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Diss Factsheets
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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
Human Toxicity Values:
Human data indicate a very low acute toxicity of aluminium sulphate.
Human clinical experience indicates that very high oral doses of aluminium sulphate,
300 mg/kg bw up to 20 grams for an adult, are well tolerated, except from (intentionally)
causing severe diarrhoea. WHO/FAO set conclusive but not sufficient data an AD for aluminium sulphate.
The acute oral LD50 values for aluminium sulphate is>4618 mg/kg bw (OECD TG 423).
The acute inhalation NOAEL values for aluminium sulphate is 10 m3/kg air.
The acute dermal LD50 values for aluminium sulphate is>2335 mg/kg bw .
No adverse clinical signs were observed.
Non-Human Toxicity Values:
LD50 Mouse (Swiss) oral 4618mg/kg bw (OECD TG 423)
LD50 Rat oral >5000 mg/kg bw (OECD TG 401)
LD50 Dobra Voda Mouse oral 6200 mg/kg
LD50 Rat oral 1930 mg/kg bw (OECD TG 423)
LD50 Mouse (Swiss) ip 253 mg /kg bw
LD50 Rat (Sprague Dawley) ip 158mg/kg bw
LD50 Mouse ip 1735 mg/kg
LD50 Mouse ip 6.3 mg/kg
LD50 Guinea pig oral 490 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 4 618 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- discriminating conc.
- Value:
- 50 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 335 mg/kg bw
Additional information
Oral exposure
The oral LD50 (lethal dose, 50% kill, single administration) for different aluminum salts, as measured in different strains of mice, rats, guinea pigs and rabbits, varies according to the aluminum salt administered as well as according to the experimental animal species.
In an early review an LD50 of apparently 6,200 mg /kg bw was reported for Al2(SO4)3 and of 3,850 mg Al/kg bw for Al(Cl)3 administered to mice (Sorenson et al. 1974).
In a study of oral and intraperitoneal administration during 14 days, Llobet et al. (1987) estimated the acute oral toxicity of aluminum chloride, nitrate and sulphate in Sprague-Dawley rats and Swiss mice.
Aluminum chloride and nitrate produced acute toxicities of similar magnitude (LD50 of 222 to 370 mg Al/kg) in the mice and rats, whereas the toxicity of aluminum sulphate was considerably lower (LD50> 4620 mg/kg in both species).
Inhalation exposure
In Golden Syrian hamsters and New Zealand rabbits exposed over a short duration (four to six hours per day for three to five days at levels of 7 to 200 mg/m3) to aluminum chlorohydrate through inhalation, the effects observed are those typically associated with inhalation of particulate matter, including alveolar wall thickening, increased number of macrophages and increased lung weight (ATSDR 2006).
A more detailed discussion of the pulmonary effects in experimental animals of inhalation exposure to aluminum oxide dust and refractory alumina fibres, and aluminum hydroxide is provided by Krewski et al. (2007).
The observed responses to various species of aluminum are described as “typical of foreign body reaction”, including alveolar proteinosis and wall thickening, and some nodule formation.
Dermal exposure
Dermal effects of aluminum compounds (10% w/v chloride, nitrate, chlorohydrate, sulphate, hydroxide) applied to skin of mice, rabbits and pigs over five-day periods (once per day) include epidermal damage, hyperkeratosis, acanthosis and microabscesses (ATSDR 2006; Krewski et al. 2007).
Justification for classification or non-classification
Based on the hazard assessment of aluminium sulphate in section 2.1 and 2.2.in IUCLID 5.2., 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” and according to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Very Toxic (T+) R28: Very toxic if swallowed R27: Very toxic in contact with skin R26: Very toxic by inhalation R39/26 R39/27 R39/28: Dangerous of very serious irreversible effects Toxic (T): R25: Toxic if swallowed R24: Toxic in contact with skin R23: Toxic by inhalation R39/23 R39/24 R39/25: Danger of very serious irreversible effects Harmful (Xn): R22: Harmful if swallowed R21: Harmful in contact with skin R20: Harmful by inhalation R65: Harmful may cause lung damage if swallowed R68/20 R68/21 R68/22: Possible risk of irreversible effects Other toxicological properties R67: Vapours may cause drowsiness and dizziness |
CLP |
H300 Acute Tox. 2 Fatal if swallowed H310 Acute Tox. 1 Fatal in contact with skin H330 Acute Tox. 2 Fatal if inhaled H370 STOT SE 1 H301 Acute Tox. 3 Toxic if swallowed H311 Acute Tox. 3 Toxic in contact with skin H331 Acute Tox. 3 Toxic if inhaled H370 STOT SE 1 H302 Acute Tox. 4 Harmful if swallowed H312 Acute Tox. 4 Harmful in contact with skin H332 Acute Tox. 4 Harmful if inhaled H304 Asp. Tox. 1 H371 STOT SE 2 (May cause damage to organs (or state all organs affected if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) Other toxicological properties H336 STOT SE 3 May cause drowsiness or dizziness
|
It is concluded that the substance aluminium sulphate does not meet the criteria to be classified for human health hazards for acute effects.
Aluminium sulfate has of relatively low acute toxicity (LD50, oral, mouse: 4618 mg/kg bw;
No epidermal and pathological changes and dermal reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw.
Aluminium sulfate has of relatively low acute inhalation toxicity. The acute inhalation NOAEL values for aluminium sulphate is >10 m3/kg air.
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