Registration Dossier
Registration Dossier
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EC number: 931-597-4 | CAS number: -
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:
- 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
- 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.
Reference
The fraction of sensitising metals (nickel) in test material is 41 mg/kg (d.w.).
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%.
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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