Registration Dossier

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.