Prednisolone

Prednisolone	Last updated: 17/08/2023
(Also known as: D1-dehydrohydrocortisone; hydroretrocortine; meticortelone)

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
Environmental fate Moderate alert: Drainflow: Moderately mobile Warning: Significant data are missing	Ecotoxicity Low alert: Daphnia chronic ecotoxicity: Low Warning: Significant data are missing	Human health High alert: Reproduction/development effects Warning: Significant data are missing

GENERAL INFORMATION

Description

Used for the control of inflammatory and allergic conditions such as asthma, rheumatoid arthritis and colitis and as an immunosuppressive drug for organ transplants

Availability status

Introduction & key dates

Examples of species treated

Dogs, Dogs, Cattle, Bears, Horses

Chemical structure

Isomerism

Isomeric

Chemical formula

C₂₁H₂₈O₅

Canonical SMILES

CC12CC(C3C(C1CCC2(C(=O)CO)O)CCC4=CC(=O)C=CC34C)O

Isomeric SMILES

C[C@]12C[C@@H]([C@H]3[C@H]([C@@H]1CC[C@@]2(C(=O)CO)O)CCC4=CC(=O)C=C[C@]34C)O

International Chemical Identifier key (InChIKey)

OIGNJSKKLXVSLS-VWUMJDOOSA-N

International Chemical Identifier (InChI)

InChI=1S/C21H28O5/c1-19-7-5-13(23)9-12(19)3-4-14-15-6-8-21(26,17(25)11-22)20(15,2)10-16(24)18(14)19/h5,7,9,14-16,18,22,24,26H,3-4,6,8,10-11H2,1-2H3/t14-,15-,16-,18+,19-,20-,21-/m0/s1

2D structure diagram/image available?

Yes

Cambridge Crystallographic Data Centre diagrams

Common Name	Relationship	Link
prednisolone	-

General status

Veterinary substance type

Immunosuppressant, Anti-inflammatory, Medicinal drug

Substance groups

Synthetic glucocorticoid

Minimum active substance purity

Known relevant impurities

Substance origin

Synthetic

Mode of action

Irreversibly binds with glucocorticoid receptors (GR) alpha and beta

Molecular targets

[Glucocorticoid receptor, agonist]

CAS RN

50-24-8

EC number

200-021-7

CIPAC number

US EPA chemical code

PubChem CID

ATCvet Code

QS02CA01; QJ51RV01

Therapeutic Class

Sensory organs: Otologicals; Antiinfectants for systemic use: Antibacterials for intramammary use

Controlled Drug?

Regulation 37/2010 MRL Classification

Allowed substance (Table 1: Bovine)

Molecular mass

360.44

PIN (Preferred Identification Name)

IUPAC name

(11β)-11,17,21-trihydroxypregna-1,4-diene-3,20-dione

CAS name

11,17-dihydroxy-17- (2-hydroxyacetyl)- 10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17- dodecahydrocyclopenta [a]phenanthren-3-one

Other status information

Relevant Environmental Water Quality Standards

Physical state

White solid

Formulations

Property

Product

Manufacturer

Authorisation Route

UK Legal Class

Example products using this active

Canaural ear drops, suspension for dogs and cats

Dechra Veterinary Products A/S

UK National authorisation

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

Multiject IMM Intramammary Suspension

Norbrook Laboratories

UK National authorisation

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

Mastiplan, 300mg intramammary suspension for lactating cows

Intervet International BV

EU Mutually recognised procedure

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

Prednicare Tablets 1 mg

Animalcare Ltd

UK National authorisation

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

Formulation and application details

It is usually taken orally but can be delivered by intramuscular injection or intravenous injection.

ENVIRONMENTAL FATE

Property

Value

Source; quality score; and other information

Interpretation

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

223

Moderate

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

33000

Ethanol

5500

Chloroform

20000

Acetone

Melting point (°C)

235

with decomposition

Boiling point (°C)

Decomposes before boiling

Degradation point (°C)

240

Flashpoint (°C)

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

4.17 X 10⁰¹

Calculated

Log P

1.62

Low

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

In methanol: 242nm = 15000

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

Stable

Note

Not expected to hydrolyse

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

Moderately mobile

K_oc

180

Notes and range

Estimated

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

prednisolone gluconoride

Animal (Liver)

prednisolone sulphate

Animal (Liver)

ECOTOXICOLOGY

Terrestrial ecotoxicology

Property

Value

Source; quality score; and other information

Interpretation

Mammals - Acute oral LD₅₀ (mg kg⁻¹)

1680

Mouse

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)

Daphnia magna

Low

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)

160

Pseudokirchneriella subcapitata

Low

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)

1680

Mouse

Moderate

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

Mammals - Inhalation LC₅₀ (mg l⁻¹)

Other Mammal toxicity endpoints

Subcutaneous LD₅₀ = 147 mg kg⁻¹

Rat

Intraperitoneal LD₅₀ > 2000 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

In dairy cows prednisolone is mainly excreted via milk during milking. In other animals it is metabolised in the liver and excreted in the urine as both metabolites and the unchanged substance

Health issues

Specific human health issues

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

IARC Group 3 carcinogen - not classifiable
May cause fluid retention, acne, constipation, and mood swings
Toxic to lungs and mucous membranes
Osteoporosis is a possible side effect of long term treatment

Handling issues

Property

Value and interpretation

General

Risk of explosion if present during electrical/static discharge

CLP classification 2013

WHO Classification

Not listed (Not listed)

UN Number

Waste disposal & packaging

Shelf-life, storage, stability and reactivity

TRANSLATIONS

Language

Name

English

prednisolone

French

German

Danish

Italian

Spanish

prednisolona

Greek

Polish

Swedish

Hungarian

Dutch

Norwegian

Record last updated:	17/08/2023
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