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.
Environmental fate
Ecotoxicity
Human health
Ecotoxicity Moderate alert: Fish acute ecotoxicity: Moderate
Warning: Significant data are missing
Human health High alert: Reproduction/development effects
Warning: Significant data are missing
GENERAL INFORMATION
Description
broad-spectrum antibiotic and antimicrobial substance isolated from the micro-organism (treptomyces aureofaciens) used in veterinary products and for aquaculture
GB regulatory status
GB COPR regulatory status
Not approved
Date COPR inclusion expires
Not applicable
GB LERAP status
Not applicable
EC Regulation 1107/2009 (repealing 91/414)
EC Regulation 1107/2009 status
Not approved
Dossier rapporteur/co-rapporteur
Not applicable
Date EC 1107/2009 inclusion expires
Not applicable
EU Candidate for substitution (CfS)
Not applicable
Listed in EU database
No
Approved for use (✓) under EC 1107/2009 in the following EU Member States
ATAustria
BEBelgium
BGBulgaria
CYCyprus
CZCzech Republic
DEGermany
DKDenmark
EEEstonia
ELGreece
ESSpain
FIFinland
FRFrance
HRCroatia
HUHungary
IEIreland
ITItaly
LTLithuania
LULuxembourg
LVLatvia
MTMalta
NLNetherlands
PLPoland
PTPortugal
RORomania
SESweden
SISlovenia
SKSlovakia
Approved for use (✓) under EC 1107/2009 by Mutual Recognition of Authorisation and/or national regulations in the following EEA countries
ISIceland
NONorway
Additional information
Also used in
Northern Ireland; Australia
Chemical structure
Isomerism
Chlortetracycline hydrochloride exhibits multiple forms of isomerism, primarily tautomerism, epimerism, and conformational isomerism, due to its complex polycyclic structure and numerous functional groups. The molecule contains several hydroxyl, keto, and amine groups that can undergo tautomeric shifts, especially in aqueous solutions at varying pH levels, leading to dynamic equilibrium between different structural forms. Additionally, epimerisation can occur at the C-4 position, forming 4-epichlortetracycline, a stereoisomer with altered biological activity.
Example manufacturers & suppliers of products using this active now or historically
Zoetis UK Ltd
aniMedica GmbH
Vetoquinon UK Ltd
LeVet Beheer B.V
Example products using this active
Aureomycin
Lederle
Aurofac Granular Premix Medicated Feed
Animedazon Spray
Chlorsol Powder
Ophtocycline Eye Ointment
Formulation and application details
Available in a variety of formulations including medicated premix feed, cutaneous sprays, ointments, cutaneous sprays and powders for oral administration
Commercial production
Chlortetracycline hydrochloride is produced through a fermentation process using the bacterium Streptomyces aureofaciens, which naturally synthesises chlortetracycline as a secondary metabolite. The organism is cultured in a nutrient-rich medium containing sources like starch, peanut meal, calcium carbonate, and corn steep liquor under aerobic submerged conditions for around 120 hours. After fermentation, the broth is acidified and filtered to separate the mycelium. The antibiotic is then precipitated by adjusting the pH and treated with solvents such as 2-ethoxyethanol and isopropanol, followed by the addition of concentrated hydrochloric acid to form the hydrochloride salt.
Impact on climate of production and use
As microbial-based products tend to use fermentation-based production processes rather than chemical synthesis, they typically have a lower fossil fuel input in formulation and active ingredient creation, and also have reduced downstream emissions due to biodegradability and minimal soil disruption, their life-cycle GHG emissions are expected to be low. Whilst hard and precise data is not available, broad estimates suggest that typically emissions are likely to be below 5 kg CO₂e/kg.
ENVIRONMENTAL FATE
Property
Value
Source; quality score; and other information
Interpretation
Solubility - In water at 20 °C (mg l⁻¹)
630
R4 R = Peer reviewed scientific publications 4 = Verified data
Moderate
Solubility - In organic solvents at 20 °C (mg l⁻¹)
-
-
-
Melting point (°C)
168.5
V3 V = ChemID Online Databases; Chemspider; PubChem. (ChemID ) 3 = Unverified data of known source
-
Boiling point (°C)
-
-
-
Degradation point (°C)
-
-
-
Flashpoint (°C)
-
-
-
Octanol-water partition coefficient at pH 7, 20 °C
P
2.40 X 10-01
Calculated
-
Log P
-0.62
V3 V = ChemID Online Databases; Chemspider; PubChem. (ChemID ) 3 = Unverified data of known source
Low
Fat solubility of residues
Solubility
-
-
-
Data type
-
-
-
Density (g ml⁻¹)
-
-
-
Dissociation constant pKa) at 25 °C
4.5
R4 R = Peer reviewed scientific publications 4 = Verified data
-
-
Vapour pressure at 20 °C (mPa)
2.09 X 10-23
R4 R = Peer reviewed scientific publications 4 = Verified data
Low volatility
Henry's law constant at 25 °C (Pa m³ mol⁻¹)
4.8 X 10-22
R4 R = Peer reviewed scientific publications 4 = Verified data
Non-volatile
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
-
Soil degradation (days) (aerobic)
DT₅₀ (typical)
30
R3 R = Peer reviewed scientific publications 3 = Unverified data of known source
Moderately persistent
DT₅₀ (lab at 20 °C)
-
-
-
DT₅₀ (field)
-
-
-
DT₉₀ (lab at 20 °C)
-
-
-
DT₉₀ (field)
-
-
-
DT₅₀ modelling endpoint
-
-
-
Note
General literature DT₅₀ range >30 days (R3)
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)
Low risk
Q3 Q = Miscellaneous data from online sources 3 = Unverified data of known source
Based on LogP < 3
Low risk
CT₅₀ (days)
-
-
Known metabolites
None
ECOTOXICOLOGY
Terrestrial ecotoxicology
Property
Value
Source; quality score; and other information
Interpretation
Mammals - Acute oral LD₅₀ (mg kg⁻¹)
> 1500
V3 V = ChemID Online Databases; Chemspider; PubChem. (ChemID ) 3 = Unverified data of known source
F3 F = U.S. EPA ECOTOX database / U.S. EPA pesticide fate database / Miscellaneous WHO documents / FAO data, IPCS INCHEM data (US EPA Databases Related to Pesticide Risk Assessment ) 3 = Unverified data of known source
F3 F = U.S. EPA ECOTOX database / U.S. EPA pesticide fate database / Miscellaneous WHO documents / FAO data, IPCS INCHEM data (US EPA Databases Related to Pesticide Risk Assessment ) 3 = Unverified data of known source
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
