The following alerts are based on the data in the tables below. An absence of an alert does not imply the substance has no implications for human health, biodiversity or the environment but just that we do not have the data to form a judgement. These hazard alerts do not take account of usage patterns or exposure, thus do not represent risk.
Example manufacturers & suppliers of products using this active now or historically
Summit Veterinary Pharmaceuticals
Active Pharma Supplies Ltd
Example products using this active
Elavil
Levate
Formulation and application details
Usually formulated as tablets for oral administration. Human brands are often used off-label.
Commercial production
Amitriptyline hydrochloride is synthesised through a multi-step chemical process beginning with the formation of the tricyclic core structure, typically derived from dibenzocycloheptene intermediates. The key step involves alkylation of the nitrogen atom using 3-dimethylaminopropyl chloride, forming the amitriptyline base. This reaction is carried out under controlled temperature and pH conditions, often using organic solvents like ethanol or acetone. Once the base is formed, it undergoes salification by reacting with hydrochloric acid, yielding amitriptyline hydrochloride as a stable crystalline salt. The final product is then purified.
Impact on climate of production and use
Published GHG data is not available for most pharmaceuticals. However, according to industry, global averages suggest producing 1 kg of a typical active pharmaceutical ingredient can range from 10 to 100 kg CO₂e for small molecule drugs and potentially up to 1000 kg CO₂e for complex biologicals such as vaccines, depending on the drug type, its formulation, complexity of synthesis, solvent recovery, and energy sources used.
ENVIRONMENTAL FATE
Property
Value
Source; quality score; and other information
Interpretation
Solubility - In water at 20 °C (mg l⁻¹)
10.84
Q3 Q = Miscellaneous data from online sources 3 = Unverified data of known source
at 25 °C
Moderate
Solubility - In organic solvents at 20 °C (mg l⁻¹)
-
-
-
Melting point (°C)
198
Q3 Q = Miscellaneous data from online sources 3 = Unverified data of known source
-
Boiling point (°C)
-
-
-
Degradation point (°C)
-
-
-
Flashpoint (°C)
-
-
-
Octanol-water partition coefficient at pH 7, 20 °C
P
1.00 X 1005
Calculated
-
Log P
5.0
Q3 Q = Miscellaneous data from online sources 3 = Unverified data of known source
High
Fat solubility of residues
Solubility
-
-
-
Data type
-
-
-
Density (g ml⁻¹)
-
-
-
Dissociation constant pKa) at 25 °C
-
-
-
-
Vapour pressure at 20 °C (mPa)
-
-
-
Henry's law constant at 25 °C (Pa m³ mol⁻¹)
-
-
-
Volatilisation as max % of applied dose lost
From plant surface
-
-
-
From soil surface
-
-
-
Maximum UV-vis absorption L mol⁻¹ cm⁻¹
-
-
-
Surface tension (mN m⁻¹)
-
-
-
Degradation
Property
Value
Source; quality score; and other information
Interpretation
General biodegradability
Not readily biodegradable
Soil degradation (days) (aerobic)
DT₅₀ (typical)
-
-
-
DT₅₀ (lab at 20 °C)
-
-
-
DT₅₀ (field)
-
-
-
DT₉₀ (lab at 20 °C)
-
-
-
DT₉₀ (field)
-
-
-
DT₅₀ modelling endpoint
-
-
-
Note
-
Dissipation rate RL₅₀ (days) on plant matrix
Value
-
-
-
Note
-
Dissipation rate RL₅₀ (days) on and in plant matrix
Value
-
-
-
Note
-
Aqueous photolysis DT₅₀ (days) at pH 7
Value
-
-
-
Note
-
Aqueous hydrolysis DT₅₀ (days) at 20 °C and pH 7
Value
-
-
-
Note
-
Water-sediment DT₅₀ (days)
-
-
-
Water phase only DT₅₀ (days)
-
-
-
Sediment phase only DT₅₀ (days)
-
-
-
Air degradation
As this parameter is not normally measured directly, a surrogate measure is used: ‘Photochemical oxidative DT₅₀’. Where data is available, this can be found in the Fate Indices section below.
Decay in stored produce DT₅₀
-
Soil adsorption and mobility
Property
Value
Source; quality score; and other information
Interpretation
Linear
Kd (mL g⁻¹)
-
-
-
Koc (mL g⁻¹)
-
Notes and range
-
Freundlich
Kf (mL g⁻¹)
-
-
-
Kfoc (mL g⁻¹)
-
1/n
-
Notes and range
-
pH sensitivity
-
Fate indices
Property
Value
Source; quality score; and other information
Interpretation
GUS leaching potential index
-
-
-
SCI-GROW groundwater index (μg l⁻¹) for a 1 kg ha⁻¹ or 1 l ha⁻¹ application rate
Value
Cannot be calculated
-
-
Note
-
Potential for particle bound transport index
-
-
-
Potential for loss via drain flow
-
-
-
Photochemical oxidative DT₅₀ (hrs) as indicator of long-range air transport risk
-
-
-
Bio-concentration factor
BCF (l kg⁻¹)
-
-
-
CT₅₀ (days)
-
-
Known metabolites
None
ECOTOXICOLOGY
Terrestrial ecotoxicology
Property
Value
Source; quality score; and other information
Interpretation
Mammals - Acute oral LD₅₀ (mg kg⁻¹)
240
E3 E = Manufacturers safety data sheets 3 = Unverified data of known source
Metabolised in the liver and eliminated in the urine with around 18% as the unchanged drug. Small amounts lost in bile and excreted in maternal milk in humans.
Q3 Q = Miscellaneous data from online sources 3 = Unverified data of known source
-
Health issues
Specific human health issues (hazard-based)
Carcinogen
Genotoxic
Endocrine disruptor
No data found
A0 A = Chromosome aberration (EFSA database) 0 = No data
;
B0 B = DNA damage/repair (EFSA database) 0 = No data
;
C0 C = Gene mutation (EFSA database) 0 = No data
;
D0 D = Genome mutation (EFSA database) 0 = No data
;
E0 E = Unspecified genotoxicity type (miscellaneous data source) 0 = No data
No data found
Reproduction / development effects
Acetyl cholinesterase inhibitor
Neurotoxicant
✓Yes, known to cause a problem
No data found
✓Yes, known to cause a problem
Respiratory tract irritant
Skin irritant
Skin sensitiser
✓Yes, known to cause a problem
✓Yes, known to cause a problem
No data found
Eye irritant
Phototoxicant
✓Yes, known to cause a problem
No data found
General human health issues
May lower blood pressure and cause drowsiness CNS toxicant May cause gastrointestinal changes
Handling issues
Property
Value and interpretation
General
Incompatible with strong oxidising agents IMDG Transport Hazard Class 6.1
CLP classification 2013
Health: H301, H319, H361d Environment: H400, H410
WHO Classification
Not listed (Not listed)
UN Number
UN2811
Waste disposal & packaging
Packaging group III (minor danger)
Shelf-life, storage, stability and reactivity
Chemically stable under standard ambient conditions
Lewis, K.A., Tzilivakis, J., Warner, D. and Green, A. (2016) An international database for pesticide risk assessments and management. Human and Ecological Risk Assessment: An International Journal, 22(4), 1050-1064. DOI: 10.1080/10807039.2015.1133242
Ecotoxicity
Warning:
Human health
