Dexmedetomidine

Dexmedetomidine	Last updated: 12/09/2025
(Not known by any other names)

GENERAL INFORMATION

Description

A sedative and analgesic veterinary drug

Examples of veterinary uses

Used in clinical examinations, clinical procedures and minor surgical procedures for sedation and anxiety control

Examples of species treated

Cats; Dogs; Exotic pets

Approval status

VMR 2013/2033 approval status (GB/UK)

Approved - usually supplied as a prescription only medicine to be authorised by a veterinarian (POM-V)

EU Regulatory approval status

Approved

Chemical structure

Isomerism

Dexmedetomidine exhibits optical isomerism, specifically enantiomerism, as it is one of two mirror-image forms of the compound medetomidine. Medetomidine exists as a racemic mixture containing both dexmedetomidine and levomedetomidine. Dexmedetomidine is the pharmacologically active enantiomer, selectively binding to alpha2-adrenoceptors to produce sedative and analgesic effects, while levomedetomidine is significantly less active.

Chemical formula

C₁₃H₁₆N₂

Canonical SMILES

CC1=C(C(=CC=C1)C(C)C2=CN=CN2)C

Isomeric SMILES

CC1=C(C(=CC=C1)[C@@H](C)C2=CN=CN2)C

International Chemical Identifier key (InChIKey)

CUHVIMMYOGQXCV-LLVKDONJSA-N

International Chemical Identifier (InChI)

InChI=1S/C13H16N2/c1-9-5-4-6-12(10(9)2)11(3)13-7-14-8-15-13/h4-8,11H,1-3H3,(H,14,15)/t11-/m1/s1

2D structure diagram/image available?

Yes

Cambridge Crystallographic Data Centre diagrams

Common Name	Relationship	Link
dexmedetomidine	-

General status

Veterinary substance type

Anesthetic, Analgesic, Sedative, Medicinal drug

Substance groups

Unclassified substance

Minimum active substance purity

Known relevant impurities

Substance origin

Synthetic

Mode of action

Antagonism of alpha-2 adrenergic receptors in certain parts of the brain

Molecular targets

[Alpha-2A adrenergic receptor, Agonist]

CAS RN

113775-47-6

EC number

CIPAC number

US EPA chemical code

PubChem CID

Therapeutic Class

Nervous system: Psycholeptics

ATCvet Code

QN05CM18

Controlled Drug?

Regulation 37/2010 MRL Classification

Molecular mass

200.28

PIN (Preferred Identification Name)

IUPAC name

(S)-4-[1-(2,3-dimethylphenyl)ethyl]-3H-imidazole

CAS name

4-((s)-α,2,3-trimethylbenzyl)imidazole

Global Governance status: Listed (✓) under

UK Poisons List Order 1972	Rotterdam Convention	Montreal Protocol
XNo The Poisons List Order 1972	XNo Rotterdam Convention	XNo Montreal Protocol
Stockholm Convention	OSPAR	EU Water Framework Directive
XNo Stockholm Convention	XNo OSPAR	XNo EU Water Framework Directive

Relevant Environmental Water Quality Standards

Forever chemical

Other status information

Physical state

As the hydrochloride it is a white or almost white powder

Related substances & organisms

detomidine

detomidine hydrochloride

medetomidine

Commercial

Property

Value

Availability status

Current

Introduction & key dates

1999, first approval

Example manufacturers & suppliers of products using this active now or historically

Orion Corporation
Le Vet Beheer B.V.

Example products using this active

Dexdomitor Solution for Injection
Sedadex Solution for Injection

Formulation and application details

Usually formulated as a solution for injection and as oromucosal gels

Commercial production

Dexmedetomidine is synthesised through a multi-step chemical process that begins with key intermediates such as 2-amino-2-methyl-1-propanol. The hydroxyl group of this compound is first protected, typically as a trimethylsilyl ester, to prevent unwanted reactions. Subsequent steps involve acylation and reduction reactions to build the core structure of dexmedetomidine. A crucial transformation includes catalytic hydrogenation using palladium on carbon under controlled temperature and hydrogen pressure, which yields the desired dexmedetomidine base.

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 at pH 7 (mg l⁻¹)

Solubility - In organic solvents at 20 °C (mg l⁻¹)

Melting point (°C)

Boiling point (°C)

Degradation point (°C)

Flashpoint (°C)

Octanol-water partition coefficient at pH 7, 20 °C

7.76 X 10⁰²

Calculated

Log P

2.89

Moderate

Fat solubility of residues

Solubility

Data type

Density (g ml⁻¹)

Dissociation constant pKa) at 25 °C

7.1

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)

Refractive Index

Environmental release

Degradation

Property

Value

Source; quality score; and other information

Interpretation

Soil degradation (days) (aerobic)

DT₅₀ (typical)

DT₅₀ (lab at 20 °C)

DT₅₀ (field)

DT₉₀ (lab at 20 °C)

DT₉₀ (field)

Note

Manure DT₅₀ (days)

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

K_d (mL g⁻¹)

K_oc (mL g⁻¹)

Notes and range

Freundlich

K_f (mL g⁻¹)

K_foc (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

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)

0.5

Rat

High

Mammals - Short Term Oral NOAEL (mg kg⁻¹ bw d⁻¹)

Mammals - Long Term (Chronic) Oral NOAEL (mg kg⁻¹ bw d⁻¹)

Birds - Acute LD₅₀ (mg kg⁻¹)

Birds - Short term dietary LC₅₀ (mg kg⁻¹ bw d⁻¹)

Birds - Chronic 21d NOEL (mg kg⁻¹ bw d⁻¹)

Earthworms - Acute 14 day LC₅₀ (mg kg⁻¹ dw soil)

Earthworms - Chronic NOEC, reproduction (mg kg⁻¹ dw soil)

Soil micro-organisms

Collembola

Acute LC₅₀ (mg kg⁻¹)

Chronic NOEC (mg kg⁻¹)

Non-target plants

Vegetative vigour ER₅₀ (g ha⁻¹)

Seedling emergence ER₅₀ (g ha⁻¹)

Honeybees (Apis spp.)

Contact acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Oral acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Unknown mode acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Chronic

Notes

Bumblebees (Bombus spp.)

Contact acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Oral acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Mason bees (Osmia spp.)

Contact acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Oral acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Other bee species (1)

Acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg insect⁻¹)

Mode of exposure

Other bee species (2)

Acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg insect⁻¹)

Mode of exposure

Beneficial insects (Ladybirds)

Beneficial insects (Lacewings)

Beneficial insects (Parasitic wasps)

Beneficial insects (Predatory mites)

Beneficial insects (Ground beetles)

Beneficial insects (Butterflies)

Contact

Notes

Oral

Notes

Aquatic ecotoxicology

Property

Value

Source; quality score; and other information

Interpretation

Temperate Freshwater Fish - Acute 96 hour LC₅₀ (mg l⁻¹)

Temperate Freshwater Fish - Chronic 21 day NOEC (mg l⁻¹)

Tropical Freshwater Fish - Acute 96 hour LC₅₀ (mg l⁻¹)

Temperate Freshwater Aquatic invertebrates - Acute 48 hour EC₅₀ (mg l⁻¹)

Temperate Freshwater Aquatic invertebrates - Chronic 21 day NOEC (mg l⁻¹)

Tropical Freshwater Aquatic invertebrates - Acute 48 hour EC₅₀ (mg l⁻¹)

Aquatic crustaceans - Acute 96 hour LC₅₀ (mg l⁻¹)

Sediment dwelling organisms - Acute 96 hour LC₅₀ (mg l⁻¹)

Sediment dwelling organisms - Chronic 28 day NOEC, static, water (mg l⁻¹)

Sediment dwelling organisms - Chronic 28 day NOEC, sediment (mg kg⁻¹)

Aquatic Plants (free-floating, fonds growth, fresh) - 7 day (mg l⁻¹)

Aquatic plants (rooted, growth rate, fresh) - 14 day (mg l⁻¹)

Algae - Acute (growth rate, fresh; mg l⁻¹)

Algae - Chronic (growth rate, fresh; mg l⁻¹)

Mesocosm study data

NOEAEC mg l⁻¹

Marine bivalves

HUMAN HEALTH AND PROTECTION

General

Property

Value

Source; quality score; and other information

Interpretation

Threshold of Toxicological Concern (Cramer Class)

High (class III)

Mammals - Acute oral LD₅₀ (mg kg⁻¹)

0.5

Rat

High

Mammals - Short Term Oral NOAEL (mg kg⁻¹ bw d⁻¹)

Mammals - Long Term (Chronic) Oral NOAEL (mg kg⁻¹ bw d⁻¹)

Mammals - Dermal LD₅₀ (mg kg⁻¹ body weight)

Mammals - Inhalation LC₅₀ (mg l⁻¹)

Other Mammal toxicity endpoints

ADI - Acceptable Daily Intake (mg kg⁻¹ bw day⁻¹)

ARfD - Acute Reference Dose (mg kg⁻¹ bw day⁻¹)

AAOEL - Acute Acceptable Operator Exposure Level (mg kg⁻¹ bw day⁻¹)

AOEL - Acceptable Operator Exposure Level - Systemic (mg kg⁻¹ bw day⁻¹)

Dermal penetration studies (%)

Dangerous Substances Directive 76/464

Exposure Routes

Public

Occupational

Mammalian dose elimination route and rate

Undergoes almost complete biotransformation with very little unchanged dexmedetomidine excreted in urine and feces

Health issues

Specific human health issues (hazard-based)

Carcinogen

Genotoxic

Endocrine disruptor

; ; ; ;

No data found

Reproduction / development effects

Acetyl cholinesterase inhibitor

Neurotoxicant

No data found

Respiratory tract irritant

Skin irritant

Skin sensitiser

No data found

Eye irritant

Phototoxicant

No data found

General human health issues

May cause respiratory depression

Handling issues

Property

Value and interpretation

General

No information available

CLP classification 2013

WHO Classification

Not listed (Not listed)

UN Number

Waste disposal & packaging

Shelf-life, storage, stability and reactivity

TRANSLATIONS

Language

Name

English

dexmedetomidine

French

German

Danish

Italian

Spanish

dexmedetomidina

Greek

Polish

Swedish

Hungarian

Dutch

Norwegian

Record last updated:	12/09/2025
Contact:	aeru@herts.ac.uk
Please cite as:	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

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