UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

SUBJECT: 

PC Code(s): 011105 

Decision No.: 455964 

Petition No(s).: NA 

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

February 2, 2012 

Perboric Acid, Sodium Salt Monohydrate (PBSM) Human Health 

Risk Assessment Scoping Document in Support of Registration 

Review. 

DP Barcode(s)/No(s): D394846 

Registration Number (s): 3573-56 and 3573-58 

Regulatory Action: Registration Review 

Risk Assess Type: Single Chemical Case No(s): 5007 

TXRNo.:NA 

MRID No(s).: NA 

FROM: 

1'0: 

THRU: 

CAS No(s): 10332-33-9 

40 CFR: None 

Nathan 

William 

Mottl, 

Hazel, 

Biologist 

Chemist 

1/' ~~ 

Jonathan Chen, Toxicologist 

Risk Assessment and Science Support Branch (RASSB) 

Antimicrobials Division (7510P) 

Seiichi Murasaki, Chemical Review Manager 

Regulatory Management Branch II 

Antimicrobials Division (751OP) 4. 

Nader Elkassabany, Branch Chief Itc 

Timothy Leighton, Senior Scientist ~....--­ Risk Assessment and Science Support Branch (RASSB) 

Antimicrobials Division (751 OP) 

1 
2

EXECUTIVE SUMMARY

The Antimicrobial Division (AD) Registration Review Team has evaluated the status 

of the human health assessments for perboric acid, sodium salt, monohydrate (PBSM). 

The PBSM registration review case includes one active ingredient PBSM (PC Code 

011105). PBSM is the active ingredient in two registered pesticide products Tide with 

Bleach II (EPA Reg 3573-56) and Gain with Bleach II (EPA Reg 3573-58). PBSM is 

used in combination with sodium nonanoyloxybenzenesulfate (NOBS) in laundry 

detergents as a sanitizer to kill odor causing germs and bacteria on clothes. NOBS was

assessed in a recent registration review decision. EPA Docket: EPA-HQ-OPP-2010-0424

The PBSM active ingredient is formulated as a dry flowable product in laundry 

detergents at concentrations of approximately 5% active ingredient (a.i.). Initially The 

Agency reviewed hazard and exposure databases for PBSM and have attempted to 

determine whether changes in science policy, use patterns, or available data have

materially affected the overall risk picture. PBSM was first registered in 1998. A 

Reregistration Eligibility Decision (RED) document was not required since PBSM was 

registered after November 1, 1984.

The purpose of this screen is to determine whether sufficient data are available to 

support registration review, report on whether past risk assessments are still applicable,

and to determine whether new human health assessments are needed to support the 

registration review process.

The original registrations for the products that included the active ingredients NOBS 

and PBSM were assessed together in conditional registrations. PBSM and NOBs were 

qualitatively assessed together in 1998 for the purpose of registration (D240707, 

D240713, D242289, D242290, and D246258). Toxicity data was required for NOBS, but 

was not required for PBSM. The reason for waiving the requirements was that the 

Agency determined that PBSM was a ‘peroxy compound.’ The Agency had waived all 

the non-acute toxicity data in the 1993 Hydrogen Peroxide RED (D250491). Quantitative 

occupational and residential and dietary risk assessments were not developed during 

registration because no toxicological endpoints were developed. Human health data 

requirements were required for NOBS, but not for PBSM. 

PBSM rapidly hydrolyzes in water to boric acid and hydrogen peroxide. The 

degradate, hydrogen peroxide, then perhydrolyzes NOBS to form pernonanoic acid in 

situ. PBSM acts as both laundry bleaching agent and as sanitizer in combination with 

NOBS. The PBSM residues are expected to be very reactive and are also expected to 

rapidly biodegrade for the laundry use. The Agency does not expect that PBSM will 

contaminate water or remain on washed clothes as directed by the present product label.

For registration review, the Agency identified potential inhalation exposure concerns 

for pouring PBSM dry flowable concentrates into a laundry machine. As a result, the

Agency anticipates that dermal and inhalation toxicological endpoints will be needed to 

develop occupational and residential risk assessments. The Agency does not expect to 

conduct risk assessments for dietary, aggregate and cumulative exposures. The Agency 
3

no longer believes that the toxicity data requirements should be waived since 1) the 

PBSM active ingredient is not included in the Peroxy Compounds RED case and 2) 

PBSM contains borate which is a known male reproductive toxicant and was already 

assessed in a recent registration review decision (EPA Docket: EPA-HQ-OPP-2007-

0675). 

Section 1. Chemical Identity

PBSM is a highly water soluble and non-volatile white dry flowable that hydrolyzes 

rapidly in water at higher pH levels and hydrolyzes and more slowly at lower pH levels 

(MRID 45236201). Table 1 presents the chemical identity of PBSM.

In aqueous solutions at room temperature, equilibrium between PBSM and hydrogen 

peroxide and sodium borate instantly established (See equation I ). Hydrogen peroxide is 

also expected to further degrade to (active) oxygen and water (Equation II). 

(Equation I)

H2O2 → H2O + [O]

(Equation II)

Table 1 Chemical Identity

Common 

Name

Perboric acid, sodium salt, monohydrate and

sodium perborate, monohydrate 

CAS name Perboric acid, sodium salt, monohydrate

PC Code 011105

CAS registry 

number

10332-33-9

Registration 

Review Case 

No.

5007

Structure
4

Section 2. Toxicology

Acute Toxicity

In acute toxicity studies, PBSM has been shown to have low toxicity by the oral 

route (Toxicity Category III) and dermal route (Toxicity Category III) and PBSM is a 

mild skin irritant (Toxicity Category IV). PBSM shows a strong response as an eye 

irritant (Toxicity Category I). There is no available acute inhalation study for PBSM. 

Therefore, an acute inhalation study for technical PBSM is considered a data gap. Acute 

toxicity for PBSM is presented below in Table 2. 

Table 2. Acute Toxicity Data for PBSM Technical Grade Active Ingredient (97.9-100%)

Guideline Number

Study Type

MRID 

Number Results Toxicity 

Category

870.1100 Acute oral toxicity 41716201 LD50(males) = 1300 mg/kg

LD50(females) = 890 mg/kg

LD50(combined) = 1120 mg/kg (M+F) 

III

870.1200 Acute dermal toxicity 41716202 LD50 > 2000 mg/kg (M and F) III

870.1300 Acute inhalation toxicity - Data gap -

870.2400 Acute eye irritation 41716203 Corrosive (corneal opacity persist up to 21-

days post-application) I

870.2500 Acute dermal irritation 4176204 Slight irritation (moderate irritation at 72 

hours post-application) III

870.2600 Skin sensitization 43375211 Non-sensitizer

M = males; F = females; NA = not applicable

Subchronic Toxicity

There is no acceptable subchronic study in the PBSM toxicology database and EPA 

anticipates the need for an inhalation toxicity study. The Agency expects that there could 

be inhalation exposure to the dry flowable detergent containing PBSM. PBSM breaks 

down to boric acid and H2O2 under physiological conditions. Both the parent compound 

and the degradation product H2O2 are strong oxidants. The data from a wide variety of 

experiments have suggested that reactive oxygen metabolites may play an important role 

in the pathophysiology of lung inflammation and injury, and evidence has shown 

formation of short-lived reactive oxygen species within the lung tissue may result in lung 

injury.

No studies are available which address potential subchronic toxicity of PBSM via the 

oral and dermal route. Since sodium perborate is rapidly hydrolyzed in water to boric 

acid and hydrogen peroxide, oral and dermal exposure of the parent compound would be 

limited once the parent compound is in water.

Prenatal Developmental Toxicity
5

There is no developmental study in the PBSM database. There is one developmental 

study on sodium perborate tetrahydrate been cited in the draft HERA Risk Assessment of 

Sodium Perborate mono- and tetrahydrate indicating sodium perborate may cause 

developmental concern including decrease fetal body weight, skeletal and visceral 

variants (HERA, 2002). A developmental toxicity is considered as a data gap.

Reproduction and Fertility Effects Toxicity

There is no reproductive study in the PBSM database. Since sodium perborate is 

rapidly hydrolyzed in water to boric acid and hydrogen peroxide. Borate is a known male 

reproductive toxicant and was already assessed in a recent registration review decision 

(EPA Docket: EPA-HQ-OPP-2007-0675). The Agency will use the decision made in the 

borate registration review to address the reproductive concern for PMBS.

Chronic Toxicity

Chronic toxicity data are not required at this time since there are no chronic exposures 

based on the current labeled use patterns for PBSM. 

Carcinogenicity

There is no carcinogenicity study in the PBSM database and not needed. 

Mutagenicity

There is no mutagenicity study in the PBSM database. Both in vitro and in vivo

mutagenicity are cited in the draft HERA Risk Assessment of Sodium Perborate monoand tetrahydrate (HERA, 2002). The reports suggest perborate may cause:

• Positive responses in Ames Assay with strains TA 100 and TA 102 in the absence 

of metabolic activation;

• A positive response was obtained in a DNA repair assay was conducted using E 

coli repair deficient and repair proficient strains suggesting the perborate was 

capable of inducing preferential DNA repair; and

• A positive response in Chinese hamster ovary mammalian cells (CHO-K1) on 

chromosomal aberrations was obtained in the absence of S9.

All the positive responses were reduced or abolished with S9 and/or catalase 

treatment, indicating the repose is caused by the degradation product H2O2. Hydrogen 

peroxide is produced under physiological conditions.

Dermal Absorption Factor

There is no dermal absorption study in the PBSM database. PBSM is an inorganic 

water-soluble solid of relatively low molecular weight. Dermal absorption of PBSM is 

assumed to be low due to the hydrophilic character and ionic structure of the substance. 
6

Toxicity Endpoint Selection for Human Health Assessments.

A toxicity endpoint selection has not been selected for PBSM.. 

Section 3. Dietary and Drinking Water Assessment

 Given that the only EPA-registered use of PBSM is as part of an antimicrobial system 

in laundry detergents, there is no opportunity for residues of this active ingredient to 

result in human dietary exposure via contaminated food.

 As PBSM is an active ingredient in laundry detergents, discharges of washing 

machine waste water into municipal waste water treatment plants are expected from 

homes and from commercial and institutional facilities. However, sodium perborate is 

rapidly hydrolyzed in water to boric acid and hydrogen peroxide. The hydrogen peroxide 

perhydrolyzes the NOBS to form pernonanoic acid in situ which acts as both laundry 

bleaching agent and as sanitizer. These residues are either very reactive or are rapidly 

biodegraded. Therefore none of these residues are expected to survive long enough to 

contaminate drinking water. Thus, human dietary exposure via contaminated drinking 

water is not likely to occur.

Section 4. Occupational/Residential Exposure

An occupational and/or residential exposure assessment is required for an active 

ingredient if (1) certain toxicological criteria are triggered and (2) there is potential 

exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering 

treated sites after application is complete. For PBSM, the Agency needs to select and 

identify toxicological endpoints before a risk assessment can be conducted. The Agency 

may need to conduct handler dermal and inhalation risk assessments once the toxicity 

data has been submitted, reviewed, and accepted by the Agency.

The Agency did not conduct a quantitative occupational and residential risk 

assessment for NOBS/PBSM in registration since there were no NOBs/PBSM 

toxicological endpoints. Based on the available use information, AD concludes that there 

is potential exposure to handlers when pouring the dry flowable detergent (i.e., 

commercial and homeowner laundry). Although potential exposure could occur via 

exposure to laundered clothes, the Agency believes this dermal and incidental oral 

exposure is negligible because of the rapid degradation of perborate after the laundry is 

washed and dried. The Agency expects that minimal residues will remain on the 

laundered clothes. 

Hander Exposure

The Agency has identified potential inhalation occupational and homeowner handler 

exposures for PBSM. Since dermal absorption of PBSM is assumed to be low due to the 

hydrophilic character and ionic structure of the substance, the Agency will not develop 

dermal handler exposures. For inhalation, the Agency is aware that the fraction of 

respirable particles in PBSM dry flowable product is low and much of the particulate 

would not be respirable. According to HERA , 90 to 100% of the PBSM particles have a 
7

diameter above 0.15 mm (HERA, 2002). However, the Agency is concerned that in the aqueous 

media of the lung, the larger PBSM particles would immediately dissociate to hydrogen peroxide 

and boric acid. The Agency is concerned since the parent compound and the degradation 

product H2O2 are strong oxidants. As a result the Agency expects to need toxicological 

inhalation endpoints for PBSM and also anticipate the need to develop inhalation risk 

assessments. The inhalation exposure scenarios include:

• Occupational applicators/loading dry flowable concentrate for laundry machines 

at commercial laundromats; and, 

• Residential applicators loading dry flowable concentrate for laundry machines 

and hand washing clothes.

Risk assessments may be needed depending on whether toxicity studies triggers the 

development of hazard endpoints. The hazard database is inadequate at this time to

permit selection of inhalation toxicological endpoints.

Product use information was provided to the Agency in 2001 (MRID 45436203), 

which will aid the Agency in developing use and usage inputs in order to estimate

occupational and residential handler exposures. The risk assessment will be conducted if 

and when appropriate toxicological endpoints are selected by the Agency. Based on the 

data submitted by the registrant, the Agency will assess the products as a dry flowable 

and will use the product use data to develop exposure assumptions. 

Postapplication Exposure

The Agency believes that dermal, inhalation and incidental ingestion exposure are 

expected to be negligible based on dilution, solubility of PBSM in water and rapid 

degradation in the resulting alkaline wash water solutions (MRID 45236201). The 

Agency came to this conclusion after review of the description of human activity data and 

hydrolysis data submitted by the registrant (MRID 45436203/MRID 45236201). As a 

result no additional data are anticipated as being needed for post-application exposure. 

Section 5. Aggregate and Cumulative Exposure

In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to pesticide residues in food and drinking water, and 

non-occupational pesticide exposures. Dietary (food and drinking water) exposures of 

concern are not anticipated for PBSM because concentrations are significantly diluted, 

does not contact food, and residues are either very reactive or are rapidly biodegraded.

The Agency does expect that it will need to conduct a residential assessment. An 

aggregate assessment is not anticipated.

Unlike other pesticides for which EPA has followed a cumulative risk approach based 

on a common mechanism of toxicity, EPA has not made a common mechanism of 

toxicity finding as to PBSM and any other substances and PBSM does not appear to 

produce a toxic metabolite produced by other substances. For the purposes of this action, 

therefore, EPA has not assumed that PBSM has a common mechanism of toxicity with 

other substances. For information regarding EPA’s efforts to determine which chemicals 
8

have a common mechanism of toxicity and to evaluate the cumulative effects of such 

chemicals, see the policy statements released by EPA’s Office of Pesticide Programs 

concerning common mechanism determinations and procedures for cumulating effects 

from substances found to have a common mechanism on EPA’s website at 

http://www.epa.gov/pesticides/cumulative/.

Section 6. Incidents

There have been no human incidents reported in any of the OPP databases associated 

with exposure to PBSM.

Section 7. Anticipated Data Needs

The Antimicrobial Division (AD) anticipates the need for the following studies to 

complete risk assessments for the registration review process for PBSM and to develop 

toxicological endpoints. Complete justifications for these studies are presented in 

Appendix A.

Toxicological Data Needs

• Acute Inhalation (GLN 870.1300)

• 90-day Inhalation (GLN 870.3465)

• Rat Developmental (GLN 870.3700)

Occupational and Residential Applicator Exposure Data Needs

Table 3: Human Health Data Needs Based on End Use Labels

Study Needed* Guideline Rationale (also see Appendix B)

Indoor Exposure from 

Loading dry Flowable

Concentrate

875.1400 (Inhalation)

875.1600 (Data Reporting)

An inhalation exposure study is needed for individuals 

loading detergent dry flowable concentrate into washing 

machines.

*Note: Product use and human activity information for NOBS/PBSM were submitted 

during registration (MRID 45436203) and are not anticipated as needed for registration 

review.

Section 8. Tolerances

There are no tolerances or exemptions from tolerances for PBSM and no registered 

food uses. Since the only registered uses are for non-food uses and no dietary assessment 

is needed, no tolerances or exemptions from tolerances will be needed to support the 

existing registered uses of PBSM. 
9

Section 9. Endocrine Disruption

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess 

potential adverse outcomes from exposure to chemicals. Collectively, these studies 

include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, 

neurotoxicity, developmental, reproductive, and general or systemic toxicity. These 

studies include endpoints which may be susceptible to endocrine influence, including 

effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual 

maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For 

ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess 

growth, developmental and reproductive effects in different taxonomic groups. As part 

of its reregistration decision, EPA reviewed these data and selected the most sensitive 

endpoints for relevant risk assessment scenarios from the existing hazard database. 

However, as required by FFDCA section 408(p), PBSM is subject to the endocrine 

screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including 

pesticide active and other ingredients) may have an effect in humans or wildlife similar to 

an effect produced by a “naturally occurring estrogen, or other such endocrine effects as 

the Administrator may designate.” The EDSP employs a two-tiered approach to making 

the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays 

to identify the potential of a chemical substance to interact with the estrogen, androgen, 

or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening 

and are found to have the potential to interact with E, A, or T hormonal systems will 

proceed to the next stage of the EDSP where EPA will determine which, if any, of the 

Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to 

identify any adverse endocrine-related effects caused by the substance, and establish a 

dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. 

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the 

first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert 

ingredients. PBSM is not among the group of 58 pesticide active ingredients on the 

initial list to be screened under the EDSP. Accordingly, as part of registration review, 

EPA will issue future EDSP orders/data call-ins, requiring the submission of EDSP 

screening assays for PBSM. For further information on the status of the EDSP, the 

policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the 

Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.

Section 10. Reference 

• U.S. EPA, 1998. RASSB Review For NOBS, Sodium Nonanoyloxybenzene 

Sulfonate and Sodium Perborate (Sodium Peroxyborate); Product Chemistry, 

Toxicology, Human Exposure, Environmental Fate, and Ecological Effects. July 

8, 1998. D240707; D240713; D242289; D242290; D246258.

• U.S. EPA, 1999. Sodium nonanoyloxybenzenesulfonate (NOBS); review of 

toxicology data in support of registration of the active ingredient. November 24, 
10

1999. Memorandum from T. McMahon, phD , RASSB to D. Edwards, Branch 

Chief, RMB1. D250491.

• MRID 45436203.Human exposure data to support the use of nonanoyloxybenzene 

(NOBS) as an active ingredient in sanitizing laundry detergents. Karen D. Smith,

ph.D., Proctor and Gamble Company. June 14, 2001.

• MRID 4523601. The determination of hydrolysis of E3411.01 as a function of 

pH. MacDonald, I.A., Howes, D.A. and G. J. Davies. September 21, 1988.

• HERA (2002). Draft Human and Environmental Risk Assessment on ingredients 

of European cleaning products – Perboric acid, sodium salt, mono and 

tetrahydrate.
11

Appendix A

Toxicity and Exposure Study Justifications
12

Guideline Number: 870.3465

Data Requirement: 90-day Inhalation Toxicity Study

Rationale for Requiring the Data

The Agency does not have a full picture of the potential effects which PBSM could occur as a result of 

exposure via the inhalation route. The needed study would provide insight into concerns regarding toxicity 

via the inhalation route. It may also provide a toxicity endpoint applicable to risk assessment.

Practical Utility of the Data

1. How would the data be used?

The study may result in a change in how risks are quantified. The data would allow the Agency to 

conclude more definitively whether or not there would be any concerns for inhalation toxicity in the rat. 

This would provide a more complete hazard characterization of biobor in regards to the potential risks to 

the U.S. general population.

2. How could the data affect the risk assessment?

The study may result in a change in how risks are quantified. It is possible that the database uncertainty 

factor be reduced or removed, resulting in different magnitude of the value of the endpoint used for 

regulation.

3. What is triggering the need for this data?

The difficulty of predicting real world human inhalation exposure with limited data and no inhalation data 

or other alternative information, such as SAR (structure-activity-relationship), surrogate data, and/or 

weight-of-evidence to the Agency triggered the need for a 90-day (guideline) Inhalation toxicity study, in 

order to adequately evaluate real world human exposure to PBSM particles based on how it is used (The 

OPPTS Guidelines require an MMAD of 1-3 μm in inhalation toxicity studies of aerosols so that a portion 

of the test article will reach the lungs). The exposure to dusts during mixing/loading are triggering the need 

for toxicological data in order to conduct a risk assessment.
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Guideline Number: 870.1300

Data Requirement: Acute Inhalation Toxicity Study

Rationale for Requiring the Data

Waiver criteria have been updated based on advances in inhalation toxicology. The newer criteria state that 

a registrant requesting a waiver on the basis of particle size must demonstrate that their product contains 

large, non-inhalable particles which are resistant to attrition and that a particle is essentially non-inhalable 

if > 99% of the particles by mass are >100 μm in diameter. The Agency’s information indicates a large 

proportion of the particles of the technical powder have diameters less than 100 microns. On this basis, the 

waiver for an acute inhalation toxicity study can no longer be supported for the dry flowable material. 

Practical Utility of the Data

1. How would the data be used?

Determination of acute oral, dermal and inhalation toxicity are one of the initial steps in the assessment and 

evaluation of the toxic characteristics of a pesticide. 

2. How could the data affect the risk assessment?

Data from acute studies serve as a basis for classification and precautionary labeling. For example, acute 

toxicity data are used to develop precautionary label statements pertaining to protective clothing 

requirements for applicators.

3. What is triggering the need for this data?

There is no available acute inhalation study for PBSM. Therefore, an acute inhalation study for 

technical PBSM is considered a data gap.

Guideline Number: 870.3700

Data Requirement: Rat Developmental Toxicity Study

Rationale for Requiring the Data

The needed study would provide insight into concerns regarding pre- and/or postnatal toxicity as required

by FQPA. It may also provide a toxicity endpoint applicable to risk assessment.

Practical Utility of the Data

1. How would the data be used?

The study may result in a change in how risks are quantified. The data would allow the Agency to 

conclude more definitively whether or not there are any concerns for pre- and/or postnatal toxicity in the 

rabbit. This would provide a more complete hazard characterization of PBSM in regards to the potential 

risk of developmental toxicity.

2. How could the data affect the risk assessment?

The study may result in a change in how risks are quantified. It is possible that the database uncertainty 

factor may be reduced or removed, resulting in different magnitude of the value of the endpoint used for 

regulation.

3. What is triggering the need for this data?

The difficulty of predicting real world human exposure via oral route with limited data and no 

developmental toxicity data in rabbit or other alternative information, such as SAR (structure-activityrelationship), surrogate data, and/or weight-of-evidence to the Agency triggered the need for a 

developmental (guideline) toxicity study in the rabbit, in order to adequately evaluate real world human 

exposure to PBSM, particularly women in the 15-49 years of age and infants and children, based on how it 

used.
14

Guideline Number: 875.1400

Data Requirement: Inhalation Exposure - Indoor

Rationale for Requiring the Data

The inhalation exposure route is very important for exposure scenarios such mixing/loading exposure for 

liquid detergent dry flowable concentrate. In addition, inhalation exposures from dry flowable concentrate

are evident in exposure studies in the Pesticide Handlers Exposure Database (PHED). The significance of 

these exposures is directly affected by the severity of the inhalation toxicological endpoint of concern. At 

this point in time, no toxicological data are available to assess the inhalation risk. The existing Chemical 

Manufacturer Association (CMA) data base and PHED for these scenarios are limited in scope for QA/QC 

and number of monitoring units. EPA presented the need for additional handler exposure data to the 

January 2007 Science Advisory Panel (SAP) as well as to the April 2007 Human Studies Review Board 

(HSRB) and both groups agreed that additional data are warranted.

Practical Utility of the Data

1. How would the data be used?

The inhalation exposure data would be used to assess the occupational exposure from mixing/loading 

exposure for detergent dry flowable concentrates.

2. How could the data affect the risk assessment?

The inhalation exposure data would be used to determine the accuracy of the inhalation risks to both 

residence and occupational workers. If risks warrant mitigation, the inhalation exposure data would 

provide the types of mitigation necessary such as respiratory protection from respirators or closed systems 

for commercial uses to potential removal of uses from the label.

3. What is triggering the need for this data?

The criteria for the inhalation exposure data are based on the potential for respiratory exposure from the 

labeled uses (e.g., exposure to PBSM dry flowable concentrate) and evidence of toxicity. If no 

toxicological endpoints of concern were identified, then the inhalation exposure data would not be needed.

Guideline Number: 875.1600

Data Requirement: Applicator Exposure Monitoring Data Reporting

Rationale for Requiring the Data

For all exposure studies this data need is needed to facilitate the review of the data.

Practical Utility of the Data

1. How would the data be used?

The study report and all raw data/calculations would be reviewed for the adequacy of the data.

2. How could the data affect the risk assessment?

The data are needed to interpret the inhalation exposure data collected.

3. What is triggering the need for this data?

This data need is triggered if an exposure study is conducted.