Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No Ames test data is available for the reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride. Read-across data is provided for the main components L-Alanyl-L-Tyrosine (L-Ala-L-Tyr) and KCl. Both substances have negative Ames test results. No data is available for L-Alanine, another component of the reaction mass. However, L-Alanine is physiological and toxicologically well characterized and no mutagenic potential is known. Therefore, the reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride is concluded negative in the Ames test.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No Ames test data is available for the reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride.

The substance consists mainly of the dipeptide L-alanyl-L-tyrosine hydrochloride (38-42%) and potassium chloride (46-50%). Besides these main components only non-hazardous / non-classified amino acids/peptides in small amounts are present (e.g. L-alanine hydrochloride 4-7%),. Based on the composition of the substance it can be assumed that the results obtained with the individual main components (L-alanyl-L-tyrosine, potassium chloride, and L-alanine) apply likewise to the test material under investigation (reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride). Therefore read-across data for the dipeptide L-alanyl-L-tyrosine and the salt potassium chloride is provided and used to derive an effect value for the UVCB substance reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride. 

L-Alanyl-L-Tyrosine (L-Ala-L-Tyr) showed negative results in an Ames test.

KCl showed negative results in several Ames tests, one key study is selected for this read-across approach.

No data is available for L-Alanine, another component of the reaction mass. However, L-Alanine is physiological and toxicologically well characterized and no mutagenic potential is known.

Therefore, the reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride is concluded negative in the Ames test.

Justification for classification or non-classification

Based on a read-across for the reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride, using negative Ames test data for the main components L-Alanyl-L-Tyrosine (L-Ala-L-Tyr) and KCl, no classification is required.