Registration Dossier
Registration Dossier
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EC number: 236-671-3 | CAS number: 13463-41-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- The information contained within this robust summary document comes from
studies which are in the ownership of Arch Chemicals Inc. and which are
protected in several regions globally. This information may not be used
for any purpose other than in support of the Chemical safety Report
submitted by Arch Chemicals Inc. under RegulationEC
1907/2006.
Table 5.6: Summary of sensitisation
Method
Results
Remarks
Reference
OECD 406 Guinea pig maximisation test modified according to Maurer & Hess
Sensitisation, Guinea pig (female)
Number of animals sensitised / total number of animals – 2/20
Non sensitising
After the challenge exposure, 2/20 animals of the test substance group had positive skin reactions 24 hr after the end of the exposures. Therefore 2/20 animals of the test substance group (10%) were regarded as sensitised, however this is below the threshold of 30% for classification as a sensitising substance.
Reliability – 1
Purpose flag
Study report type
Test material Zinc Pyrithione powder (97.9%)
Key study
Weiss-Fuchs U (2002)
(unpublished)
US EPA 81-6, which complies with OECD 406 (Buehler method)
GLP (self certification by the laboratory)
Sensitisation, Guinea pig (male)
Number of animals sensitised / total number of animals – 0/15
Non sensitising
The induction and challenge concentration was 100% mineral oil moistened zinc pyrithione. No visible signs of erythema were observed following any induction or challenge applications.
Reliability – 1
Purpose flag
Study result type
Test material: Zinc pyrithione powder (96%)
Chmura P (1994)
(unpublished)
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
