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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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Carcinogenicity
Administrative data
Description of key information
Evidence for Carcinogenicity:
A4: Not classifiable as a human carcinogen. /Aluminum metal and insoluble compounds/
[American Conference of Governmental Industrial Hygienists TLVs and BEIs. Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Cincinnati, OH, 2008, p. 11]
There are conclusive but not suffcient data for the classification of substance Aluminium sulphate with regard to carcinogenicity.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 850 mg/kg bw/day
Carcinogenicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 6.1 mg/m³
Carcinogenicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 21.3 mg/kg bw/day
Justification for classification or non-classification
Based on the hazard assessmentof 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 |
Carcinogenicity Carc. Cat. 1; R45 May cause cancer. Carc. Cat. 1; R49 May cause cancer by inhalation. Carc. Cat. 2; R45 May cause cancer. Carc. Cat. 2; R49 May cause cancer by inhalation. Carc. Cat. 3; R40 Limited evidence of a carcinogenic effect.
|
CLP |
Carcinogenicity Carc. 1A Carc. 1B Carc. 2 H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>. |
It is concluded that the substance aluminium sulphate does not meet the criteria to be classified for human health hazards for Carcinogenicity.
Additional information
The literature concerning oral exposure bioassays is very limited. An increase in gross tumours was reported in male rats and female mice in a one-dose study but few study details were reported (Schroeder and Mitchener 1975a, 1975b, as reported in ATSDR 2006). Two other studies reported no increased incidence of tumours in rats and mice exposed orally to aluminum compounds (Hackenberg 1972; Oneda et al. 1994).
No increased tumour incidence was observed in rats following inhalation of alumina fibres at concentrations of up to 2.45 mg/m3 ( Pigott GH et al.1981, Krewski et al. 2007).
The International Agency for Research on Cancer did not classify specific aluminum compounds for carcinogenicity, but classified the exposure circumstances of aluminum production as carcinogenic to humans (Group 1) (IARC 1987).
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
850 mg/kg bw/day * 0.025 kg =
NOAELrat 21.3 mg/kg bw/day
Carcinogenicity: via oral route (target organ): other: all gross lesions and masses
Carcinogenicity: via inhalation route (target organ): respiratory: lung
Carcinogenicity: via dermal route (target organ): other: all gross lesions and masses
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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