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

Endpoint summary

Description of key information

Oral LD50 in several species such as rats for potassium chloride and l-alanyl-l-glutamine were always above 2000 mg/kg. The dermal LD50 for L-alanyl-L-glutamine was also >2000 mg/kg in rabbits. As potassium chloride in the absence of published data or studies is not expected to induce acute dermal toxicity, the reaction mass of L-alanyl-L-glutamine and potassium chlroide is also considered as not classified regarding acute dermal toxicity. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

mg/kg bw

Quality of whole database:

The studies or publications contributing to this endpoint conclusion are partly not reporting on investigations conducted according to guidelines and GLP regulations, but are covering the most relevant endpoints such as mortality and post-mortem examinations. Therefore they are considered to be usable for the overall classification of the substance regarding its acute oral toxicity. Both main ingredients of reaction mass of l-analyl-l-glutamine and potassium chloride were tested individually, but no synergistic or antagonistic activity is expected.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

mg/kg bw

Quality of whole database:

The studies or publications contributing to this endpoint conclusion are partly not reporting on investigations conducted according to guidelines and GLP regulations, but are covering the most relevant endpoints such as mortality and post-mortem examinations. Therefore they are considered to be usable for the overall classification of the substance regarding its acute oral toxicity. Both main ingredients of reaction mass of l-analyl-l-glutamine and potassium chloride were tested individually, but no synergistic or antagonistic activity is expected.

Additional information

No data is available on the acute oral toxicity to rodents of the reaction mass of L-Alanyl-L-glutamine and potassium chloride.

The substance consists of two components namely the dipeptide L-Alanyl-L-glutamine and the salt potassium chloride.

Besides these two main components only non-hazardous / non-classified amino acids in small amounts are present. Based on the composition of the substance it can be assumed that the results obtained with the individual main components (L-Alanyl-L-glutamine and potassium chloride) apply likewise to the test material under investigation (reaction mass of L-Alanyl-L-glutamine and potassium chloride). Therefore read-across data for the dipeptide L-Alanyl-L-glutamine and the salt potassium chloride is provided. Both substances showed LD50 values above 2000 mg/kg body weight for dermal and oral acute toxicity and therefore do not have to be classified.

Justification for selection of acute toxicity – dermal endpoint
For the main component L-alany-L-glutamine an acute dermal toxicity study indicated an LD50 >2000 mg/kg body weight and for the second main component potassium chloride acute dermal toxicity is not expected for intact skin from the nature of the molecule and its physicochemical properties.

Justification for classification or non-classification

Both individual main components (potassium chloride and L-alanyl-L-glutamine) showed LD50 values above 2000 mg/kg body weight for dermal (only data for L-alanyl-L-glutamine available, but potassium chloride is considered to be uncritical regarding its acute dermal toxicity in intact skin) and oral acute toxicity and therefore the substance "reaction mass of L-alanyl-L-glutamine and potassium chloride" does not have to be classified.