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:
Justification for selection of skin sensitisation endpoint:
For Glycyl-L-glutamine, one of the main components of reaction mass of Glycyl-L-glutamine and potassium chloride, a LLNA study in mice was conducted. In this study based on the sum of all determined parameters no sensitizing potential for Glycyl-L-glutamine could be determined.
There is no data available to inform about the skin sensitization potency of potassium chloride. Potassium and chloride are essential constituents and 2 of the most abundant ions in all humans as in all animal species. In adult humans, the body potassium is approx. 3.5 mol (135 g); the total body chloride in adult humans is approx. 2.1 mol (75 g). KCl is essential for intracellular osmotic pressure and buffering, cell permeability , acid-base balance, muscle contraction and nerve function. Due to the low vapor pressure (5.73 hPa) and the low calculated octanol-water partition coefficient (Log POW: -0.46) of the substance, the potential for dermal absorption is low. Based on the above considerations, it is not anticipated that potassium chloride has any sensitizing potential. This is confirmed by the lack of evidence for skin sensitization potential despite the wide dispersive use (see UNEP 2003) and no testing was proposed in the OECD HPV program.

Based on the study data for Glycyl-L-glutamine and the sound scientific waiving for testing on the skin sensitzing properties of potassium chloridee, and in the absence of synergistic or antagonistic effects, the overall assessment for the reation mass of Glycyl-L-glutamine and potassium chloride is not sensitizing to the skin.

Justification for classification or non-classification

For Glycyl-L-glutamine, one of the main components of reaction mass of Glycyl-L-glutamine and potassium chloride, a LLNA study in mice was conducted. In this study based on the sum of all determined parameters no sensitizing potential for Glycyl-L-glutamine could be determined.

There is no data available to inform about the skin sensitization potency of potassium chloride. Potassium and chloride are essential constituents and 2 of the most abundant ions in all humans as in all animal species. In adult humans, the body potassium is approx. 3.5 mol (135 g); the total body chloride in adult humans is approx. 2.1 mol (75 g). KCl is essential for intracellular osmotic pressure and buffering, cell permeability , acid-base balance, muscle contraction and nerve function. Due to the low vapor pressure (5.73 hPa) and the low calculated octanol-water partition coefficient (Log POW: -0.46) of the substance, the potential for dermal absorption is low. Based on the above considerations, it is not anticipated that potassium chloride has any sensitizing potential. This is confirmed by the lack of evidence for skin sensitization potential despite the wide dispersive use (see UNEP 2003) and no testing was proposed in the OECD HPV program.

Based on the study data for Glycyl-L-glutamine and the sound scientific waiving for testing on the skin sensitzing properties of potassium chloridee, and in the absence of synergistic or antagonistic effects, the overall assessment for the reation mass of Glycyl-L-glutamine and potassium chloride is not sensitizing to the skin.