INCIDENT REPORTS ASSOCIATED WITH

Iodine and iodophors

PC CODE: 

046923, 046903, 046904, 046905, 075701, 046901, 046914

May 10, 2005

U.S. Environmental Protection Agency

Office of Pesticide Programs

Antimicrobials Division

TABLE OF CONTENTS

 TOC \f 

0.0	INTRODUCTION	1

1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF IODINE and
IODOPHORS  EXPOSURE	1

1.1 	OPP(s Incident Data System (IDS)	2

1.2 	 Poison Control Center	2

1.3 	California Data - 1982 through 2003	2

1.4 	National Pesticide Telecommunications Network (NPTN)	3

1.5 	Incident Reports Associated with Toxic Effects of phenols Published
in Scientific Literature.	4

2.0	SUMMARY AND CONCLUSION	10

3.0	REFERENCE	11

 

0.0	INTRODUCTION tc \l1 "0.0	INTRODUCTION 

Iodine, a halogen,  is a bluish-black, lustrous solid, volatizing at
ordinary temperatures into a blue-violet gas with an irritating odor; it
forms compounds with many elements, but is less active than the other
halogens, which displace it from iodides. Iodine exhibits some
metallic-like properties. It dissolves readily in chloroform, carbon
tetrachloride, or carbon disulfide to form beautiful purple solutions.
It is only slightly soluble in water. Iodine compounds are important in
organic chemistry and very useful in medicine.  This reports summarized
the potential health effects of iodine and iodophores in humans,
reported as incident reports from different sources. Seven active
ingredient are covered in this report:  PC code 046923 ,046903,  046904,
046905, 075701, 046901, and 046914.

Two approaches are used in this section:

The potential health effects of phenol in humans, reported as incident
reports from different sources, are summarized. 

A literature search of chronic health effects associated with phenol
exposure, including results of epidemiological studies, are summarized.

1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF PHENOL
EXPOSURE tc \l1 "1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH
EFFECTS OF PHENOL EXPOSURE 

The following databases have been consulted for the poisoning incident
data

OPP Incident Data System (IDS) - The Incident Data System of The Office
of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA)
contains  reports of incidents from various sources, including
registrants, other federal and state health and environmental agencies
and individual consumers, submitted to OPP since 1992.  Reports
submitted to the Incident Data System represent anecdotal reports or
allegations only, unless otherwise stated.  Typically no conclusions can
be drawn implicating the pesticide as a cause of any of the reported
health effects.  Nevertheless, sometimes with enough cases and/or enough
documentation risk mitigation measures may be suggested.

Poison Control Centers - as the result of a data purchase by EPA, OPP
received Poison Control Center data covering the years 1993 through 1998
for all pesticides.  Most of the national Poison Control Centers (PCCs)
participate in a national data collection system, the Toxic Exposure
Surveillance System, which obtains data from about 65-70 centers at
hospitals and universities.  PCCs provide telephone consultation for
individuals and health care providers on suspected poisonings, involving
drugs, household products, pesticides, etc.



California Department of Pesticide Regulation - California has collected
uniform data on suspected pesticide poisonings since 1982.  Physicians
are required, by statute, to report to their local health officer all
occurrences of illness suspected of being related to exposure to
pesticides.  The majority of the incidents involve workers.  Information
on exposure (worker activity), type of illness (systemic, eye, skin,
eye/skin and respiratory), likelihood of a causal relationship, and
number of days off work and in the hospital are provided.

National Pesticide Telecommunications Network (NPTN) - NPTN is a
toll-free information service supported by OPP.  A ranking of the top
200 active ingredients for which telephone calls were received during
calendar years 1984-1991, inclusive, has been prepared.  The total
number of calls was tabulated for the categories human incidents, animal
incidents, calls for information, and others.

Published Incident Reports - Some incident reports associated with
hydantoins related human health hazard are published in the scientific
literature.

1.1 	OPP(s Incident Data System (IDS) tc \l2 "1.1 	OPPs Incident Data
System (IDS) 

A total of 8 individual human incident cases submitted to the EPA Office
of Pesticide Programs are associated with exposed to Iodine containing
compounds.  Inhalation and dermal are the two important routes of
exposure.  The most common symptoms reported for cases of inhalation
exposure were coughing, wheezing, tightness of chest and shortness of
breath. Dermal irritation caused skin burning, blisters and rash have
been reported when expose to the chemical through dermal exposure. None
of these effects were considered severe effects.

1.2 	 Poison Control Center tc \l2 "1.2 	 Poison Control Center 

There is no iodine incident been reported in the American Association of
Poison Control Centers (PCC)  Toxic Exposure Surveillance System (TESS)
in the years between 1993 - 1998.

1.3 	California Data - 1982 through 2003 tc \l2 "1.3 	California Data -
1982 through 2003 

Detailed descriptions of 61 cases with a definite, probable or possible
relationship cases associated with phenolic disinfectants submitted to
the California Pesticide Illness Surveillance Program (1982-2003) were
reviewed.  Table 1 presents the types of illnesses reported by year. 
Table 2 gives the total number of workers that took time off work as a
result of their illness and how many were hospitalized and for how
long..

Table 1: Cases Due to Iodine, Iodine-Complex or Potassium Iodide
Exposure in California Reported by Type of Illness and Year, 1986-2002.

Year	

Illness Type

	

Systemic	

Gastrointestinal	

Eye	

Skin	

Respiratory	

Combinationa	

Total



1986	

10	

-	

-	

1	

-	

-	

11



1987	

-	

-	

1	

2	

1	

-	

4



1988	

-	

-	

-	

1	

-	

-	

1



1989	

5	

-	

-	

3	

-	

2	

10



1990	

1	

-	

-	

1	

1	

2	

5



1991	

1	

-	

3	

3	

3	

-	

10



1992	

2	

-	

2	

-	

1	

-	

5



1993	

1	

-	

1	

-	

1	

-	

3



1994	

1	

-	

-	

1	

1	

-	

3



1995	

-	

-	

1	

-	

-	

-	

1



1996	

1	

-	

1	

1	

-	

-	

3



1997	

-	

-	

-	

1	

-	

-	

1



1998	

-	

-	

-	

1	

-	

1	

2



1999	

-	

-	

-	

-	

-	

-	

-



2000	

-	

-	

-	

-	

-	

-	

-



2001	

-	

-	

1	

-	

-	

-	

1



2002	

-	

-	

-	

1	

-	

-	

1



Total	

22	

-	

10	

16	

8	

5	

61



a Category includes combined irritative effects to eye, skin,
gastrointestinal and respiratory systems.

Table 2: Number of Persons Disabled (taking time off work) or
Hospitalized for Indicated Number of Days After Iodine, Iodine-Complex
or Potassium Iodide Exposure in California, 1986-2002.

	

Number of Persons Disabled	

Number of Persons Hospitalized



One day	

13	

-



Two days	

-	

-



3-5 days	

3	

-



6-10 days	

1	

-



More than 10 days	

-	

-



Unknown	

1	

-



1.4 	National Pesticide Telecommunications Network (NPTN) tc \l2 "1.4 
National Pesticide Telecommunications Network (NPTN) 

There is no incident reported in the  NPTN database related to
4-tert-amylphenol.

1.5 	Incident Reports Associated with Toxic Effects of Iodine and iodine
compounds Published in Scientific Literature. tc \l2 "1.5 	Incident
Reports Associated with Toxic Effects of Iodine and iodine compounds
Published in Scientific Literature. 

There are a large number of human incident reports and epidemiological
studies on the effects of excess iodine on human health have been
reported.  Based on the effects noticed in the incidents reported, it
appears that pure iodine would exert more severe acute toxic effects
than iodine related salts.  It was reported that death can be caused
from ingestion of iodine at dosage of  tinctures ranged from 1,200 to
9,500 mg (17(120 mg/kg), and deaths usually occurred within 48 hours of
the dose.  Acute irritation effects was noticed through both oral or
dermal routes of exposure osure to both iodine and iodides at high dose
of exposure.  Goetrogenic effects were  noticed in several incidences.

Table 3: Incident Reports Associated with Oral or Dermal exposure to
Iodine Containing Mixtures

Reference	

Description of Incident	

Dose	

Effects



Finkelstein and Jacobi, 1937	

18 deaths over a period of 6 years from suicides in which adults
ingested iodine tinctures (mixtures of molecular iodine and sodium
triiodide)	

1,200-9,500 mg (17-120 mg/kg)	

death within 48 hours of the dose



Finkelstein and Jacobi, 1937	

a 29-year-old man was admitted to the hospital four days after
attempting suicide by taking tincture of iodine 	

unknown amount of tincture of iodine	

ulcerations in the mouth, increased respiratory rate, vomiting,
abdominal soreness/cramps, urinary retention, twitching, irrationality,
fever, coma, death



Clark, 1981	

a man was found dead in his residence with a skull fracture and severe
pneumonia, he was known to be epileptic and a heavy consumer of alcohol;
a 13 oz. rye whiskey bottle was found with him that was 3/4 full of a
brownish liquid that turned out to be iodine	

unclear	

death



Dyck et al., 1979	

a woman was admitted to the hospital after attempting suicide by
ingesting an unknown quantity of Lugol(s iodine (5% diatomic iodine and
10% potassium iodide)	

not reported	

throat burning, esophagitis, gastritis, dyspnea, tachycardia,
hyperthyroidism, acute renal failure, metabolic acidosis



Vicens-Colvet et al., 1998	

woman ingested iodine during pregnancy	

260-390 mg I/day (4.6 mg/kg/day)	

infant developed goiter in utero



Shetty and Duthie, 1990	

an adult male received providone-iodine skin washes for 6 months to
treat dermal ulcers; he had no other history of excess iodine intake.	

not reported	

hyperthyroidism and thyrotoxicosis



Prager and Gardner, 1979	

an adult female had an open fistula which was swabbed 3 days/week for 22
months with providone-iodine and packed with iodoform impregnated gauze	

22 mg I, 3 days/week for 22 months	

clinical hypothyroidism with thyroid enlargement; became euthyroid
within 6 weeks after the treatment was discontinued



Okano, 1989	

a 2-year-old girl suffered extensive, patchy erythema on her back,
buttocks and thighs after these areas were in contact with a 10%
providone-iodine solution for 8 hours	

10% providone-iodine solution (exact dose unknown)	

acute irritant contact dermititis



Table 4: Incident Reports Associated with Oral or Dermal exposure to
Iodides



Reference	

Description of Incident	

Dose	

Effects



Galina et al., 1962	

two cases of infant deaths: death was from complications related to
compression of the trachea by a goiterous thyroid gland; mothers had
ingested potassium iodide during their pregnancies	

approx. 850-1,180 mg I/day (12-17 mg/kg/day)	

Infant death from goiter in infant



Iancu et al., 1974	

woman consumed sodium iodide for two years including during pregnancy	

200 mg I/day (2.9 mg/kg/day)	

hypothyroidism and goiter in infant



Coakley et al., 1989	

two cases in which women ingested iodide during pregnancy	

96 mg I/day during the first 8 months of pregnancy and 510 mg I/day
during the last month	

infants had a transient goiter at birth



Penfold et al., 1978	

two cases in which mothers ingested potassium iodide during the last
trimester of pregnancy in one case and during the last four months of
pregnancy in the other case	

approx. 380 mg I/day (5.4 mg/kg/day) and approx. 460 mg I/day (6.6
mg/kg/day)	

one infant born with a goiter and second infant born with a goiter and
hypothyriodism



Hassan et al., 1968	

three cases of mothers ingesting a daily dose of potassium iodide during
pregnancy	

approx. 450-765 mg I/day (6-11 mg/kg/day)	

infants born with goiter and hypothyroidism



Bostanci et al., 2001	

mother ingested potassium iodide during the last four months of
pregnancy	

130 mg I/day	

infant born with goiter and hypothyroidism



Martin and Rento, 1962	

two cases where mothers ingested potassium iodide during pregnancy	

920 and 1,530 mg I/day (13-22 mg/kg/day)	

infants born with goiter and severe but reversible hypothyroidism



Shilo and Hirsch, 1986	

72-year-old woman without apparent preexisting thyroid problems ingested
sea-kelp tablets; her thyroid status reverted to normal within 6 months
after she stopped taking the tablets	

2.8-4.2 mg I/day (0.05 mg/kg/day)	

hyperthyroidism



Reference	

Description of Incident	

Dose	

Effects



Rajatanavin et al., 1984	

a 56-year-old man had been treated for asthma for two years with
potassium iodide	

270 mg potassium iodide and 50 mg niacinamide hydroiodide	

hyperthyroidism, thyrotoxicosis, chest pain, heat intolerance, tremor,
fatigue



Rajatanavin et al., 1984	

a 64-year-old man was given amiodarone (75 mg of iodine per 200 mg
tablet) for intermittent atrial flutter	

75 mg I/day	

angina, fatigue, weight loss, hyperthyroidism, tremor, muscle weakness



Vaginalis et al., 1972	

four healthy adult females, who had nontoxic goiter, received oral doses
of a saturated potassium iodide solution for 10-18 weeks	

180 mg I/day (2.6 mg/kg/day)	

clinical hyperthyroidism and thyrotoxicosis



Ahmed et al., 1974	

a 15-year-old male received a saturated solution of potassium iodide for
4 months; his thyroid status reverted to normal within 6 months after
the potassium iodide was discontinued	

1,440 mg I/day (23 mg/kg/day)	

hyperthyroidism and thyrotoxicosis



Vagenakis et al., 1972	

in a clinical study, eight healthy adult females with nontoxic goiter
received oral doses of a saturated potassium iodide solution for 10-18
weeks	

180 mg I/day (2.6 mg/kg/day)	

four of the eight patients developed hyperthyroidism and thyrotoxicosis



Shelly, 1967	

two cases where transient dermal lesions resulted from a single oral
dose of potassium iodide	

360 and 500 mg iodide (5.1 and 7.1 mg/kg/day)	

transient dermal lesions typical of ioderma





Soria et al., 1990	

an adult male received potassium iodide along with penicillin for an
acute respiratory tract infection	

300 mg I/day (5.1 mg/kg/day)	

five days after dose, developed proliferating dermal lesions of the
face, scalp and trunk



Reference	

Description of Incident	

Dose	

Effects



Soria et al., 1990	

an adult male received potassium iodide along with theophylline for
obstructive pulmonary disease for 8 months	

600 mg I/day (10 mg/kg/day)	

vegetative dermal lesions of the neck and trunk



Kincaid et al., 1981	

an adult female received oral doses of potassium iodide for 6 months as
part of a treatment for obstructive lung disease.  Other drugs used in
the patient(s treatment were ephedrine, theophylline and phenobarbitol	

740 mg I/day (11 mg/kg/day)	

lesions on the face and conjunctiva of the eye; healed several weeks
after the potassium iodide was discontinued



Rosenburg et al., 1972	

an adult female received oral doses of potassium iodide for 1 year as
part of a treatment for asthma.  Other drugs used in the patient(s
treatment were ephedrine, theophylline and phenobarbitol	

990 mg I/day (14 mg/kg/day)	

vegetative lesions on the face and arms; healed within 3 weeks after the
potassium iodide was discontinued



Baumgartner, 1976	

a 75-year-old male suffering from pneumonia was giving a saturated
solution of potassium iodide among other medication	

1,200 mg potassium iodide per day	

skin lesions 



Soria et al., 1990	

a woman received potassium iodide for pneumonia	

400 mg I/day (6 mg/kg/day)	

lesions of the skin and oral mucosa which healed within 3 weeks after
the treatment was discontinued



Reference	

Description of Incident	

Dose	

Effects



Khan et al., 1973	

a 65-year-old woman with pneumonia, left ventricular failure and chronic
bronchitis was given potassium iodide daily by mouth	

approx. 200 mg potassium iodide per day	

skin lesions on the face and hands, which healed completely within 3
weeks after the potassium iodide was discontinued



Pena-Penabad et al., 1993	

a 75-year-old man had suffered from numerous colds that were treated
with  potassium iodide and theophylline taken orally	

not reported	

outbreaks of papulo-pustulous lesions that formed vegetating masses on
the head and arms and conjunctival hemorrhage; lesions disappeared
within one week after treatment with iodine was discontinued



Kint and Van Herpe, 1977	

two women were taking Calcidrine, an expectorant that contains 150 mg
calcium iodide per 5 ml syrup, for respiratory infections	

not specified	

vegetative skin lesions



Kurtz and Abner, 1982	

an adult male received oral doses of a potassium iodide solution for 15
years	

1,080 mg I/day (15 mg/kg/day)	

recurrent fevers; fevers stopped within 2 weeks after the potassium
iodide was discontinued



Horn and Kabins, 1972	

an adult male was given a daily regimen of a saturated solution of
potassium iodide for treatment of a respiratory illness	

1,440 mg I/day	

fever; fever stopped within 3 days after the potassium iodide was
discontinued



Horn and Kabins, 1972	

an adult female received a saturated potassium iodide solution along
with ampicillin to treat pneumonia	

1,620 mg I/day (23 mg/kg/day)	

fever; fever stopped within 36 hours after the potassium iodide was
discontinued



Horn and Kabins, 1972	

an adult female diabetic patient received a saturated potassium iodide
solution along with antibiotics, cortisone, and aminophylline for
pneumonia	

1,080 mg I/day (15 mg/kg/day)	

fever, which stopped when the potassium iodide was discontinued



Tresch et al., 1974	

an adult male inadvertently drank a potassium iodide solution	

15 grams of iodide	

cardiac irritability; ventricular tachycardia; swelling of the face,
neck and mouth; edema; conjunctivitis; enlarged salivary glands

2.0 Conclusion and Summary

Iodine is a naturally occurring element that is essential for the good
health of people and animals. Iodine is found in small amounts in sea
water and in certain rocks and sediments. Iodine occurs in many
different forms. Most forms of iodine easily dissolve in water or
alcohol. Iodine has many uses. Its most important use is as a
disinfectant. Death incidences have been reported but only happened at
high dose of exposure to iodine.  Irritation effects were reported when
exposure to iodine compounds through either any routs of exposure (oral,
dermal, or inhalation).

 PAGE  10 

Table 4: Incident Reports Associated with Oral or Dermal exposure to
Iodides (Continue)

