irritating to skin R43 May cause sensitization by skin contact Eye Irritation (Ocular Lesions) Xi R36 Irritating to eyes R41 Risk of serious damage to eyes |
CLP |
Skin Corrosivity H314 Skin Corr 1A Causes severe skin burns and eye damage H314 Skin Corr 1B Causes severe skin burns and eye damage Skin Irritation H315 Skin Irrit. 2 Causes skin irritation H317 Skin Sens. 1 May cause an allergic skin reaction Eye Irritation (Ocular Lesions) Xi H319 Eye Irrit. 2 Causes serious eye irritation H318 Eye Dam. 1 Causes serious eye damage |
It is concluded that the substance aluminium sulphate meet the criteria to be classified for human health hazards for Dermal-local effect:R41 Risk of serious damage to eyes, Eye Damage 1, H318: Causes serious eye damage.
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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