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BACILLUS THURINGIENSIS

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Bacillus thuringiensis is a micro-organism that is used as an insecticide. It is being used extensively in the control of gypsy moths. To date, B. thuringiensis strains are not considered serious pathogens and spray programs utilizing various varieties have not been associated with a specific illness pattern in animals or man.
    B) Within the synonym listing of this document, "*" denotes subspecies utilized commercially.

Specific Substances

    A) SYNONYMS FOR THE GROUP
    1) B. thuringiensis
    2) Bacillus thuringiensis
    3) Bt
    4) CONSTITUENTS OF THE GROUP
    a) aizawai
    b) alesti
    c) canadensis
    d) darmstadiensis
    e) dendrolimus
    f) entomocidus
    g) finitimus
    h) galleriare
    i) indianae
    j) israelensis*
    k) kenyae
    l) kumamotoensis
    m) kurstaki*
    n) kyushuensis
    o) morrisoni
    p) ostriniae
    q) pakistani
    r) sotto
    s) subtoxicus
    t) thompsoni
    u) thuringiensis
    v) tochigiensis
    w) tohokuensis
    x) tolworthi
    y) toummanoffi
    z) yunnanensis
    aa) wuhanensis

Available Forms Sources

    A) FORMS
    1) There are 28 subspecies (or varieties) of B. thuringiensis known (Himeno, 1987).
    2) The insecticidal product contains roughly 2.5 x 10(11) viable spores per gram and is applied to crops as a powder via the air (Hayes & Jr, 1982).
    3) The strains used commercially are thought not to produce the exotoxin that has a harmful effect on mammals (Lilley et al, 1980).
    B) USES
    1) This Bacillus is being used extensively in the control of gypsy moths (Dubois et al, 1993), with few reported side effects (Anon, 1986).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) Human experience is limited. To date, B. thuringiensis strains are not considered serious pathogens and spray programs utilizing various varieties have not been associated with specific illness patterns in animals or humans.
    B) There have been a few isolated reports where this agent appeared to produce a Bacillus cereus group-like food poisoning with an incubation period of about 8 hours. Many exposed individuals do NOT develop symptoms.
    C) ANIMALS show fever, appetite loss, hematological changes and electrolyte changes post B. thuringiensis var galleriae administration via oral, intravenous, intranasal, and intradermal routes.
    0.2.8) GASTROINTESTINAL
    A) Vomiting, nausea, diarrhea, and abdominal pains have been seen in patients exposed to food contaminated with this agent.

Laboratory Monitoring

    A) This bacteria may be isolated via standard bacteriologic methods. Isolation and identification of the endo and exotoxins is beyond most hospital laboratory capabilities.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) ACTIVATED CHARCOAL: Administer charcoal as a slurry (240 mL water/30 g charcoal). Usual dose: 25 to 100 g in adults/adolescents, 25 to 50 g in children (1 to 12 years), and 1 g/kg in infants less than 1 year old.
    B) Symptoms, if they appear, are those of bacterial food poisoning. Monitor the patient for fluid and electrolyte loss. Control vomiting and diarrhea as needed. Treatment is supportive; there is no antidote.
    0.4.3) INHALATION EXPOSURE
    A) INHALATION: Move patient to fresh air. Monitor for respiratory distress. If cough or difficulty breathing develops, evaluate for respiratory tract irritation, bronchitis, or pneumonitis. Administer oxygen and assist ventilation as required. Treat bronchospasm with an inhaled beta2-adrenergic agonist. Consider systemic corticosteroids in patients with significant bronchospasm.
    0.4.4) EYE EXPOSURE
    A) DECONTAMINATION: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, the patient should be seen in a healthcare facility.
    0.4.5) DERMAL EXPOSURE
    A) OVERVIEW
    1) DECONTAMINATION: Remove contaminated clothing and jewelry and place them in plastic bags. Wash exposed areas with soap and water for 10 to 15 minutes with gentle sponging to avoid skin breakdown. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).

Range Of Toxicity

    A) Doses of 1 gram of a preparation containing 3 x 10(9) spores orally in 100 mg of the same powder (taken at the same time for 5 days on alternate days) failed to produce symptoms.
    B) The strains used commercially are thought not to produce the exotoxin that has a harmful effect on mammals.

Clinical Effects

Summary Of Exposure

    A) Human experience is limited. To date, B. thuringiensis strains are not considered serious pathogens and spray programs utilizing various varieties have not been associated with specific illness patterns in animals or humans.
    B) There have been a few isolated reports where this agent appeared to produce a Bacillus cereus group-like food poisoning with an incubation period of about 8 hours. Many exposed individuals do NOT develop symptoms.
    C) ANIMALS show fever, appetite loss, hematological changes and electrolyte changes post B. thuringiensis var galleriae administration via oral, intravenous, intranasal, and intradermal routes.

Vital Signs

    3.3.3) TEMPERATURE
    A) FEVER was noted in patients who ingested food contaminated with B. thuringiensis (Pivovarov et al, 1977).

Heent

    3.4.3) EYES
    A) CASE REPORT - CORNEAL ULCER was reported in one human case when B. thuringiensis was splashed in the eyes (Samples & Buettner, 1983).

Gastrointestinal

    3.8.1) SUMMARY
    A) Vomiting, nausea, diarrhea, and abdominal pains have been seen in patients exposed to food contaminated with this agent.
    3.8.2) CLINICAL EFFECTS
    A) NAUSEA AND VOMITING
    1) Vomiting and nausea were seen in patients exposed to food contaminated with B. thuringiensis (Pivovarov et al, 1977).
    B) DIARRHEA
    1) Diarrhea and tenesmus were seen in patients exposed to food contaminated with B. thuringiensis (Pivovarov et al, 1977).
    C) ABDOMINAL PAIN
    1) Colic-like pains were seen in patients exposed to food contaminated with B. thuringiensis (Pivovarov et al, 1977).
    D) GASTROENTERITIS
    1) In an outbreak of gastroenteritis in a chronic care institution, B. thuringiensis was isolated from 4 affected patients. In 3 patients, no other enteric pathogen was discovered. Symptoms of patients included nausea, vomiting, and watery diarrhea. The authors suggested that B. thuringiensis be considered in otherwise unexplained cases of foodborne disease (Jackson et al, 1995).

Hematologic

    3.13.2) CLINICAL EFFECTS
    A) INJECTION SITE REACTION
    1) HEMATOMA - When the endotoxin from B. israelensis is injected subcutaneously, a severe hematoma occurs around the injection site (Warren et al, 1984).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) INJECTION SITE REACTION
    1) INFECTION - Accidental injection in the hand of a mixture of B. thuringiensis var israelensis and Acinetobacter calcoaceticus caused local infection (Warran et al, 1984).

Immunologic

    3.19.2) CLINICAL EFFECTS
    A) CONTACT SENSITIVITY RESPONSE
    1) In a study of immune responses in farm workers, exposure to B. thuringiensis pesticide spray was associated with positive skin prick tests to spore extracts 1 to 4 months after exposure. In addition, skin prick tests were significantly higher in workers exposed to high levels of pesticide spray compared to those worker with medium or low exposure. Specific IgE antibodies and IgG antibodies were more prevalent in the high exposure group, indicating allergic sensitization (Bernstein et al, 1999). There was no evidence of exposure-related respiratory symptoms among the workers.
    B) LACK OF INFORMATION
    1) The effect of B. thuringiensis on immunosuppressed individuals or those people with chronic respiratory diseases has not been conclusively studied (Elliott et al, 1988).
    3.19.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LACK OF EFFECT
    a) GUINEA PIGS were tested via topical application, intradermal injection, and inhalation. No allergic responses were elicited (Hayes & Jr, 1982).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS68038-71-1 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) This bacteria may be isolated via standard bacteriologic methods. Isolation and identification of the endo and exotoxins is beyond most hospital laboratory capabilities.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) Monitor fluid and electrolytes if vomiting and diarrhea have been extensive.

Methods

    A) OTHER
    1) The bacteria can be isolated via standard bacteriology methods. Isolation and identification of the endo and exotoxins is beyond most hospital laboratory capabilities.

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) This bacteria may be isolated via standard bacteriologic methods. Isolation and identification of the endo and exotoxins is beyond most hospital laboratory capabilities.

Oral Exposure

    6.5.2) PREVENTION OF ABSORPTION
    A) SUMMARY
    1) In most cases gastrointestinal decontamination will not be necessary. If large amounts (greater than several grams of the powder) are ingested, and the patient is found early, decontamination may be attempted. It is uncertain if this will prevent infection.
    B) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) SUPPORT
    1) There is no specific antidote. Control vomiting and diarrhea as necessary. Monitor for fluid and electrolyte loss.

Inhalation Exposure

    6.7.1) DECONTAMINATION
    A) Move patient from the toxic environment to fresh air. Monitor for respiratory distress. If cough or difficulty in breathing develops, evaluate for hypoxia, respiratory tract irritation, bronchitis, or pneumonitis.
    B) OBSERVATION: Carefully observe patients with inhalation exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    C) INITIAL TREATMENT: Administer 100% humidified supplemental oxygen, perform endotracheal intubation and provide assisted ventilation as required. Administer inhaled beta-2 adrenergic agonists, if bronchospasm develops. Consider systemic corticosteroids in patients with significant bronchospasm (National Heart,Lung,and Blood Institute, 2007). Exposed skin and eyes should be flushed with copious amounts of water.

Eye Exposure

    6.8.1) DECONTAMINATION
    A) EYE IRRIGATION, ROUTINE: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, an ophthalmologic examination should be performed (Peate, 2007; Naradzay & Barish, 2006).

Dermal Exposure

    6.9.1) DECONTAMINATION
    A) DERMAL DECONTAMINATION
    1) DECONTAMINATION: Remove contaminated clothing and wash exposed area thoroughly with soap and water for 10 to 15 minutes. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).

Abstracts

Case Reports

    A) ROUTE OF EXPOSURE
    1) ORAL: Three of 4 volunteers who ingested food contaminated with 1 x 10(5) to 1 x 10(9) cells per 1 gram of Bacillus thuringiensis var galleriae developed nausea, vomiting, diarrhea, fever, colic-like abdominal pains, and tenesmus. The incubation period was 8 hours (Pivovarov et al, 1977).
    2) ORAL/INHALATION - Eighteen volunteers ingested 1 gram of a B. thuringiensis product which contained 3 x 10(9) spores daily for 5 days on alternate days. Five of this group also inhaled 100 mg of this same powder daily for 5 days. No signs or symptoms were noted (Fisher & Rosner, 1959).
    3) INHALATION: Workers exposed for 7 months to the fermentation broth, moist bacterial cake, efferent, and the commercial powder developed no symptoms (Hayes & Jr, 1982).

Range Of Toxicity

Summary

    A) Doses of 1 gram of a preparation containing 3 x 10(9) spores orally in 100 mg of the same powder (taken at the same time for 5 days on alternate days) failed to produce symptoms.
    B) The strains used commercially are thought not to produce the exotoxin that has a harmful effect on mammals.

Maximum Tolerated Exposure

    A) GENERAL/SUMMARY
    1) Doses of 1 gram of a preparation containing 3 x 10(9) spores orally and 100 milligrams of the sample powder (taken at the same time) for 5 days on alternate days, failed to produce symptoms (Fisher & Rosner, 1959).
    2) Food contaminated with 1 x 10(5) to 1 x 10(9) cells/gram did produce bacterial food poisoning symptoms in 3 of 4 human volunteers (Pivovarov et al, 1977).

Workplace Standards

    A) ACGIH TLV Values for CAS68038-71-1 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS68038-71-1 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS68038-71-1 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS68038-71-1 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) Soluble B. thuringiensis var israelensis endotoxin

Pharmacology Toxicology

Toxicologic Mechanism

    A) B. thuringiensis produces at least 4 endotoxins (alpha, beta, gamma, and delta) and two exotoxins in crystalline protein bodies (Hayes & Jr, 1982; VanKova, 1978; Himeno, 1987).
    B) Many different toxins are produced. Two strains of the sample species may not produce the same toxins, and even the same strain may produce different toxins under different environmental conditions (Anderson & Rogoff, 1966).
    C) Endotoxins: Are thermosensitive, proteinaceous, and occur as a parasporal crystal.
    1) Insects may die either through sensitivity to the crystalline toxin (which causes death before vegetative growth of the spores) or by a true infection that injures cells of the insect's gut wall (Anderson & Rogoff, 1966).
    2) The alpha toxin is a lecithinase or phospholipase (Luty, 1980).
    3) The beta toxin (fly toxin) is heat stable, and a nucleotide derivative and RNA synthesis inhibitor (Himeno, 1987).
    4) Gamma toxin is an exoenzyme thought to be a lecithinase, chitinase, or protease. It is insecticidal.
    5) The delta-endotoxin specific for lepidopteran or coleapteran larva consists of two peptides of molecular weight 6.5 kilodalton (Kd). There is a dipteran specific delta endotoxin which has one peptide of molecular weight 2.8 Kd.
    a) The delta endotoxin, upon ingestion, causes swelling of midgut cells and an elevation of K+ concentration and pH of the hemolymph. This is seen in insect, not mammalian cells (in vitro) (Himeno, 1987). It causes the insect to stop feeding and die a few days later from an apparent paralysis (Tyski et al, 1986).
    b) The dipteran specific delta endotoxin has cytolytic activity for insect and mammalian cells (in vitro), is hemolytic for mammalian erythrocytes, is neurotoxic for cockroaches, and entomocidal for mosquito larvae (Himeno, 1987).
    D) Exotoxins: One is proteinaceous and thermosensitive and is highly toxic to mice; the other has a nucleotide structure and is thermostabile and is toxic to insects, but not mice (Hayes & Jr, 1982).
    1) IN PLANTS - The exotoxin thuringiensin A from Bacillus thuringiensis inhibits spindles and cytokinesis. It also induces micronuclei, chromocentric nuclei, and minor changes in spindle activity. Chromosomes and microtubules appear to be the primary targets. It has an effect similar to the spindle poison colchicine (Sharma & Sahu, 1977).
    2) Since thuringiensin A is a spindle poison in plants, there is some concern that this insecticide would be a plant mutagen when sprayed on plants (Sharma & Sahu, 1977).
    E) The vegetative and spore forms are not virulent in mice (Krieg, 1970).
    F) In rabbit erythrocytes, B. thuringiensis var israelensis causes red blood cell hemolysis of the colloid-osmotic type (Weinstein et al, 1988).

References

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