11.1 Information on toxicological effects
Acute toxicity
LD50 Oral - Rat - female - > 5.000 mg/kg (OECD Test Guideline 425)
Remarks: The value is given in analogy to the following substances: Tris(hydroxymethyl) aminomethane
Inhalation: No data available
LD50 Dermal - Rat - male and female - > 5.000 mg/kg (OECD Test Guideline 402)
Remarks: The value is given in analogy to the following substances: Tris(hydroxymethyl) aminomethane
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: Tris(hydroxymethyl) aminomethane
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: Tris(hydroxymethyl) aminomethane
Respiratory or skin sensitization
Classified based on available data. For more details, see section 2
Germ cell mutagenicity
Test Type: Mutagenicity (mammal cell test): chromosome aberration.
Test system: Chinese hamster lung 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: Tris(hydroxymethyl) aminomethaneTest Type: In vitro mammalian cell gene mutation test
Test system: Chinese hamster ovary 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: Tris(hydroxymethyl) aminomethaneCarcinogenicity
No data available
Reproductive toxicity
Classified based on available data. For more details, see section 2
Specific target organ toxicity - single exposure
Classified based on available data. For more details, see section 2
Specific target organ toxicity - repeated exposure
Classified based on available data. For more details, see section 2
Aspiration hazard
Classified based on available data. For more details, see section 2
11.2 Additional Information
Endocrine disrupting properties
Product:
Assessment : The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
Repeated dose toxicity - Rabbit - male and female - 28 d - LOAEL (Lowest observed adverse effect level) - 500 mg/kg
Remarks: Subacute toxicity
The value is given in analogy to the following substances: Tris(hydroxymethyl) aminomethaneThe value is given in analogy to the following substances:
Repeated dose toxicity - Rat - male and female - Oral - 90 d - NOAEL (No observed adverse effect level) - 250 mg/kg - LOAEL (Lowest observed adverse effect level) - 1.000 mg/kg
Remarks: Subchronic toxicity
The value is given in analogy to the following substances:
To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.
After swallowing of large amounts:
Diarrhea
Nausea
Vomiting
Convulsions
The following applies to aliphatic amines in general: irritations after contact with eyes and skin. Mucosal irritations, coughing, and dyspnoea after inhalation.
This substance should be handled with particular care.
Under given conditions, contact with nitrites or nitric acid can lead to the formation of nitrosamines, which have shown themselves to be carcinogenic in animal experiments.
However, when the product is handled appropriately, hazardous effects are unlikely to occur.
Handle in accordance with good industrial hygiene and safety practice.