Registration Dossier
Registration Dossier
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EC number: 949-344-1 | CAS number: -
Endpoint summary
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.
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