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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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