Registration Dossier
Registration Dossier
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EC number: 412-300-2 | CAS number: 139504-68-0 AMBER CORE
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:
A key study was identified (Parcell, 1992, rel. 1). In this dermal sensitization study performed according to the EU test method B.6 and in compliance with GLP, P-#620 was tested using the Guinea-Pig Maximisation Test method. No irritation was achieved in the preliminary study.
P-#620 diluted in Alembicol D at 20% (v/v) was administered by intradermal injection for the induction. As the substance is not a skin irritant, 6 days after the injections the site was pre-treated with 0.2 mL of 10% w/w sodium lauryl sulphate in petrolatum. Then topical induction was performed with P-#620 as supplied on day 7. For the challenge, P-#620 was tested at 100% and 50% (v/v in Alembicol D.).
No signs of ill health or toxicity were recorded in any animals during the observation period.
P-#620 did not produce evidence of skin sensitization (delayed contact hypersensitivity).
Migrated from Short description of key information:
P-#620 did not produce evidence of skin sensitization (delayed contact hypersensitivity).
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
no data.
Justification for classification or non-classification
Harmonized classification:
The test item has no harmonized classification for human health according to the Regulation (EC) No. 1272/2008 including the ATP2 draft.
Self classification:
Based on the available data, no additional classification is proposed regarding the skin sensitization. No data for the respiratory sensitisation was available.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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