Reaction mass of L-alanyl-L-glutamine and potassium chloride

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

For both main components of the reaction mass of L-alanyl-L-glutamine and potassium chloride either a suitable study (L-alanyl-L-glutamine) for the determination of sensitizing properties has been conducted or a sound scientifical justification for endpoint waiving (potassium chlroide) are available. For both main components and the registered reaction mass of them based on the available information no evidence for skin sensitizing properties is given.

Justification for selection of skin sensitisation endpoint:
Potassium chloride:
After an intensive literature search it has to be concluded that there is no adequate data available covering the skin sensitization potency of potassium chloride. On the other hand 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.
L-alanyl-L-glutamine:
For L-alanyl-L-glutamine a guideline (OECD 406) and GLP compliant study for skin sensitizating properties has been conducted. Based on this study the substance does not have to be classified for the endpoint skin sensitization.
Overall assessment for reaction mass of L-alanyl-L-glutamine and potassium chloride:
Based on the data available for one of the main components L-alany-L-glutamine and the scientifically justified waiving for the testing on senitizing properties for potassium chlroide and considering the absence of synergistic or antagonistic properties, the substance raction mass of L-alanyl-L-glutamine and potassium chloride is considered to be not sensitizing.

Justification for classification or non-classification

For both main components of the reaction mass of L-alanyl-L-glutamine and potassium chloride either a suitable study (L-alanyl-L-glutamine) for the determination of sensitizing properties has been conducted or a sound scientifical justification for endpoint waiving (potassium chlroide) are available. For both main components and the registered reaction mass of them based on the available information no evidence for skin sensitizing properties is given.