Oxytetracycline hydrochloride	Last updated: 30/06/2022
(Also known as: terramycin; oxytracyl; oxytetrin; terramitsin; oxitetracycline; crop antibiotic)

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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: Potential for particle bound transport: Medium	Ecotoxicity Moderate alert: Bees acute unknown ecotoxicity: Moderate	Human health Moderate alert: Possible Reproduction/development effects

GENERAL INFORMATION

Description	A highly active broad spectrum antibiotic used to control infection animals diseses and bacterial pathogens
Availability status	Current
Introduction & key dates	-
Examples of species treated	Calves, Non-lactating dairy cattle, Beef, Pigs, Fish, Poultry, Cats, Dogs

Chemical structure

Isomerism	A complex molecule with 6 chiral centres
Chemical formula	C₂₂H₂₅ClN₂O₉
Canonical SMILES	CC1(C2C(C3C(C(=O)C(=C(C3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O)O.Cl
Isomeric SMILES	C[C@@]1([C@H]2[C@@H]([C@H]3[C@@H](C(=O)C(=C([C@]3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O)O.Cl
International Chemical Identifier key (InChIKey)	SVDOODSCHVSYEK-IFLJXUKPSA-N
International Chemical Identifier (InChI)	-
2D structure diagram/image available?	Yes

Cambridge Crystallographic Data Centre diagrams

Common Name	Relationship	Link
oxytratracycline	Parent

General status

Veterinary substance type	Bactericide, Antimicrobial, Antiseptic
Substance groups	Micro-organism derived substance
Minimum active substance purity	-
Known relevant impurities	-
Substance origin	Natural
Mode of action	Broad spectrum, protein synthesis inhibitor and binds to the 30S and 50S bacterial ribosomal subunits
Molecular targets	[30S ribosomal protein S9, antagonist], [30S ribosomal protein S4, antagonist], [16S rRNA, antagonist]
CAS RN	2-58-46-0
EC number	218-161-2
CIPAC number	-
US EPA chemical code	-
PubChem CID	-
ATCvet Code	QD06AA03 for topical use; QJ01AA06 for systemic use; Others available
Therapeutic Class	Dermatologicals: Antibiotics and chemotherapeutics for dermatological use; Antiinfectants for systemic use: Antibacterials for systemic use
Controlled Drug?	No
Regulation 37/2010 MRL Classification	Allowed substance (Table 1: All food producing species)
Molecular mass	496.90
PIN (Preferred Identification Name)	(4S,4aR,5S,5aR,6S,12aR)-4-(dimethylamino)-1,5,6,10,11,12a-hexahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride
IUPAC name	(4S,4aR,5S,5aR,6S,12aR)-4-(dimethylamino)-1,5,6,10,11,12a-hexahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride
CAS name	-
Other status information	Possible groundwater contaminant
Relevant Environmental Water Quality Standards	-
Physical state	Yellow crystalline powder
Related substances & organisms	copper sulphate

Formulations

Property	Product	Manufacturer	Authorisation Route	UK Legal Class
Example products using this active	Alamycin LA Injection 300mg/ml	Norbrook Labs	UK National authorisation	Prescription only medicine to be authorised by a veterinarian (POM-V)
	Engemycin DD Solution for Injection	Intervet International	EU Mutually recognised procedure	Prescription only medicine to be authorised by a veterinarian (POM-V)
	Alamycin Aerosol 3.58% w/w Cutaneous Spray, Solution	Norbrook Laboratories Limited	UK National authorisation	Prescription only medicine to be authorised by a veterinarian (POM-V)
	Cyclosol LA 200mg/ml Solution for Injection	Eurovet Animal Health B.V.	EU Mutually recognised procedure	Prescription only medicine to be authorised by a veterinarian (POM-V)
Formulation and application details	Supplied as a water soluble powder for preparation as injection when used as a veterinary product. For crop protection it is used as a foliar spray

ENVIRONMENTAL FATE

Property		Value	Source; quality score; and other information	Interpretation
Solubility - In water at 20 °C (mg l⁻¹)		1000	R4 R = Peer reviewed scientific publications 4 = Verified data	High
Solubility - In organic solvents at 20 °C (mg l⁻¹)		-	-	-
Melting point (°C)		121	L3 L = Pesticide manuals and hard copy reference books / other 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	6.03 X 10-02	Calculated	-
	Log P	-1.22	R4 R = Peer reviewed scientific publications 4 = Verified data	Low
Fat solubility of residues	Solubility	-	-	-
	Data type	-	-	-
Density (g ml⁻¹)		1.63	Q2 Q = Miscellaneous internet resources 2 = Unverified data of unknown source	-
Dissociation constant pKa) at 25 °C		4.5	R4 R = Peer reviewed scientific publications 4 = Verified data	-
		Weak acid
Vapour pressure at 20 °C (mPa)		1.29 X 10-19	V3 V = ChemID online databases / IPCS INCHEM (ChemID; IPCS INCHEM ) 3 = Unverified data of known source at 25 °C	Low volatility
Henry's law constant at 25 °C (Pa m³ mol⁻¹)		1.72 X 10-20	V3 V = ChemID online databases / IPCS INCHEM (ChemID; IPCS INCHEM ) 3 = Unverified data of known source at 25 °C	Non-volatile
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)	18	R4 R = Peer reviewed scientific publications 4 = Verified data	Non-persistent
	DT₅₀ (lab at 20 °C)	21	F3 F = U.S. EPA ECOTOX database / U.S. EPA pesticide fate database / Miscellaneous WHO documents (US EPA Databases Related to Pesticide Risk Assessment ) 3 = Unverified data of known source	Non-persistent
	DT₅₀ (field)	-	-	-
	DT₉₀ (lab at 20 °C)	-	-	-
	DT₉₀ (field)	-	-	-
	Note	Literature estimates give DT₅₀ 1 to 10 wks
Manure DT₅₀ (days)		43.8	R4 R = Peer reviewed scientific publications 4 = Verified data Aerobic sediment slurry; Other data 79 days slurry	-
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)		9	R3 R = Peer reviewed scientific publications 3 = Unverified data of known source	Moderately fast

Soil adsorption and mobility

Property		Value	Source; quality score; and other information	Interpretation
Linear	Kd	698	R4 R = Peer reviewed scientific publications 4 = Verified data	Non-mobile
	Koc	52875
	Notes and range	Literature data: Kd range 417-1626 mL g⁻¹, Koc range 27792-93317 mL g⁻¹, soils=4; Other Literature data 27792-93317 generally quoted for tetracyclines (R4)
Freundlich	Kf	-	-	-
	Kfoc	-
	1/n	-
	Notes and range	-
pH sensitivity		-

Fate indices

Property		Value	Source; quality score; and other information	Interpretation
GUS leaching potential index		-0.96	Calculated	Low leachability
Bio-concentration factor	BCF (l kg⁻¹)	0.6	J2 J = Pesticide Action Network database (click here ) 2 = Unverified data of unknown source Mollusca	Low potential
	CT₅₀ (days)	Not available		-

Known metabolites

None

ECOTOXICOLOGY

Terrestrial ecotoxicology

Property		Value	Source; quality score; and other information	Interpretation
Mammals - Acute oral LD₅₀ (mg kg⁻¹)		> 4800	V3 V = ChemID online databases / IPCS INCHEM (ChemID; IPCS INCHEM ) 3 = Unverified data of known source Rat	Low
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)		> 5620	F4 F = U.S. EPA ECOTOX database / U.S. EPA pesticide fate database / Miscellaneous WHO documents (US EPA Databases Related to Pesticide Risk Assessment ) 4 = Verified data Anas platyrhynchos	Low
Birds - Short term dietary (LC₅₀/LD₅₀)		-	-	-
Birds - Chronic 21d NOEL (mg kg⁻¹ bw d⁻¹)		-	-	-
Earthworms - Acute 14 day LC₅₀ (mg kg⁻¹)		1954	R4 R = Peer reviewed scientific publications 4 = Verified data	Low
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)	100	F3 F = U.S. EPA ECOTOX database / U.S. EPA pesticide fate database / Miscellaneous WHO documents (US EPA Databases Related to Pesticide Risk Assessment ) 3 = Unverified data of known source	Moderate
	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 pollinators (1)	Acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg insect⁻¹)	-	-	-
	Mode of exposure	-
Other pollinators (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)		116	F4 F = U.S. EPA ECOTOX database / U.S. EPA pesticide fate database / Miscellaneous WHO documents (US EPA Databases Related to Pesticide Risk Assessment ) 4 = Verified data Oncorhynchus mykiss	Low
Fish - Chronic 21 day NOEC (mg l⁻¹)		-	-	-
Aquatic invertebrates - Acute 48 hour EC₅₀ (mg l⁻¹)		102	F4 F = U.S. EPA ECOTOX database / U.S. EPA pesticide fate database / Miscellaneous WHO documents (US EPA Databases Related to Pesticide Risk Assessment ) 4 = Verified data Daphnia magna	Low
Aquatic invertebrates - Chronic 21 day NOEC (mg l⁻¹)		46.2	R3 R = Peer reviewed scientific publications 3 = Unverified data of known source 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)		0.342	R4 R = Peer reviewed scientific publications 4 = Verified data Selenastrum capricornutum	Moderate
Algae - Chronic 96 hour NOEC, growth (mg l⁻¹)		0.183	R4 R = Peer reviewed scientific publications 4 = Verified data Selenastrum capricornutum	Moderate
Mesocosm study data	NOEAEC mg l⁻¹	-	-	-
	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)		> 4800	V3 V = ChemID online databases / IPCS INCHEM (ChemID; IPCS INCHEM ) 3 = Unverified data of known source Rat	Low
Mammals - Dermal LD₅₀ (mg kg⁻¹ body weight)		5700	L3 L = Pesticide manuals and hard copy reference books / other sources 3 = Unverified data of known source Mouse	-
Mammals - Inhalation LC₅₀ (mg l⁻¹)		-	-	-
Other Mammal toxicity endpoints		Intraperitoneal LD₅₀ = 260 mg kg⁻¹	V3 V = ChemID online databases / IPCS INCHEM (ChemID; IPCS INCHEM ) 3 = Unverified data of known source Mouse	-
		Intravenous LD₅₀ = 260 mg kg⁻¹	V3 V = ChemID online databases / IPCS INCHEM (ChemID; IPCS INCHEM ) 3 = Unverified data of known source 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		Systemically available oxytetracycline was primarily excreted in the urine and bile	Q3 Q = Miscellaneous internet resources 3 = Unverified data of known source	-

Health issues

Specific human health issues		Carcinogen Genotoxic Endocrine disruptor XNo, known not to cause a problem 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 ?Possibly, status not identified XNo, known not to cause a problem XNo, known not to cause a problem Respiratory tract irritant Skin irritant Skin sensitiser XNo, known not to cause a problem ✓Yes, known to cause a problem ?Possibly, status not identified Eye irritant Phototoxicant   ✓Yes, known to cause a problem No data found
General human health issues		May cause hypersensitivity reactions May cause tooth discoloration

Handling issues

Property	Value and interpretation
General	No information available
CLP classification 2013	-
WHO Classification	NL (Not listed)
UN Number	-
Waste disposal & packaging	-

TRANSLATIONS

Language	Name
English	oxytetracycline hydrochloride
French	oxytetracycline
German	Oxytetracyclin
Danish	oxytetracyclin
Italian	oxytetracicline
Spanish	oxitetraciclina
Greek	-
Polish	oksytetracyklina
Swedish	-
Hungarian	-
Dutch	-

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Record last updated:	30/06/2022
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