Registration Dossier
Registration Dossier
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EC number: 939-524-8 | CAS number: 71949-28-5
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 skin sensitising properties of ZPS were determined in a GLP study according OECD guideline 429 (Local Lymph Node Assay (LLNA)) and EU method B.42 (Harlan CCR, 2012). For this purpose, three groups of 5 female mice each were treated with increasing concentrations of ZPS (2.5%, 5% and 10% in vehicle (w/w), respectively) applied on the dorsum of both ears (25 µL per ear) for three consecutive days. Three days after the last treatment, all animals received an intravenous injection of 3H-methyl Thymidine (3HTdR). Five hours later, the 3HTdR incorporation in the draining auricular lymph nodes was determined. The results were compared with those of a control group which was treated with the vehicle (ethanol/sterile water, 3:7 v/v). A positive control group treated with α-hexyl cinnamaldehyde (up to 25% HCA solution in acetone:olive oil, 4:1 v/v) was included in the report as a reliability check.
No signs of irritation were observed after application of a 2.5%, 5% and 10% concentration of ZPS.
Stimulation indices (SIs) of 1.14, 0.96 and 1.97 were calculated in response to a 2.5%, 5% and 10% ZPS concentration, respectively. Since the SIs were lower than 3 at all concentrations the results indicted that ZPS should not be considered a skin sensitiser (a SI of 3 is the limiting value required for classification as a skin sensitiser).
Migrated from Short description of key information:
The substance was not a skin sensitiser in a local lymph node assay in the mouse.
Justification for classification or non-classification
Based on the results of the skin sensitisation study, ZPS does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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