Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
other justification
Justification for data waiving:
other:
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the data of the major component, glycerol, polyglycerol would have no skin-sensitizing properties.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no data for polyglycerine; however, data exist for the major component, glycerine. Data are available from RIPT human studies and from extensive use of glycerine in consumer products and in diagnostic patch testing as a vehicle control. Based on several human studies and use data, glycerine is not a dermal sensitizer. Therefore, target substance polyglycerine would also be expected not to have skin sensitizing potential. For more read-across justification and support, please refer to the attached justification document.


Migrated from Short description of key information:
Data do not exist for polyglycerine. However, data exist for the major component, glycerine. Based on several human studies and use data, glycerine is not a dermal sensitizer (see e.g. Hannuksela, M, 1979). Therefore, polyglycerine would also be expected to have no skin sensitizing potential.

Justification for selection of skin sensitisation endpoint:
Human data exists for glycerine. As glycerine is the major conponent of polyglycerol, the target substance would also be expected to have no skin sensitizing potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
Based on low skin irritation potential and dermal sensitizing potential, respiratory sensitization from polyglycerine is not expected to occur.

Justification for classification or non-classification

Classification concerning skin sensitization according to GHS and the Directive 67/584/EEC (DSD) is not warranted.