Page 2 of 14

additives (21 C.F.R. § 172.665) and both are approved by the EPA as inert ingredients for food use 

(40 C.F.R. § 180.950 (e)) and non-food use. Diutan, gellan and xanthan gums have similar 

saccharide components, differing in the specific arrangement of the polysaccharide components 

and saccharide units. Therefore, data available on polysaccharide, gellan and xanthan gums were 

used to fill data gaps for diutan gum.

D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt 

exhibits low levels of acute toxicity. The oral LD50 of Sprague-Dawley rats is greater than 5 g/kg

(5000 mg/kg). The inhalation LC50 in the rat is > 0.316 mg/L (~81.9 mg/kg). It is minimally 

irritating to the rabbit eye. It is not an irritant to the rabbit skin and it was not a skin sensitizer in 

Dunkin-Hartley guinea pigs. 

In a 28-day repeat dose oral toxicity (OECD Test Guideline 407) study there were no treatmentrelated adverse toxicological effects at doses up to 1000 mg/kg/day. The NOAEL is 1000 

mg/kg/day. 

The reverse gene mutation assay with Salmonella typhimurium and Escherichia coli and a 

chromosome aberration test with human lymphocytes show that diutan gum is neither mutagenic 

nor clastogenic, respectively. 

In a metabolism study in male and female rats the compound was absorbed, metabolized and 

excreted rapidly. The major route of excretion was the feces. There was no bioaccumulation. 

No toxicological point of departure (toxicological endpoint) was identified due to the low levels of 

toxicity exhibited and due to the very large molecular weight and lack of systemic absorption of 

diutan gum. Quantitative assessments of exposure and risk are not necessary and have not been 

conducted. The requested end-use formulation concentration is 1.5% w/w. Exposures to humans 

(dermal, inhalation, oral) are expected to be low, based upon the low level of requested use and 

toxicological concerns are low based on the low levels of toxicity exhibited in the available 

toxicological studies.

Based upon the toxicity testing to fish, algae and daphnids and based upon physical/chemical 

properties, the compound is not expected to present concerns for adverse environmental fate and 

effects.

In view of the information summarized above and discussed in detail below, the Agency approves 

of the establishment of an exemption from the requirements of a tolerance for residues of Dglucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt (CAS 

Reg. No. 595585-15-2) when used as an inert ingredient in pesticides formulations under 40 CFR 

§180.910 (pre- and post-harvest application to crops) and §180.940 (use in antimicrobial pesticide 

formulations) for residues of and for the approval of non-food use in agricultural and residential 

settings. 
Page 3 of 14

II. BACKGROUND

On 27 March 2015 the U.S. Environmental Protection Agency received a petition (IN- 10815

from Keller and Heckman LLP (1001 G Street, N.W., Suite 500 West, Washington, DC 20001) on 

behalf of CP Kelco U.S., Inc. (3100 Cumberland Blvd., Suite 600, Atlanta, GA 30339) to establish 

an exemption from the requirement of a tolerance under 40 CFR §180.910 (pre- and post-harvest 

application to crops) and §180.940(a) (contact food surface areas) for residues of D-glucurono-6-

deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt (diutan gum) (CAS 

Reg. No. 595585-15-2) when used as an inert ingredient (stabilizer/suspension agent) Dglucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt may 

be referred hereinafter as diutan gum. Much of the remaining discussion is taken from the various 

volumes (cited) of information/data submitted in support of this petition. 

Diutan gum is a polysaccharide similar to gellan gum (CAS Reg. No. 71010-52-1) and xanthan 

gum (CAS Reg. No. 11138-66-2). Gellan and xanthan gums are approved by the U.S. Food and 

Drug Administration (FDA) for use as food additives (21 C.F.R. § 172.665) and both are approved 

by the EPA as inert ingredients for food use (40 C.F.R. § 180.950 (e)) and non-food use. Diutan, 

gellan and xanthan gums have similar saccharide components, differing in the specific 

arrangement of the polysaccharide components and saccharide units. 

Diutan gum is used commercially in cementitious packaged products, oilfield spacer fluid and 

oilfield drilling fluids, oil drilling cement application, fire-fighting foam application, concrete 

application, tire sealant products, cleaner products and coating products.

III. PHYSICAL/CHEMICAL PROPERTIES

Table 1.0 Physical/Chemical Properties Diutan Gum

Color White to tan

Physical state Powder

Odor Slight odor

pH Approximately neutral (1% solution)

Density 1.43 kg/m3at 20.5 ± 0.05 ° C

Partition coefficient Log KOW -2.76

Water solubility Soluble, forms viscous solutions. 6.3 g/L @ pH 1 @ 20° C

Vapor pressure ~0.1kPa @ 25° C

Molecular formula (C40H61O30K)n

Average Molecular Weight 5.18 Million Daltons
Page 4 of 14

Repeating Chemical Structure of Diutan Gum

IV. HAZARD CHARACTERIZATION

Limited studies are available on diutan gum. However, diutan gum is a polysaccharide similar to 

gellan gum (CAS Reg. No. 71010-52-1) and xanthan gum (CAS Reg. No. 11138-66-2). Gellan 

and xanthan gums are approved by the U.S. Food and Drug Administration (FDA) for use as food 

additives (21 C.F.R. § 172.665) and both are approved by the EPA as inert ingredients for food use 

(40 C.F.R. § 180.950 (e)) and non-food use. Diutan, gellan and xanthan gums have similar 

saccharide components, differing in the specific arrangement of the polysaccharide components 

and saccharide units. Therefore, data available on polysaccharide, gellan and xanthan gums were 

used fill data gaps for diutan gum.

Acute Oral Toxicity

The oral LD50 in Sprague-Dawley rats treated with “polysaccharide gum” (purity not specified) is 

greater than 5 g/kg (Baker, 1983; MRID 49601405). Six male and six female rats were treated 

with a single oral dose by gavage with 5000 mg/kg. All animals appeared normal after intubation 

and during the two week observation period. There was no gross pathology in any animals at 

necropsy.

Acute Inhalation Toxicity
Page 5 of 14

Diutan gum was tested for a four-hour acute inhalation toxicity in Sprague-Dawley rats (5/sex) 

based on OECD Test Guideline 403 (OCSPP Harmonized Test Guideline 870.1300). The 

concentration in air achieved 0.316 mg/L was below the nominal concentration of 4.9 mg/L. Test 

animals appeared normal throughout the four-hour exposure period except for intermittent nose 

rubbing which would indicate possible nasal irritation. One animal in the test group, two in the 

air-exposed control group, and one in the unexposed control group exhibited a net weight loss. In 

the test group two animals exhibited mottled lungs; one animal exhibited mottled lungs with areas 

of consolidation and one animal exhibited a mottled left kidney. All other organs and tissues 

appeared normal. In the exposed control group, all organ and tissues appeared normal. In the 

unexposed control group, two animals exhibited mottled lungs. All other organs and tissues 

appeared normal. Histopathological examination of the lungs of each group revealed some 

adverse effects – focal tracheitis, small areas of interstitial pneumonia and small areas of lymphoid 

interstitial infiltrates. The effects occurred in all groups however one animal in the test group also 

showed an area of consolidation, with lymphocytic, histiocytic and neutrophilic infiltrates and 

many bronchiole filled with suppurative exudate. There were no deaths in the study. Some rats 

had tracheitis and focal pneumonitis or peribronchitis. The incidence and severity of lesions does 

not seem to be significantly different among the test groups, the controls on arrival, those only 

exposed to air and unexposed controls. As a result it was concluded that the lesions were evidence 

of inter-current infection not due to exposure to the test substance. The LC50 was determined to be 

> 0.316 mg/L (Marrapese et al. 2015; Administrative volume no MRID number). 

Eye Irritation

“Polysaccharide gum” (purity not specified) was used to test the potential for eye irritation in 

albino rabbits (Baker, 1983; MRID 49601405). One hundred mg of test material was instilled 

under the lower eyelid in one eye, each of six rabbits. The eye was allowed to close for one 

second, then rinsed and evaluated using the Draize method of scoring. None of the animals 

showed a positive reaction. The mean Draize score at 24 hours was 4.3 which indicates 

“minimally irritating” to the rabbit eye.

Skin Irritation

Moreno (1984; MRID 49601406) conducted a skin irritation test on albino rabbits (strain not 

specified) exposed to the test substance (diutan gum purity not specified). 7.5 g of the test article 

was mixed with Mazola Oil to a total volume of 15 ml (50%). The back and sides of each animal 

were clipped free of hair. The left side of each animal was abraded the right side remained intact. 

The test article was covered with 2.5 cm square gauze patches and secured with adhesive tape. 

The torso was then wrapped with plastic which was secured with adhesive tape. The sites were 

occluded for 24 hours at which time the patches were removed. Animals were observed for skin 

reactions at 24 and 72 hours. Erythema and edema were scored according to the numerical Draize 

technique. Erythema was slight at 24 and 72 hours. Edema was slight to moderate at 24 hours and 

slight at 72 hours. Mean scores for erythema and edema decreased during the study. The primary 

irritation index is 3.38 therefore the test article in considered a non-irritant as defined in 40 CFR 

1500.(3)(4).

Skin Sensitization

Dunkin-Hartley guinea pigs were exposed 50, 25, 10 and 5 % w/w in dried arachis oil BP 

respectively of test substance to two guinea pigs. Exposures were applied to the clipped flanks 
Page 6 of 14

under occlusive dressings for a period of 24 hr. The degree of erythema and edema was evaluated 

1, 24 and 48 hours after dressing removal. The highest non-irritant concentration of the test 

material and one concentration lower were selected for the main study. In the main study, 10 

guinea pigs were tested and 5 served as controls. A row of three injections (0.1 ml each) was made 

on each side of the mid-line into a 20 x 40 mm area. The injections were: Freund’s Complete 

Adjuvant plus distilled water in the ratio of 1:1, a 5 % w/w formulation of the test material in dried 

arachis oil BP and a 5 % w/w formulation of the test material in a 1:1 preparation of Freund’s 

Complete Adjuvant plus dried arachis oil BP. The test results were that the test material produced 

a 0 % (0/10) sensitization rate and therefore is classified as a non-sensitizer to the guinea pig under 

the conditions of this study. 

Repeat Dose Toxicity

A 28-day repeated dose oral toxicity (OECD Test Guideline 407) study was conducted by 

Blagden, Mullee and Brooks (2001; MRID 49601409). The test material purity not specified, 

maintained in sponsor files) was administered by gavage to three groups each of five male and five 

female Sprague-Dawley Crl:CD® (SD) IGS BR rats for twenty eight consecutive days at dose 

levels of 150, 500 or 1000 mg/kg/day. A control group of five males and five females was dosed 

with vehicle alone (Arachis oil BP). Two recovery groups, each of five males and five females

were treated with the high dose (1000 mg/kg/day) or the vehicle alone for twenty eight consecutive 

days and then maintained without treatment for a further fourteen days. 

Clinical signs, functional observations, bodyweight development and food and water consumption 

were monitored throughout the study. Hematology, blood chemistry and urinalysis were evaluated 

for all non-recovery group animals at the end of the treatment period and for all recovery group 

animals at the end of the treatment free period. All animals were subjected to gross necropsy and 

histopathological evaluation of selected tissues. 

There were no deaths during the study. There were no toxicologically significant abnormal 

clinical observations. There were no treatment related effects for behavioral assessments, 

functional performance tests, sensory reactivity assessments, body weight development, no effect 

on body weight development, food or water consumption, no treatment related effects on 

hematology or blood chemistry, there were no treatment related effects seen in urinalysis. No 

treatment related effects in organ weights. No treatment related macroscopic effects seen at 

necropsy. No treatment related histopathological effects.

Repeated oral doses of the test material up to 1000 mg/kg/day did not result in any toxicologically 

significant changes in any of the parameters measured. The No Observed Effect Level (NOEL) 

was considered to be 1000 mg/kg/day. 

Genetic Reverse Mutation Assay

A reverse mutation assay was conducted according to OECD Test Guideline No. 471 (Thompson, 

2001; MRID 49601410). Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 

were used along with Escherichia coli strain WP2uvrA and treated with suspensions of the test 

material (purity not stated) using the Ames incorporation method at five dose levels, in triplicate, 

both with and without metabolic activation with rat liver homogenate metabolizing system (10% 

liver S9 in standard co-factors). From data in a preliminary assay, the doses chosen were 50 to 
Page 7 of 14

5000 μg/plate. The vehicle (sterile distilled water) control plates gave counts of revertant colonies 

with in the normal range. All of the positive control chemicals used in the test induced marked 

increases in the frequency of revertant colonies, both with and without metabolic activation. 

The test material caused no visible reduction in the growth of the bacterial background lawn at any 

dose level. The test material was tested up to the maximum recommended level of 5000 μg/plate. 

An opaque sheen to the background lawns was observed at 5000 μg/plate. When viewed under an 

inverted microscope, a very light globularity/oily appearance was noted. This did not prevent the 

scoring of revertant colonies.

No significant increases in the frequency of revertant colonies were recorded for any of the 

bacterial strains with any dose of the test material either with or without metabolic activation. 

Under the conditions of this study the test material is considered to be non-mutagenic.

Chromosome Aberration Test 

Wright and Jenkinson (2001; MRID 49601411) conducted a chromosome aberration test in human 

lymphocytes in vitro. The protocol followed the OECD Test Guideline 473. Duplicate cultures of 

human lymphocytes, treated with the test material were evaluated for chromosome aberrations at 

three dose levels 1250 μg/ml, 2500 μg/ml and 5000 μg/ml as well as with vehicle and positive 

controls. Four treatment conditions were used in the study. 

Experiment 1, 4 hours in the presence of an induce rat liver homogenate metabolizing system (S9) 

at a 1 % final concentration with cell harvest after a 20-hour expression period. 

Experiment 1, 4-hour exposure in the absence of metabolic activation (S9) with a 20-hour 

expression period.

Experiment 2, the 4-hour exposure with addition of S9 was repeated (using a 2% final S9 

concentration)

Experiment 2, exposure time in the absence of metabolic activation was increased to 24 hours. 

All vehicle (culture medium) controls gave frequencies of cells with aberrations within the range 

expected for normal human lymphocytes. All the positive control treatments gave statistically 

significant increases in the frequency of cells with aberrations indicating satisfactory performance 

of the test and activity of the metabolizing system. The test material did not induce any 

statistically significant increases in the frequency of cells with aberrations in either of two separate 

experiments, using a dose range that included a maximum concentration which was either the 

maximum scorable level of exposure or the maximum recommended dose level. The test material 

was shown to be non-clastogenic to human lymphocytes in vitro. 

Metabolism

A study (OCSPP Harmonized Guideline 870.7485) was conducted to determine the absorption, 

tissue distribution and excretion of gellan gum (Selim, 1984; MRID 49601412). One adult male 

and female Sprague-Dawley rats were orally dosed (gavage) with a single dose of 14C and 3H 

labeled gellan gum (950 or 980 mg/kg test substance purity not stated) and placed in Roth 

metabolism cages to determine respiratory levels of 14CO2. An average of 0.5 % of dosed 

radioactivity was excreted as 14CO2.
Page 8 of 14

Four male rats and 4 female rats were dosed as described above and placed in metabolism cages. 

Urine and feces were collected for 7 days. All rats excreted almost all of the dosed radioactivity in 

the feces. Females excreted 86.79 % and 1.8 % of the dose 14C in their feces and urine 

respectively. Males excreted 85.16 and 3.26 % of the dosed 14C in their feces and urine 

respectively. Females excreted 4.06 % of the 3H in their urine and 100.86 % in their feces, the 

males excreted 3.57 of the dosed 3H radioactivity in their urine and 99.62 in their feces. Tissue 

and carcass radioactivity for 14C averaged 3.77 % of the dose for males and 2.96 % of the dose for 

female rats. 

Four additional male and female rats were orally dosed with ~ 1 g/kg (1000 mg/kg) of the 

radiolabelled gellan gum and blood samples were collected from the tail vein at different intervals. 

Average peak level of radioactivity for male and female rats was 5.5 hours and 5.25 hours 

respectively. The test data show most of the dosed radioactivity is excreted in the feces and that 

tissue levels of radioactivity at sacrifice is very low. Blood level of radioactivity is very low. 

Absorption via the GI tract is also low. 

Neurotoxicity/Immunotoxicity

There were no neurotoxicity or immunotoxicity study data per se’. However, the possibility for 

neurotoxic and immunotoxic effects was considered. Based on the findings in the 28-day repeat 

dose study and the metabolism study, there are no concerns for neurotoxicity or immunotoxicity. 

In the 28-day repeat dose study there were no toxicologically significant clinical observations,

behavioral assessments, functional performance tests or sensory reactivity assessments. There 

were no treatment-related effects regarding body weight development or food or water 

consumption.

Carcinogenicity

Based on the findings in the 28-day repeat-dose oral toxicity study and upon the findings in the 

metabolism study as well as the findings in the mutagenicity studies, the Agency believes there are 

no indications that indicate d-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 

potassium sodium salt is a potential carcinogen.

V. Toxicity Endpoint Selection

There were no toxicologically adverse effects noted in the 28-day oral feeding study (OECD 

Guideline 407) at doses up to and including 1000 mg/kg/day. Diutan gum is a high molecular

weight compound (MW=5.18 million dalton) which indicates it is unlikely to be absorbed via any 

route of exposure (dermal, oral, inhalation) which is supported by the lack of toxicity noted in the 

OECD study and the metabolism study. In the metabolism study, approximately 85% of the 

compound was eliminated via the feces. Therefore no toxicological endpoints have been identified 

for risk assessment for any route of exposure.
Page 9 of 14

VI. EXPOSURE 

Human exposure may occur via dietary exposure from residues on crops or food handling and 

processing areas. Exposure could occur from use by residential pesticide handlers (applicators) 

and exposure could occur to persons occupationally involved in pesticide handling (mixing, 

loading, applying) this compound. Since no toxicological endpoint of concern has been identified, 

based on the lack of toxicological effects noted in the available studies, quantitative exposure and 

risk assessments are not necessary for dietary, dermal or inhalation exposure.

VII. AGGREGATE RISK

As there are no toxicological effects of concern and no toxicological endpoints have been 

identified for purposes of risk assessment, a quantitative aggregate risk assessment is not necessary 

and had not been conducted.

VIII. CUMULATIVE EXPOSURE

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 D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 

potassium sodium salt to share a common mechanism of toxicity with any other substances, and

benzyl acetate does do not appear to produce a toxic metabolite produced by other substances. For 

the purposes of this tolerance action, therefore, EPA has assumed that D-glucurono-6-deoxy-Lmanno-D-glucan, acetate, calcium magnesium potassium sodium salt 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 FATE & EFFECTS

Ready Biodegradability

A study was performed to assess the ready biodegradability of the test substance (purity not stated) 

in an aerobic aqueous medium (Mead, 2001; MRID 49601413). The protocol followed the OECD 

Test Guideline No. 301B. At a concentration of 10 mg C/L (carbon/litre) was exposed to activated 

sewage sludge micro-organisms with culture medium in sealed culture vessels in the dark at 21° C 

for 28 days. The degradation of the test material was assessed by the determination of the carbon 

dioxide produced. Control solutions with inoculum and the standard material, sodium benzoate 

were used for validation purposes. The study data show 95 % degradation after 28 days and 

satisfied the 10-day treatment window validation criterion whereby 60 % degradation must be 

attained within 10 days of the degradation rate exceeding 10 %. The test material can be 

considered to be biodegradable under the terms and conditions of OECD Guideline No. 301B. The 

viscosity of the 25 g/L stock dispersion used to prepare the test vessels was determined in order to 

confirm complete hydration of the test material. The results of the viscosity analysis showed a 
Page 10 of 14

measure stock dispersion concentration of 101 % of the nominal value, thereby confirming 

complete hydration of the test material in the medium (deionized reverse osmosis water). 

Toxicity to Rainbow Trout

A fish acute toxicity test was conducted by Wetton and Mullee (2001; MRID 49601414) using 

rainbow trout (Oncorhynchus mykiss) using the OECD Test Guideline 203 (1992). Two groups of 

10 fish were exposed in an aqueous dispersion of the test material at a single concentration of 100 

mg/L for 96 hours under semi-static conditions. The number of mortalities and any sub-lethal 

effects of exposure were determined at 3 and 6 hours after the start of exposure then daily for the 

duration until 96 hours. The 96-hour LC50 based on nominal test concentrations was greater than 

100 mg/L thus the No Observed Effect Concentration was 100 mg/L. It was considered unrealistic 

to test at concentrations higher than 100 mg/L. 

Algal Inhibition Test

An algal inhibition test was conducted by Mead and Mullee (2001; MRID 49601418) on the alga 

Scenedesmus subspicatus exposed to the test substance (purity not stated). Following a rangefinding test the alga was exposed to a test material concentration of 100 mg/L (six replicate flasks) 

for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1° C. Samples of 

algal populations were removed daily and cell concentrations determined for the test group and 

control group using a hemocytometer and light microscope. The test data show the EC50 values of 

> 100 mg/L thus the No Observed Effect Level was correspondingly determined to be 100 mg/L. 

It was considered unrealistic to expect concentrations in excess of 100 mg/L.

Marine Algal Inhibition Test

Mead and Mullee (2002; MRID 49601417) conducted a marine algal inhibition test (purity not 

specified) to assess the effects on growth of Skeletonema costatum and Phaeodaclytum 

tricornutum according to ISO Test Guideline 10523. After a range-finding test S. costatum was 

exposed to an aqueous dispersion of the test material at a concentration of 1000 mg/L (triplicate 

flasks) for 72 hours under constant illumination and shaking at a temperature of 21 ± 1° C. 

Observations were conducted as described above. The EC50 values for the test substance under the 

conditions of the study is > 1000 mg/L and the NOEC is > 1000 mg/L. 

Acute Toxicity/Daphnia

A Daphnia sp. acute immobilization test was conducted by Mead and Mullee (200149601418) 

according to OECD Test Guideline 202. Following a range-finding test, 40 daphnids (4 replicates 

of 10 animals) were exposed to an aqueous dispersion of the test material (EX 8343 purity not 

specified) at a concentration of 100 mg/L for 48 hours under static conditions. Immobilization and 

any adverse reactions to exposure were recorded after 24 and 48 hours. The 48 hour EC50 for the 

test material to Daphnia magna, based on nominal concentrations was greater than 100 mg/L thus 

the NOEC was considered to be 100 mg/L. Higher concentrations were considered unrealistic and 

therefore not assayed. 

Acute Toxicity/Marine Copepod

A study was performed according to the recommendation of the United Kingdom Proposal 

TC147/SC5/WG2 to assess acute toxicity to the marine copepod Acartia tonsa. After a range 
Page 11 of 14

finding study, 4 replicates of 5 animals were exposed to an aqueous dispersion of the test material 

at concentrations of 10, 18, 32, 56, 100, 180, 320, 560, and 1000 mg/L for 48 hours under static 

conditions. The number of mortalities were recorded after 24 and 48 hours. The 48 hour LC50 for 

the test material to Acartia tonsa based on nominal concentrations was 250 mg/L with 95% 

confidence limits of 210-300 mg/L. The No Observed Effect Concentration was 100 mg/L.

X. DETERMINATION OF SAFETY

Aggregate exposures to D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 

potassium sodium salt would result from exposures to residues on food and water, exposure from 

handling (applying) and from exposure to post-application residues. Exposures to the general U.S. 

population and to population subgroups via the dietary route have been considered. Based on the 

lack of toxicological concerns, aggregate exposure assessments have not been conducted and are 

not necessary. The proposed use of D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium 

magnesium potassium sodium salt does not exceed the Agency’s level of risk concern. 

XI. ENVIRONMENTAL JUSTICE

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, HED 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 

the Continuing Survey of Food Intake by Individuals (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.

XII. HUMAN STUDIES

This assessment does not rely on any studies in which human subjects were intentionally exposed 

to a pesticide. 
Page 12 of 14

XIII INTERNATIONAL LIMITS:

There is no listing of this compound in the Codex Alimentarius and there is no known international 

limit set by any country.

XIV. RISK CHARACTERIZATION

The Agency has considered the request for exemption from the requirement of a tolerance under 

40 CFR §180.910 (pre- and post-harvest application to crops) and §180.940 (contact food surface 

areas) for the compound D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 

potassium sodium salt (CAS Reg. No. 595585-15-2) as an inert ingredient used in pesticide 

formulations intended for food-use and non-food use in agricultural and residential settings. The 

compound exhibits low levels of toxicity from acute and subchronic exposures. It is not 

considered potentially mutagenic, immunotoxic or carcinogenic. Based upon the toxicological 

database, the Agency did not identify a toxicological point of departure (endpoint) and thus did not 

conduct quantitative assessments of exposure and risk. They are not necessary. The Agency 

believes the general population, the most highly exposed subpopulations (children) and workers 

are not placed at unacceptable risks from expected low exposures to D-glucurono-6-deoxy-Lmanno-D-glucan, acetate, calcium magnesium potassium sodium salt (diutan gum). 

Therefore, the Agency approves of the requested use of D-glucurono-6-deoxy-L-manno-D-glucan, 

acetate, calcium magnesium potassium sodium salt (diutan gum) (CAS Reg. No. 595585-15-2) as 

an inert ingredient (stabilizer/suspension agent) used in pesticide formulations intended for fooduse and non-food use in agricultural and residential settings. 
Page 13 of 14

REFERENCES

Baker, J.K., 1983. Toxicity Test Results for S-657. Performing Lab. Applied Biological Science 

Labs. Glendale, CA. Unpublished report. MRID 49601405

Blagden, S.M., D. Mullee and P.N. Brooks. 2001. Twenty-Eight Day Repeated Dose Oral 

(Gavage) Study in the Rat Test Article: EX 8343. Performing Lab. SafePharm Lab’s. Ltd. 

Derby, U.K. Unpublished study. MRID 49601409.

Hamburger, R.N. 1989. Report Of The Data From The Advanced Allergy Management Clinical 

Laboratory Study of PRIST and RAST and Gellan Gum Test Article EX 4967, 43013 and 43033. 

Performing Lab. Advanced Allergy Management. La Jolla, CA. Unpublished report. MRID 

49601408.

Marrapese, M.E., Q.K. Ke and D.G. Graham. 2015. Petition Proposing an Exemption from the 

Requirement of a Tolerance for Diutan Gum Under 40 C.F.R. §180.910 and C.F.R §180.940.

Mead, C. 2001. Assessment of Ready Biodegradability; CO2 Evolution Test. Test Article EX 

8343. Performing Lab. SafePharm Lab’s. Ltd. Derby U.K. Unpublished study. MRID 

49601413.

Mead, C. and D.M. Mullee. 2001. Algal Inhibition Test. Test Article EX 8343. Performing 

Lab. SafePharm Lab’s., Ltd. Derby, U.K., Unpublished study. MRID 49601418.

Mead, C. and D.M. Mullee. 2002. Marine Algal Inhibition Test. Test Article: EX 8343. 

Performing Lab. SafePharm Lab’s., Ltd. Derby U.K. Unpublished study. MRID 49601417.

Moreno, O. 1984. Primary Dermal Irritation in Albino Rabbits. Test Article EX-4967. 

Performing Lab. M B Research Laboratories, Inc. Spinnerstown, PA. Unpublished report. 

MRID 49601406

O’Connor, B.J. and D.M. Mullee. 2001. Determination of General Physico-Chemical Properties 

and Spectra Test Article: EX 8343. Performing Lab. SafePharm Lab’s Ltd., Derby, U.K. 

Unpublished report. MRID 49601403.

Sanders, A. 2001. Skin Sensitization in the Guinea Pig – Magnusson and Kligman Maximization 

Method Test Article EX 8343. Performing Lab. Safepharm Laboratories Ltd. Derby, U.K. 

Unpublished study. MRID 49601407.

Selim, S. 1984. Rat Balance Study, Tissue Distribution and Blood Level of 14C and 3H Labeled 

Gellan Gum. Test Article 14C and 3H Labeled Gellan Gum. Performing Lab. Primate Research 

Institute N. M. State Univ., Holloman AFB, New Mexico. Unpublished study. MRID 49601412.
Page 14 of 14

Sewell, I.G. and D.M. Mullee. 2002. Water Quality, Determination of Acute Lethal Toxicity to 

Marine Copepods (Copepoda, Crustacea). Acute Toxicity to Acartia tonsa Test Article: EX8343. 

Performing Lab. SafePharm Lab’s., Ltd. Derby, U.K. Unpublished study. MRID 49601416.

Thompson, P.W. 2001. Reverse Mutation Assay “Ames Test” Using Salmonella typhimurium and 

Escherichia coli. Performing Lab. SafePharm Lab’s. Ltd. Derby, U.K. Unpublished study. 

MRID 49601410.

Tremain, S.P. 2001. Determination of Hazardous Physico-Chemical Properties Test Article: EX 

8343. Performing Lab. SafePharm Lab’s., Inc. Derby U.K. Unpublished report. MRID 

49610404. 

Wetton, P.M. and D.M. Mullee. 2001a. Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) 

Test Article: EX 8343. Performing Lab. SafePharm Lab’s., Inc. Derby U.K. Unpublished study. 

MRID 49601414.

Wetton, P.M. and D.M. Mullee. 2001b. Acute Toxicity to Daphnia magna Test Article: EX 8343. 

Performing Lab. SafePharm Lab’s., Ltd. Derby, U.K. Unpublished study. MRID 49601415.

Wright, N.P. and P.C. Jenkinson. 2001. Chromosome Aberration Test in Human Lymphocytes In 

Vitro Test Article EX 8343. Performing Lab. SafePharm Lab’s. Derby, U.K. Unpublished study. 

MRID 49601411.