UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

 

April 5, 2007

MEMORANDUM:

Subject:		INCIDENT REPORTS ASSOCIATED WITH OCTHILINONE

To:			K. Avivah Jacob, Chemical Review Manager,

			Regulatory Management Branch II

Antimicrobials Division (7510P)

From: 			Jonathan Chen

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Thru:			Norm Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

DP Barcode: 		

Chemical Name:	2-n-Octyl-4-isothiazolin-3-one (Octhilinone or OIT)	

		

PC Code:		099901 

CAS Registry No. 	26530-20-1

INCIDENT REPORTS ASSOCIATED WITH

OCTHILINONE

(PC CODE:  099901)

April 5, 2007

U.S. Environmental Protection Agency

Office of Pesticide Programs

Antimicrobials Division

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc163554932"  0.0
INTRODUCTION	  PAGEREF _Toc163554932 \h  4  

  HYPERLINK \l "_Toc163554933"  1.0 	INCIDENT REPORT DATA ASSOCIATED
WITH HEALTH EFFECTS OF OCTHILINONE	  PAGEREF _Toc163554933 \h  4  

  HYPERLINK \l "_Toc163554934"  1.1 	OPP’s Incident Data System (IDS)	
 PAGEREF _Toc163554934 \h  5  

  HYPERLINK \l "_Toc163554935"  1.2 	 Poison Control Center (1993
through 2002)	  PAGEREF _Toc163554935 \h  5  

  HYPERLINK \l "_Toc163554936"  1.3 	California Data - 1982 through 2004
  PAGEREF _Toc163554936 \h  5  

  HYPERLINK \l "_Toc163554937"  1.4 	National Pesticide
Telecommunications Network (NPTN)	  PAGEREF _Toc163554937 \h  5  

  HYPERLINK \l "_Toc163554938"  1.5 	Incident Reports Associated with
Acute Toxic Effects of Octhilinone Published in Scientific Literature.	 
PAGEREF _Toc163554938 \h  6  

  HYPERLINK \l "_Toc163554939"  3.0	SUMMARY AND CONCLUSION	  PAGEREF
_Toc163554939 \h  6  

  HYPERLINK \l "_Toc163554940"  4.0	REFERENCE	  PAGEREF _Toc163554940 \h
 7  

 

0.0	INTRODUCTION tc  \l 0 "10.0	INTRODUCTION" 

Octhilinone (PC Code 099901) is used as an antimicrobial agent for
materials preservation, wood preservation, and water systems biocide
treatments.  Examples of the materials preserved using OIT include
carpeting, vinyl, leather, textiles, mattresses, metalworking fluids,
plastics, polymers, and coatings (e.g., stains, paints). Some of the
usages are considered high exposure scenarios, such as metal working
fluids, sap-stain prevention in wood preservation etc.  The purpose of
this chapter is to review the incidences of health effects in humans and
environment resulting from exposure to octhilinone. This reports
summarized the potential health effects of octhilinone in humans,
reported as incident reports from different sources.

1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF OCTHILINONE

The following databases have been consulted for the poisoning incident
data on the active ingredient octhilinone:

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 2002
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
octhilinone related human health hazard are published in the scientific
literature.

1.1 	OPP’s Incident Data System (IDS)  tc  \l 0 "21.1 	OPPs Incident
Data System (IDS)" 

A total of 30 individual incident cases submitted to the EPA Office of
Pesticide Programs reported to be related to exposure to octhilinone. 
After carefully review all these incidences, only one incidence is
potentially associated with octhilinone exposure.  In this incidence, a
mechanic exposed to octhilinone containing solution with water on
opening a pipe.  He did not realize he had been exposed until he felt
burning.  Burns, blistering and swelling ensued and he was hospitalized
two days after the initial incident for skin infection at the site of
exposure.  

1.2 	 Poison Control Center (1993 through 2002) tc  \l 0 "21.2 	 Poison
Control Center" 

No incidence were reported in the Poison Control Center database
covering the years 1993 through 2002 related to octhilinone exposure.

1.3 	California Data - 1982 through 2004

Detailed descriptions of 5 definite cases associated with octhilinone
exposure submitted to the California Pesticide Illness Surveillance
Program (1982-2004) were reviewed. All the reported cases are
occupationally related.  Table 1 presents the types of illnesses
reported by year.  All the incidences involved skin irritation type
reaction at the site of exposure.  Redness, burning of the skin,
moderate to severe erythematous and second degree burn are the reported
symptoms associated in these incidences.  There is one worker in the
reported incidences took one day off work as a result of the illness.

1.4 	National Pesticide Telecommunications Network (NPTN) 

There are no incident reported in the NPTN database related octhilinone
exposure.

Table 1.  Cases Due to Octhilinone Exposure in California Reported by
Type of Illness and Year, 1982-1998

Year	

Illness Type

	

Systemica	

Eye	

Skin	

Respiratory	

Combination	

Total



1983	

-	

-	

2	

-	

-	

2



1991	

-	

-	1	-	

-	

1



1992	

-	

-	

1	

-	

-	

1



1995	

-	

-	

1	

-	

-	

1



Total	

-	

-	

5	

-	

-	

5

a Category include cases where skin, eye, or respiratory effects were
also reported.

b Category includes combined irritative effects to eye, skin, and
respiratory system.

1.5 	Incident Reports Associated with Acute Toxic Effects of Octhilinone
Published in Scientific Literature. 

Several papers have been published outlining the problems associated
with the use of octhilinone.  All the incidences were related to dermal
exposure to the chemical of concern.  Contact dermatitis wase reported
as the primary concern for all these reported incidences (Young et al.,
2004; Thormann 1982).  Allergic contact dermatitis is also been
suggested in some of the incidences (Foussereau, 1982; Mathias,  et al.
1983; Oleaga et al, 1992).  In a human cumulative patch test, allergic
contact dermatitis were induced with octhilinone exposure . In the
subsequent challenging patch testing using octhilinone elicited allergy
in 6 out of 6 sensitized individuals at lower concentration.

3.0	SUMMARY AND CONCLUSION  tc  \l 0 "13.0	SUMMARY AND CONCLUSION" 

There are some incident reported associated with exposure to
octhilinone. Most of involved incidences are happened in occupational
setting.  Dermal exposure is the primary exposure route for all these
reported incidence.  Most of the incidences are related to irritation
and/or allergic type reaction.  The most common symptoms reported for
cases of dermal exposure were skin irritation/burning, rash, itching,
redness and blistering.  Allergic contact dermatitis also been
reported.. 

4.0	REFERENCE tc  \l 0 "14.0	REFERENCE" 

Andersen,  KE;  and Veien NK. 1985. Biocide Patch . Contact Dermatitis,
Vol. 12, No. 2, pages 99-103 

Emmett, EA; , Ng,  SK;  Levy,  MA.; Moss, JN; and Morici,  IJ. 1989. 
The irritancy and allergenicity of 2-n-octyl-4-isothiazolin-3-one (Skane
M-8), with recommendations for patch test concentration. Contact
Dermatitis. 20(1):21-6.

Foussereau, J.; Brändle I.; Boujnah-Khouadja,  A. 1984.  Allergic
contact eczema caused by isothiazolin-3-one derivatives. Derm Beruf
Umwelt. 1984; 32(6):208-211

Mathias,  CG, Andersen,  KE; and Hamann,  K. 1983.  Allergic contact
dermatitis from 2-n-octyl-4-isothiazolin-3-one, a paint mildewcide.
Contact Dermatitis. Nov; 9(6):507-9.

Oleaga,  JM;  Aguirre,  A.; Landa,  N.; Gonzalez,  M. and  Diaz-Perez,
JL 1992. Allergic contact dermatitis from Kathon 893. Contact
Dermatitis. 27(5):345-6.

Thormann,  J.  1982.  Contact dermatitis to a new fungicide,
2-n-octyl-4-isothiazolin-3-one. Contact Dermatitis.  May; 8(3):204 

Young,  HS,; Ferguson,  JE., Beck MH. 2004 Contact dermatitis from
2-n-octyl-4-isothiazolin-3-one in a PhD student. Contact Dermatitis.
50(1):47-8.

Attachment 1

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