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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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)
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

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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).


Short description of key information:
The possible sensitising properties of Ash were evaluated on the basis of the fraction of sensitising metals in Ash. The fraction of sensitising metals is under 0.1%.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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).



Short description of key information:
The possible sensitising properties of Ash were evaluated on the basis of the fraction of sensitising metals in Ash. The fraction of sensitising metals is under 0.1%.

Justification for classification or non-classification

No classification is required under Directive 67/548/EEC or Regulation EC 1272/2008 for skin or respiratory sensitisation, since the fraction of sensitising metals in Ash is under 0.1%.

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