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DAMINOZIDE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Daminozide is an organic acid used as a translocated plant growth regulator.
    B) Toxicity may be related to the contamination or breakdown product, unsymmetrical dimethylhydrazine (UDMH). Refer to "HYDRAZINES" management for further information.
    C) Daminozide was voluntarily withdrawn from the market in the United States in 1989, due to concerns over potential carcinogenicity (Anon, 1989).

Specific Substances

    1) Aminozide
    2) Butanedioic acid mono (2,2-dimethylhydrazide)
    3) Dimethyl-amino-beta-carbamyl propionic acid
    4) Dimethylaminosuccinamic acid
    5) DMASA
    6) DMSA
    7) Mono(2,2-dimethylhydrazide) succinic acid
    8) Succinic acid 2,2-dimethylhydrazide
    9) Succinic,1,1-dimethylhydrazide
    10) Alar
    11) Aminocide
    12) B-995
    13) B-Nine
    14) Dimas
    15) Kylar
    16) Sadh
    17) B995
    18) DMASA (DAMINOZIDE)
    19) DMSA (DAMINOZIDE)

Available Forms Sources

    A) SOURCES
    1) Daminozide was originally developed by Uniroyal Chemical and sold under a number of brand names.
    2) Daminozide was voluntarily withdrawn from the market in the United States in 1989, due to concerns over potential carcinogenicity (Anon, 1989).
    B) USES
    1) This product is used as a plant growth regulator. It reduces internode elongation, induces heat, drought, and frost resistance, produces darker foliage and stronger stems, and produces earlier and multiple flowers and fruits. A spray is often applied at a rate of 1500 to 10,000 ppm.

Overview

Life Support

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

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) There are little data on mammalian toxicity. No human case reports could be found. Toxicity may be related to the contamination or breakdown product, unsymmetrical dimethylhydrazine (UDMH). Refer to "HYDRAZINES" management for further information.
    B) ANIMALS - Based on laboratory animal data, this material should be low in toxicity (LD50=6,810 to 8,000 mg/kg). The primary toxic effects seen in animals include ptosis, CNS depression, GI irritation, and possibly liver function abnormalities.
    0.2.4) HEENT
    A) Fatally poisoned animals developed ptosis. Instilled daminozide solutions caused only mild irritation in the eyes.
    0.2.7) NEUROLOGIC
    A) CNS depression was reported in fatally poisoned animals.
    0.2.8) GASTROINTESTINAL
    A) Gastrointestinal irritation and diarrhea were noted in animals fatally poisoned.
    0.2.9) HEPATIC
    A) Liver function abnormalities were reported by one author in animals administered large doses.
    0.2.20) REPRODUCTIVE
    A) No teratogenic effects were seen in rats.
    0.2.21) CARCINOGENICITY
    A) Preliminary data show that a metabolite of daminozide produced tumors in mice at extremely high dose levels. Daminozide was determined not to represent an imminent health hazard by the EPA.

Laboratory Monitoring

    A) No toxic levels have been established. No consistent abnormal laboratory values have been seen except for abnormal liver function tests in one group of animals.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) Toxicity may be related to the contamination or breakdown product, unsymmetrical dimethylhydrazine (UDMH). Refer to "HYDRAZINES" management for further information.
    B) No specific treatment is yet indicated for daminozide. Patients should be monitored for CNS depression, ptosis, and liver function abnormalities if significant amounts (greater than 8 grams) have been taken.
    C) For amounts greater than a swallow of the 85% solution, gastric decontamination by activated charcoal may be indicated.
    D) 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.

Range Of Toxicity

    A) Rats have been given up to 43,200 ppm in their diets without demonstrable effect. The LD50 in rats orally is 8,400 mg/kg, and dermally for rabbits is greater than 1600 mg/kg.
    B) Human data on range of toxicity are not available.

Clinical Effects

Summary Of Exposure

    A) There are little data on mammalian toxicity. No human case reports could be found. Toxicity may be related to the contamination or breakdown product, unsymmetrical dimethylhydrazine (UDMH). Refer to "HYDRAZINES" management for further information.
    B) ANIMALS - Based on laboratory animal data, this material should be low in toxicity (LD50=6,810 to 8,000 mg/kg). The primary toxic effects seen in animals include ptosis, CNS depression, GI irritation, and possibly liver function abnormalities.

Heent

    3.4.1) SUMMARY
    A) Fatally poisoned animals developed ptosis. Instilled daminozide solutions caused only mild irritation in the eyes.
    3.4.3) EYES
    A) Fatally poisoned animals developed PTOSIS (Prod Info, 1963).
    B) When instilled into test animals' eyes, a solution was a mild irritant (Prod Info, 1977).

Neurologic

    3.7.1) SUMMARY
    A) CNS depression was reported in fatally poisoned animals.
    3.7.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) CNS DEPRESSION
    a) Fatally poisoned animals developed central nervous system depression (Prod Info, 1963).

Gastrointestinal

    3.8.1) SUMMARY
    A) Gastrointestinal irritation and diarrhea were noted in animals fatally poisoned.
    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) DIARRHEA
    a) Fatally poisoned animals developed diarrhea proportional to dose. Gastrointestinal irritation was noted in these animals at postmortem examination (Prod Info, 1963).

Hepatic

    3.9.1) SUMMARY
    A) Liver function abnormalities were reported by one author in animals administered large doses.
    3.9.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HEPATIC FUNCTION ABNORMAL
    a) Abnormalities have been mentioned when very large doses have been administered to animals (Grabliauskiene, 1974).
    b) HYDRAZINE DERIVATIVES at a DOSE OF 1/10 (LD50) INHIBIT microsomal oxidation, decrease dismutase activity, and activate lipid peroxidation in the rat hepatic microsomes (Koshkarian et al, 1988).

Reproductive

    3.20.1) SUMMARY
    A) No teratogenic effects were seen in rats.
    3.20.3) EFFECTS IN PREGNANCY
    A) LACK OF EFFECT
    1) RATS - No effect in pregnancy was seen in 3 generations of rats tested (Prod Info, 1966).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS1596-84-5 (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
    3.21.2) SUMMARY/HUMAN
    A) Preliminary data show that a metabolite of daminozide produced tumors in mice at extremely high dose levels. Daminozide was determined not to represent an imminent health hazard by the EPA.
    3.21.3) HUMAN STUDIES
    A) CARCINOMA
    1) In 1989, the National Resources Defense Council released claims that children face a massive public health problem from pesticide (especially ALAR) residues on food, claiming cancer risks are 100 times higher than estimated by the EPA.
    a) The data used by NRDC were rejected by an independent board in 1985 (Young et al, 1989).
    2) The EPA is currently reviewing preliminary data that show an increase in blood vessel tumors from UDMH at very high doses in mice (4 million times human exposure) and will continue to monitor daminozide residues to assess the hazard.
    a) As of March 16, 1989, the EPA did not feel there was an imminent health hazard and the use of daminozide has not been cancelled (Young et al, 1989).
    3) The estimated cancer risk of current dietary exposure to UDMH reported by EPA was 45 in a million (Anon, 1989). This is 45 times the "socially acceptable" risk as defined by EPA.
    4) Neither daminozide nor its contaminant and breakdown product, unsymmetrical dimethylhydrazine, were carcinogenic in one rapid in vivo rat bioassay (IPCS, 1992).
    5) UNSYMMETRICAL DIMETHYLHYDRAZINE (UDMH) is a contaminant and breakdown product of daminozide (IPCS, 1992). UDMH caused a significantly increased incidence of pulmonary neoplasms in mice at 20 ppm in drinking water, and a significantly increased incidence of hepatocellular neoplasms and pituitary adenomas in female rats at 50 and 100 ppm in drinking water in 2-year bioassays (IPCS, 1992).
    6) Daminozide alone and in combination with its principal contaminant, 1,1-dimethylhydrazine, was not carcinogenic in an 8-week study of male Fischer 344 rats. Carcinogenic potential was assessed by studying rat liver for the number and size of preneoplastic foci positive for glutathione-S-transferase placental form (Cabral et al, 1995).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) No toxic levels have been established. No consistent abnormal laboratory values have been seen except for abnormal liver function tests in one group of animals.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) No toxic levels have been established.
    2) No consistent abnormal laboratory values have been seen, but one Russian author did report abnormal liver function tests in animals poisoned with large amounts.

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) No toxic levels have been established. No consistent abnormal laboratory values have been seen except for abnormal liver function tests in one group of animals.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) EMESIS/NOT RECOMMENDED -
    1) EMESIS: Ipecac-induced emesis is not recommended because of the potential for CNS depression.
    B) ACTIVATED CHARCOAL -
    1) PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION
    a) Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).
    1) In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
    2) The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).
    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).
    6.5.2) PREVENTION OF ABSORPTION
    A) 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) MONITORING OF PATIENT
    1) No specific treatment is yet indicated for daminozide. Patients should be monitored for CNS depression, ptosis, and liver function abnormalities if significant amounts (greater than 8 grams) have been taken.

Range Of Toxicity

Summary

    A) Rats have been given up to 43,200 ppm in their diets without demonstrable effect. The LD50 in rats orally is 8,400 mg/kg, and dermally for rabbits is greater than 1600 mg/kg.
    B) Human data on range of toxicity are not available.

Maximum Tolerated Exposure

    A) ANIMAL DATA
    1) Rats have been given up to 43,200 parts per million in their diet without demonstrable effect (Prod Info, 1964).

Serum Plasma Blood Concentrations

    7.5.2) TOXIC CONCENTRATIONS
    A) TOXIC CONCENTRATION LEVELS
    1) GENERAL
    a) No toxic serum or blood concentrations have been established.

Workplace Standards

    A) ACGIH TLV Values for CAS1596-84-5 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS1596-84-5 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS1596-84-5 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Assessed under the IRIS program. ; Listed as: Alar
    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 CAS1596-84-5 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) References: (Farm Chem, 1985; RTECS, 1988
    1) LD50- (ORAL)MOUSE:
    a) 6300 mg/kg
    2) LD50- (ORAL)RAT:
    a) 8400 mg/kg

Pharmacology Toxicology

Pharmacologic Mechanism

    A) The growth retardant action has been attributed to formation of 1,1-dimethylhydrazine, which inhibits tryptamine oxidation by PEA epicotyl homogenates (Reed, 1965).

Physicochemical

Physical Characteristics

    A) white crystal

Molecular Weight

    A) 160.17

References

General Bibliography

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