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:

One study was available for this endpoint and was considered as the key study (Kr: 1). In a dermal sensitization study (Tuffnell PP, 1992), female albino Dunkin-Hartley guinea pigs (20 tested + 10 control) were used to test the skin contact sensitisation potential of ITC 288/S using the method of guinea pigs maximisation test (OECD 406, method B6 in Commission Directive 84/449/EEC) and in compliance with GLP. In this study, ITC 288/S induced evidence of skin sensitisation in 58 % of the animals at challenge readings (score 1 at 24h and 48 h) following topical application at 50%. Based on this result, ITC 288/S should be considered as a sensitizer by skin contact.

Migrated from Short description of key information:

Positive in guinea pigs maximisation test (OECD 406, Kr: 1), and therefore classified as skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Migrated from Short description of key information:

No data was available

Justification for classification or non-classification

Skin sensitisation:

ITC 288/S produced a 63 % (12/19) sensitisation rate (OECD 406, Kr:1). Therefore ITC 288/S was classified in category 1B, H317 ( May cause an allergic skin reaction) according to the CLP regulation (1272/2008) and as a sensitiser to guinea pig skin (Xi, R43) according to the Directive 67/548/EEC.

Respiratory sensitisation:

Classification not possible due to lack of data.