Registration Dossier

Administrative data

Description of key information

The skin sensitization potential of target chemical was assessedin various experimental studies which were conducted on humans.Based on the available key data and supporting study,it can be concluded thatchemical is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Various studies have been summarized to determine the extent of dermal sensitization caused by inc stearate to living organisms. These results include in vivo experimental studies for the target chemical performed on humans.

Draize Shelanski Patch test was performed to evaluate the dermal sensitization potential of ZInc stearate present in an eye shadow formulation.

The eye shadow formulation containing 10% test chemical was exposed to the skin of 99 human volunteers, and observed for dermal reactions (duration of exposure, observation period not specified).

The eye shadow formulation did not cause any dermal reactions to 99 volunteers tested.

Hence, the eye shadow formulation containing 10% zinc stearate can be considered to be not sensitizing to human skin.

This is supported by the results of another patch performed according to Schwartz-Peck Prophetic Patch Test method to evaluate the dermal sensitization potential of ZInc stearate present in an eye shadow formulation.

The eye shadow formulation containing 10% test chemical was exposed to the skin of 202 human volunteers, and observed for dermal reactions (duration of exposure, observation period not specified).

The eye shadow formulation did not cause any dermal reactions to 202 volunteers tested.

Hence, the eye shadow formulation containing 10% zinc stearate can be considered to be not sensitizing to human skin.

Available results for Zinc stearate indicate a very strong possibility of it being not sensitizing to skin.

Hence, Zinc stearate can be considered to be not sensitizing to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, Zinc stearate is not classified for skin sensitization according to CLP Regulation (EC) No. 1272/2008.