Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No sensitisation studies have been carried out on the registered THPC-urea-amine. The studies submitted are for a closely related substance ITC 826. Read-across is considered justified since the only differences between ITC 826 and the current product are in amine carbon chain length (C16 -18for ITC 826 and C14for the registered THPC-urea-amine).

One study was available for this endpoint and considered as the key study (Lees, 1996).The sensitisation potential of ITC 826 concentrate was assessed using a method based on the maximisation test of Magnusson and Kligman (1970).The test substance was ITC 826 Concentrate.

Challenge of previously-induced guinea pigs with a 30% w/v preparation of the test sample elicited a 30% sensitisation response (6/20 animals) with an intradermal induction at 0.03%. Challenge of previously-induced guinea pigs with a 10% w/v preparation of the test sample elicited a 10% sensitisation response (2/20 animals). The control animals showed the anticipated reactions.

By analogy with ITC 826 concentrate, THPC-urea-amine is considered as a skin sensitizer.


Migrated from Short description of key information:
Based on a maximisation test according to the method of Magnusson and Kligman ITC 826 concentrate, elicited a 30% sensitisation response and is considered to be sensitizing to the skin. By analogy with ITC 826, THPC-urea-amine is considered as a skin sensitizer.

Justification for selection of skin sensitisation endpoint:
Only one study was available for this endpoint (Kr.2). This study was performed on ITC 826 concentrate.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Migrated from Short description of key information:
No data available

Justification for selection of respiratory sensitisation endpoint:
No data available.

Justification for classification or non-classification

Skin sensitization:

Following a maximisation test according to the method of Magnusson and Kligman ITC 826 concentrate, elicited a 30% sensitisation response (intradermal induction at0.03%) and should be classified into Category 1A, H317 (may cause an allergic skin reaction) according to theCLPregulation (1272/2008) and as sensitising (Xi; R43) according to the Directive 67/548/EEC criteria.By analogy with ITC 826 concentrate, THPC-urea-amine is considered as a skin sensitizer ans has the same classification.

Respiratory sensitization:

No data available, therefore no classification is possible.