11.1 Information on toxicological effects
Acute toxicity
LD50 Oral - Rat - female - > 2,000 mg/kg (OECD Test Guideline 423)
Remarks: The value is given in analogy to the following substances: L-isoleucine
LC50 Inhalation - Rat - male and female - 4 h - > 5.4 mg/l - aerosol (OECD Test Guideline 403)
Remarks: The value is given in analogy to the following substances: L-isoleucine
Dermal: No data available
Skin corrosion/irritation
Skin - Rabbit
Result: No skin irritation - 4 h (OECD Test Guideline 404)
Remarks: The value is given in analogy to the following substances: L-isoleucine
Serious eye damage/eye irritation
Eyes - Rabbit
Result: No eye irritation (OECD Test Guideline 405)
Remarks: The value is given in analogy to the following substances: L-isoleucine
Respiratory or skin sensitization
Local lymph node assay (LLNA) - Mouse
Result: negative (OECD Test Guideline 429)
Remarks: The value is given in analogy to the following substances: L-isoleucine
Germ cell mutagenicity
Test Type: In vitro mammalian cell gene mutation test
Test system: mouse lymphoma cells
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 476
Result: negative
Remarks: The value is given in analogy to the following substances: L- isoleucineTest Type: Chromosome aberration test in vitro
Test system: Chinese hamster ovary cells
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 473
Result: negative
Remarks: The value is given in analogy to the following substances: L- isoleucineTest Type: Ames test
Test system: Escherichia coli/Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 471
Result: negative
Remarks: The value is given in analogy to the following substances: L- isoleucineCarcinogenicity
No data available
Reproductive toxicity
No data available
Specific target organ toxicity - single exposure
No data available
Specific target organ toxicity - repeated exposure
No data available
Aspiration hazard
No data available
11.2 Additional Information
Repeated dose toxicity - Rat - male and female - Oral - 13 Weeks - NOAEL (No ob- served adverse effect level) - 600 mg/kg
Remarks: Subchronic toxicity
The value is given in analogy to the following substances: L-isoleucine
The levorotary (l) forms of leucine, isoleucine, and valine have been found to have tumor-promoting activity for bladder carcinomas.
To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.