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Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. 1

2

3

4

5

6



## I MMEDIATELY 

## D ANGEROUS TO 

## L IFE OR 

## H EALTH 

## (IDLH) V ALUE 

## P ROFILE 7

8



### FOR 9

10

11

12



## P ERACETIC 

## A CID 13

14

15

16



## [CAS N O



## . 79-21-0] 17

18

19

20

21

22

23

Department of Health and Human Services 24

Centers for Disease Control and Prevention 25

National Institute for Occupa tional Safety and Health 26

27

28External Review Draft

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Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. 

## D ISCLAIMER 1

Mention of any company or product does not constitute endorsement by the National Institute for Occupational 2

Safety and Health (NIOSH). In add ition, citations of Web sites extern al to NIOSH do not constitute NIOSH 3

endorsement of the sponsoring organizations or thei r programs or products. Furthermore, NIOSH is not 4

responsible for the content of these Web sites. 5

6



## O RDERING 

## I NFORMATION 7

This document is in the public domain and may be freely copied or reprinted. To receive NIOSH documents or 8

other information about occupational safet y and health topics, contact NIOSH at 9

Telephone: 1-800-CDC-IN FO (1-800-232-4636) 10

TTY: 1-888-232-6348 11

E-mail: cdcinfo@cdc.gov 12

13

or visit the NIOSH Web site at www.cdc.gov/niosh. 14

15External Review Draft

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Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. 

## Foreword 1

Chemicals are a ubiquitous component of the modern wo rkplace. Occupational exposures to chemicals have the 2

potential to adversely affect the health and lives of workers. Acute or short-term exposures to high concentrations 3

of some airborne chemicals have the ability to quickly overwhelm workers, resulting in a spectrum of undesirable 4

health outcomes that may inhibit the ability to escape from the exposure envi ronment (e.g., irritation of the eyes 5

and respiratory tract or cognitive impairment), cause severe irreversible effects (e.g., damage to the respiratory 6

tract or reproductive toxicity), and in extreme cases, cause death. Airborne concentrations of chemicals capable 7

of causing such adverse health effects or of impeding escape from high-risk conditions may arise from a variety of 8

non-routine workplace situations , including special wo rk procedures (e.g., in confined spaces), industrial 9

accidents (e.g., chemical spills or explosions), and chemical releases into the community (e.g., during 10

transportation incidents or other uncontrolled-release scenarios). 11

12

The “immediately dangerous to life or health air concen tration values (IDLH values)” developed by the National 13

Institute for Occupational Safety a nd Health (NIOSH) characterize these high-risk exposure concentrations and 14

conditions [NIOSH 2013]. IDLH values are based on a 30-minute exposure duration and have traditionally 15

served as a key component of the decision logic for the selection of respiratory protection devices [NIOSH 2004]. 16

Occupational health professionals have employed these values beyond their initial purpose as a component of the 17

NIOSH Respirator Selection Logic to assist in developi ng Risk Management Plans for non-routine work practices 18

governing operations in high-risk envi ronments (e.g., confined spaces) and the development of Emergency 19

Preparedness Plans. 20

21

The approach used to derive IDLH values for high priority chemicals is outlined in the NIOSH Current 22

Intelligence Bulletin (CIB) 66: Derivation of Immediately Da ngerous to Life or Health Values [NIOSH 2013]. 23

CIB 66 provides 1) an update on the scientific basis a nd risk assessment methodology used to derive IDLH 24

values, 2) the rationale and derivati on process for IDLH values, and 3) a demonstration of the derivation of 25

scientifically credible IDLH values using available data resources. The purpose of this technical report is to 26

present the IDLH value for peracetic acid (CAS # 79-21- 0). The scientific basis, toxicologic data and risk 27

assessment approach used to derive the IDLH value are summarized to ensure tr ansparency and scientific 28

credibility. 29

30

John Howard, M.D. 31

Director 32

National Institute for Occupa tional Safety and Health 33External Review Draft

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policy. Centers for Disease Control and Prevention 1External Review Draft

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policy. 

## Contents 1

FOREWORD

............................................................................................................................... ................................. III 2

ABBREVIATIONS

............................................................................................................................... ........................ VI 3

GLOSSARY

............................................................................................................................... .................................. VII 4

ACKNOWLEDGMENTS

............................................................................................................................... .............. XI 5

1.0 INTRODUCTION

............................................................................................................................... ............... 1 6

1.1 O VERVIEW OF IDLH V ALUE FOR P ERACETIC A CID

.................................................................................................... 1 7

1.2 P URPOSE

............................................................................................................................... ...................................... 1 8

1.3 G ENERAL S UBSTANCE I NFORMATION

......................................................................................................................... 2 9

2.0 ANIMAL TOXICITY DATA

............................................................................................................................. 5 10

3.0 HUMAN DATA

............................................................................................................................... .................. 9 11

4.0 SUMMARY

............................................................................................................................... ......................... 9 12

5.0 REFERENCES

............................................................................................................................... ................. 10 13

14

15

16

17

18

19External Review Draft

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policy. 

## Abbreviations 1

2

ACGIH American Conference of Gove rnmental Industrial Hygienists 3

AEGL Acute Exposure Guideline Levels 4

AIHA American Industrial Hygiene Association 5

BMC benchmark concentration 6

BMCL benchmark concentra tion lower confidence limit 7

C ceiling 8

CAS chemical abstract service 9

ERPG Emergency Response Planning Guidelines 10

IDLH immediately dangerous to life or health 11

LC 50 median lethal concentration 12

LC Lo lowest concentration of a chemical that caused death in humans or animals 13

LEL lower explosive limit 14

LOAEL lowest observed adverse effect level 15

mg/m 3 milligram(s) per cubic meter 16

NAC National Advisory Committee 17

NAS National Academy of Sciences 18

NIOSH National Institute for O ccupational Safety and Health 19

NOAEL no observed adverse effect level 20

OSHA Occupational Safety and Health Administration 21

PEL permissible exposure limit 22

ppm parts per million 23

RD 50 concentration of a chemical in the air that is estimated to cause a 50% decrease in the respiratory 24

rate 25

REL recommended exposure limit 26

SCP Standard Completion Program 27

STEL short term exposure limit 28

TLV threshold limit value 29

TWA time weighted average 30

UEL upper explosive limit 31

WEEL workplace environmental exposure level 32External Review Draft

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policy. 

## Glossary 1

2

Acute Exposure : Exposure by the oral, dermal, or inhalation route for 24 hours or less. 3

4

Acute Exposure Guideline Levels (AEGLs) : Threshold exposure limits for the general public applicable to 5

emergency exposure periods ranging from 10 minutes to 8 hours. AEGL-1, AEGL 2, and AEGL-3 are 6

developed for five exposure periods (10 and 30 minutes, 1 hour, 4 hours, and 8 hours) and are distinguished 7

by varying degrees of severity of toxic effects ranging fro m transient, reversible effects to life-threatening 8

effects [NAS 2001]. AEGLs are intended to be guideline le vels used during rare events or single once-in-a9

lifetime exposures to airborne concentrations of acu tely toxic, high-priority chemicals [NAS 2001]. The 10

threshold exposure limits are designed to protect the general population, including the elderly, children or 11

other potentially sensitive groups that are generally not considered in the development of workplace exposure 12

recommendations (additional information av ailable at http://www.epa.gov/oppt/aegl/). 13

14

Acute Reference Concentration (RfC) : An estimate (with uncertainty spa nning perhaps an order of magnitude) 15

of a continuous inhalation exposure for an acute dur ation (24 hours or less) of the human population 16

(including sensitive subgroups) that is li kely to be without an appreciable risk of deleterious effects during a 17

lifetime. It can be derived from a NOAEL, LOAEL, or benchmark concentration, with uncertainty factors 18

(UFs) generally applied to reflect li mitations of the data used. Generally used in USEPA noncancer health 19

assessments [USEPA 2014]. 20

21

Acute Toxicity : Any poisonous effect produced within a short period of time following an exposure, usually 24 22

to 96 hours. 23

24

Adverse Effect : A substance-related biochemical change, functional impairment, or pathologic lesion that affects 25

the performance of an organ or system or alters the ab ility to respond to additional environmental challenges. 26

27

Benchmark Dose/Concentration (BMD/BMC) : A dose or concentration that produces a predetermined change 28

in response rate of an effect (called the benchmar k response, or BMR) compared to background [USEPA 29

2014] (additional information available at http://www.epa.gov/ncea/bmds/). 30

31

Benchmark Response (BMR) : A predetermined change in response rate of an effect. Common defaults for the 32

BMR are 10% or 5%, reflecting study design, da ta variability, and sensitivity limits used. 33

34

BMCL : A statistical lower confidence limit on th e concentration at the BMC [USEPA 2014]. 35

36

Bolus Exposure : A single, relatively large dose. 37

38

Ceiling Value (“C”) : U.S. term in occupational exposure indicati ng the airborne concentration of a potentially 39

toxic substance that should never be exceeded in a worker’s breathing zone. 40

41

Chronic Exposure : Repeated exposure for an extended period of time. Typically exposures are more than 42

approximately 10% of life span for humans and >90 days to 2 years for laboratory species. 43

44

Critical Study : The study that contributes most significantly to the qualitative and quantitative assessment of risk 45

[USEPA 2014]. 46External Review Draft

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policy. 1

Dose : The amount of a substance available for interactions with metabolic processes or biologically significant 2

receptors after crossing the outer boundary of an organism [USEPA 2014]. 3

4

ECt 50 : A combination of the effective concentration of a s ubstance in the air and the exposure duration that is 5

predicted to cause an effect in 50% (one half) of the experimental test subjects. 6

7

Emergency Response Planning Guidelines (ERPGs) : Maximum airborne concentrations below which nearly all 8

individuals can be exposed without experiencing health effects for 1-hour exposure. ERPGs are presented in a 9

tiered fashion with health effects ranging from mild or transient to serious, irreversible, or life threatening 10

(depending on the tier). ERPGs are developed by the Am erican Industrial Hygiene Association [AIHA 2006]. 11

12

Endpoint : An observable or measurable biological event or si gn of toxicity ranging from biomarkers of initial 13

response to gross manifestations of clinical toxicity. 14

15

Exposure : Contact made between a chemical, physical, or biological agent and the outer boundary of an 16

organism. Exposure is quantified as the amount of an agent available at the exchange boundaries of the 17

organism (e.g., skin, lungs, gut). 18

19

Extrapolation : An estimate of the response at a point outside the range of the experimental data, generally 20

through the use of a mathematical model, although qualitative extrapol ation may also be conducted. The 21

model may then be used to extrapolate to res ponse levels that cannot be directly observed. 22

23

Hazard : A potential source of harm. Hazard is distinguished from risk, which is the probability of harm under 24

specific exposure conditions. 25

26

Immediately Dangerous to Life or Health (IDLH) condition : A situation that poses a threat of exposure to 27

airborne contaminants when that exposure is likely to cause death or immediate or delayed permanent adverse 28

health effects or prevent escape from such an environment [NIOSH 2004, 2013]. 29

30

IDLH value : A maximum (airborne concentration) level above which only a highly reliable breathing apparatus 31

providing maximum worker protection is permitted [NIOSH 2004, 2013]. IDLH values are based on a 30- 32

minute exposure duration. 33

34

LC 01 : The statistically determined concentra tion of a substance in the air that is estimated to cause death in 1% of 35

the test animals. 36

37

LC 50 : The statistically determined concentr ation of a substance in the air that is estimated to cause death in 50% 38

(one half) of the test animals; median lethal concentration. 39

40

LC LO : The lowest lethal concentration of a substance in the air reported to cause death, usually for a small 41

percentage of the test animals. 42

43

44

LD 50 : The statistically determined lethal dose of a substance that is estimated to cause death in 50% (one half) of 45

the test animals; median lethal concentration. 46External Review Draft

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policy. 1

LD LO : The lowest dose of a substance that causes death, usua lly for a small percentage of the test animals. 2

3

LEL : The minimum concentration of a gas or vapor in air, below which propagation of a flame does not occur in 4

the presence of an ignition source. 5

6

Lethality : Pertaining to or causing death; fatal; referring to th e deaths resulting from acute toxicity studies. May 7

also be used in lethality threshold to describe the poi nt of sufficient substance concentration to begin to cause 8

death. 9

10

Lowest Observed Adverse Effect Level (LOAEL) : The lowest tested dose or concentration of a substance that 11

has been reported to cause harmful (adverse) health effects in people or animals. 12

13

Mode of Action : The sequence of significant events and processes that describes how a substance causes a toxic 14

outcome. Mode of action is distinguished from the more detailed mechanism of action, which implies a more 15

detailed understanding on a molecular level. 16

17

No Observed Adverse Effect Level (NOAEL) : The highest tested dose or concentration of a substance that has 18

been reported to cause no harmful (adverse) health effects in people or animals. 19

20

Occupational Exposure Limit (OEL) : Workplace exposure recommendations developed by governmental 21

agencies and non-governmental organizations. OELs are intended to represent the maximum airborne 22

concentrations of a chemical substance below wh ich workplace exposures should not cause adverse health 23

effects. OELs may apply to ceiling, short-term (STELs), or time-weighted average (TWA) limits. 24

25

Peak Concentration : Highest concentration of a substance record ed during a certain period of observation. 26

27

Permissible Exposure Limit (PEL) : Occupational exposure limits devel oped by OSHA (29 CFR 1910.1000) or 28

MSHA (30 CFR 57.5001) for allowable occupational air borne exposure concentr ations. PELs are legally 29

enforceable and may be designated as ceiling, STEL, or TWA limits. 30

31

Point of Departure (POD) : The point on the dose–response curve fro m which dose extrapolation is initiated. 32

This point can be the lower bound on dose for an estim ated incidence or a change in response level from a 33

concentration-response model (BMC), or it can be a NOAEL or LOAEL for an observed effect selected from 34

a dose evaluated in a health e ffects or toxicology study. 35

36

RD 50 : The statistically determined concentr ation of a substance in the air that is estimated to cause a 50% (one 37

half) decrease in the respiratory rate. 38

39

Recommended Exposure Limit (REL) : Recommended maximum exposure limit to prevent adverse health 40

effects based on human and animal studies and established for occupational (up to 10-hour shift, 40-hour 41

week) inhalation exposure by NIOSH. RELs may be designated as ceiling, STEL, or TWA limits. 42

43

Short-Term Exposure Limit (STEL) : A worker’s 15-minute time-weighted average exposure concentration that 44

shall not be exceeded at any time during a work day. 45

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Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. Target Organ : Organ in which the toxic injury manifests in terms of dysfunction or overt disease. 1

2

Threshold Limit Values (TLVs®) : Recommended guidelines for occupa tional exposure to airborne 3

contaminants, published by the American Conference of Governmental Industrial Hygienists (ACGIH). TLVs 4

refer to airborne concentrations of chemical substa nces and represent conditions under which it is believed 5

that nearly all workers may be repeatedly exposed, da y after day, over a working lifetime, without adverse 6

effects. TLVs may be designated as ceiling, short-term (STELs), or 8-hr TWA limits. 7

8

Time-Weighted Average (TWA) : A worker’s 8-hour (or up to 10-hour) time-weighted average exposure 9

concentration that shall not be exceeded during an 8- hour (or up to 10-hour) work shift of a 40-hour week. 10

The average concentration is weighted to take into ac count the duration of different exposure concentrations. 11

12

Toxicity : The degree to which a substance is able to ca use an adverse effect on an exposed organism. 13

14

Uncertainty Factors (UFs) : Mathematical adjustments applied to th e POD when developing IDLH values. The 15

UFs for IDLH value derivation are determined by consid ering the study and effect used for the POD, with 16

further modification based on the overall database. 17

18

Workplace Environmental Exposure Levels (WEELs) : Exposure levels developed by the American Industrial 19

Hygiene Association (AIHA) that provide guidance for protecting most workers from adverse health effects 20

related to occupational chemical expos ures expressed as a TWA or ceiling limit. 21External Review Draft

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Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. 

## Acknowledgments 1

2

This document was developed by the Education and Info rmation Division (Paul Schulte, Ph.D., Director). G. 3

Scott Dotson, Ph.D., was the project officer and lead NIOS H author for this technical report. The basis for this 4

document was a report contracted by NIOSH and prepar ed by Andrew Maier, Ph.D., Ann Parker, and Lynn 5

Haber, Ph.D. (Toxicology Excellen ce for Risk Assessment [TERA]). 6

7



### Education and Information Division 8

Devin Baker, M.Ed. 9

Charles L. Geraci, Ph.D. 10

Thomas J. Lentz, Ph.D. 11

Richard Niemeier, Ph.D. 12

Chris Sofge, Ph.D. 13

14

NIOSH would like to acknowledge the contribution of th e following subject matter experts for their critical 15

technical review of this report. 16

17

Mary A. Fox, Ph.D., Assistant Professor; Co-Direct or, Risk Sciences and Public Policy Institute; 18

Department of Health Policy and Management, Bl oomberg School of Public Health, Johns Hopkins 19

University 20

21

Richard B. Schlesinger, Ph.D., Fellow A.T.S., Senior Associate Dean for Academic Affairs and Research 22

Professor of Biology, Dyson College of Arts and Sciences, Pace University 23External Review Draft

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Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. 

## 1.0 Introduction 1

2



## 1.1 Overview of IDLH Va lue for Peracetic Acid 3

4

IDLH Value: 1.7 mg/m 3 (0.64 ppm) 5

6

Basis for IDLH Value: A human study [Fraser and Thorbinson 198 6] reported that exposure to 4.67 mg/m 3 for 7

12 minutes caused slight to mild irritation, which is classified as a potentially escape- impairing effect, and 8

exposure to 6.23 mg/m 3 for 60 minutes caused extreme discomfort and possibly escape-impairing effects. The 9

threshold for severe irritation lies between these two valu es. In order to be health protective, 4.67 mg/m 3 is 10

selected as the point of departure. Time adjustment to a 30-minute equivalent concentration yields 5 mg/m 3

. 11

Applying a composite uncertainty factor of 3 to account for extrapolation from a concentration that potentially 12

causes escape-impairing effects in human s, results in an IDLH value of 1.7 mg/m 3

. 13

14



## 1.2 Purpose 15

16

This IDLH Value Profile presents (1) a brief summary of technical data associated with acute inhalation 17

exposures to n-butyl acrylate and (2) the rationale behind the Immediately Dangerous to Life or Health (IDLH) 18

value for peracetic acid. IDLH values are developed based on the scientific rationale and logic outlined in the 19

NIOSH Current Intelligence Bulletin (CIB) 66: Derivation of Immediately Dangerous to Life or Health (IDLH) 20

Values [NIOSH 2013]. As described in CIB 66, NIOSH perfo rms in-depth literature searches to ensure that all 21

relevant data from human and animal studies with acute exposures to the substance are identified. Information 22

included in CIB 66 on the literature search includes per tinent databases, key terms, and guides for evaluating data 23

quality and relevance for the establishment of an IDLH valu e. The information that is identified in the in-depth 24

literature search is evaluated with ge neral considerations that include d escription of studies (i.e., species, study 25

protocol, exposure concentration and duration), health endpoint evaluated, and criti cal effect levels (e.g., 26

NOAELs, LOAELs, LC 50 values). For peracetic acid, the in-dep th literature search was conducted through 27

February 2014. 28

29

30

31

32

33External Review Draft

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policy. 

## 1.3 General Substance Information 1

2

Chemical: Peracetic acid 3

CAS No: 79-21-0 4

Synonyms: Ethaneperoxoic acid; Peroxyacetic acid * 5

Chemical category: Organic peroxides † 6

Structural formula: 7

8

9

10

11

Table 1 highlights selected physiochemical properties of peracetic acid relevant to IDLH conditions. Table 2 12

provides alternative exposure guidelines for peracetic aci d. Table 3 summarizes the Acute Exposure Guidelines 13

Level (AEGL) values for peracetic acid. 14

15

Table 1: Physiochemical Properties of Peracetic Acid 16

17

Property Value

Molecular weight 76.05 ‡

Chemical formula C 2 H 4 O 3 Description Colorless liquid

Odor Disagreeable, pungent; Acrid

Odor Threshold Not available

UEL Not available

LEL Not available

Vapor pressure 14.5 mmHg at 25°C (77°F) ‡

Flash point 40.6°C (105°F) ‡

Ignition temperature 200°C (392°F) ‡

Solubility Mixable in water †

Abbreviation: C ° – Celsius; °F – Fahrenheit; mmHg – millimeter mercury; LEL – lower explosive limit; UEL – upper explosive limit 18

* NLM [2014] 19

† IFA [2014] 20

‡ HSDB [2014] 21

22

23

24

25

26

27 O

CH 3 O

OHExternal Review Draft

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information quality guidelines. It has not been formally di sseminated by the National Institute for Occupational

Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. Table 2: Alternative Exposure Guidelines for Peracetic Acid 1

2

Organization Value

Original (SCP) IDLH value None

NIOSH REL Not available

OSHA PEL [2014] Not available

ACGIH TLV [2014] Not available

AIHA ERPG [2010] Not available

AIHA WEEL [2010] Not available

Abbreviation: ACGIH – American Conference of Governmental I ndustrial Hygienists; AIHA – Am erican Industrial Hygiene 3

Association; ERPG – Emergency Re sponse Preparedness Guidelines; IDLH – immediatel y dangerous to life or health; NIOSH – Nationa l 4

Institute for Occupational Safety and Hea lth; OSHA – Occupational Safety and Health Administration; PEL – permissible exposure limit; 5

REL – recommended exposure limit; SCP – Standards Completion Program; WEEL – workplace envi ronmental exposure level 6

7External Review DraftMarch 2015This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not beenformally disseminated by the National Institute for Occupational Safety and Health. It does not represent and should not be construed to represent anyagency determination or policy.Table 3: AEGL Values for Peracetic Acid12Classification 10-min 30-min 1-hour4-hour 8-hour Endpoint [reference]AEGL-1 0.17 ppm0.52 mg/m30.17 ppm0.52 mg/m30.17 ppm0.52 mg/m30.17 ppm0.52 mg/m30.17 ppm0.52 mg/m3Threshold for irritation[Fraser and Thorbinson1986; McDonagh 1997]AEGL-2 0.51 ppm1.6 mg/m30.51 ppm1.6 mg/m30.51 ppm1.6 mg/m30.51 ppm1.6 mg/m30.51 ppm1.6 mg/m3Mild irritation [Fraserand Thorbinson 1986]AEGL-3 19.2 ppm60.0 mg/m39.6 ppm30.0 mg/m34.8 ppm15.0 mg/m32.0 ppm6.3 mg/m31.3 ppm4.1 mg/m3Highest concentrationcausing no deaths[Janssen 1989a]Abbreviation: AEGL – acute exposure guideline levels; mg/m3– milligrams per cubic meter; min – minute; ppm – parts per million3*References: NAS [2010]4External Review Draft

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policy. 

## 2.0 Animal Toxicity Data 1

2

No exposure data are available for pure peracetic acid. Technical or commercial peracetic acid products contain 3

peracetic acid, acetic acid, hydrogen peroxide, and small amounts of sulfuric acid. Pe racetic acid is unstable and 4

decomposes to sulfuric acid, acetic acid, and hydrogen pe roxide. Peracetic acid is extremely irritating to the 5

respiratory tract of animals. Janssen [1989a] exposed ma le CPB-WU Wistar rats (nose-only) to Proxitane 1507 ® 6

(15% peracetic acid, ~28% acetic acid, 14% hydrogen peroxide, ~1% stabilizer, and ~43% water) at 320 mg 7

peracetic acid/m 3 for 15 or 30 minutes, 390 mg peracetic acid /m 3 for 60 minutes, or 1450 mg peracetic acid/m 3 8

for 60 minutes. Janssen [1989b] performed a second study exposing male CPB-WU Wistar rats (nose-only) to 9

Proxitane 1507 ® at 499 mg peracetic acid/m 3 for 15 minutes, 304 or 578 mg peracetic acid/m 3 for 30 minutes, 329 10

or 589 mg peracetic acid/m 3 for 60 minutes, or 172 or 355 mg peracetic acid /m 3 for 90 minutes Reduced 11

respiratory rate, respiratory difficulties, blood around the nose and mouth, sneezing, and rubbing the nose were 12

observed at all concentrations except the control, with the severity increasing from slight to severe as the exposure 13

concentration increased. In a preliminary study, Janssen [1989c] exposed rats to Proxitane 1507 ® containing 14

varying ratios of peracetic acid and hy drogen peroxide. There was no clear c oncentration-related trend, and the 15

estimated RD 50 (50% depression in respiratory rates) valu es ranged from 21.5 to 24.1 mg peracetic acid/m 3

, 16

depending on which groups were included in the calcu lation. In a follow-up study conducted with higher 17

concentrations of Proxitane 1507 ® (components same as for Janssen 1989a), peracetic acid concentrations ranging 18

from 221 to 461.5 mg peracetic acid/m 3 caused 71-74% decreases in respiratory rate during a 25-minute exposure 19

[Janssen 1990]. Another rat study [Janssen and Van Doorn 1994] exposed male and female rats (nose only) to 87, 20

163, 185, or 267 mg/m 3 of Proxitane AHC ® (4.7-5.4% (~5%) peracetic acid, 19% (minimum) hydrogen peroxide, 21

10% acetic acid, water, and 1% surfactant) for 4 hours. Clinical signs including apathy, respiratory difficulties, 22

reduced respiratory rate, noisy breathing, drooping u pper eyelids, twitching, hypothermia, abnormal gait and 23

posture, crusts on nose, and blood u nder cage were observed in the 87 mg/m 3 exposure group; the higher exposure 24

groups had the same signs, with the addition of cyanosis, lacrimation, and salivation. 25

26

Merka and Urban [1978] exposed mice for 60 minutes to 150, 300, 450, 600, 800, 1,000, 1,300, or 1,600 mg 27

peracetic acid/m 3 as laboratory peracetic acid (made from acetic acid and hydrogen with sulfuric acid as the 28

catalyst, but containing no sulfuric acid) or Persteril ® (commercial product containing 40% peracetic acid). 29

Similar LC 50 values of 524 mg peracetic acid/m 3 and 512 mg peracetic acid/m 3 were obtained for laboratory 30

peracetic acid and for Persteril, respectively, indicating th at the small amount of sulfuric acid in Persteril had no 31External Review Draft

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information quality guidelines. It has not been formally di sseminated by the National Institute for Occupational

Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. effect on lethality in the mouse. Clinical signs were si milar to the ones seen in rats: eye and nasal discharge with 1

nose rubbing, respiratory distress, gasp ing, increased respiration, restlessn ess, bristling fur, and red swollen 2

drooping eyelids. Histological examination revealed lung lesions with concentration-related severity. 3

4

Table 4 summarizes the LC data identified in animal st udies and provides 30-minute equivalent derived values for 5

peracetic acid. Table 5 provides non-lethal data reporte d in animal studies with 30-minute equivalent derived 6

values. Information in these tables includes species of test animals, toxicological metrics (i.e., LC, NOAEL, 7

LOAEL), adjusted 30-minute concentration, and the justifi cation for the composite uncertainty factors applied to 8

calculate the derived values. 9

10

11External Review DraftMarch 2015This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not beenformally disseminated by the National Institute for Occupational Safety and Health. It does not represent and should not be construed to represent anyagency determination or policy.Table 4: Lethal Concentration Data for Peracetic Acid12Reference SpeciesLC50(mg/m3)LCLo(mg/m3)Time(min)Adjusted30-minConcentration*(mg/m3)CompositeUncertaintyFactorDerivedValue(mg/m3)†Merka and Urban [1978] Mice 524 -- 60 660 30‡ 22Janssen [1989a] Rat 476 -- 30 476 30‡ 16Janssen and Van Doorn [1994]Rat 204 -- 240 748 30‡ 253Abbreviation:LC – lethal concentration; LC50– median lethal concentration; LCLo– lowest concentration of a chemical that caused death in humans or animals; min –4minute; ppm – parts per million5*For exposures other than 30 minutes the ten Berge et al. [1986] relationship is used for duration adjustment (Cnx t = k). NAS [2008] empirically estimated n = 1.6 for6rats; no time scaling was used for the human studies, based on the absence of increased irritation with exposure duration. Thedefault value of n = 3 was used for mice,7since the study duration was >30 minutes and no datawere available supporting a species-specific value.8†The derived value is the result of the adjusted 30-minute LC value divided by the composite uncertainty factor.9‡Composite uncertainty factor to account for adjustment of LC50values to LC01values, use of lethal concentration threshold in animals, interspecies differences and10human variability.11External Review DraftMarch 2015This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not beenformally disseminated by the National Institute for Occupational Safety and Health. It does not represent and should not be construed to represent anyagency determination or policy.Table 5: Non-lethal Concentration Data for Peracetic Acid12Reference SpeciesNOAEL(mg/m3)LOAEL(mg/m3)Time(min)Adjusted30-minConcentration*CompositeUncertaintyFactorDerivedValue†(mg/m3)Fraser and Thorbinson [1986] Human -- 15.6 7 16 3‡ 5.3Fraser and Thorbinson [1986] Human -- 9.4 20 9 3‡ 3Fraser and Thorbinson [1986] Human -- 6.2 60 6 3‡ 2Fraser and Thorbinson [1986] Human -- 4.7 12 5 3‡ 1.73Abbreviation: NOAEL – no observed adverse effect level; min – minute; LOAEL – lowest observed adverse effect level; ppm – parts per million4* For exposures other than 30 minutes the ten Berge et al. [1986] relationship is used for duration adjustment (Cn x t = k). NAS [2008] empirically estimated n = 1.6 for5rats; no time scaling was used for the human studies, based on the absence of increased irritation with exposure duration. Thedefault value of n = 3 was used for mice,6since the study duration was >30 minutes and no datawere available supporting a species-specific value.7†The derived value is the result of the adjusted 30-min value divided by the composite uncertainty factor. The composite uncertainty factor used varies for each study8based on the nature and severity of the endpoint observed.9‡Composite uncertainty factor assigned to account for human variability.10External Review Draft

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information quality guidelines. It has not been formally di sseminated by the National Institute for Occupational

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policy. 

## 3.0 Human Data 1

2

No human lethality studies for peracetic acid were located. Peracetic acid is highly irritating to the human eye 3

and nasal mucous membranes [Bock et al. 1975]. A case study [McDonagh 1997] reported that concentrations of 4

1.56-1.87 mg/m 3 (0.5-0.6 ppm) were not immediately irritating but that this concentration range was considered 5

“unpleasant for an extended period of time.” Fraser and Thorbinson [1986] exposed volunteers (number of 6

subjects not reported) to fogged Perato l diluted 1:20 (5% peracetic acid, corr esponding to 1904 mg/L in the liquid 7

formulation) for about 2 hours of continuous fogging, followed by 45 minutes of monitoring after the fogger was 8

turned off. Exposure and effects were measured at va rious time points during the study and at various distances 9

from the fogger; exposure levels tended to decrease with time. The authors reported lacrimation at 15.6 mg 10

peracetic acid/m 3 , extreme discomfort and mucous membrane irritation at 6.23 mg peracetic acid/m 3 , slight to 11

mild discomfort at 1.56-4.67 mg peracetic acid/m 3 , and no discomfort at  1.56 mg peracetic acid/m 3 . Because of 12

the nature of the exposure protocol, these concentra tions may not reflect continuous exposures at these 13

concentrations. 14

15



## 4.0 Summary 16

17

Both animal and human data exist for peracetic acid. A lthough an appropriate animal study exists for derivation 18

of an IDLH, exposures were 2 orders of magnitude higher than those causing possible escape impairing effects in 19

humans. Fraser and Thorbinson [1986] reported that exposure to 4.67 mg/m 3 for 12 minutes caused slight to mild 20

irritation, and exposure to 6.23 mg/m 3 for 60 minutes caused extreme discomfort and possibly escape impairing 21

effects. These effects are can be classified as potentially escape impairing. The threshold for severe irritation lies 22

between these two values. In order to be health protective 4.67 mg/m 3 is selected as the point of departure. Time 23

adjustment to a 30-minute equivalent concentration yields 5 mg/m 3 . Applying an uncertainty factor of 3 to 24

account for human variability results in an IDLH value of 1.7 mg/m 3

. 25

26

27

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Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. 

## 5.0 References 1

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Bock FG, Meyers HK, Fox HW [1975]. Cocarcinogenic activity of peroxy compounds. J Nat Cancer Inst 13

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Fraser JAL, Thorbinson A [1986]. Fogging trials with Te nneco Organics Limited (30th June, 1986) at Collards 16

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44External Review Draft

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information quality guidelines. It has not been formally di sseminated by the National Institute for Occupational

Safety and Health. It does not represent and should not be construed to represent any agency determination or

policy. McDonagh J [1997]. Atmospheric monitoring of peracetic acid on the existing caprolactone plant distillation 1

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44