Acepromazine maleate

Acepromazine maleate	Last updated: 30/08/2023
(Also known as: acetylpromazine maleate; ACP; ACE)

Data alerts

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.

Environmental fate	Ecotoxicity	Human health
		Human health High alert: Neurotoxicant

GENERAL INFORMATION

Description

A veterinary treatment used as a premedication for quietening and calming animals. It also has antihistamine effects.

Availability status

Introduction & key dates

1950's, first use in humans; late 1960's veterinary applications

Examples of species treated

Horses, Dogs, Cats, Elephants, Deer

Chemical structure

Isomerism

Chemical formula

C₂₃H₂₆N₂O₅S

Canonical SMILES

CC(=O)C1=CC2=C(C=C1)SC3=CC=CC=C3N2CCCN(C)C.C(=CC(=O)O)C(=O)O

Isomeric SMILES

CC(=O)C1=CC2=C(C=C1)SC3=CC=CC=C3N2CCCN(C)C.C(=C/C(=O)O)\C(=O)O

International Chemical Identifier key (InChIKey)

FQRHOOHLUYHMGG-WLHGVMLRSA-N

International Chemical Identifier (InChI)

InChI=1S/C19H22N2OS.C4H4O4/c1-14(22)15-9-10-19-17(13-15)21(12-6-11-20(2)3)16-7-4-5-8-18(16)23-19;5-3(6)1-2-4(7)8/h4-5,7-10,13H,6,11-12H2,1-3H3;1-2H,(H,5,6)(H,7,8)/b;2-1-

2D structure diagram/image available?

Yes

General status

Veterinary substance type

Tranquiliser, Antihistamine

Substance groups

Phenothiazine neuroleptic

Minimum active substance purity

Known relevant impurities

Substance origin

Synthetic

Mode of action

Has a depressant effect on the central nervous system and therefore causes sedation. Dopamine antagonist.

Molecular targets

[D(2) dopamine receptor, antagonist], [D(1A) dopamine receptor, antagonist], [5-hydroxytryptamine 2A receptor, antagonist], [5-hydroxytryptamine 1A receptor, antagonist], [Alpha-1A adrenergic receptor, antagonist], [Alpha-1B adrenergic receptor, antagonist]

CAS RN

3598-37-6

EC number

222-748-9

CIPAC number

US EPA chemical code

PubChem CID

6420038

ATCvet Code

QN05AA04

Therapeutic Class

Nervous system: Antipsychotics

Controlled Drug?

Regulation 37/2010 MRL Classification

No data

Molecular mass

442.50

PIN (Preferred Identification Name)

IUPAC name

(E)-but-2-enedioic acid;1-[10-[3-(dimethylamino)propyl]phenothiazin-2-yl]ethanone

CAS name

10-(3-dimethylaminopropyl)phenothiazine-2-yl methyl hydrogen maleate

Other status information

Relevant Environmental Water Quality Standards

Physical state

Yellow, crystalline powder

Formulations

Property

Product

Manufacturer

Authorisation Route

UK Legal Class

Example products using this active

ACP (injections/Tablets)

Novartis Animal Health

UK National authorisation

Prescription only medicine to be authorised by a veterinarian (POM-V)

Large animal immobilion solution for injection

Novartis Animal Health

UK National authorisation

Prescription only medicine to be authorised by a veterinarian (POM-V)

Sedaline 35 mg/ml Oral Gel

Vetoquinol UK Ltd

UK National authorisation

Prescription only medicine to be authorised by a veterinarian (POM-V)

Oralject Sedazine Acepromazine (1.20% w/v) Oral Paste Tranquilliser for Horses

Vetsearch International (UK) Ltd

UK National authorisation

Prescription only medicine to be authorised by a veterinarian (POM-V)

Formulation and application details

Usually supplied as a solution for injection or in tablet form

ENVIRONMENTAL FATE

Property

Value

Source; quality score; and other information

Interpretation

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

37000

High

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

333000

Chloroform

77000

Methanol

Melting point (°C)

135

Boiling point (°C)

497

Degradation point (°C)

Flashpoint (°C)

254.4

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

Log P

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)

Maximum UV-vis absorption L mol⁻¹ cm⁻¹

Surface tension (mN m⁻¹)

Refractive Index

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)

Soil adsorption and mobility

Property

Value

Source; quality score; and other information

Interpretation

Linear

K_d

K_oc

Notes and range

Freundlich

K_f

K_foc

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 soil and groundwater metabolites

None

Other known metabolites

Metabolite name and reference

Aliases

Formation medium / Rate

Estimated maximum occurrence fraction

Metabolising enzymes

2-(1-hydroxyethyl)promazine sulfoxide
Note: C19H24N2O2S; Mwt = 344.47

Animal

ECOTOXICOLOGY

Terrestrial ecotoxicology

Property

Value

Source; quality score; and other information

Interpretation

Mammals - Acute oral LD₅₀ (mg kg⁻¹)

400

Rat

Moderate

Mammals - Short term dietary NOEL

(mg kg⁻¹)

(ppm diet)

Mammals - Chronic 21d NOAEL (mg kg⁻¹ bw d⁻¹)

Birds - Acute LD₅₀ (mg kg⁻¹)

Birds - Short term dietary (LC₅₀/LD₅₀)

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

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

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

Soil micro-organisms

Collembola

Acute LC₅₀ (mg kg⁻¹)

Chronic NOEC (mg kg⁻¹)

Non-target plants

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

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)

Aquatic ecotoxicology

Property

Value

Source; quality score; and other information

Interpretation

Fish - Acute 96 hour LC₅₀ (mg l⁻¹)

Fish - Chronic 21 day NOEC (mg l⁻¹)

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

Aquatic invertebrates - Chronic 21 day NOEC (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 - Acute 7 day EC₅₀, biomass (mg l⁻¹)

Algae - Acute 72 hour EC₅₀, growth (mg l⁻¹)

Algae - Chronic 96 hour NOEC, growth (mg l⁻¹)

Mesocosm study data

NOEAEC mg l⁻¹

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)

400

Rat

Moderate

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

Mammals - Inhalation LC₅₀ (mg l⁻¹)

Other Mammal toxicity endpoints

Subcutaneous LD₅₀ = 65 mg kg⁻¹

Mouse

Intravenous LD₅₀ = 95 mg kg⁻¹

Rat

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

Metabolised by liver, excreted in urine

Health issues

Specific human health issues

Carcinogen

Genotoxic

Endocrine disruptor

; ; ; ;

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 affect heart and respiratory rate leading to hypotension
Ingestion may cause gastrointestinal disturbances

Handling issues

Property

Value and interpretation

General

When heated to decomposition it emits highly toxic fumes of NOx and SOx

CLP classification 2013

Health: H317

WHO Classification

Not listed (Not listed)

UN Number

Waste disposal & packaging

Shelf-life, storage, stability and reactivity

TRANSLATIONS

Language

Name

English

acepromazine maleate

French

maléate d'acépromazine

German

Danish

Italian

Spanish

maleato de acepromazina

Greek

Polish

Swedish

Hungarian

Dutch

Norwegian

Record last updated:	30/08/2023
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