Registration Dossier
Registration Dossier
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EC number: 233-141-3 | CAS number: 10043-67-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- Species:
- mouse
- Strain:
- other: TF1 Carworth
- Sex:
- female
- Route:
- other: no data available
- Vehicle:
- water
- Concentration / amount:
- 10% and 15% (w/w)
- Route:
- other: no data available
- Vehicle:
- water
- Concentration / amount:
- 10% and 15% (w/w)
- No. of animals per dose:
- 5 animals/dose
- 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.
- 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) .
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Because the read across study results on aluminium sulfate and aluminium chlorohydrate show no skin
sensitization and available information about potassium sulfate shows no skin sensitization effects, therefore aluminium potassium bis sulphate
is not classified as "skin sensitising" according to EU regulation EU 1272/2008 and EU regulation 286/2011 (2. ATP).
Migrated from Short description of key information:
Based on the results of the key study including the ATSDR report and the study from Lansdown on aluminium
sulfate as read across substance and the Weight of Evidence study from Nixon et al. on aluminium chlorohydrate
as read across substance of aluminium potassium bis sulphate, these read across substances are not classified
as "skin sensitizing". Available information about potassium sulfate shows no skin sensitization effects.
Therefore aluminium potassium bis sulphate is not classified as "skin sensitising" according to EU regulation EU 1272/2008 and
EU regulation 286/2011 (2. ATP).
Justification for selection of skin sensitisation endpoint:
Based on the study results of the Read across substance aluminium sulfate and
non-sensitising effects of potassium sulfate as second substance in
solution of aluminium potassium bis(sulphate) there is no skin sensitization
to be assumed from the substance aluminium potassium bis(sulphate).
Therefore the substance Aluminium potassium bis sulphate is not classified as
"skin sensitising" according to EU regulation EU 1272/2008 and EU regulation 286/2011 (2. ATP).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the key study and supporting study and based on the acute inhalative studies, especially the study of Thomson et al. (1986), no effects were observed at 10, 50 and 100 mg Al as Al2O3 (see chapter 7.2.2 of the IUCLID dataset.
Based on results of these studies the substance aluminium potassium bis(sulphate) is classified as "not skin sensitising" according to EU regulation EU 1272/2008.
The identified uses are done in closed systems and semi-closed charge systems with local exhaust ventilation and proper respiratory filters.
Therefore no relevant inhalative exposure to the workers is to be expected.
Migrated from Short description of key information:
The substance is used for manufacture of solutions and preparations.
The identified uses are done in closed system and semi-closed charge system with
local exhaust ventilation and proper respiratory filters.
Therefore no relevant inhalative exposure is to be expected
Justification for selection of respiratory sensitisation endpoint:
The substance is used for manufacture of solutions and preparations.
The identified uses are done in closed system and semi-closed charge system with
local exhaust ventilation and proper respiratory filters.
Therefore no relevant inhalative exposure is to be expected.
Justification for classification or non-classification
Based on the key study and supporting study and based on the acute inhalative studies, especially the study of Thomson et al. (1986), no effects were observed at 10, 50 and 100 mg Al as Al2O3 (see chapter 7.2.2 of the IUCLID dataset.
Based on results of these studies the substance aluminium potassium bis(sulphate) is classified as "not skin sensitising" according to EU regulation EU 1272/2008.
The identified uses are conducted in closed systems and semi-closed charge systems with local exhaust ventilation and proper respiratory filters.
Therefore no relevant inhalative exposure to the workers is to be expected.
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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