UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

 WASHINGTON, D.C. 20460 

 OFFICE OF CHEMICAL SAFETY 

 AND POLLUTION PREVENTION 

December 3, 2015 

MEMORANDUM 

SUBJECT: Petition No.: IN-10777; Salicylaldehyde. Human Health Risk Assessment and 

Ecological Effects Assessment to Support Proposed Exemption from the 

Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide 

Formulations. 

PC Code: 730944 DP Barcode: N/A 

Decision No.: N/A Regulatory Action: Inert Tolerance 

Exemption; 40 CFR 180.910 

Petition No.: IN-10777 CAS Reg. No.: 90-02-8 

Inert Tracking No.: N/A

 

FROM: William Cutchin, Chemist 

Chemistry, Inerts and Toxicology Assessment Branch (CITAB) 

 Registration Division (RD) (7505P) 

THROUGH: Kerry Leifer, Team Leader 

 CITAB/RD (7505P) 

TO: Pv Shah, Branch Chief 

 CITAB/RD (7505P) 

 
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Table of Contents

EXECUTIVE SUMMARY .............................................................................................................................................. 3

I. BACKGROUND .................................................................................................................................................... 5

II. INERT INGREDIENT PROFILE ........................................................................................................................... 6

III. HUMAN HEALTH ASSESSMENT .................................................................................................................. 6

IV. DIETARY EXPOSURE ASSESSMENT ......................................................................................................... 13

V. RESIDENTIAL EXPOSURE AND ASSESSMENT ............................................................................................ 15

VI. AGGREGATE RISK AND DETERMINATION OF SAFETY ....................................................................... 15

VII. OCCUPATIONAL EXPOSURE/RISK PATHWAY ....................................................................................... 16

VIII. CUMULATIVE EXPSOURE ........................................................................................................................... 28

IX. ENVIRONMENTAL JUSTICE STATEMENT ............................................................................................... 28

X. ENVIRONMENTAL FATE CONSIDERATIONS .............................................................................................. 29

XI. ECOTOXICITY ................................................................................................................................................ 29

XII. RISK CHARACTERIZATION ......................................................................................................................... 29
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EXECUTIVE SUMMARY 

 Ag-Chem Consulting LLC, on behalf of Omex Agrifluids, is proposing, pursuant to 

section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 

amend 40 CFR part 180.910 to establish an exemption from the requirement of a tolerance for 

salicylaldehyde (2-hydroxybenzaldehyde; CAS Reg. No. 90-02-8) in or on food crops at no more 

than 14% of the pesticide formulation to help the active ingredient properly penetrate and remain 

available to act in the soil. 

 The acute oral toxicity of salicylaldehyde was examined in female rats with 3 rats in one 

group, and a study was performed using the stepped method in which one-time oral 

administrations were performed in stages while checking the death conditions for a fixed dosage. 

From the above results, the general lethal amount in rat oral administration of salicylaldehyde is 

estimated to be 500mg/kg. The dermal LD50 for salicylaldehyde was determined to be greater than 

23 g/kg. Dermal irritation studies found salicylaldehyde to be irritating, with eschar formation and 

scarring 14 days after administration.

 Salicylaldehyde was negative in a rat bone marrow micronucleus test and had no 

clastogenicity in rat bone marrow cells. 

In a study in male and female rats (Crj: CD (SD) type SPF), no effects of administration of 

the salicylaldehyde substance were found on the female estrus cycle and estrus count, on the male 

and female mating and impregnation, and on the female animal pregnancy period and parturition. 

No effects of administration of salicylaldehyde were found on nursing Day 0 in the number of live 

birth infants, number of stillborns, sex ratio, parturition rate, and birth rate. At doses below 40 

mg/kg, no effects of administration of salicylaldehyde were found in general conditions, weight, 

feed volume, hematological test values, blood chemistry test values, autopsy findings, and organ 

weight. 

There are no cancer studies available for salicylaldehyde. Based on predicted rapid 

metabolism and excretion, lack of specific target organ toxicity in the repeat dose studies study and 

lack of mutagenicity, salicylaldehyde is not expected to be carcinogenic. 

 The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is 

intended to provide an additional l0-fold safety factor (10X), to protect for special sensitivity in 

infants and children. Based on available information, the FQPA safety factor should be reduced to 

IX. 

No acute toxicological endpoint of concern has been identified for salicylaldehyde. On the 

basis of the Repeated Dose and Reproductive/Developmental Toxicity Screening study, a no 

observed adverse effect level (NOAEL) for parental systemic toxicity and embryo/developmental 

toxicity NOAEL for salicylaldehyde was 40 mg/kg bw/day. Based on the reduced FQPA Safety 

Factor for salicylaldehyde of IX, the chronic reference dose (cRfD) and the chronic population 

adjusted dose (cPAD) are 0.4 mg/kg. The chronic oral NOAEL is also applicable to the dermal and 

inhalation exposure routes. 
4

 The Agency assessed the dietary exposures to salicylaldehyde as an inert ingredient used in 

pesticide formulations applied to growing crops and livestock. No adverse effects attributable to a 

single exposure to salicylaldehyde were seen in the toxicity databases; therefore, an acute dietary 

risk assessment is not appropriate. In conducting the chronic dietary exposure assessment using the 

Dietary Exposure Evaluation Model DEEM–FCIDTM, no residue data were submitted for 

salicylaldehyde. In the absence of specific residue data, EPA has developed an approach which 

uses surrogate information to derive upper bound exposure estimates for the subject inert 

ingredient. Upper bound exposure estimates are based on the highest tolerance for a given 

commodity from a list of high-use insecticides, herbicides, and fungicides. In the dietary exposure 

assessment, the Agency assumed that the residue level of the inert ingredient would be no higher 

than the highest tolerance for a given commodity. Implicit in this assumption is that there would be 

similar rates of degradation (if any) between the active and inert ingredient and that the 

concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no 

higher than the concentration of the active ingredient. DEEM model estimates for oral exposure 

from the use of salicylaldehyde in pesticidal formulations (including exposure through drinking 

water) resulted in chronic dietary exposure estimates for food and drinking water below the 

Agency’s level of concern (<100% cPAD) for the U.S. population and all population subgroups. 

The chronic dietary exposure from food and water to salicylaldehyde is 13% of the cPAD for the 

U.S. population and 49% of the cPAD for children 1-2 years old, the most highly exposed 

population subgroup. 

 The Agency has not identified any concerns for carcinogenicity relating salicylaldehyde; 

therefore, a cancer dietary exposure assessment was not performed.

The term “residential exposure” is used in this document to refer to non-occupational, nondietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea 

and tick control on pets). While there are no current or proposed residential uses for 

salicylaldehyde, it is possible that salicylaldehyde may be used as an inert ingredient in pesticide 

products. In the absence of specific residential exposure scenarios, risk estimates for residential 

exposures to salicylaldehyde can be modeled based on occupational exposure assessments for 

salicylaldehyde. Given the larger treatment areas and higher concentrations of salicylaldehyde 

used in occupational use pesticide products than would be seen in residential uses, MOEs for 

residential use scenarios would exceed 1,000 or more. Since our level of concern is for MOEs of 

100 or less, there are no concerns for residential exposures to salicylaldehyde. 

There was no hazard attributable to a single exposure seen the in the toxicity database for 

salicylaldehyde; therefore, an acute aggregate risk assessment is not required. 

It is possible that salicylaldehyde may be used as an inert ingredient in pesticide products 

even though no residential or commercial uses on lawns or ornamentals are proposed. The dietary 

exposures to food and drinking water are aggregated with residential uses to calculate aggregate 

short- or intermediate term risks. Using the exposure assumptions described in this unit, EPA has 

concluded the combined short- and intermediate-term food, water, and residential exposures result 

in aggregate MOEs of 430 for adults and 170 for children (1-2 years old). Because EPA's level of 

concern for salicylaldehyde is a MOE of 100 or below, these MOEs are not of concern.
5

 Occupational handler and post-application exposure may occur by the dermal and 

inhalation routes of exposure only. RD initially assessed handler exposure and risks for 

salicylaldehyde in pesticides at baseline personal protective equipment (PPE; long pants, a longsleeved shirt, shoes, socks, no chemical-resistant gloves, and no respiratory protection) which the 

Agency considers to be the typical minimal worker clothing. When handlers are wearing typical 

worker clothing (i.e., baseline PPE) the majority of occupational handler scenarios do not indicate 

risks of concern. For the occupational handler scenarios which involve the handling of large 

volumes of pesticides, those which EPA believes that handlers will be wearing chemical-resistant 

gloves, occupational handler scenarios do not indicate risks of concern with the addition of 

chemical-resistant gloves to baseline PPE (i.e., baseline plus gloves). A variety of pesticide 

formulations may contain salicylaldehyde. PPE is usually not required for worker re-entry, and 

therefore these postapplication risk estimates are based on the baseline exposure scenario (i.e., 

typical work clothing but no gloves). Typically, the Agency characterizes the risk estimate in 

relation to the restricted entry interval (REI) for a particular active ingredient. While REIs for 

specific products are not discussed in this risk assessment, occupational post-application scenarios 

assessed generally result in margins of exposure (MOEs) that do not indicate risks of concern on 

Day 0 (the day of application) except for ten postapplication scenarios. These scenarios were 

activities involving corn, specifically the hand-harvesting harvesting/ detassling scenario; activities 

involving on grape, table, specifically the harvest, pull, thin, prune, train, tie scenario and the cane 

turning, girdling scenario; and activities involving turf, specifically the transplant, weed, harvest 

scenario. The Agency notes that it is not expected to be typical agricultural practice to apply 

herbicides, insecticides or fungicides on the same day workers would be conducting corn hand 

harvesting, detassling or grape vine training activities or turf harvesting. As noted earlier in this 

assessment, herbicides, insecticides and fungicides are typically applied relatively early in a 

growing season. Typically, the Agency characterizes the risk estimate in relation to the restricted 

entry interval (REI) for a particular active ingredient. While REIs for specific products are not 

discussed in this risk assessment, occupational post-application scenarios assessed result in MOEs 

that do not indicate risks of concern on Day 0 (the day of application). 

Salicylaldehyde has been tested for ecological toxicity. This chemical is expected to be 

biodegradable and is not likely to bioconcentrate. Based on the studies, salicylaldehyde has the 

potential to affect aquatic organisms. The chemical is ready biodegradable and not expected to 

have adverse ecological effects due to dilution factor and biodegradability potential 

Taking into consideration all available information on salicylaldehyde, EPA concludes that 

there is a reasonable certainty that no harm to any population subgroup will result from aggregate 

exposure to salicylaldehyde when considering occupation, dietary exposure and all other 

nonoccupational sources of pesticide exposure for which there is reliable information. Therefore, 

the Agency recommends for the establishment of an exemption from tolerance for residues of 

salicylaldehyde when used as a pesticide inert ingredient in pesticide formulations under 40 CFR 

§180.910 with the limitation that the end-use concentration not to exceed 14%. 

I. BACKGROUND 
6

Ag-Chem Consulting LLC, 122O8 Quinque Lane, Clifton VA 20124 on behalf of Omex 

Agrifluids, 24730 Avenue 13, Madera CA 93637 proposing, pursuant to section 408(d) of the 

Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 

180.910 to establish an exemption from the requirement of a tolerance for salicylaldehyde 

(salicylaldehyde) (CAS Reg. No. 90-02-8) in or on food crops at no more than 14% of the 

pesticide formulation to help the active ingredient properly penetrate and remain available to act in 

the soil. 

II. INERT INGREDIENT PROFILE 

A. .Summary of Uses 

The proposed use of salicylaldehyde is as an inert ingredient solvent in pesticide formulations 

which include use on crops for pre- and post-harvest to help the active ingredient properly 

penetrate and remain available to act in the soil. 

B. Physical Chemical Properties 

Some of the physical and chemical characteristics of salicylaldehyde, along with its 

structure and nomenclature, are found in Table 1. 

Table 1. Physical and Chemical Properties of Salicylaldehyde 

Parameter Value Source 

Structure 

Ag-Chem Consulting, 

Ltd 

CAS Reg. No. 90-02-8 

Molecular Weight (g/mol) 122.12 

Chemical Formula C7H6O2

CAS Chem Name salicylaldehyde 

IUPAC Name salicylaldehyde 

Common Names hydroxybenzaldehyde, salicylic 

aldehyde; o-hydroxybenzaldehyde 

Physical State colorless oily liquid 

Odor bitter almond 

Melting Point (°C) 1 

Boiling Point (°C) 197°C 

Density 1.167 g/mL @ 25°C 

Water Solubility slight 

Vapor Pressure (Hg at 22°C) 0.4 

III. HUMAN HEALTH ASSESSMENT 

A. Summary of Toxicity Data 
7

A.1. Acute Toxicity 

Acute 

 The approximate acute oral LD50's of salicylaldehyde were 566 mg/kg/day for male rats 

and 504 mg/kg/day for male mice. Clinical signs of toxicity were slight to severe weakness, 

salivation, prostration and death. 

Dermal 

 When applied undiluted to the depilated abdomen of guinea pigs under an occlusive wrap 

for 24 hours, Salicylaldehyde produced strong skin irritation. The acute dermal LD50 vas greater 

than 20 ml/kg for the guinea pig. The highest dose tested, 20 ml/kg, produced tremors which may 

be an indication of percutaneous absorption. Repeated applications (10) to the uncovered clipped 

backs of guinea pigs produced moderate exacerbation of the irritative response. None of five 

guinea pigs tested for allergic skin reactions exhibited a positive response. 

Eye 

 Eye irritation tests were not done, however, based on the severe skin reaction, it is assumed 

that this compound would produce severe eye irritation. 

Metabolism 

 A single dose of 400 mg salicylaldehyde /kg bw was administered to a fasted rabbit. 

Approximately 75% of the dose was excreted in the urine collected over 24 hr. Urine analysis 

revealed mainly ether soluble acids, with 27% and 3% accounted for as glucuronic acid and sulfate 

conjugates of vanillic acid, respectively. 

A.2. Combined Repeated Dose Toxicity Study with the 

Reproductive/Developmental Toxicity Screening Test 

 To perform the repeated dose toxicity and reproductive developmental toxicity combined 

test based on oral administration using salicylaldehyde rats (Crj: CD (SD) type SPF), we used 

dosages of 0 (contrast group), 2.5, 10, 40, and 160 mg/kg/day to discover the general toxicological 

effects in male and female animals due to repeated doses, and also to discover the effects on 

gonadal performance, mating behavior, impregnation, and parturition and other reproductive 

development. 

Repeated Dose Toxicity 

 No effects of administration of the tested substance to male rats were found in general 

conditions, weight, feed volume, hematological test values, blood chemistry test values, autopsy 

findings, and organ weight. In the tested substance administration groups of 40 mg/kg/day or more, 

the degree of lobular peripheral adiposity in the liver and the frequency of appearance was less 

than in the contrast group. This is not considered to be an adverse effect. 
8

 In the test on female rats, aside from one mother in the 40 mg/kg/day administration group 

that was partway through parturition on pregnancy Day 22, and one mother in the 160 mg/kg/day 

administration group that died on pregnancy Day 22, no changes were observed in the general 

condition. In the 160 mg/kg administration group, the liver weight showed a high value, and the 

ovaries a low value. However, no effects of administration of the tested substance were found in 

weight, feed volume, and autopsy findings. In the tested substance administration groups of 40 

mg/kg/day or more, a slight increase in the glycogen volume was observed inside liver cells. 

 From the above, we concluded that general toxicological effects under the test conditions 

showed no adverse effects in both males and females at 40 mg/kg/day. 

Reproductive Developmental Toxicity 

 No effects of administration of salicylaldehyde were found on the female estrus cycle and 

estrus count, on the male and female mating and impregnation, and on the female animal 

pregnancy period and parturition. No nursing abnormalities were found in the tested substance 

administration groups of 40 mg/kg or less. Nevertheless, in the 160 mg/kg administration group, 

two cases of maternal animals were found in which all infants had died by Day 4 of nursing. No 

effects of administration of the tested substance were found in the number of live birth females, 

delivery rate, luteal number, number of implantation scars, and implantation rate. 

 No effects of administration of the tested substance were found on nursing Day 0 in the 

number of live birth infants, number of stillborns, sex ratio, parturition rate, and birth rate. No 

outward abnormalities were found that could be considered to be traced to the tested substance 

administration in newborn infants and stillborns. A large trend toward infant deaths during the 

nursing period was seen in the 160 mg/kg/day administration group, and there was a low trend for 

newborn infant live birth rates on Day 4 of nursing in this same group. In addition, the weights on 

nursing Day 0 and Day 4 showed a trend toward a slightly low value in the 160 mg/kg/day 

administration group. 

 From the above, we concluded that reproductive developmental toxicological effects under 

the test conditions showed no effects for males at 160 mg/kg/day, for females at 40 mg/kg/day, and 

for newborn infants at 40 mg/kg/day. 

A.3. Genotoxicity 

Micronucleus Test 

 Male and female rats [Crl:CD(SD), 7 weeks at time of administration, were used to study 

the presence or absence of salicylaldehyde micronucleus inducement in rat bone marrow cells. In 

five animals per one group, the tested substance was forcibly orally administered to males at 50, 

100, 200, and 400 mg/kg, and to females at 25, 50, 100, and 200 mg/kg, on two times with an 

interval of 24 hours. The negative contrast substance (Japanese Pharmacopoeia olive oil) and the 

positive contrast substance (cyclophosphamide monohydrate, CP) were also administered with the 

same method. Since no death cases were found in any of the administration groups, we looked for 
9

the appearance frequency of PCE (MNPCE) with micronucleus, for all animals in the negative 

contrast group, the tested substance administration groups of 100, 200, and 400 mg/kg/day groups 

(male), and of 50, 100, and 200 mg/kg/day groups (female), and the positive contrast group. As a 

result, for both males and females, in the tested substance groups no significant increase in the 

MNPCE count was seen in any of the groups in comparison with the negative contrast group. 

 The average value of the MNPCE appearance frequency and PCE ratio in the negative 

contrast group was in every case within the range of the test facility background values, and in the 

negative contrast group a significantly clear micronucleus inducement was seen. Therefore, we 

concluded that this test was suitably implemented. 

 From the above results, salicylaldehyde had micronucleus test negativity; it has no 

clastogenicity in rat bone marrow cells. 

Chromosome Aberration 

 The salicylaldehyde in vitro chromosome aberration inducement was studied using Chinese 

hamster cultured cells (CHL/IU), and a positive result was obtained. The proliferation suppression 

concentration exceeding 50% for salicylaldehyde CHL/IU cells was 0.020 mg/mL in the 

continuous process (48 hours), and in the short-time process (6 hours) under S9 mix existence and 

non-existence, 0.20 mg/mL for both. As a result, the concentrations of 0.020 mg/mL for the 

continuous process, and 0.20 mg/mL/ for the short-time process, were set as the maximum process 

concentration for this test. One-half and one-fourth concentrations of the maximum process 

concentration were set as the medium concentration and low concentration, respectively. In the 

continuous process group, specimens after 24-hour and 48-hour processing were manufactured 

under S9 mix non-existence, and chromosome analysis performed. In the short-time process group, 

6-hour processing was performed under S9 mix existence and non-existence, followed by 18 hours 

culturing in a fresh culturing solution to manufacture a specimen, and chromosome analysis was 

performed. 

 As a result of 24-hour and 48-hour continuous processing, the CHL/IU cells showed a 

significant increase of cells having chromosome structural aberrations, in the 24-hour process 

high-concentration group (0.020 mg/mL), and significance was obtained in the trend test as well. 

In addition, in the 48-hour process high-concentration group (0.020 mg/mL/), a significant increase 

of cultured cells was seen, and a significant difference in the trend test was obtained as well. 

Meanwhile, the groups with 6-hour processing under S9 mix existence and non-existence were 

both dependent on the concentration, with a significant increase in cells with structural aberrations. 

In addition, the group under S9 mix existence was dependent on the concentration, with a 

significant increase in polyploidy cells. 

Reverse Mutation 

 A reverse mutation test using bacteria was used to investigate the presence or absence of 

salicylaldehyde mutagenicity, and this test obtained a negative result. For the assay bacteria, five 

bacterial strains were used, including Salmonella typhimurium TA100, TA1535, TA98, TA1537, 

and Escherichia coli WP2 uvrA, and a dosage setting test was performed for this test using the 

plate method with S9 mix no-additive and additive conditions. When the dosage setting test was 
10

performed at a dosage of 50 to 5000 ug/plate, in the S9 mix no-additive, antibiotic action was 

found at dosages of 1500 ug/plate or more (TA 100 at 500 ug/plate or more, and WP2 uvrA at 

5000 ug/plate or more), while in the S9 mix additive, it was found at 1500 ug/plate or more (TA 

100 at 500 ug/plate or more). In this test, the S9 mix no-additive test was set at dosages in a range 

of 31.3 to 1000 ug/plate (TA100 at 15.6 to 500 ug/plate, and WP2 uvrA at 125 to 4000 ug/plate), 

and the S9 mix additive test was set at 62.5 to 2000 ug/plate (TA 100 at 15.6 to 500 ug/plate, and 

WP2 uvrA at 125 to 4000 ug/plate), and the test was implemented. 

 As a result, in both of the two rounds of tests, since no increase was found in the revertant 

colony numbers that were more than double the solvent contrast value in all dosages of the five 

types of assay strain used, we concluded that salicylaldehyde does not have any mutagenicity 

(negative) in the test system used. 

B. Chronic Toxicity 

 To perform the repeated dose toxicity and reproductive developmental toxicity combined 

test based on oral administration using salicylaldehyde rats, we used dosages of 0 (contrast group), 

2.5, 10, 40, and 160 mg/kg/day to discover the general toxicological effects in male and female 

animals due to repeated doses, and also to discover the effects on gonadal performance, mating 

behavior, impregnation, and parturition and other reproductive development. 

B. 1. Repeated Dose Toxicity 

 In the repeated dose toxicity study, no effects of administration of the tested substance were 

found in general conditions, weight, feed volume, hematological test values, blood chemistry test 

values, autopsy findings, and organ weight were found on males. In the tested substance 

administration groups of 40 mg/kg or more, the degree of lobular peripheral adiposity in the liver 

and the frequency of appearance was less than in the contrast group in males. 

 The effects on females were aside from one mother in the 40 mg/kg administration group 

that was partway through parturition on pregnancy Day 22, and one mother in the 160 mg/kg 

administration group that died on pregnancy Day 22, no changes were observed in the general 

condition. In the 160 mg/kg administration female group, the liver weight showed a high value, 

and the ovaries a low value. However, no effects of administration of the tested substance were 

found in weight, feed volume, and autopsy findings in females. In the tested substance 

administration female groups of 40 mg/kg or more, a slight increase in the glycogen volume was 

observed inside liver cells. 

 From the above, the general toxicological effects under the test conditions showed no 

adverse effects in both males and females at 40 mg/kg/day. 

B. 2. Reproductive Developmental Toxicity 

 No effects on reproductive developmental toxicity in parent animals of the tested substance 

were found on the female estrus cycle and estrus count, on the male and female mating and 

impregnation, and on the female animal pregnancy period and parturition. No nursing 
11

abnormalities were found in the tested substance administration groups of 40 mg/kg or less. 

Nevertheless, in the 160 mg/kg administration group, two cases of mother animals were found in 

which all infants had died by Day 4 of nursing. No effects of administration of the tested substance 

were found in the number of live birth females, delivery rate, luteal number, number of 

implantation scars, and implantation rate. 

 No effects of administration of the tested substance were found on nursing Day 0 in the 

number of live birth infants, number of stillborns, sex ratio, parturition rate, and birth rate. No 

outward abnormalities were found that could be considered to be traced to the tested substance 

administration in newborn infants and stillborns. A large trend toward infant deaths during the 

nursing period was seen in the 160 mg/kg administration group, and there was a low trend for 

newborn infant live birth rates on Day 4 of nursing in this same group. In addition, the weights on 

nursing Day 0 and Day 4 showed a trend toward a slightly low value in the 160 mg/kg 

administration group. 

 From the above, we concluded that reproductive developmental toxicological effects under 

the test conditions showed no effects for males at 160 mg/kg/day, for females at 40 mg/kg/day, and 

for newborn infants at 40 mg/kg/day. 

 C. Carcinogenicity 

There are no cancer studies available for salicylaldehyde. Salicylaldehyde is metabolized 

mainly to ether soluble acids, with 27% and 3% accounted for as glucuronic acid and sulfate 

conjugates of vanillic acid, respectively. These metabolites are generally recognized as safe: 

glucuronic acid is a precursor of ascorbic acid (Vitamin C) and vanillic acid is a common food 

additive. Based on predicted rapid metabolism and excretion, lack of specific target organ toxicity 

in the repeat dose studies study and lack of mutagenicity, salicylaldehyde is not expected to be 

carcinogenic. 

D. Special Considerations for Infants and Children 

The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is 

intended to provide an additional l0-fold safety factor (10X), to protect for special sensitivity in 

infants and children. Based on available information discussed thus far and below in Special 

Consideration for Infants and Children, the FQPA safety factor should be reduced to IX. 

Completeness of the Toxicological Database 

A mammalian toxicology database that includes acute toxicity, subchronic toxicity, 

reproductive toxicity, developmental toxicity and genotoxicity data is available and is adequate for 

characterizing the toxicity of salicylaldehyde and for the quantification of hazard for dietary 

exposure assessment. No immunotoxicological or neurotoxicological findings were reported in the 

database. There are no residual uncertainties for pre- and/or post-natal toxicity. 

Evidence of Neurotoxicity 
12

There is no evidence of neurotoxicity in the toxicological database for salicylaldehyde. In 

the repeat dose study, no clinical effects indicative of neurotoxicity were reported, no adverse 

findings were reported from the acute oral, dermal and ocular assessments conducted in the study, 

and no neuropathological findings were reported in the study. 

Evidence of Sensitivity/Susceptibility in the Developing or Young Animal 

 No effects on reproductive developmental toxicity in parent animals of 

salicylaldehydewere found on the female estrus cycle and estrus count, on the male and female 

mating and impregnation, and on the female animal pregnancy period and parturition. No nursing 

abnormalities were found in the tested substance administration groups of 40 mg/kg or less. 

Nevertheless, in the 160 mg/kg administration group, two cases of maternal animals were found in 

which all infants had died by Day 4 of nursing. No effects of administration of the tested substance 

were found in the number of live birth females, delivery rate, luteal number, number of 

implantation scars, and implantation rate. 

 No effects of administration of the tested substance were found on nursing Day 0 in the 

number of live birth infants, number of stillborns, sex ratio, parturition rate, and birth rate. No 

outward abnormalities were found that could be considered to be traced to the tested substance 

administration in newborn infants and stillborns. A large trend toward infant deaths during the 

nursing period was seen in the 160 mg/kg administration group, and there was a low trend for 

newborn infant live birth rates on Day 4 of nursing in this same group. In addition, the weights on 

nursing Day 0 and Day 4 showed a trend toward a slightly low value in the 160 mg/kg 

administration group. 

 From the above, we concluded that reproductive developmental toxicological effects under 

the test conditions showed no effects for males at 160 mg/kg/day, for females at 40 mg/kg/day, and 

for newborn infants at 40 mg/kg/day. 

Considering the overall toxicity profile and the endpoints and doses selected for 

salicylaldehyde, the degree of concern for the effects observed in the salicylaldehyde reproductive 

and developmental toxicity screening study is low; noting that there is a clear NOAEL for the 

offspring effects and regulatory doses were selected to be protective of these effects. No other 

residual uncertainties were identified with respect to susceptibility. The endpoints and doses 

selected for the dietary risk assessment of salicylaldehyde are protective of adverse effects in both 

offspring and adults. 

Residual Uncertainty in the Exposure Database 

The dietary risk assessment for salicylaldehyde is based on conservative, high-end 

assumptions and as such the exposure assessment is not likely to underestimate actual exposures 

Since there is an adequate repeat dose study at doses up to 160 mg/kg/day, the FQPA 

Safety Factor (SF) has been reduced to 1X. The acute and chronic population-adjusted doses 

(aPAD and cPAD) would be equal to the acute and chronic RfDs, respectively. 
13

E. Toxicity Endpoint Selection 

No acute toxicological endpoint of concern has been identified for salicylaldehyde. 

On the basis of the Repeated Dose and Reproductive/Developmental Toxicity Screening 

study, a NOAEL for parental systemic toxicity and embryo/developmental toxicity NOAEL for 

salicylaldehyde was 40 mg/kg bw/day. As summarized above, the available toxicology data 

support that the FQPA safety factor for salicylaldehyde should be reduced from 10X to IX. 

Therefore, only the 10X factors for intra- and inter- species variability should be included in 

calculating the chronic reference dose (cRfD) and the chronic population adjusted dose (cPAD). 

The chronic reference dose (cRfD) is therefore 0.4 mg/kg (40 mg/kg bw/day /100). 

The chronic NOAEL is also applicable to the dermal and inhalation exposure routes. 

IV. DIETARY EXPOSURE ASSESSMENT 

 In conducting the chronic dietary exposure assessment using the Dietary Exposure 

Evaluation Model DEEM–FCIDTM, Version 3.18, EPA used food consumption information from 

the U.S. Department of Agriculture’s (USDA’s) 2003-2008 National Health and Nutrition 

Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, 

no residue data were submitted for salicylaldehyde. In the absence of specific residue data, EPA 

has developed an approach which uses surrogate information to derive upper bound exposure 

estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest 

tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A 

complete description of the general approach taken to assess inert ingredient risks in the absence of 

residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments 

for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in 

docket ID number EPA-HQ-OPP-2008-0738.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert 

ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this 

assumption is that there would be similar rates of degradation (if any) between the active and inert 

ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of 

tolerances would be no higher than the concentration of the active ingredient. 

The Agency believes the assumptions used to estimate dietary exposures lead to an 

extremely conservative assessment of dietary risk due to a series of compounded conservatisms. 

First, assuming that the level of residue for an inert ingredient is equal to the level of residue for 

the active ingredient will overstate exposure. The concentration of active ingredient in agricultural 

products is generally at least 50 percent of the product and often can be much higher. Further, 

pesticide products rarely have a single inert ingredient; rather there is generally a combination of 

different inert ingredients used which additionally reduces the concentration of any single inert 

ingredient in the pesticide product in relation to that of the active ingredient. 
14

Second, the conservatism of this methodology is compounded by EPA’s decision to assume 

that, for each commodity, the active ingredient which will serve as a guide to the potential level of 

inert ingredient residues is the active ingredient with the highest tolerance level. This assumption 

overstates residue values because it would be highly unlikely, given the high number of inert 

ingredients, that a single inert ingredient or class of ingredients would be present at the level of the 

active ingredient in the highest tolerance for every commodity. Finally, a third compounding 

conservatism is EPA’s assumption that all foods contain the inert ingredient at the highest 

tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert 

ingredient at the rate and manner necessary to produce the highest residue legally possible for an 

active ingredient. In summary, EPA chose a very conservative method for estimating what level of 

inert residue could be on food, then used this methodology to choose the highest possible residue 

that could be found on food and assumed that all food contained this residue. No consideration was 

given to potential degradation between harvest and consumption even though monitoring data 

shows that tolerance level residues are typically one to two orders of magnitude higher than actual 

residues in food when distributed in commerce. 

Accordingly, although sufficient information to quantify actual residue levels in food and 

drinking water is not available, the compounding of these conservative assumptions will lead to a 

significant exaggeration of actual exposures. EPA does not believe that this approach 

underestimates exposure in the absence of residue data. 

A. Acute Dietary Exposure and Risk 

 No adverse effects attributable to a single exposure to salicylaldehyde were seen in the 

toxicity databases; therefore, an acute dietary risk assessment is not a concern. 

B. Chronic Dietary Exposure and Risk 

A chronic dietary risk assessment takes into account exposure estimates from chronic 

dietary consumption of food and drinking water. Model estimates for oral exposure from the use of 

salicylaldehyde in pesticidal formulations (including exposure through drinking water) resulted in 

chronic dietary exposure estimates for food and drinking water below the Agency’s level of 

concern (<100% cPAD) for the U.S. population and all population subgroups. The chronic dietary 

exposure from food and water to salicylaldehyde is 13% of the cPAD for the U.S. population and 

also 49% of the cPAD for children 1-2 years old, the most highly exposed population subgroup. 

C. Cancer Dietary Exposure and Risk 

 The Agency has not identified any concerns for carcinogenicity relating to salicylaldehyde; 

therefore, a cancer dietary exposure assessment was not performed. 

Table 4. Dietary Exposure Assessment for Salicylaldehyde 

Population 

Subgroup Acute Exposure

Chronic Exposure

Dietary Exposure 

from DEEM

Total

mg/kg/day %aPAD mg/kg/day %cPAD

US Pop. NA 0.053016 13 
15

All Infants (<1yr) 0.110440 28 

Children 1-2yr 0.197747 49 

Children 3-5yr 0.135978 34 

Children 6-12yr 0.070155 18 

Youth 13-19yr 0.037743 9.4 

Adult 20-49yr 0.040527 10 

Adult 50-99yr 0.042501 11 

Female 13-49yr 0.040973 10 

V. RESIDENTIAL EXPOSURE AND ASSESSMENT 

The term “residential exposure” is used in this document to refer to non-occupational, nondietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea 

and tick control on pets). While there are no current or proposed residential uses for 

salicylaldehyde, it is possible that salicylaldehyde may be used as an inert ingredient in pesticide 

products for which short-term and intermediate-term residential exposures may result. In the 

absence of specific residential exposure scenarios, risk estimates for residential exposures to 

salicylaldehyde can be modeled based on occupational exposure assessments for salicylaldehyde. 

Occupational exposure assessments for salicylaldehyde for occupational mixer/loader/applicator 

exposure and occupational post-application exposure for comparable use scenarios (e.g., low 

pressure handwand turf application) with only baseline personal protective equipment result in 

MOEs of 500 or greater (i.e., exposures are not of concern). Given the larger treatment areas and 

higher concentrations of salicylaldehyde used in these occupational use pesticide products than 

would be seen in residential uses, MOEs for residential use scenarios would exceed 1,000 or more. 

Since our level of concern is for MOEs of 100 or less, there are no concerns for residential 

exposures to salicylaldehyde. 

VI. AGGREGATE RISK AND DETERMINATION OF SAFETY 

A. Acute Risk 

There was no hazard attributable to a single exposure seen the in the toxicity database for 

salicylaldehyde; therefore, an acute aggregate risk assessment is not required. 

B. Chronic Risk. 

Using the exposure assumptions described in Section III for chronic dietary exposure, EPA 

has concluded that chronic exposure to salicylaldehyde from food and water is conservatively 

estimated to utilize 49% of the cPAD for children 1-2 yrs old, the population group receiving the 

greatest exposure. Chronic residential exposure to residues of salicylaldehyde not expected. 

C. Short- and Intermediate-term Risk 

Short- and intermediate term aggregate exposure takes into account short-term residential 

exposure plus chronic exposure through food and drinking water (considered to be a background 
16

exposure level). Since it is possible that salicylaldehyde may be used as an inert ingredient in 

pesticide products for which short-term and intermediate-term residential exposures may result, the 

Agency has determined that it is appropriate to aggregate chronic exposure through food and water 

with short-term residential exposures to salicylaldehyde. 

Using the exposure assumptions described in this unit for short-term exposures, EPA has 

concluded the combined short-term food, water, and residential exposures result in aggregate 

MOEs of 430 for adults and 170 for children (1-2 years old). Because EPA's level of concern for 

salicylaldehyde is a MOE of 100 or below, these MOEs are not of concern. 

Table 5. Short- and Intermediate-Term Exposure Assessment for 

Salicylaldehyde

Population 

Subgroup

Chronic 

Dietary 

Exposure 

from DEEM 

(mg/kg/day) 

Total Dietary 

MOE1

Residental Uses 

MOE Total MOE2

US Pop. 0.053016 750 1000 430 

Children 1-2yr 0.197747 200 1000 170 1 MOE = POD (NOAEL of 40 mg/kg/day)/ (Dietary mg/kg/day) 2 Total MOE = 1/ (1/Dietary MOE + 1/Residential MOE) 

D. Cancer Risk.

The Agency has not identified any concerns for carcinogenicity for salicylaldehyde; 

therefore, an aggregate cancer exposure assessment was not performed. 

VII. OCCUPATIONAL EXPOSURE/RISK PATHWAY 

 EPA has determined that exposure to handlers as the result of using pesticide products 

which might potentially contain salicylaldehyde as an inert ingredient may occur in a variety of 

occupational environments. The representative occupational scenarios selected by the Agency for 

assessment were evaluated based on likely maximum application rates for products which may 

contain salicylaldehyde as an inert ingredient for the short-term exposure assessment, and average 

application rates for products likely to contain salicylaldehyde as an inert ingredient for the 

intermediate- and long-term exposure durations. Active ingredient application rates were corrected 

for the maximum amount of the inert ingredient likely to be in the final formulations to determine 

exposure and risk from exposure salicylaldehyde. A summary of the occupational assessment is 

presented below. 

A. Handler Risk 

Exposure Scenarios 
17

 Exposure to pesticide handlers is likely during the occupational use of pesticides containing 

salicylaldehyde as an inert ingredient. Dermal and inhalation exposure was estimated using the 

Pesticide Handlers Exposure Database (PHED) and Outdoor Residential Exposure Task Force 

(ORETF) data. The quantitative exposure/risk assessment developed for occupational handlers to 

support the requested tolerance exemption for salicylaldehyde is based on the following scenarios. 

RD notes that these scenarios were selected to represent the scenarios with the highest potential 

exposure. 

Mixer/Loader/Applicators: 

1) Mixer/Loader for aerial application- high acreage field crops (liquids) 

2) Mixer/Loader for airblast application- tree nuts crops (both liquid and wettable powder) 

3) Mixer/Loader for groundboom application- high acreage field crops and turf (liquids 

and wettable powder) 

4) Applicators for aerial application- high acreage field crops (liquid) 

5) Applicators for airblast- tree nut crops 

6) Applicators for groundboom- high acreage field crops and turf 

7) Mixer/Loader/Applicator- low pressure handwand (liquids and wettable powders)* 

8) High pressure handwand- greenhouse (wettable powders) 

9) Flagging- high acreage field crops (liquids) 

* Uses ORETF unit exposure data. All others use PHED data. 

 Risk estimates were calculated using the Margin of Exposure (MOE) which is a ratio of the 

toxicological POD to the daily dose. Daily dose values are calculated by first calculating exposures 

by considering application parameters (i.e., rate and area treated) along with unit exposures. 

Exposures are then normalized by body weight to calculate dose levels. Dermal and inhalation 

short-term exposure is compared to the dermal and inhalation POD of 40 mg/kg/day. Dermal and 

inhalation intermediate-term exposure is compared to the intermediate term dermal and inhalation 

POD of 40 mg/kg/day. For the scenarios where applicable, dermal and inhalation intermediateterm exposure is compared to the long-term dermal and inhalation POD of 40 mg/kg/day. For both 

short- and intermediate-term dermal assessments, 100% dermal absorption was assumed and 

exposures were compared to the POD from an oral toxicity study. For both short- and 

intermediate-term inhalation assessments, inhalation toxicity was assumed to be equivalent to oral 

toxicity. A combined dermal and inhalation MOE was also calculated for each exposure duration 

for salicylaldehyde as common toxicity endpoints were utilized for both the dermal and inhalation 

routes of exposure. To assess handler risks, the Agency used surrogate unit exposure data from the 

PHED, and ORETF data. 

 Occupational handler exposure assessments are completed by the Agency using different 

levels of personal protection. The Agency typically evaluates all exposures with a tiered approach. 

The lowest tier is represented by the baseline exposure scenario followed by increasing the levels 

of personal protection represented by personal protective equipment or PPE (e.g., gloves, extra 

clothing, and respirators) and engineering controls (e.g., closed cabs and closed loading systems). 

This approach is always used by the Agency in order to be able to define label language using a 

risk-based approach and not based on generic requirements for label language. In addition, the 

minimal level of adequate protection for a chemical is generally considered by the Agency to be 
18

the most practical option for risk reduction. The levels of protection that form the basis for the 

calculations in this assessment include: 

 Baseline Exposure Scenario: Represents typical work clothing; a long-sleeved shirt, long 

pants, socks, and shoes. Chemical-resistant gloves or respiratory protection are not 

included in this scenario. 

 Baseline Plus Gloves: Represents the baseline exposure scenario with the use of chemicalresistant gloves. No respiratory protection is included in this scenario. 

 Engineering Controls: Represents the use of an appropriate engineering control such as a 

closed cockpit. Engineering controls are not applicable to handheld application methods 

which have no known devices that can be used to routinely lower the exposures for these 

methods. 

 The following assumptions and factors were used in order to complete the exposure and 

risk assessment for occupational handlers/applicators: 

 All worker scenarios were assumed to be short- and intermediate-term in exposure 

durations (i.e., 1-30 days and 1-6 months) with the exception of greenhouse/hothouse 

applications. 

 For scenarios where greenhouse/hothouse applications are possible, a long-term exposure 

duration (6+ months) has also been calculated. 

 The exposure assessment assumes an 8 hour work day. 

 The maximum application rate per pesticide group (herbicide/pesticide/fungicide) has been 

assessed for the short-term exposure duration. 

 The average application rate per pesticide group (herbicide/pesticide/fungicide) has been 

assessed for the intermediate-term exposure duration. 

 A body weight of 80 kg was assumed because the relevant toxicological PODs were not 

gender specific (HED HotSheet #31, 1/17/12). 

 All exposures were assessed at the baseline exposure scenario. 

 For high acreage crops (e.g. corn, soybeans) where applicators can mix/load large 

quantities of pesticide, exposure assessments have also been completed for the baseline 

exposure scenario plus chemical-resistant gloves (described in the previous paragraph), and 

no respiratory protection. 

Risk Characterization: 

 RD initially assessed handler exposure and risks for salicylaldehyde in pesticides at 

baseline PPE (long pants, a long-sleeved shirt, shoes, socks, no chemical-resistant gloves, and no 

respiratory protection) which the Agency considers to be the typical minimal worker clothing. 

When these assessments indicated that there were potential risks of concern for scenarios where 

workers would be handling large quantities of pesticide for high volume operations typically 

involving aerial applications to high acreage crops, RD repeated the assessments and included 

additional PPE (i.e., chemical-resistant gloves for pesticide handlers). The Agency believes 

workers handling large volumes of pesticides will be wearing chemical-resistant gloves. 
19

When handlers are wearing typical worker clothing (i.e., baseline PPE) the majority of 

occupational handler scenarios do not indicate risks of concern. However, for those handler 

scenarios which do indicate risks of concern, which involve the handling of large volumes of 

pesticides, EPA believes that handlers will be wearing chemical-resistant gloves and other 

protective equipment. Therefore, occupational handler scenarios do not indicate risks of concern 

with the addition of chemical-resistant gloves to baseline PPE (i.e., baseline plus gloves). 

Table 6. Exposure and Risks for Occupational Handlers of Salicylaldehyde in Pesticide Products (All 

Exposure Durations) at Baseline Exposure Scenario 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High Acreage 

Crops (ST) 

1.456 

1200 

2.9 1.2 

72 0.029952 >1 1300 >1 

Liquids/ Aerial 

Application/ High Acreage 

Crops (IT) 

0.28 14 0.00576 36 87000 36 

Liquids/ Airblast/ Nut Tree 

(ST) 1.008 

40 

1.7 0.0006912 300 720000 300 

Liquids/ Airblast/ Nut Tree 

(IT) 0.448 0.7 0.0003072 670 1600000 670 

Liquids/ Groundboom/ 

High Acreage Crops (ST) 1.456 

200 

12 0.004992 41 100000 41 

Liquids/ Groundboom/ 

High Acreage Crops (IT) 0.28 2.3 0.00096 220 520000 220 

Liquids/ Groundboom/ Turf 

(ST) 1.456 

40 

2.4 0.0009984 210 500000 210 

Liquids/ Groundboom/ Turf 

(IT) 0.28 0.46 0.000192 1100 2600000 1100 

Liquids/ Low Pressure 

Handwand/ Turf (ST) 1.008 

5 

0.21 0.0000864 2400 5800000 2400 

Liquids/ Low Pressure 

Handwand/ Turf (IT) 1.008 0.21 0.0000864 2400 5800000 2400 

Wettable Powder/ Airblast/ 

Nut Tree (ST) 0.224 

40 

3.7 43 

0.4736 0.005504 84 7300 83 

Wettable Powder/ Airblast/ 

Nut Tree (IT) 0.224 0.4736 0.005504 84 7300 83 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (ST) 

0.224 

200 

2.368 0.02752 17 1500 17 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (IT) 

0.14 1.48 0.0172 27 2300 27 

Wettable Powder/ 

Groundboom/ Turf (ST) 0.224 

40 

0.4736 0.005504 84 7300 83 

Wettable Powder/ 

Groundboom/ Turf (IT) 0.14 0.296 0.00344 135 12000 130 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(ST) 

1.008 

5 

0.2664 0.003096 150 13000 150 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(IT) 

1.008 0.2664 0.003096 150 13000 150 

Applicator Scenarios 

Liquid/ Aerial Application/ 

High Acreage Crops (ST)9 1.456 

1200 

Eng 

control 

only: 

0.0055 

Eng 

control 

only: 

0.068 

0.13728 0.001697 290 24000 290 

Liquid/ Aerial Application/ 

High Acreage Crops (IT)9 0.28 0.0264 0.000326 1500 120000 1500 

Airblast/ Nut Tree (ST) 0.224 40 0.36 4.5 0.04608 0.000576 870 69000 860 
20

Table 6. Exposure and Risks for Occupational Handlers of Salicylaldehyde in Pesticide Products (All 

Exposure Durations) at Baseline Exposure Scenario 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Airblast/ Nut Tree (IT) 0.224 0.04608 0.000576 870 69000 860 

Groundboom/ High 

Acreage Crops (ST) 1.456 

200 

0.014 0.74 

0.05824 0.003078 690 13000 650 

Groundboom/ High 

Acreage Crops (IT) 0.28 0.0112 0.000592 3600 68000 3400 

Groundboom/ Turf (ST) 1.456 40 0.011648 0.000615 3400 65000 3300 

Groundboom/ Turf (IT) 0.28 0.00224 0.000118 18000 340000 17000 

Mixer/Loader/Applicator Scenarios 

Low Pressure Handwand/ 

Turf (ORETF data) (ST)10 1.008 

5 no data 6.6 

NA 0.000475 NA 84000 NA 

Low Pressure Handwand/ 

Turf (ORETF data) (IT)10 1.008 NA 0.000475 NA 84000 NA 

Flagger Scenarios 

Liquid/ Flagger/ High 

Acreage Crops (ST) 1.456 

1200 0.011 0.35 

0.27456 0.008736 150 4600 140 

Liquid/ Flagger/ High 

Acreage Crops (IT) 0.28 0.0528 0.00168 760 24000 730 

1Application rates are based on maximum application rates of products containing inerts multiplied by 14% to convert to application 

rate of just inert. Application rates for Short-term (ST) exposure risk estimates are based on maximum application rates. Application 

rates for Intermediate-term (IT) and long-term (LT) exposures are based on average application rates. Baseline Exposure Scenario 

represents typical work clothing, no gloves. 

2Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of concern. 3Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline exposure scenario and baseline inhalation exposure except for aerial applicator scenarios, which assess 

inhalation and dermal exposures with engineering controls. 4Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor of 100% (1.0) 

5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = POD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7ST Inhalation MOE = POD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8Total MOE = 1/ (1/Dermal MOE + 1/Inhalation MOE) 

9Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. All other exposure scenarios 

assess the baseline exposure scenario and baseline inhalation exposure. 10These scenarios have baseline inhalation unit exposures, but not baseline dermal unit exposures. The M/L/A scenario assessed in

Table 5 results in a higher exposure (and therefore is health protective) than either of the two “NA” scenarios shown at baseline plus 

gloves dermal exposure. 

Table 7. Exposure and Risks for Occupational Handlers of Salicylaldehyde in Pesticide Products (All 

Exposure Durations) with Baseline Plus Gloves for High Acreage Mixer/ Loader Scenarios and Turf 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline + 

Gloves 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline + 

Gloves 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High Acreage 

Crops (ST) 

1.456 

1200 

0.023 1.2 

0.57408 0.029952 70 1300 66 

Liquids/ Aerial 

Application/ High Acreage 

Crops (IT) 

0.28 0.1104 0.00576 360 6900 340 

Liquids/ Groundboom/ 

High Acreage Crops (ST) 1.456 200 0.09568 0.004992 420 8000 400 
21

1Application rates are based on maximum application rates of products containing inerts multiplied by 14% to convert to application 

rate of just inert. Application rates for Short-term (ST) exposure risk estimates are based on maximum application rates. Application 

rates for Intermediate-term (IT) and long-term (LT) exposures are based on average application rates. 2Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of concern. 3Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline plus gloves plus baseline inhalation exposure except for aerial applicator scenarios, which assess 

inhalation and dermal exposures with engineering controls. 4Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor of 100% (1.0) 

5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = POD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7ST Inhalation MOE = POD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8Total MOE = 1/ (1/Dermal MOE + 1/Inhalation MOE) 

*Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. All other exposure scenarios 

assess baseline plus gloves and baseline inhalation exposure. 

 

 B. Occupational Postapplication Risk 

 The Agency uses the term postapplication to describe exposures that occur when 

individuals are present in an environment that has been previously treated with a pesticide (also 

referred to as re-entry exposure). Such exposures may occur when workers enter previously treated 

areas to perform job functions, including activities related to crop production, such as scouting for 

pests or harvesting. Postapplication exposure levels vary over time and depend on such things as 

the type of activity, the nature of the crop or target that was treated, the type of pesticide 

application, and the chemical’s degradation properties. In addition, the timing of pesticide 

applications, relative to harvest activities, can greatly reduce the potential for postapplication 

exposure. 

 Inhalation exposures are not typically calculated for occupational post-application 

scenarios because inhalation exposures generally account for a negligible percentage of the overall 

body burden for most pesticide chemicals. 

Exposure Scenarios 

 This assessment is considered to be a screening level estimate, demonstrating that there are 

minimal potential risks to workers re-entering fields treated with pesticides containing 

salicylaldehyde as an inert ingredient. While salicylaldehyde may be present in formulations 

designated for crops besides those assessed in this document, risk estimates for those occupational 

postapplication scenarios are expected to be less than those scenarios assessed in this document 

(i.e., calculated MOEs will be higher). The three occupational postapplication scenarios assessed 

are for postapplication activities associated with: 

 Tall field/row crops (including scouting, weeding, hand harvesting sweet corn) 

Liquids/ Groundboom/ 

High Acreage Crops (IT) 0.28 0.0184 0.00096 2200 42000 2100 

Liquids/ Groundboom/ 

Turf (ST) 1.456 

40 

0.019136 0.000998 2100 40000 2000 

Liquids/ Groundboom/ 

Turf (IT) 0.28 0.00368 0.000192 11000 210000 10000 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (ST) 

0.224 

200 0.17 43 

0.1088 0.02752 370 15003 290 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (IT) 

0.14 0.068 0.0172 590 2300 470 
22

 Turf (golf course/sod farm) (including mowing, transplanting, hand weeding) 

 Vine/Trellis crops (including scouting, training, tying, thinning, and grape girding and cane 

turning) 

 Exposure Data and Assumptions 

 The assumptions used in the postapplication risk assessment calculations are detailed as 

follows: 

 The average occupational workday is assumed to be 8 hours. 

 The adverse effects for the short- and intermediate-term dermal POD’s are based on studies 

where the effects were observed in both sexes; therefore, the body weight of 80 kg was 

used to estimate exposure (HED HotSheet #31, 1/17/12). 

 HED has developed standard transfer coefficient values for occupational postapplication 

scenarios to ensure consistency in exposure assessments. These standard values were used 

to calculate postapplication exposures. 

 Anticipated post-application activities and their respective dermal transfer coefficients 

(TCs) are summarized in Table 8. The TC information is based on the Science Advisory 

Council for Exposure Policy Number 3.1. 

 The transfer coefficient for sod transplanting, and hand weeding used to represent dermal 

exposure is from Agriculture Reentry Task Force (ARTF) data; study ARF-035 (MRID 

45432303). 

 Calculations of postapplication exposures are completed using maximum application rates 

of pesticide products for short-term exposures and average application rates of pesticide 

products for intermediate-term exposures. 

 No postapplication data were submitted for salicylaldehyde; a default 50% of the 

application rate (for agricultural crops) and 10% (for turf) is considered available as a 

transferrable residue with a 10% default daily dissipation rate. 

 Dermal absorption is assumed to be 100%. 

 Risks were calculated using the MOE approach, which is a ratio of the exposure to the 

toxicological PoD. 

Risk Characterization 

 A variety of pesticide formulations may contain salicylaldehyde. PPE is usually not 

required for worker re-entry, and therefore these postapplication risk estimates are based on the 

baseline exposure scenario (i.e., typical work clothing but no gloves). Typically, the Agency 

characterizes the risk estimate in relation to the restricted entry interval (REI) for a particular 

active ingredient. While REIs for specific products are not discussed in this risk assessment, 

occupational post-application scenarios assessed generally result in MOEs that do not indicate 

risks of concern on Day 0 (the day of application) except for ten postapplication scenarios. 

Occupational postapplication risk estimates are presented in Table 8. The risk estimates for the 

three exposure scenarios assessed resulted in MOEs do not demonstrate risks of concern (i.e., 

MOEs > 100) on Day 0, except for ten scenarios: 
23

 1) The short- and intermediate-term worker postapplication activities involving herbicides 

on corn, specifically the hand-harvesting harvesting/ detassling scenario. That scenario resulted in 

a short-term MOE of 7 and an intermediate-term MOE of 62 on the day of application (Day 0). 

Assuming an herbicide application at the maximum application rate, the short-term MOE would 

exceed 100 for this scenario at day 25 after application and the intermediate-term MOE would 

exceed 100 at day 5 after application. The Agency notes that it is not expected to be typical 

agricultural practice to apply herbicides on the same day workers would be conducting hand 

harvesting and detassling activities. As noted earlier in this assessment, herbicides are typically 

applied relatively early in a growing season. 

 2) The short- and intermediate-term worker postapplication activities involving herbicides 

on grape, table, specifically the harvest, pull, thin, prune, train, tie scenario. That scenario resulted 

in a short-term MOE of 53 and an intermediate-term MOE of 90 on the day of application (Day 0). 

For the short-term, assuming an herbicide application at the maximum application rate, the MOE 

would exceed 100 for this scenario at day 6 after application. For the intermediate-term, assuming 

an herbicide application at the maximum application rate, the MOE would exceed 100 for this 

scenario at day 1 after application. The Agency notes that it is not expected to be typical 

agricultural practice to apply herbicides on the same day workers would be conducting harvest, 

pull, thin, prune, train, tie activities. As noted earlier in this assessment, herbicides are typically 

applied relatively early in a growing season. 

 3) The short- and intermediate-term worker postapplication activities involving herbicides 

on grape, table, specifically the cane turning, girdling scenario. That scenario resulted in a shortterm MOE of 27 and an intermediate-term MOE of 45 on the day of application (Day 0). For the 

short-term, assuming an herbicide application at the maximum application rate, the MOE would 

exceed 100 for this scenario at day 13 after application. For the intermediate-term, assuming an 

herbicide application at the maximum application rate, the MOE would exceed 100 for this 

scenario at day 8 after application. The Agency notes that it is not expected to be typical 

agricultural practice to apply herbicides on the same day workers would be conducting hand cane 

turning, girdling activities. 

4) The short-term worker postapplication activities involving herbicides on turf, 

specifically the transplant, weed, harvest scenario. That scenario resulted in an MOE of 72 on the 

day of application (Day 0). Assuming an herbicide application at the maximum application rate, 

the MOE would exceed 100 for this scenario at day 3 after application. The Agency notes that it is 

not expected to be typical agricultural practice to apply herbicides on the same day workers would 

be conducting transplant, weed, harvest activities. As noted earlier in this assessment, herbicides 

are typically applied relatively early in a growing season. 

5) The short-term worker postapplication activities involving insecticides on corn, 

specifically the hand-harvesting harvesting/ detassling scenario. That scenario resulted in an MOE 

of 20 on the day of application (Day 0). Assuming an insecticide application at the maximum 

application rate, the MOE would exceed 100 for this scenario at day 16 after application. The 

Agency notes that it is not expected to be typical agricultural practice to apply insecticides on the 

same day workers would be conducting hand harvesting and detassling activities. As noted earlier 

in this assessment, insecticides are typically applied relatively early in a growing season. 
24

6) The short- term worker postapplication activities involving insecticides on grape, table, 

specifically the cane turning, girdling scenario. That scenario resulted in a short-term MOE of 37 

on the day of application (Day 0). For the short-term, assuming an insecticide application at the 

maximum application rate, the MOE would exceed 100 for this scenario at day 10 after 

application. The Agency notes that it is not expected to be typical agricultural practice to apply 

insecticides on the same day workers would be conducting hand cane turning, girdling activities. 

7) The short-term worker postapplication activities involving insecticides on turf, 

specifically the transplant, weed, harvest scenario. That scenario resulted in an MOE of 47 on the 

day of application (Day 0). Assuming an insecticide application at the maximum application rate, 

the MOE would exceed 100 for this scenario at day 6 after application. The Agency notes that it is 

not expected to be typical agricultural practice to apply insecticides on the same day workers 

would be conducting transplant, weed, harvest activities. As noted earlier in this assessment, 

insecticides are typically applied relatively early in a growing season. 

8) The short-term worker postapplication activities involving fungicides on corn, 

specifically the hand-harvesting harvesting/ detassling scenario. That scenario resulted in a shortterm MOE of 37 on the day of application (Day 0). Assuming a fungicide application at the 

maximum application rate, the short-term MOE would exceed 100 for this scenario at day 9 after 

application. The Agency notes that it is not expected to be typical agricultural practice to apply 

fungicides on the same day workers would be conducting hand harvesting and detassling activities. 

As noted earlier in this assessment, fungicides are typically applied relatively early in a growing 

season. 

9) The short-term worker postapplication activities involving fungicides on grape, table, 

specifically the cane turning, girdling scenario. That scenario resulted in a short-term MOE of 64 

on the day of application (Day 0). For the short-term, assuming a fungicide application at the 

maximum application rate, the MOE would exceed 100 for this scenario at day 4 after application. 

The Agency notes that it is not expected to be typical agricultural practice to apply fungicides on 

the same day workers would be conducting hand cane turning, girdling activities. 

10) The short-term worker postapplication activities involving fungicides on turf, 

specifically the transplant, weed, harvest scenario. That scenario resulted in an MOE of 94 on the 

day of application (Day 0). Assuming a fungicide application at the maximum application rate, the 

MOE would exceed 100 for this scenario at day 1 after application. The Agency notes that it is not 

expected to be typical agricultural practice to apply fungicides on the same day workers would be 

conducting transplant, weed, harvest activities. As noted earlier in this assessment, insecticides are 

typically applied relatively early in a growing season. 

All other insecticide postapplication scenarios result in MOEs that do not demonstrate risks 

of concern on the day of application (Day 0). 

A variety of pesticide formulations may contain salicylaldehyde. PPE is usually not 

required for worker re-entry, and therefore these postapplication risk estimates are based on the 

baseline exposure scenario (i.e., typical work clothing but no gloves). Typically, the Agency 
25

characterizes the risk estimate in relation to the restricted entry interval (REI) for a particular 

active ingredient. While REIs for specific products are not discussed in this risk assessment, 

occupational post-application scenarios assessed result in MOEs that do not indicate risks of 

concern on Day 0 (the day of application). 

Table 8. Short- and Intermediate-Term Occupational Postapplication Dermal Exposures 

and Risks for Salicylaldehyde 

Crop & 

Exposure 

Duration 

Application 

Rate 

(lb inert /A) 

Work Activity 

Transfer 

Coefficient1

(cm2/hr) 

Day after 

Treatment2

DFRt

(μg/cm2)

3

Daily Dose 

(mg/kg/day)4 MOE5

Herbicide Product Scenarios 

Corn 

(ST) 1.456 

Scout, weed 

low foliage 100 0 

3.27 

0.0327 1200 

Scout, weed 

high foliage 400 0 0.1306 310 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.3265 120 

Harvesting/ 

detassling 17,000 0 5.5513 7 

Corn (IT) 0.168 

Scout, weed 

low foliage 100 0 

0.377 

0.0038 11000 

Scout, weed 

high foliage 400 0 0.0151 2700 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0377 1100 

Harvesting/ 

detassling 17,000 0 0.6405 62 

Grapes 

(Table) 

(ST) 

0.672 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 

1.51 

0.0754 530 

Scout, train, tie 1,000 0 0.1507 270 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.7536 53 

Cane turning, 

girdle 10,000 0 1.5071 27 

Grapes 

(Table) 

(IT) 

0.392 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 

0.879 

0.0440 910 

Scout, train, tie 1,000 0 0.0879 460 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.4396 90 

Cane turning, 

girdle 10,000 0 0.8792 45 

Turf/ sod 

(ST) 1.456 

Mowing 500 0 

0.816 

0.0408 980 

Transplant, 

weed, harvest 6,800 0 0.5551 72 

Turf/ Sod 

(IT) 0.168 Mowing 500 0 0.094 0.0047 8500 
26

Table 8. Short- and Intermediate-Term Occupational Postapplication Dermal Exposures 

and Risks for Salicylaldehyde 

Crop & 

Exposure 

Duration 

Application 

Rate 

(lb inert /A) 

Work Activity 

Transfer 

Coefficient1

(cm2/hr) 

Day after 

Treatment2

DFRt

(μg/cm2)

3

Daily Dose 

(mg/kg/day)4 MOE5

Transplant, 

weed, harvest* 6,800 0 0.0641 620 

Insecticide Product Scenarios 

Corn 

(ST) 0.56 

Scout, weed 

low foliage 100 0 

1.26 

0.0126 3200 

Scout, weed 

high foliage 400 0 0.0502 800 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.1256 320 

Harvesting/ 

detassling 17,000 0 2.1351 20 

Corn (IT) 0.056 

Scout, weed 

low foliage 100 0 

0.126 

0.0013 32000 

Scout, weed 

high foliage 400 0 0.0050 8000 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0126 3200 

Harvesting/ 

detassling 17,000 0 0.2135 190 

Grapes 

(Table) 

(ST) 

0.28 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 

0.628 

0.0314 1300 

Scout, train, tie 1,000 0 0.0628 640 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.3140 130 

Cane turning, 

girdle 10,000 0 0.6280 64 

Grapes 

(Table) 

(IT) 

0.168 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 

0.377 

0.0188 2100 

Scout, train, tie 1,000 0 0.0377 1100 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.1884 210 

Cane turning, 

girdle 10,000 0 0.3768 110 

Turf/ sod 

(ST) 0.56 

Mowing 500 0 

1.26 

0.0628 640 

Transplant, 

weed, harvest 6,800 0 0.8540 47 

Turf/ Sod 

(IT) 0.056 

Mowing 500 0 

0.00314 

0.0016 26000 

Transplant, 

weed, harvest* 6,800 0 0.0214 1900 

Fungicide Product Scenarios 
27

Table 8. Short- and Intermediate-Term Occupational Postapplication Dermal Exposures 

and Risks for Salicylaldehyde 

Crop & 

Exposure 

Duration 

Application 

Rate 

(lb inert /A) 

Work Activity 

Transfer 

Coefficient1

(cm2/hr) 

Day after 

Treatment2

DFRt

(μg/cm2)

3

Daily Dose 

(mg/kg/day)4 MOE5

Corn 

(ST) 0.28 

Scout, weed 

low foliage 100 0 

0.628 

0.0063 64000 

Scout, weed 

high foliage 400 0 0.0251 1600 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0628 640 

Harvesting/ 

detassling 17,000 0 1.0676 37 

Corn (IT) 0.056 

Scout, weed 

low foliage 100 0 

0.126 

0.0013 32000 

Scout, weed 

high foliage 400 0 0.0050 8000 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0126 3400 

Harvesting/ 

detassling 17,000 0 0.2135 190 

Grapes 

(Table) 

(ST) 

0.28 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 

0.628 

0.0314 130 

Scout, train, tie 1,000 0 0.0628 640 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.3140 130 

Cane turning, 

girdle 10,000 0 0.6280 64 

Grapes 

(Table) 

(IT) 

0.112 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 

0.251 

0.0126 3200 

Scout, train, tie 1,000 0 0.0251 1600 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.1256 320 

Cane turning, 

girdle 10,000 0 0.2512 160 

Turf/ sod 

(ST) 0.28 

Mowing 500 0 

0.628 

0.0314 1300 

Transplant, 

weed, harvest* 6,800 0 0.4270 94 

Turf/ Sod 

(IT) 0.056 

Mowing 500 0 

0.0.0314 

0.0016 26000 

Transplant, 

weed, harvest* 6,800 0 0.0214 1900 

1 The TC from this exposure scenario uses ARTF data - study ARF-035 (MRID 45432303).

2

 Day after Treatment set to 0 by default 

3

 Dislodgable Foliar Residue (μg/cm2) = AR * F * (1-D)t * CF1 * CF2. Where: AR = Application Rate (lb inert/acre), 

F = fraction of ai retained on foliage or 20% for foliar crop or 5% for turf (unitless), D = fraction of residue that 

dissipates daily or 10% (unitless), t = number of days after application day (days), CF1 = 4.54 x 108

 μg/lb, CF2 = 24.7 

x 10-9 acre/cm2 
28

4

 Daily Dermal Dose (mg/kg/day) = DFRt * CF3 * Tc * DA * ET/BW (kg). Where: DFRt = dislodgable foliar residue 

on day “t” (μg/cm2), CF3 = 1 x 10-3 mg/μg, Tc = transfer coefficient (cm2/hr), DA = dermal absorption factor 100% 

(unitless) default with no data submitted, ET = exposure time 8 (hr/day), BW = body weight 80 (kg) (HED Hot Sheet 

#31, 1/17/12) 

5

 Margin of Exposure: MOE = POD (40 mg/kg/day) / DDD (mg/kg/day). MOE (unitless), POD = Point of Departure 

usually NOAEL = No Observed Adverse Effect Level: Dose level in a toxicity study, DDD = Dermal Daily Dose: the 

absorbed dose received from exposure to a pesticide in a given scenario.

VIII. CUMULATIVE EXPSOURE 

Cumulative effects from substances with a common mechanism of toxicity. Section 

408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke 

a tolerance, the Agency consider “available information” concerning the cumulative effects of a 

particular pesticide's residues and “other substances that have a common mechanism of toxicity.” 

EPA has not found salicylaldehyde to share a common mechanism of toxicity with any 

other substances, and that salicylaldehyde does not appear to produce a toxic metabolite produced 

by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 

salicylaldehyde does not have a common mechanism of toxicity with other substances. For 

information regarding EPA's efforts to determine which chemicals have a common mechanism of 

toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at 

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

IX. ENVIRONMENTAL JUSTICE STATEMENT 

Potential areas of environmental justice concerns, to the extent possible, were considered in 

this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal 

Actions to Address Environmental Justice in Minority Populations and Low-Income Populations," 

http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf. 

As a part of every pesticide risk assessment, OPP considers a large variety of consumer 

subgroups according to well-established procedures. In line with OPP policy, RD estimates risks to 

population subgroups from pesticide exposures that are based on patterns of that subgroup’s food 

and water consumption, and activities in and around the home that involve pesticide use in a 

residential setting. Extensive data on food consumption patterns are compiled by the USDA under 

CSFII and are used in pesticide risk assessments for all registered food uses of a pesticide. These 

data are analyzed and categorized by subgroups based on age, season of the year, ethnic group, and 

region of the country. Additionally, OPP is able to assess dietary exposure to smaller, specialized 

subgroups and exposure assessments are performed when conditions or circumstances warrant. 

Whenever appropriate, non-dietary exposures based on home use of pesticide products and 

associated risks for adult applicators and for toddlers, youths, and adults entering or playing on 

treated areas post-application are evaluated. Further considerations are currently in development as 

OPP has committed resources and expertise to the development of specialized software and models 

that consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary 

patterns among specific subgroups 
29

X. ENVIRONMENTAL FATE CONSIDERATIONS 

Salicylaldehyde is expected to have high biological oxygen demand, and it is expected to 

cause significant oxygen depletion in aquatic systems. It has a high potential to affect aquatic 

organisms and the growth of some plants. It has a moderate potential to affect secondary waste 

treatment microorganisms and the germination of some plants. This chemical is expected to be 

biodegradable and is not likely to bioconcentrate. The direct instantaneous discharge to a receiving 

body of water of an amount of this chemical which will rapidly produce, by dilution, a final 

concentration of 0.1 mg/L or less is not expected to cause an adverse environmental effect. After 

dilution with a large amount of water, followed by secondary waste treatment, this chemical is not 

expected to have any adverse environmental impact.

XI. ECOTOXICITY 

Salicylaldehyde has been tested for ecological toxicity. Based on the studies, 

salicylaldehyde has the potential to affect aquatic organisms. The chemical is ready biodegradable 

and not expected to have adverse ecological effects due to dilution factor and biodegradability 

potential. A summary of the ecological toxicity is presented below: 

Table 9 Ecotoxicity of Salicylaldehyde 

Test Organism Result 

96 hour LC50 Fathead 

Minnow 

3.2 uL/L 

96 hour LC50 Water Flea 3.0 uL/L 

24 hour LC50 Water Flea 6.8 mg/L 

 Salicylaldehyde is a naturally occurring benzaldehyde found in food and is also used as a 

food additive. It is Generally Regarded as Safe (GRAS) with a human average daily intake of 16 

ug/day and an annual natural occurrence in 66,470 kg of food per year. As a component of 

pesticides, up to 448 gm/acre of salicylaldehyde may be applied to a crop in a year. Based on the 

above toxicological data, potential residues of salicylaldehyde are unlikely to exceed the amount 

found naturally in foods and currently ingested.

XII. RISK CHARACTERIZATION 

Ag-Chem Consulting LLC, 122O8 Quinque Lane, Clifton VA 20124 on behalf of Omex 

Agrifluids, 24730 Avenue 13, Madera CA 93637 proposing, pursuant to section 408(d) of the 

Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 

180.910 to establish an exemption from the requirement of a tolerance for salicylaldehyde 

(salicylaldehyde) (CAS# 90-02-8) in or on food crops at no more than 14% of the pesticide 

formulation to help the active ingredient properly penetrate and remain available to act in the soil. 

The approximate acute oral LD50's of salicylaldehyde were 566 mg/kg/day for male rats 

and 504 mg/kg/day for male mice due to slight to severe weakness, salivation, prostration and 

death. 
30

Salicylaldehyde produced strong skin irritation to guinea pigs. The acute dermal LD50 vas 

greater than 20 ml/kg for the guinea pig. The highest dose tested produced tremors which may be 

an indication of percutaneous absorption. Repeated applications (10) to the uncovered clipped 

backs of guinea pigs produced moderate exacerbation of the irritative response. None of five 

guinea pigs tested for allergic skin reactions exhibited a positive response. Eye irritation tests were 

not done, however, based on the severe skin reaction, it is assumed that this compound would 

produce severe eye irritation. 

A single dose of salicylaldehyde was administered to a fasted rabbit. Approximately 75% 

of the dose was excreted in the urine collected over 24 hr revealing ether soluble acids, with 27% 

and 3% accounted for as glucuronic acid and sulfate conjugates of vanillic acid, respectively. 

Repeated dose toxicity and reproductive developmental toxicity combined test based on 

oral administration using salicylaldehyde rats, we used dosages of 0 (contrast group), 2.5, 10, 40, 

and 160 mg/kg/day. No effects of administration of the tested substance to male rats were found in 

general conditions, weight, feed volume, hematological test values, blood chemistry test values, 

autopsy findings, and organ weight. In the tested substance administration groups of 40 mg/kg/day 

or more, the degree of lobular peripheral adiposity in the liver and the frequency of appearance 

was less than in the contrast group. This is not considered to be an adverse effect. In the test on 

female rats, aside from one mother in the 40 mg/kg/day administration group that was partway 

through parturition on pregnancy Day 22, and one mother in the 160 mg/kg/day administration 

group that died on pregnancy Day 22, no changes were observed in the general condition. In the 

160 mg/kg administration group, the liver weight showed a high value, and the ovaries a low 

value. However, no effects of administration of the tested substance were found in weight, feed 

volume, and autopsy findings. In the tested substance administration groups of 40 mg/kg/day or 

more, a slight increase in the glycogen volume was observed inside liver cells. From the above, we 

concluded that general toxicological effects under the test conditions showed no adverse effects in 

both males and females at 40 mg/kg/day. No effects of administration of the tested substance were 

found on the female estrus cycle and estrus count, on the male and female mating and 

impregnation, and on the female animal pregnancy period and parturition. No nursing 

abnormalities were found in the tested substance administration groups of 40 mg/kg or less. 

Nevertheless, in the 160 mg/kg administration group, two cases of mother animals were found in 

which all infants had died by Day 4 of nursing. No effects of administration of the tested substance 

were found in the number of live birth females, delivery rate, luteal number, number of 

implantation scars, and implantation rate. No effects of administration of the tested substance were 

found on nursing Day 0 in the number of live birth infants, number of stillborns, sex ratio, 

parturition rate, and birth rate. No outward abnormalities were found that could be considered to be 

traced to the tested substance administration in newborn infants and stillborns. A large trend 

toward infant deaths during the nursing period was seen in the 160 mg/kg/day administration 

group, and there was a low trend for newborn infant live birth rates on Day 4 of nursing in this 

same group. In addition, the weights on nursing Day 0 and Day 4 showed a trend toward a slightly 

low value in the 160 mg/kg/day administration group. From the above, we concluded that 

reproductive developmental toxicological effects under the test conditions showed no effects for 

males at 160 mg/kg/day, for females at 40 mg/kg/day, and for newborn infants at 40 mg/kg/day. 
31

 Male and female rats [Crl:CD(SD), 7 weeks at time of administration] were used to study 

the presence or absence of salicylaldehyde micronucleus inducement in rat bone marrow cells. In 

five animals per one group, the tested substance was forcibly orally administered to males at 50, 

100, 200, and 400 mg/kg, and to females at 25, 50, 100, and 200 mg/kg, on two times with an 

interval of 24 hours. Since no death cases were found in any of the administration groups, we 

looked for the appearance frequency of PCE (MNPCE) with micronucleus, for all animals in the 

negative contrast group, the tested substance administration groups of 100, 200, and 400 

mg/kg/day groups (male), and of 50, 100, and 200 mg/kg/day groups (female), and the positive 

contrast group. As a result, for both males and females, in the tested substance groups no 

significant increase in the MNPCE count was seen in any of the groups in comparison with the 

negative contrast group. The average value of the MNPCE appearance frequency and PCE ratio in 

the negative contrast group was in every case within the range of the test facility background 

values, and in the negative contrast group a significantly clear micronucleus inducement was seen. 

Therefore, we concluded that this test was suitably implemented. From the above results, we 

judged that the tested substance salicylaldehyde had micronucleus test negativity; it has no 

clastogenicity in rat bone marrow cells. 

The salicylaldehyde in vitro chromosome aberration inducement was studied using Chinese 

hamster cultured cells (CHL/IU), and a positive result was obtained. The concentrations of 0.020 

mg/mL for the continuous process, and 0.20 mg/mL/ for the short-time process, were set as the 

maximum process concentration for this test. One-half and one-fourth concentrations of the 

maximum process concentration were set as the medium concentration and low concentration, 

respectively. As a result of 24-hour and 48-hour continuous processing, the CHL/IU cells showed 

a significant increase of cells having chromosome structural aberrations, in the 24-hour process 

high-concentration group (0.020 mg/mL), and significance was obtained in the trend test as well. 

In addition, in the 48-hour process high-concentration group (0.020 mg/mL/), a significant increase 

of cultured cells was seen, and a significant difference in the trend test was obtained as well. 

Meanwhile, the groups with 6-hour processing under S9 mix existence and non-existence were 

both dependent on the concentration, with a significant increase in cells with structural aberrations. 

In addition, the group under S9 mix existence was dependent on the concentration, with a 

significant increase in polyploidy cells. 

 A reverse mutation test using bacteria was used to investigate the presence or absence of 

salicylaldehyde mutagenicity, and this test obtained a negative result. For the assay bacteria, five 

bacterial strains were used, including Salmonella typhimurium TA100, TA1535, TA98, TA1537, 

and Escherichia coli WP2 uvrA, and a dosage setting test was performed for this test using the 

plate method with S9 mix no-additive and additive conditions. When the dosage setting test was 

performed at a dosage of 50 to 5000 ug/plate, in the S9 mix no-additive, antibiotic action was 

found at dosages of 1500 ug/plate or more (TA 100 at 500 ug/plate or more, and WP2 uvrA at 

5000 ug/plate or more), while in the S9 mix additive, it was found at 1500 ug/plate or more (TA 

100 at 500 ug/plate or more). In this test, the S9 mix no-additive test was set at dosages in a range 

of 31.3 to 1000 ug/plate (TA100 at 15.6 to 500 ug/plate, and WP2 uvrA at 125 to 4000 ug/plate), 

and the S9 mix additive test was set at 62.5 to 2000 ug/plate (TA 100 at 15.6 to 500 ug/plate, and 

WP2 uvrA at 125 to 4000 ug/plate), and the test was implemented. As a result, in both of the two 

rounds of tests, since no increase was found in the revertant colony numbers that were more than 

double the solvent contrast value in all dosages of the five types of assay strain used, we concluded 

that salicylaldehyde does not have any mutagenicity (negative) in the test system used. 
32

 For chronic toxicity, data from the repeated dose toxicity study was used. In the repeated 

dose toxicity study, no effects of administration of the tested substance were found in general 

conditions, weight, feed volume, hematological test values, blood chemistry test values, autopsy 

findings, and organ weight were found on males. In the tested substance administration groups of 

40 mg/kg or more, the degree of lobular peripheral adiposity in the liver and the frequency of 

appearance was less than in the contrast group in males. The effects on females were aside from 

one mother in the 40 mg/kg administration group that was partway through parturition on 

pregnancy Day 22, and one mother in the 160 mg/kg administration group that died on pregnancy 

Day 22, no changes were observed in the general condition. In the 160 mg/kg administration 

female group, the liver weight showed a high value, and the ovaries a low value. However, no 

effects of administration of the tested substance were found in weight, feed volume, and autopsy 

findings in females. In the tested substance administration female groups of 40 mg/kg or more, a 

slight increase in the glycogen volume was observed inside liver cells. From the above, we 

concluded that general toxicological effects under the test conditions showed no adverse effects in 

both males and females at 40 mg/kg/day. No effects on reproductive developmental toxicity in 

parent animals of the tested substance were found on the female estrus cycle and estrus count, on 

the male and female mating and impregnation, and on the female animal pregnancy period and 

parturition. No nursing abnormalities were found in the tested substance administration groups of 

40 mg/kg or less. Nevertheless, in the 160 mg/kg administration group, two cases of mother 

animals were found in which all infants had died by Day 4 of nursing. No effects of administration 

of the tested substance were found in the number of live birth females, delivery rate, luteal number, 

number of implantation scars, and implantation rate. No effects of administration of the tested 

substance were found on nursing Day 0 in the number of live birth infants, number of stillborns, 

sex ratio, parturition rate, and birth rate. No outward abnormalities were found that could be 

considered to be traced to the tested substance administration in newborn infants and stillborns. A 

large trend toward infant deaths during the nursing period was seen in the 160 mg/kg 

administration group, and there was a low trend for newborn infant live birth rates on Day 4 of 

nursing in this same group. In addition, the weights on nursing Day 0 and Day 4 showed a trend 

toward a slightly low value in the 160 mg/kg administration group. From the above, we concluded 

that reproductive developmental toxicological effects under the test conditions showed no effects 

for males at 160 mg/kg/day, for females at 40 mg/kg/day, and for newborn infants at 40 

mg/kg/day. 

There are no cancer studies available for salicylaldehyde. Salicylaldehyde is metabolized 

mainly to ether soluble acids, with 27% and 3% accounted for as glucuronic acid and sulfate 

conjugates of vanillic acid, respectively. These metabolites are generally recognized as safe: 

glucuronic acid is a precursor of ascorbic acid (Vitamin C) and vanillic acid is a common food 

additive. Based on predicted rapid metabolism and excretion, lack of specific target organ toxicity 

in the repeat dose studies study and lack of mutagenicity, salicylaldehyde is not expected to be 

carcinogenic. 

The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is 

intended to provide an additional l0-fold safety factor (10X), to protect for special sensitivity in 

infants and children. Based on available information discussed thus far and below in Special 

Consideration for Infants and Children, the FQPA safety factor should be reduced to IX. 
33

No acute toxicological endpoint of concern has been identified for salicylaldehyde. On the 

basis of the repeated dose and reproductive/developmental toxicity screening study, a NOAEL for 

parental systemic toxicity and embryo/developmental toxicity NOAEL for salicylaldehyde was 40 

mg/kg bw/day. As summarized above, the available toxicology data support that the FQPA safety 

factor for salicylaldehyde should be reduced from 10X to IX. Therefore, only the 10X factors for 

intra- and inter- species variability should be included in calculating the chronic reference dose 

(cRfD) and the chronic population adjusted dose (cPAD). The chronic reference dose (cRfD) is 

therefore 0.4 mg/kg (40 mg/kg bw/day /100). The chronic NOAEL is also applicable to the dermal 

and inhalation exposure routes. 

No adverse effects attributable to a single exposure to salicylaldehyde were seen in the 

toxicity databases; therefore, an acute dietary risk assessment is not a concern. A chronic dietary 

risk assessment takes into account exposure estimates from chronic dietary consumption of food 

and drinking water. Model estimates for oral exposure from the use of salicylaldehyde in pesticidal 

formulations (including exposure through drinking water) resulted in chronic dietary exposure 

estimates for food and drinking water below the Agency’s level of concern (<100% cPAD) for the 

U.S. population and all population subgroups. The chronic dietary exposure from food and water 

to salicylaldehyde is 13% of the cPAD for the U.S. population and also 49% of the cPAD for 

children 1-2 years old, the most highly exposed population subgroup. The Agency has not 

identified any concerns for carcinogenicity relating to salicylaldehyde; therefore, a cancer dietary 

exposure assessment was not performed.

The term “residential exposure” is used in this document to refer to non-occupational, nondietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea 

and tick control on pets). While there are no current or proposed residential uses for 

salicylaldehyde, it is possible that salicylaldehyde may be used as an inert ingredient in pesticide 

products for which short-term and intermediate-term residential exposures may result. In the 

absence of specific residential exposure scenarios, risk estimates for residential exposures to 

salicylaldehyde can be modeled based on occupational exposure assessments for salicylaldehyde. 

Occupational exposure assessments for salicylaldehyde for occupational mixer/loader/applicator 

exposure and occupational post-application exposure for comparable use scenarios (e.g., low 

pressure handwand turf application) with only baseline personal protective equipment result in 

MOEs of 500 or greater (i.e., exposures are not of concern). Given the larger treatment areas and 

higher concentrations of salicylaldehyde used in these occupational use pesticide products than 

would be seen in residential uses, MOEs for residential use scenarios would exceed 1,000 or more 

and therefore there are no concerns for residential exposures to salicylaldehyde. 

There was no hazard attributable to a single exposure seen the in the toxicity database for 

salicylaldehyde; therefore, an acute aggregate risk assessment is not required. 

The chronic exposure to salicylaldehyde from food and water is conservatively estimated to 

utilize 49% of the cPAD for children 1-2 yrs old, the population group receiving the greatest 

exposure. Chronic residential exposure to residues of salicylaldehyde not expected. 

Short- and intermediate term aggregate exposure takes into account short-term residential 

exposure plus chronic exposure through food and drinking water (considered to be a background 
34

exposure level). Since it is possible that salicylaldehyde may be used as an inert ingredient in 

pesticide products for which short-term and intermediate-term residential exposures may result, the 

Agency has determined that it is appropriate to aggregate chronic exposure through food and water 

with short-term residential exposures to salicylaldehyde. Using the exposure assumptions 

described in this unit for short-term exposures, EPA has concluded the combined short-term food, 

water, and residential exposures result in aggregate MOEs of 430 for adults and 170 for children 

(1-2 years old). Because EPA's level of concern for salicylaldehyde is a MOE of 100 or below, 

these MOEs are not of concern. 

The Agency has not identified any concerns for carcinogenicity for salicylaldehyde; 

therefore, an aggregate cancer exposure assessment was not performed. 

EPA has determined that exposure to handlers as the result of using pesticide products 

which might potentially contain salicylaldehyde as an inert ingredient may occur in a variety of 

occupational environments. The representative occupational scenarios selected by the Agency for 

assessment were evaluated based on likely maximum application rates for products which may 

contain salicylaldehyde as an inert ingredient for the short-term exposure assessment, and average 

application rates for products likely to contain salicylaldehyde as an inert ingredient for the 

intermediate- and long-term exposure durations. Active ingredient application rates were corrected 

for the maximum amount of the inert ingredient likely to be in the final formulations to determine 

exposure and risk from exposure salicylaldehyde. A summary of the occupational assessment is 

presented below. 

RD initially assessed handler exposure and risks for salicylaldehyde in pesticides at 

baseline PPE (long pants, a long-sleeved shirt, shoes, socks, no chemical-resistant gloves, and no 

respiratory protection) which the Agency considers to be the typical minimal worker clothing. 

When these assessments indicated that there were potential risks of concern for scenarios where 

workers would be handling large quantities of pesticide for high volume operations typically 

involving aerial applications to high acreage crops, RD repeated the assessments and included 

additional PPE (i.e., chemical-resistant gloves for pesticide handlers). The Agency believes 

workers handling large volumes of pesticides will be wearing chemical-resistant gloves. When 

handlers are wearing typical worker clothing (i.e., baseline PPE) the majority of occupational 

handler scenarios do not indicate risks of concern. For the occupational handler scenarios which 

involve the handling of large volumes of pesticides, those which EPA believes that handlers will 

be wearing chemical-resistant gloves, occupational handler scenarios do not indicate risks of 

concern with the addition of chemical-resistant gloves to baseline PPE (i.e., baseline plus gloves). 

The Agency uses the term postapplication to describe exposures that occur when 

individuals are present in an environment that has been previously treated with a pesticide (also 

referred to as re-entry exposure). Such exposures may occur when workers enter previously treated 

areas to perform job functions, including activities related to crop production, such as scouting for 

pests or harvesting. Postapplication exposure levels vary over time and depend on such things as 

the type of activity, the nature of the crop or target that was treated, the type of pesticide 

application, and the chemical’s degradation properties. In addition, the timing of pesticide 

applications, relative to harvest activities, can greatly reduce the potential for postapplication 

exposure. 
35

 Inhalation exposures are not typically calculated for occupational post-application 

scenarios because inhalation exposures generally account for a negligible percentage of the overall 

body burden for most pesticide chemicals. 

A variety of pesticide formulations may contain salicylaldehyde. PPE is usually not 

required for worker re-entry, and therefore these postapplication risk estimates are based on the 

baseline exposure scenario (i.e., typical work clothing but no gloves). Typically, the Agency 

characterizes the risk estimate in relation to the restricted entry interval (REI) for a particular 

active ingredient. While REIs for specific products are not discussed in this risk assessment, 

occupational post-application scenarios assessed generally result in MOEs that do not indicate 

risks of concern on Day 0 (the day of application) except for three postapplication scenarios. 

Occupational postapplication risk estimates for the three exposure scenarios assessed 

resulted in MOEs do not demonstrate risks of concern (i.e., MOEs > 100) on Day 0, except for ten 

scenarios: 

 1) The short- and intermediate-term worker postapplication activities involving herbicides 

on corn, specifically the hand-harvesting harvesting/ detassling scenario. That scenario resulted in 

a short-term MOE of 7 and an intermediate-term MOE of 62 on the day of application (Day 0). 

Assuming an herbicide application at the maximum application rate, the short-term MOE would 

exceed 100 for this scenario at day 25 after application and the intermediate-term MOE would 

exceed 100 at day 5 after application. The Agency notes that it is not expected to be typical 

agricultural practice to apply herbicides on the same day workers would be conducting hand 

harvesting and detassling activities. As noted earlier in this assessment, herbicides are typically 

applied relatively early in a growing season. 

 2) The short- and intermediate-term worker postapplication activities involving herbicides 

on grape, table, specifically the harvest, pull, thin, prune, train, tie scenario. That scenario resulted 

in a short-term MOE of 53 and an intermediate-term MOE of 90 on the day of application (Day 0). 

For the short-term, assuming an herbicide application at the maximum application rate, the MOE 

would exceed 100 for this scenario at day 6 after application. For the intermediate-term, assuming 

an herbicide application at the maximum application rate, the MOE would exceed 100 for this 

scenario at day 1 after application. The Agency notes that it is not expected to be typical 

agricultural practice to apply herbicides on the same day workers would be conducting harvest, 

pull, thin, prune, train, tie activities. As noted earlier in this assessment, herbicides are typically 

applied relatively early in a growing season. 

 3) The short- and intermediate-term worker postapplication activities involving herbicides 

on grape, table, specifically the cane turning, girdling scenario. That scenario resulted in a shortterm MOE of 27 and an intermediate-term MOE of 45 on the day of application (Day 0). For the 

short-term, assuming an herbicide application at the maximum application rate, the MOE would 

exceed 100 for this scenario at day 13 after application. For the intermediate-term, assuming an 

herbicide application at the maximum application rate, the MOE would exceed 100 for this 

scenario at day 8 after application. The Agency notes that it is not expected to be typical 

agricultural practice to apply herbicides on the same day workers would be conducting hand cane 

turning, girdling activities. 
36

4) The short-term worker postapplication activities involving herbicides on turf, 

specifically the transplant, weed, harvest scenario. That scenario resulted in an MOE of 72 on the 

day of application (Day 0). Assuming an herbicide application at the maximum application rate, 

the MOE would exceed 100 for this scenario at day 3 after application. The Agency notes that it is 

not expected to be typical agricultural practice to apply herbicides on the same day workers would 

be conducting transplant, weed, harvest activities. As noted earlier in this assessment, herbicides 

are typically applied relatively early in a growing season. 

5) The short-term worker postapplication activities involving insecticides on corn, 

specifically the hand-harvesting harvesting/ detassling scenario. That scenario resulted in an MOE 

of 20 on the day of application (Day 0). Assuming an insecticide application at the maximum 

application rate, the MOE would exceed 100 for this scenario at day 16 after application. The 

Agency notes that it is not expected to be typical agricultural practice to apply insecticides on the 

same day workers would be conducting hand harvesting and detassling activities. As noted earlier 

in this assessment, insecticides are typically applied relatively early in a growing season. 

6) The short- term worker postapplication activities involving insecticides on grape, table, 

specifically the cane turning, girdling scenario. That scenario resulted in a short-term MOE of 37 

on the day of application (Day 0). For the short-term, assuming an insecticide application at the 

maximum application rate, the MOE would exceed 100 for this scenario at day 10 after 

application. The Agency notes that it is not expected to be typical agricultural practice to apply 

insecticides on the same day workers would be conducting hand cane turning, girdling activities. 

7) The short-term worker postapplication activities involving insecticides on turf, 

specifically the transplant, weed, harvest scenario. That scenario resulted in an MOE of 47 on the 

day of application (Day 0). Assuming an insecticide application at the maximum application rate, 

the MOE would exceed 100 for this scenario at day 6 after application. The Agency notes that it is 

not expected to be typical agricultural practice to apply insecticides on the same day workers 

would be conducting transplant, weed, harvest activities. As noted earlier in this assessment, 

insecticides are typically applied relatively early in a growing season. 

8) The short-term worker postapplication activities involving fungicides on corn, 

specifically the hand-harvesting harvesting/ detassling scenario. That scenario resulted in a shortterm MOE of 37 on the day of application (Day 0). Assuming a fungicide application at the 

maximum application rate, the short-term MOE would exceed 100 for this scenario at day 9 after 

application. The Agency notes that it is not expected to be typical agricultural practice to apply 

fungicides on the same day workers would be conducting hand harvesting and detassling activities. 

As noted earlier in this assessment, fungicides are typically applied relatively early in a growing 

season. 

9) The short-term worker postapplication activities involving fungicides on grape, table, 

specifically the cane turning, girdling scenario. That scenario resulted in a short-term MOE of 64 

on the day of application (Day 0). For the short-term, assuming a fungicide application at the 

maximum application rate, the MOE would exceed 100 for this scenario at day 4 after application. 
37

The Agency notes that it is not expected to be typical agricultural practice to apply fungicides on 

the same day workers would be conducting hand cane turning, girdling activities. 

10) The short-term worker postapplication activities involving fungicides on turf, 

specifically the transplant, weed, harvest scenario. That scenario resulted in an MOE of 94 on the 

day of application (Day 0). Assuming a fungicide application at the maximum application rate, the 

MOE would exceed 100 for this scenario at day 1 after application. The Agency notes that it is not 

expected to be typical agricultural practice to apply fungicides on the same day workers would be 

conducting transplant, weed, harvest activities. As noted earlier in this assessment, insecticides are 

typically applied relatively early in a growing season. 

All other insecticide postapplication scenarios result in MOEs that do not demonstrate risks 

of concern on the day of application (Day 0). 

A variety of pesticide formulations may contain salicylaldehyde. PPE is usually not 

required for worker re-entry, and therefore these postapplication risk estimates are based on the 

baseline exposure scenario (i.e., typical work clothing but no gloves). Typically, the Agency 

characterizes the risk estimate in relation to the restricted entry interval (REI) for a particular 

active ingredient. While REIs for specific products are not discussed in this risk assessment, 

occupational post-application scenarios assessed result in MOEs that do not indicate risks of 

concern on Day 0 (the day of application). 

Salicylaldehyde is expected to have high biological oxygen demand, and it is expected to 

cause significant oxygen depletion in aquatic systems. It has a high potential to affect aquatic 

organisms and the growth of some plants. It has a moderate potential to affect secondary waste 

treatment microorganisms and the germination of some plants. This chemical is expected to be 

biodegradable and is not likely to bioconcentrate. The direct instantaneous discharge to a receiving 

body of water of an amount of this chemical which will rapidly produce, by dilution, a final 

concentration of 0.1 mg/L or less is not expected to cause an adverse environmental effect. After 

dilution with a large amount of water, followed by secondary waste treatment, this chemical is not 

expected to have any adverse environmental impact.

Salicylaldehyde has been tested for ecological toxicity. Based on the studies, 

salicylaldehyde has the potential to affect aquatic organisms. The chemical is ready biodegradable 

and not expected to have adverse ecological effects due to dilution factor and biodegradability 

potential. 

 Salicylaldehyde is a naturally occurring benzaldehyde found in food and is also used as a 

food additive. It is Generally Regarded as Safe (GRAS) with a human average daily intake of 16 

ug/day and an annual natural occurrence in 66,470 kg of food per year. As a component of 

pesticides, up to 448 gm/acre of salicylaldehyde may be applied to a crop in a year. Based on the 

above toxicological data, potential residues of salicylaldehyde are unlikely to exceed the amount 

found naturally in foods and currently ingested. 
38

Appendix 1. Dietary Exposure Assessment 

EPA Ver. 3.16, 03-08-d 

DEEM-FCID Chronic analysis for INERTS- SALICYLALDEHYDE NHANES 2003-2008 2-day 

Residue file name: J:\IN-10777\INERTS_57ACTIVE_100PPBH2OREV.R08 

 Adjustment factor #2 used. 

Analysis Date 10-09-2015/13:54:20 Residue file dated: 10-09-2015/13:53:41 

Reference dose (RfD, Chronic) = .4 mg/kg bw/day 

COMMENT 1: Inert 57 active ingredients + drinking water (100ppb) 

=============================================================================== 

 Total exposure by population subgroup 

------------------------------------------------------------------------------- 

 Total Exposure 

 ----------------------------------- 

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

-------------------------------------- ------------- ---------------- 

Total US Population 0.053016 13.3% 

Hispanic 0.057893 14.5% 

Non-Hisp-White 0.052024 13.0% 

Non-Hisp-Black 0.049266 12.3% 

Non-Hisp-Other 0.062540 15.6% 

Nursing Infants 0.069497 17.4% 

Non-Nursing Infants 0.128725 32.2% 

Female 13+ PREG 0.046267 11.6% 

Children 1-6 0.153068 38.3% 

Children 7-12 0.063675 15.9% 

Male 13-19 0.037453 9.4% 

Female 13-19/NP 0.038061 9.5% 

Male 20+ 0.039479 9.9% 

Female 20+/NP 0.042885 10.7% 

Seniors 55+ 0.042752 10.7% 

All Infants 0.110440 27.6% 

Female 13-50 0.040993 10.2% 

Children 1-2 0.197747 49.4% 

Children 3-5 0.135978 34.0% 

Children 6-12 0.070155 17.5% 

Youth 13-19 0.037743 9.4% 

Adults 20-49 0.040527 10.1% 

Adults 50-99 0.042501 10.6% 

Female 13-49 0.040973 10.2% 

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