Registration Dossier
Registration Dossier
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EC number: 949-344-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on the results for the individual components of the reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride it can be concluded that the oral LD50 value exceeds 2000 mg/kg body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data is available on the acute toxicity in rats 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, the salt potassium chloride, and L-alanine is provided and used to derive an effect value for the UVCB substance reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride.
The oral LD50 value of L-Alanyl-L-Tyrosine (L-Ala-L-Tyr) in Wistar Han rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
The LD50 value of KCl has been determined 3020 mg/kg bw.
The LD50 value of L-alanine via the oral route represented by male and female rats was > 5110 mg/kg body weight.
Based on the results for the individual components of the reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride it can be concluded that the oral LD50 value exceeds 2000 mg/kg body weight.
Justification for classification or non-classification
For the main components L-Alanyl-L-Tyrosine (L-Ala-L-Tyr) and L-Alanine the LD50 is considered to exceed 5000 mg/kg bw. However, for the main component KCL the LD50 value is 3020 mg/kg bw. Therefore, the reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride is classified as Category 5 for acute oral toxicity according to UN GHS.
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