Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.