Bacillus thuringiensis subsp. israelensis strain AM65-52 (Ref: SAN402)

Bacillus thuringiensis subsp. israelensis strain AM65-52 (Ref: SAN402)	Last updated: 25/08/2025
(Also known as: Bacillus thuringiensis; Bt; Bti)

Hazard 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. These hazard alerts do not take account of usage patterns or exposure, thus do not represent risk.

Environmental fate	Ecotoxicity	Human health
Environmental fate Moderate alert: Potential for particle bound transport: Medium	Ecotoxicity Moderate alert: Daphnia acute ecotoxicity: Moderate	Human health Low alert

GENERAL INFORMATION

Description

A specific strain of the bacterial insecticide Bt selected for its control of Diptera species

Example pests controlled

Diptera species such as mosquito larvae, fungus gnats, blackfly larvae

Example applications

Water environments: Glasshouses: Mushroom houses; Ornamentals

Efficacy & activity

Appearance and life cycle

Bacillus cultures are found in nature in one of two states. They are found either as vegetative cells that are actively growing and dividing or as spores.

Taxonomic classification

Class: Bacilli; Order: Bacillales; Family: Bacillaceae

GB regulatory status

GB COPR regulatory status

Approved

Date COPR inclusion expires

30/04/2029

GB LERAP status

None

EC Regulation 1107/2009 (repealing 91/414)

EC Regulation 1107/2009 status

Approved

Dossier rapporteur/co-rapporteur

Sweden/Spain

Date EC 1107/2009 inclusion expires

30/06/2038

EU Candidate for substitution (CfS)

Listed in EU database

Yes

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

Known to be also used in the following countries

India, USA, South Africa, China, Australia

Chemical structure

Isomerism

Not applicable

Chemical formula

Canonical SMILES

Isomeric SMILES

International Chemical Identifier key (InChIKey)

International Chemical Identifier (InChI)

2D structure diagram/image available?

General status

Biopesticide type

Insecticide; Other substance

Other bioactivity & uses

Bactericide

Substance groups

Micro-organism

Minimum active substance purity

Known relevant impurities

EU 2018 dossier - none reported

Substance origin

Natural

Mode of action

Stomach poison. Microbial disruptor of insect midgut membranes.

Substance source

Isolates occur widely in soils and in most insect-rich environments

Uses

General pest management

Target pests

Diptera species such as mosquito larvae, fungus gnats, blackfly larvae

Target host

Water environments: Glasshouses: Mushroom houses; Ornamentals

Farming system suitability

Suitable for use in all farming systems where approved for use in that country

CAS RN

68038-71-1

EC number

CIPAC number

770

US EPA chemical code

PubChem CID

Molecular mass

35792.0

Chemical name

Bacillus thuringiensis Israelensis (serotype H14) strain AM65-52

PIN (Preferred Identification Name)

IUPAC name

CAS name

Forever chemical

Other status information

Relevant Environmental Water Quality Standards

Herbicide Resistance Class (HRAC MoA class)

Not applicable

Herbicide Resistance Class (WSSA MoA class)

Not applicable

Insecticide Resistance Class (IRAC MoA class)

11A

Fungicide Resistance Class (FRAC MOA class)

Not applicable

Examples of recorded resistance

Many cases reported

Physical state

Bacterium

Related substances & organisms

Bacillus thuringiensis subsp. aizawai strain GC-91

Bacillus thuringiensis Berliner subsp. japonensis

Bacillus thuringiensis subsp. kurstaki strain ABTS 351

Bacillus thuringiensis Berliner subsp. morrisoni

Commercial

Property

Value

Availability status

Current

Introduction & key dates

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

Granular Products Assets Pty Ltd
Arbico
Beneficial Insect Company
Valent Biosciences Corp

Example products using this active

GP MozX Biological Larvicide
Bacillus thuringiensis israelensis
Vectobac (Gnatrol)

Formulation and application details

Often supplied as aqueous suspensions, flowable concentrates and water dispersible granules. Frequent applications required.

Commercial production

Commercial production of Bacillus species typically involves large-scale aerobic fermentation. The process begins with selecting a robust strain, often genetically optimised for yield and stability. These bacteria are cultivated in bioreactors under tightly controlled conditions, temperature (usually 30–37 degrees C), pH (neutral to slightly alkaline), and oxygen levels are carefully regulated to maximise growth and productivity. Nutrient-rich media, often containing glucose or other carbon sources, support rapid biomass accumulation. After fermentation, the culture is harvested, and the desired products, such as enzymes or spores, are extracted and purified.

Impact on climate of production and use

As microbial-based biopesticide production processes tend to use fermentation-based production rather than chemical synthesis, have a lower fossil fuel input in formulation and active ingredient creation, and have reduced downstream emissions due to biodegradability and minimal soil disruption, the life-cycle GHG emissions are expected to be low. Whilst hard and precise data are 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)

Moderate

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

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)

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)

2.7

Non-persistent

DT₅₀ (lab at 20 °C)

2.7

Non-persistent

DT₅₀ (field)

DT₉₀ (lab at 20 °C)

DT₉₀ (field)

DT₅₀ modelling endpoint

Note

Other sources DT₅₀s up to 120days

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

K_d (mL g⁻¹)

Non-mobile

K_oc (mL g⁻¹)

5000

Notes and range

Estimated

Freundlich

K_f (mL g⁻¹)

K_foc (mL g⁻¹)

¹/_n

Notes and range

pH sensitivity

Known metabolites

None

ECOTOXICOLOGY

Terrestrial ecotoxicology

Property

Value

Source; quality score; and other information

Interpretation

Mammals - Acute oral LD₅₀ (mg kg⁻¹)

> 5000

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)

> 5000

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)

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

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)

> 100

Low

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

> 108.0

Low

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)

Harmless

Aphidius rhopalosiphi

Beneficial insects (Predatory mites)

Beneficial insects (Ground beetles)

Aquatic ecotoxicology

Property

Value

Source; quality score; and other information

Interpretation

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

> 370

Oncorhynchus mykiss

Low

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)

> 50

Daphnia magna 10 day

Moderate

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)

Not applicable

Mammals - Acute oral LD₅₀ (mg kg⁻¹)

> 5000

Rat

Low

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

5000

Rabbit

Mammals - Inhalation LC₅₀ (mg l⁻¹)

Other Mammal toxicity endpoints

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

None allocated

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

None allocated

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

None allocated

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

None allocated

Dermal penetration studies (%)

Dangerous Substances Directive 76/464

Exposure Routes

Public

Public are unlikely to be exposed due to patterns of use

Occupational

Negliglible due to patterns of use and low toxicological concerns

Mammalian dose elimination route and rate

Bt does not persist in the digestive systems of mammals that ingest it

Health issues

Specific human health issues

Carcinogen

Genotoxic

Endocrine disruptor

; ; ; ;

Reproduction / development effects

Acetyl cholinesterase inhibitor

Neurotoxicant

Respiratory tract irritant

Skin irritant

Skin sensitiser

Eye irritant

Phototoxicant

No data found

General human health issues

Microorganisms may have the potential to provoke sensitising reactions

Handling issues

Property

Value and interpretation

General

No information available

CLP classification 2013

Health: H317, H319, H334, H335

WHO Classification

III (Slightly hazardous)

UN Number

Waste disposal & packaging

Shelf-life, storage, stability and reactivity

TRANSLATIONS

Language

Name

English

Bacillus thuringiensis subsp. israelensis strain AM65-52

French