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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
other: prediction of skin sensitisation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP, Guideline study. CLP Classification criteria for mixtures has been used for classification of the substance (Ash)

Data source

Referenceopen allclose all

Reference Type:
other:
Title:
REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
Author:
THE EUROPEAN PARLIAMENT AND THE COUNCIL
Year:
2008
Bibliographic source:
Official Journal of the European Union 31.12.2008 L/353
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Principles of method if other than guideline:
Prediction of skin sensitisation based on REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (CLP Regulation).
GLP compliance:
no
Type of study:
other: prediction of skin sensitisation

Test material

Constituent 1
Reference substance name:
The product from the burning of a combination of carbonaceous materials.
EC Number:
931-597-4
Molecular formula:
UVCB substance, not available. View remarks field.
IUPAC Name:
The product from the burning of a combination of carbonaceous materials.
Details on test material:
Name of test material (as cited in study report): Mixed ash 1_01032010
- Physical state: solid, fine powder
- Composition range of test material (% (w/w)): Aluminium (Al) 13.07, Calcium (Ca) 45.52 , Iron (Fe) 4.15 , Magnesium (Mg) 3.49, Phosphorus (P) 0.79 , Potassium (K) 2.56, Silicon (Si) 28.07, Sodium (Na) 1.08, Sulphur (S) 1.27.
- The critical minor components examined (mg/kg d.w.): Arsenic (As) 18, Barium (Ba) 670 Cadmium (Cd) 3.6, Copper (Cu) 410, Lead (Pb) 180 and Antimony (Sb) 22.
- Purity test date: the substance is UVCB substance
- Lot/batch No.: Mixed ash 1_01032010
- Expiration date of the lot/batch: March 2011
- Stability under test conditions: stable
- Storage condition of test material: stored in a refrigerator (+ 4 °C) until analysis
- Other: Mixed Ash is named in dossier as Ash. Mixed in the substance name has meant that there has been several (mixed) fuels when producing ash

Results and discussion

Any other information on results incl. tables

The fraction of sensitising metals (nickel) in test material is 41 mg/kg (d.w.).

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
Not sensitizing
Conclusions:
According to test report, the fraction of sensitising metals is below the generic concentration limit of ingredients of a mixture (Regulation EC N:o1272/2008, Table 3.4.3).
Executive summary:

According to test report, the fraction of sensitising metals in Ash is below the generic concentration limit of ingredients of a mixture (Regulation EC N:o1272/2008, Table 3.4.3). Thus, the test material (Ash) is not a skin sensitiser.