Registration Dossier
Registration Dossier
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EC number: 233-135-0 | CAS number: 10043-01-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Aluminium sulphate (AS) was found to significantly reduce the skin test response in sensitized patients to each of the allergens tested: dust mite, Alternaria, dog, cat, and cockroach. The exact mechanism in which aluminium sulphate (AS) produces this effect is not known. However, the results demonstrate that aluminium sulphate (AS) does not block the effects of histamine, and produces its effect without being present in the skin test sample. It appears that aluminium sulphate (AS) alters the allergen, changing its epitopes, thus reducing the ability of specific IgE to bind and ultimately mast cell degranulation.
Aluminium sulphate (AS) does not stain, is cheap, nontoxic, is stable in solution, and appears to have long acting affects, making it a great candidate for use as an environmental control agent.
Migrated from Short description of key information:
Aluminum sulfate exhibited no toxicity,
Aluminum sulfate significantly reduces the allergen-induced skin prick response,
Aluminum sulfate does not block histamine effects,
Exposure to aluminum sulfate alters the allergen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
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” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Respiratory Sensitisation Xn R42 May cause sensitization by inhalation Respiratory Irritation Xi R37 irritating to respiratory system |
CLP |
Respiratory Sensitisation H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled Respiratory Irritation H335 STOT SE 3 May cause respiratory irritation |
It is concluded that the substance aluminium sulphate does not meet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory irritation/corrosion and/or respiratory sensitisation.
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