Registration Dossier
Registration Dossier
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EC number: 233-141-3 | CAS number: 10043-67-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008/1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: peer-reviewed report and publication
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- TOXICOLOGICAL PROFILE FOR ALUMINUM
- Author:
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Year:
- 2 008
- Bibliographic source:
- Agency for Toxic Substances and Disease Registry Division of Toxicology and Environmental Medicine/Applied Toxicology Branch 1600 Clifton Road NE Mailstop F-32 Atlanta, Georgia 30333
- Reference Type:
- publication
- Title:
- Production of epidermal damage in mammalian skins by some simple aluminum compounds.
- Author:
- Lansdown AB.
- Year:
- 1 973
- Bibliographic source:
- Br J Dermatol 89:67-76
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Data from peer-reviewed report from ATSDR.Method:study of effect of simple aluminium compounds on epidermis of mammals. Groups of 5 female mice were shaved with hurt and 0.5 ml test solution applied at 5 successive days on an area of 2 cm². Control followed by application of water.
- GLP compliance:
- not specified
- Type of study:
- not specified
Test material
- Reference substance name:
- Aluminium sulfate
- IUPAC Name:
- Aluminium sulfate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: TF1 Carworth
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data available
- Vehicle:
- water
- Concentration / amount:
- 10% and 15% (w/w)
Challengeopen allclose all
- Route:
- other: no data available
- Vehicle:
- water
- Concentration / amount:
- 10% and 15% (w/w)
- No. of animals per dose:
- 5 animals/dose
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: application with water
- Hours after challenge:
- 120
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no dermal effects from aluminium sulfate
- Remarks on result:
- other: Reading: other: application with water. . Hours after challenge: 120.0. Group: test group. Dose level: 10% . No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no dermal effects from aluminium sulfate.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Aluminium sulfate did not cause skin effects using 10% (w/w) concentration of aluminium sulfate.Therefore Aluminium sulfate is not sensitising as one soluble part of aluminium potassium bis(sulphate).Therefore Aluminium potassium bis sulphate is not classified as sensitising according EU Regulation 1272/2008 andEU Regulation 286/2011 (2. ATP).
- Executive summary:
Aluminium sulfate did not cause skin effects using 10% (w/w) concentration of aluminium sulfate.
Therefore Aluminium sulfate is not sensitising as one soluble part of aluminium potassium bis(sulphate).
Therefore Aluminium potassium bis sulphate is not classified as sensitising according EU Regulation 1272/2008
and EU Regulation 286/2011 (2. ATP) .
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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