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:

Skin sensitisation

One reliable animal study described in Vaeth (2004) (according to LLNA/IMDS test, GLP compliant) is considered to be reliable with restrictions. The substance was determined not to be a skin sensitiser.

Migrated from Short description of key information:
Skin sensitisation: not sensitizing (according to LLNA/IMDS test, GLP complaint)

Justification for classification or non-classification

Skin sensitisation

The reference Vaeth (2004) is considered as the key study on skin sensitisation and will be used for classification. The overall sensitisation results are as follows:

Local lymph node assay (LLNA/IMDS test) in mice

SIs of less than 3.0 (0.95 - 1 .11) were observed at all test concentrations of SymWhite 377. Thus, the classification criteria acc. to regulation (EC) 1272/2008 as skin sensitiser are not met and SymWhite does not have to be labelled as such.

Respiratory sensitisation:

SymWhite® 377 does not need to be classified as respiratory sensitiser according to regulation (EC) 1272/2008, due to the following:

(i) virtually all small chemicals causing respiratory tract sensitisation are also skin sensitizers and SymWhite® 377 is not skin sensitising,

(ii) the possibility to inhale SymWhite® 377are very limited due to the very low vapour pressure and small percentage of particles of inhalable size, and

(iii) no cases of respiratory sensitisation among workers involved in the industrial production of SymWhite® 377 have been reported.