UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460

 Office of Chemical Safety and Pollution Prevention 

 

MEMORANDUM 06/17/2015

SUBJECT: Application for registration of VBC-60347 Biological Insecticide 

Emulsifiable Suspension, an end use product that contains methyl salicylate 

EPA File Symbol No.: 73049-LNN

DP Barcode: 423840, 426347

Decision No.: 489428, 489428

PC Code: 076601; 006522

CAS No. 119-36-8

MRIDs: 49343601 – 29343639; 49484401- 49484402

FROM: Miachel Rexrode, Ph.D., Senior Biologist /s/ 06/17/2015

Biochemical Pesticides Branch, 

Biopesticide & Pollution Prevention Division (7511P)

 

TO: Gina Burnett, Regulatory Action Leader 

Biochemical Pesticides Branch

Biopesticide & Pollution Prevention Division (7511P)

*CONTAINS CONFIDENTIAL BUSINESS INFORMATION*

ACTION REQUESTED

Valent Biosciences Corp. has submitted a request for registration for VBC-60347 Biological 

Insecticide Emulsifiable Suspension, an end use product that contains methyl salicylate (Oil of 

Wintergreen) and Bacillus thuringiensis subsp kurstaki strain ABTS-351 as the active ingredient

to be used as an insecticide for use against Lepidoptera caterpillars. Use of this end product will 

also induce a systemic response in treated plants that helps plants to resist disease. In support of 

the registration, the applicant has submitted product chemistry data, a Confidential Statement of 

Formula, acute Toxicological studies, Enforcement Analytical Methods, and waiver requests for 

Subchronic Toxicology studies and certain Tier I Non-Target Organism testing. 
RECOMMENDATIONS AND CONCLUSIONS 

Executive Summary

VBC-60347 Biological Insecticide Emulsifiable Suspension (EPA Reg. No. 73049-LNN) is an 

end use product to be used in the field or greenhouse to control larvae of lepidopterist insects. 

The active ingredients are 25.5% w/w Bacillus thuringiensis subsp. kurstaki strain ABTS-351 

(supplied by ) and 5.9% w/w 

methyl salicylate (oil of wintergreen). 

 is a registered product, the registrant provided a 

description of the manufacturing process for Bacillus thuringiensis subsp. kurstaki strain ABTS351 . An acceptable description of the starting materials and

production process, the formation of impurities and a five-batch analysis are provided. The 

certified limits for Bacillus thuringiensis subsp. kurstaki strain ABTS-351 exceed the OCSPPrecommended limits, but an acceptable explanation is provided. An acceptable description of the 

enforcement analytical method is provided. Toxicology and Ecotoxicity studies were submitted, 

as well as all physical chemistry characteristics for the unregistered methyl salicylate active 

ingredient. Since Bacillus thuringiensis subsp. kurstaki strain ABTS-351 

) is previously registered all chemistry and toxicology and ecotoxicology studies for this active 

ingredient have been submitted and evaluated (USEPA 1998). 

Methyl salicylate (MeSa) is exempt from the requirement of a tolerance when used in accordance 

with good agricultural practice as an inert or an occasional active ingredient in pesticide 

formulations applied to growing crops or agricultural commodities after harvest, as referred to in 

the MeSa RED and in 40CFR 180.1001 (c). Oil of wintergreen is also found on EPA's List 4A 

and thus considered a minimal risk inert ingredient. A tolerance exemption will need to be 

obtained for Bacillus thuringiensis subsp. kurstaki strain ABTS-351 and for methyl salicylate 

applied to crops. 

BPPD has reviewed the Toxicological information that was submitted to fulfill the registration 

requirements for methyl salicylate and the EP (VBC-60347 Biological Insecticide Emulsifiable 

Suspension). Based on this information methyl salicylate is nontoxic to mammalian species on 

an acute oral basis (LD50 > 5,000 mg/kg; Toxicology Cat. IV); can cause slight acute dermal 

effects (Toxicology Cat. III), and slight eye irritation (Toxicology Cat. III); no acute dermal or 

inhalation toxicity (LD50 > 5,000mg/kg; LC50 > 400 mg/m3

; Toxicology Cat. IV); Sensitization 

study showed that the MeSa was not a dermal sensitizer (Toxicology Cat. III). Studies on the 

VBC-60347 (ai. Bacillus thuringiensis subsp. kurstaki, Strain ABTS-351, 26.55% and Methyl 

Salicylate, 5.9%) show that the EP has a Toxicological Cat. IV for Acute Oral (LD50 > 5,000 

mg/kg), for Acute Dermal (LD50 > 5,000 mg/kg), and Acute Inhalation (LC50 > 5.15 mg/L). 

VBC-60347 showed minimal effects in the Acute Eye Irritation test and slight irritation in the 
Acute Dermal Irritation study. The Skin Sensitization study showed that the EP was a dermal 

sensitizer (Toxicology Cat. III). 

Ecotoxicity data on methyl salicylate (Table 6.0) show that the compound is slight to practically 

non-toxic to avian species (LD50 > 2,510 mg/kg; LC50 > 5,620 ppm); slight to practically 

nontoxic to fish (LC50 = 26 mg/L and LC50 = 135 mg/L); slight toxicity to aquatic invertebrates 

(LC50 = 38 mg/L); and not phytotoxic. A study on honey bees using the EP showed no toxic 

effect with the 24- and 48-hr LD50 for contact toxicity greater than 125 μg ai/bee. A waiver is 

granted for plant studies 850.4100 (vegetative vigor and seedling emergence) because methyl 

salicylate has significant vapor pressure, resulting in volatilization and rapid losses from 

surfaces, is nontoxic to plants (efficacy studies) and is found in many plants. 

Deficiencies but Upgradeable

Certified Limits

Deficiencies: An explanation must be provided for the excessive certified limits given for the 

inert, he name of the source material for Bacillus thuringiensis subsp. kurstaki

strain ABTS-351 is incomplete on the CSF. Box 7 (pounds/Gal or Bulk Density) and 8 (pH) on 

the CSF must be completed. 

The name of the Bacillus active ingredient does not match exactly on the CSF and product label. 

Label: Bacillus thuringiensis subsp. kurstaki strain ABTS-351; CSF: Bacillus thuringiensis

subsp. kurstaki ATCC-1275, Strain ABTS-351. 

The complete name of the source material for Bacillus thuringiensis subsp. kurstaki strain 

ABTS-351 must be given on the CSF 

The CAS No. for must be added to the 

CSF. 

Physical/ Chemical Characteristics

Deficiencies: Outstanding data requirements on the EP (VBC-60347 Biological Insecticide 

Emulsifiable Suspension) include pH, storage stability and corrosion characteristics.

Waiver Request

Requests a waiver from the testing requirements for; Terrestrial Plant Toxicity Seedling 

Emergence Testing (OCSPP 850.4100) and Terrestrial Plant Toxicity Vegetative Vigor Testing 

(OCSPP 850.4150) for Methyl Salicylate and for VBC-60347,

Agency Response: Acceptable
Product Identity (OCSPP 830.1550)

I. Manufacturing Process: 
II. Discussion of Formation of Unintentional Ingredients (OCSPP 885.1300)
Five lots of VBC-60347 Biological Insecticide Emulsifiable Suspension were counted for 

viable aerobic bacteria, anaerobic spore forming bacteria, total coliforms, 

Streptococci/Enterococci, yeasts, and molds (Table 1). Aerobic bacteria counts ranged from 

8.33 x 102

 to 3.40 x 103 cfu/g. Anaerobic spore forming bacteria ranged from <100 to 2.33 x 

102 cfu/g. Coliforms were not detected, with the results expressed as <100 cfu/g. 

Streptococci/Enterococci ranged from <100 to 3.80 x 102 cfu/g. Yeast and molds were <100 

cfu/g.

TABLE 1. Viable counts for VBC-60347 Biological Insecticide Emulsifiable Suspension

Lot no. Viable counts (cfu/g)

Aerobic 

bacteria

Anaerobic 

spore-forming 

bacteria

Total 

coliforms

Streptococci/

Enterococci

Yeast and 

molds

25-006-VB 3.40 x 103 1.00 x 102 <100 3.80 x 102 <100

25-007-VB 1.93 x 103 1.33 x 102 <100 3.70 x 102 <100d

25-008-VB 1.27 x 103 <100a <100 <100b 100

25-009-VB 8.33 x 102 <100 <100 <100c <100

25-011-VB 1.77 x 103 2.33 x 102 <100 1.80 x 102 <100

Data from p. 14, MRID 49343624

<100a represents a mean plate count of 67 cfu/g

<100b represents a mean plate count of 60 cfu/g

<100c represents a mean plate count of 50 cfu/g

<100d represents a mean plate count of 67 cfu/g

The five lots were also examined for the presence of E. coli, Staphylococcus, Pseudomonas 

aeruginosa and Salmonella (Table 2). E. coli, Staphylococcus, and P. aeruginosa were 

absent in 1 g, and Salmonella was absent in 25 g. 

TABLE 2. Presence of microbial contaminants in VBC-63047 Biological Insecticide Emulsifiable 

Suspension

Lot no. Presence/absence per g or per 25 g

E. coli Staphylococcus Pseudomonas

aeruginosa

Salmonella

25-006-VB Absent in 1 g Absent in 1 g Absent in 1 g Absent in 25 g

25-007-VB Absent in 1 g Absent in 1 g Absent in 1 g Absent in 25 g

25-008-VB Absent in 1 g Absent in 1 g Absent in 1 g Absent in 25 g

25-009-VB Absent in 1 g Absent in 1 g Absent in 1 g Absent in 25 g

25-011-VB Absent in 1 g Absent in 1 g Absent in 1 g Absent in 25 g

Data from p. 15, MRID 49343624

 Deficiencies: None. 
III. Analysis of Sample (OCSPP 885.1400) 

Five batches of VBC-60347 Biological Insecticide Emulsifiable Suspension were analyzed 

for methyl salicylate and bioactivity (Table 4). The methyl salicylate content (determined 

using GC with an external standard) ranged from 5.8 to 6.1% w/w, which is within the 

certified limits given on the CSF. A dietary bioassay with larvae of a target pest, the cabbage 

looper (Trichoplusia ni), showed the biopotency ranged from 21708 to 22063 IU/mg (Table 

4). 

TABLE 4. Five batch analysis for biopotency and methyl salicylate content of VBC-60347 Biological 

Insecticide Emulsifiable Suspension

Batch no. Biopotency (IU/mg) Methyl salicylate (%w/w)

25-006-VB 21,821 5.8

25-007-VB 21,708 5.9

25-008-VB 21,856 5.9

25-009-VB 21,926 5.9

25-011-VB 22,063 6.1

Data from p. 8, MRID 49343622

Deficiencies: None. 

IV. Certified Limits for VB-60347 Biological Insecticide Emulsifiable Suspension (OCSPP 

885.1500)

Table 5 lists the nominal concentration and certified limits for the ingredients in VBC-60347 

Biological Insecticide Emulsifiable Suspension as given on the CSF. The certified limits for 

methyl salicylate are within the OCSPP recommended guideline of ±5%. The certified limits for 

Bacillus thuringiensis subsp. kurstaki strain ABTS-351 exceed the OCSPP recommended limits 

of ±3% while the applicant has used about

(MRID 49343623). 
The certified limits for the inert ingredient exceeds the EPA recommendation for 

upper and lower limits; while the applicant used The name of the source 

material for Bacillus thuringiensis subsp. kurstaki strain ABTS-351 is incomplete on the CSF. 

Box 7 (pounds/Gal or Bulk Density) and 8 (pH) on the CSF must be completed. 

TABLE 5. Nominal concentration and certified limits for VBC-60347 Biological Insecticide Emulsifiable 

Suspensiona

Ingredients (CAS number)

PC 

Code Purpose

Concentration (% by weight)

Nominal Lower Upper

Active Ingredients

Methyl salicylate, 

Methyl 2-hydroxybenzoate

(119-36-8)

076601 Active 

ingredient

5.9

Bacillus thuringiensis subsp. kurstaki strain 

ABTS-351, 

ATCC-1275

(68038-71-1)

006552 Active 

ingredient

25.5

Inert Ingredients

aData from CSF (3/17/2014)

Deficiencies: An explanation must be provided for the excessive certified limits given for

the inert, The name of the source material for Bacillus thuringiensis subsp. 

kurstaki strain ABTS-351 is incomplete on the CSF. Box 7 (pounds/Gal or Bulk Density) 

and 8 (pH) on the CSF must be completed.

IV. ENFORCEMENT ANALYTICAL METHOD (OCSPP 830.1800)

The analytical method to determine the content of methyl salicylate in VBC-60347 

Biological Insecticide Emulsifiable Suspension is GC/FID, with results compared to those for 

an external standard. The method is described in MRID 49343622, but is not explicitly stated 
to be the enforcement analytical method for the product. The instrument is a Hewlett Packard 

5890 GC with Chemstation software. The column is a DB-5 MS (25 m, 0.32 mm i.d., film 

thickness of 0.52 μm). The carrier gas is helium. The conditions are as follows:

Injection technique: Split (ratio 20:1)

Injection temperature: 240°C

Injection volume: 5 μL

Oven temperature

Initial: 70°C for 1.2 min

Ramp: 35°C/min to 300°C

Final: 300°C for 7.25 min

Detector: FID

Detector gas flow

Air: 420 mL/min

Hydrogen: 46 mL/min

Auxiliary: 31 mL/min

Detector temperature: 300°C

Retention time: ~ 5 min

Run time: 15 min

The samples are diluted in toluene, and duplicate standard solutions are prepared and used as 

bracketing standards for the test material sample solutions. The methyl salicylate content is 

calculated by reference to the bracketing standards. Sample chromatograms are provided in 

MRID 49343622. It is stated on p. 14 of MRID 49343622 that the method was validated at 

the test facility, with results given in Huntington Life Sciences Report No. ZAB0172, which 

was not included in the submission.

 Deficiencies: None 

V. Physical and Chemical Characteristics (OCSPP 830.6302-7950)

The data for the applicable physical/chemical characteristics of methyl salicylate were 

provided (Table 6.0) and the applicable physical and chemical characteristics of VBC-60347 

Biological Insecticide Emulsifiable Suspension are provided in Table 7.0.
TABLE 6. Physical and Chemical Properties for Methyl Salicylatea

Guideline Reference No./Property Description of Result Methods

830.6302 Color Yellowish or reddish Visual observation

830.6303 Physical State Liquid Visual observation

830.6304 Odor Wintergreen

830.6313 Stability Stable under normal use and 

conditions of storage

830.6314 Oxidation/Reduction: 

Chemical Incompatibility

Not applicable, the product does 

not contain oxidizing or reducing 

ingredients.

830.6315 Flammability Flash point; 1010C EEC Method A9

Pensky-Martens closed cup

830.6316 Explodability Not explosive EEC Method A14

830.6317 Storage Stability NA

830.6319 Miscibility NA

830.6320 Corrosion Characteristics NA

830.6321 Dielectric Breakdown 

Voltage

NA

830.7000 pH 5.9 CIPAC MT 75

830.7050 UV light absorption 237 nm ECHA data base

830.7100 Viscosity 2.38 n/Pas at 20°C ECHA data base

830.7200 Melting Range 19.40 C ECHA data base

830.7220 Boiling Range 2220 C ECHA data base

830.7300 Density/Relative 

Density/Bulk Density

1.184 @ 250 C

830.7370 Dissociation Constant in 

Water

NA

830.7550 Partition Coefficient 2.55 Kow Lyman et al. 1993

830.7840 Water Solubility 0.74% w @ 300 C

830.7950 Vapor Pressure 0.0343 mm Hg @ 250 C

a MRID 49343603
TABLE 7. Physical and Chemical Properties for VBC-60347 Biological Insecticide Emulsifiable Suspensiona

Guideline Reference No./Property Description of Result Methods

830.6302 Color Brown Visual observation

830.6303 Physical State Liquid Visual observation

830.6304 Odor Not required for EP

830.6313 Stability Not required for EP

830.6314 Oxidation/Reduction: Chemical 

Incompatibility

Not applicable, the product does 

not contain oxidizing or reducing 

ingredients.

830.6315 Flammability None determinable, no flash point 

observed

EEC Method A9

Pensky-Martens closed cup

830.6316 Explodability Not explosive EEC Method A14

830.6317 Storage Stability Storage stability study is required

830.6319 Miscibility Not applicable, the product is not 

to be diluted with nonpolar 

solvents.

830.6320 Corrosion Characteristics Corrosion characteristics study is 

required

830.6321 Dielectric Breakdown Voltage Not applicable, the product is not 

for use around electrical equipment

830.7000 pH Not provided. Requirement 

outstanding

830.7100 Viscosity Shows pseudoplastic behavior

170-3300 mPa/s at 20°C

97-2500 mPa/s at 40°C

OECD 114

Brookfield rotational viscometer

830.7200 Melting Range Not required for EP

830.7220 Boiling Range Not required for EP

830.7300 Density/Relative Density/Bulk 

Density

Relative density D204 = 0.98 OECD Method 109

EE Method A3

830.7370 Dissociation Constant in Water Not required for EP

830.7550 Partition Coefficient Not required for EP

830.7840 Water Solubility Not required for EP

830.7950 Vapor Pressure Not required for EP

aData from MRID 49343627 

Deficiencies: Outstanding data requirements on the EP include pH, storage stability and 

corrosion characteristics.
Toxicology 

Toxicology Methyl Salicylate

Summaries of the toxicology profile for methyl salicylate are shown in Table 8.0. Based on this 

information methyl salicylate is nontoxic to mammalian species on an acute oral basis (LD50 > 

5,000 mg/kg; Toxicology Cat. IV); can cause slight acute dermal effects (Toxicology Cat. III), 

and slight eye irritation (Toxicology Cat. III); no acute dermal or inhalation toxicity (LD50 > 

5,000mg/kg; LC50 > 400 mg/m3

; Toxicology Cat. IV).

Table 8.0. Acute Toxicological Values for Methyl Salicylatea

Guideline Results Category MRID #/Reference

Acute Oral Toxicity/ rat

OCSPP 870.1100

LD50 = 887 mg/kg III 49343605

Jenner et al. 1964 

Acute Dermal Toxicity/

OCSPP 870.1200

LD50 > 5,000 mg/kg IV 49343606

Acute Inhalation/

OCSPP 870.1300

LC50 > 400 mg/m3 IV 49343607

Rumyantsev et al. (1992)

Acute Eye Irritation/

OCSPP 870.2400

Severe irritant II 44213010

Acute Dermal Irritation/ 

OCSPP 870.2500

Mild irritant III 44213011

Skin Sensitization/ 

OCSPP 870.2600

Non sensitizer 49343610

90-day Dermal

OCSPP 870.3250

Animals dosed with 4.0 

ml/kg died after 6, 8, 

and 28 days; the 

animals had "anorexia, 

weight loss, and 

depression.

49435404

Webb and Hansen (1963)

Acute Oral (rat) (OCSPP 830.1100)

Valent BioSciences Corp. request that Acute Oral Toxicity presented in the literature be used to 

fulfill data requirements. The LD50 value calculated for the rat was 887 mg/kg (MRID 4213005).

Agency Response: Acceptable

Acute Dermal Toxicity (OCSPP 830.1200)

The acute dermal LD50 value in rabbits was reported as exceeding 5,000 mg/kg (Moreno, 1973).

Since methyl salicylate is metabolized to salicylic acid, a dermal study with salicylic acid was 

also performed. A 14-day percutaneous study was performed in four groups of 3 male and 3 

female New Zealand White rabbits administered topically at 2 g/kg/day of salicylic acidcontaining solutions. The concentrations tested were 0%, 2%, 10% and 25% (corresponding to 0, 

40, 200 and 500 mg/kg/day) of salicylic acid in a vehicle solution (8% propylene glycol butyl 

ether in ethanol). After a 7-hour period of daily exposure, the application site was washed with

water and dried. No death was observed during the study. Dose-related slight to marked

erythema and edema were noted for all dosage groups. Desquamation was most often noted in 

the 25% salicylic acid group; fissuring of varying degree was observed in all dosage groups. 

Eschar was noted in the 10% and 25% dosage groups; exfoliation was noted on day 13 in a 25% 

dosage group. Atonia was predominantly observed in the animals treated with 10% and 25% 
salicylic acid. These signs were generally noted on or between days 7 to 14. The changes in the 

body weights of animals were considered as not remarkable during the study. Concerning 

clinical findings, no visible abnormalities were noted at necropsy in any animal beyond the 

dermal irritation observed at the test sites. Under the experimental conditions adopted, the test 

articles were considered as dermal irritants by the investigators (MRID 49343606).

Agency Response: Acceptable

Acute Inhalation (OCSPP 830.1300)

Valent BioSciences Corp. request that Acute Inhalation Toxicity presented in the literature be 

used to fulfill data requirements. Rumyantsev et al. (1992) found that methyl salicylate, heated to 

80°C and given by inhalation for an unknown duration to white mice and rats was not lethal; the

LC50 > 400 mg/m3 (MRID 49343607) 

Agency Response: Acceptable

Acute Dermal Irritation (OCSPP 830.2500)

Test material was suspended in water or dissolved in PEG 400, 70% ethanol, or 70% ethanol 

plus emollients at concentrations of 1, 3 or 6% and was applied to shaved intact skin of test 

rabbits. No irritation was observed at sites treated with 1% water suspension at 24 and 72 hours 

following application of test material. Primary irritation indexes are summarized as follows:

Methyl Salicylate in Various Vehicles: Rabbit Primary Irritation Indices On Skin

Methyl Salicylate %

Vehicle 1 3 6

H2O 0.0 0.83 1.83

PEG 400 0.33 0.50 0.50

70% ethanol 1.17 4.17 4.00

70% ethanol + emollients 2.17 3.00 3.00

Results show mild irritation for all three concentrations of methyl salicylate. The two higher 

concentrations in 70% ethanol were moderate irritants which produced necrosis, the 70% plus 

emollient were all moderately irritating. The 1% solution was the least reactive, but all 

concentrations elicited necrosis and intradermal and subcutaneous hemorrhage (MRID 

44213011).

Agency Response: Acceptable

Sensitization (OCSPP 830.2600)

Methyl salicylate (MeSa), a skin irritant was found to be negative in predictive human 

sensitization tests (Basketter et al., 1994; Arts et al 1996) (MRID 49343610).

Agency Response: Acceptable

90-Day Dermal (OCSPP 870.3250)

Webb and Hansen (1963) presented information that showed the following: three rabbits were 

dosed dermally with synthetic methyl salicylate (99% pure) 5 days per week for up to 96 days. A 

dose of 0.5, 1.0, 2.0, or 4.0 ml/kg was applied to the clipped skin on the back of restrained 

animals for 6.5 h each day of dosing. The test sites were not wiped because the compound was 
absorbed. The three animals dosed with 4.0 ml/kg died after 6, 8, and 28 days of dosing; the 

animals had "anorexia, weight loss, and depression." A "slight sloughing of epidermal scales" 

was observed for two of the animals dosed with 2.0 ml/kg. No other observations were noted 

(MRID 49435404).

Agency Response: Acceptable

Toxicology VBC-60347

Studies (Table 8.0) on VBC-60347 (a.i.: Bacillus thuringiensis subsp. kurstaki, Strain ABTS351, 26.55% and Methyl Salicylate, 5.9%) show that the EP has a Toxicological Cat. IV for 

Acute Oral (LD50 > 5,000 mg/kg), for Acute Dermal (LD50 > 5,000 mg/kg), and Acute Inhalation 

(LC50 > 5.15 mg/L). VBC-60347 showed minimal effects in the Acute Eye Irritation test and 

slight irritation in the Acute Dermal Irritation study. The Skin Sensitization study showed that 

the EP was a dermal sensitizer (Toxicology Cat. III).

Table 9.0. Acute Toxicological Values for VBC-60347

Guideline Results Category MRID #

Acute Oral Toxicity/ 

OCSPP 870.1100

LD50 > 5,000mg/kg IV 49343628

Acute Dermal Toxicity/

OCSPP 870.1200

LD50 > 5,000 mg/kg IV 49343629

Acute Inhalation/

OCSPP 870.1300

LC50 > 5.15 mg/L IV 49343630

Acute Eye Irritation/OCSPP 

870.2400

Minimal effects 

clearing in less than 

24 hrs.

III 49343631

Acute Dermal Irritation/ 

OCSPP 870.2500

slightly irritating III 49363432

Skin Sensitization/ 

OCSPP 870.2600

dermal sensitizer III 49343633

Mutagenicity: In vitro Mammalian 

Cell Assay/

OCSPP 870.5300

Negative 40898201

Toxicology VBC-60347

Acute Oral (rat) (OCSPP 830.1100)

In an acute oral toxicity study three female Sprague-Dawley rats (10 week old) were dosed by

gavage with VBC-60347, Lot No. 25-006-VB (a.i.: Bacillus thuringiensis subsp. kurstaki, Strain 

ABTS-351, 26.55% and methyl salicylate, 5.9%) at 5,000 mg/kg, respectively (up and down 

procedure). Body weight was recorded prior to dosing, and on days 7 and 14. The test animals 

were observed for mortality and clinical signs of toxicity during the first several hours postdosing and at least daily thereafter for 14 days. The Oral LD50 > 5,000 mg/kg, VBC-60347 is a 

Toxicity Category IV (MRID 49343628).

Agency Response: Acceptable

Acute Dermal (OCSPP 830.1200)

In an acute dermal toxicity study five male and five female Sprague-Dawley rats (10 week old) 

were dermally exposed to VBC-60347, Lot No. 25-006-VB (a.i.: Bacillus thuringiensis subsp. 

kurstaki, Strain ABTS-351, 26.55% and Methyl Salicylate, 5.9%) at a dose of 5000 mg/kg bw 
for 24 hours to an area of approximately 10% of body surface. Following exposure, the animals 

were observed for a period of 14 days. All animals were active and healthy during other days. 

No abnormalities were noted at necropsy (MRID 49343629).

Dermal LD50 Males > 5,000 mg/kg bw

Females > 5,000 mg/kg bw

Combined > 5,000 mg/kg bw (limit test)

This places VBC-60347 in Toxicity Category IV

Agency Response: Acceptable

Acute Inhalation (OCSPP 830.1300) 

In an acute inhalation toxicity study groups of young adult Sprague-Dawley rats (9-10 weeks 

old; 5/sex/group) were exposed nose-only to VBC-60347, Lot No. 25-006-VB (a.i.: Bacillus 

thuringiensis subsp. kurstaki, Strain ABTS-351, 26.55% and methyl salicylate, 5.9%) for 4 hours 

at a concentration of 5.15 mg/L. The animals were observed for 14 days. All animals survived to 

scheduled termination. Following exposure, all rats exhibited abnormal respiration and two 

females exhibited ano-genital staining and/or abnormal distention with recovery by day 7. All 

animals appeared active and healthy thereafter and through the end of the study. All rats lost 

weight by day 1 and one female lost weight through day 3; thereafter, all animals gained weight 

through the end of the study. No gross abnormalities were noted from any animal at necropsy 

(MRID 49343630).

Inhalation LC50 Males > 5.15 mg/L

Females > 5.15 mg/L

Combined > 5.15 mg/L

VBC-60347 is in EPA Toxicity Category IV.

Agency Response: Acceptable

Acute Eye Irritation (OCSPP 870.2400)

In a primary eye irritation study 0.1 mL of VBC-60347, Lot No. 25-006-VB (a.i.: Bacillus 

thuringiensis subsp. kurstaki, Strain ABTS-351, 26.55% and Methyl Salicylate, 5.9%) as 

supplied was instilled into the conjunctival sac of the right eye of three female New Zealand 

White rabbits. The contralateral eye was not treated and served as control. Animals were 

observed at 1, 24, 48, and 72 hours after test material instillation. No corneal opacity or iritis was 

noted on any rabbit throughout the study. Positive conjunctival irritation (redness score = 2) was 

noted on two rabbits one hour after test material instillation with resolution on one rabbit by 48 

hours and on the other rabbit by 72 hours. The third rabbit had positive conjunctival irritation 24 

hours after test material instillation. The maximum average score was 5.3 at one hour after test 

material instillation. In this study, VBC-60347 was minimally irritating to the eye and the test 

material is in EPA Toxicity Category III for primary eye irritation (MRID 49343631).

Agency Response: Acceptable
Acute Dermal Irritation (OCSPP 830.2500)

In a primary dermal irritation study three female New Zealand White rabbits were dermally 

exposed to 0.5 mL of VBC-60347, Lot No. 25-006-VB (a.i.: Bacillus thuringiensis subsp. 

kurstaki, Strain ABTS-351, 26.55% and Methyl Salicylate, 5.9%) as supplied for 4 hours on an 

approximately 6 cm2 clipped area of the dorsal area and trunk. The animals were observed at 1, 

24, 48, and 72 hours and day 7 after patch removal. One rabbit had no dermal irritation 

throughout the study. Another rabbit had well defined erythema with very slight edema at 48 

hours after patch removal that became well defined erythema with slight edema by 72 hours with 

clearance by day 7. The third rabbit had well defined erythema with very slight edema at 48 and 

72 hours after patch removal with clearance by day 7. Desquamation was noted on the third 

rabbit on day 7. The primary irritation index was 1.1. In this study, VBC-60347 was slightly 

irritating and is represents EPA Toxicity Category III (MRID 49363432).

Agency Response: Acceptable

Skin Sensitization (OCSPP 870.2600)

In a dermal sensitization study with VBC-60347, Lot No. 25-006-VB (a.i.: Bacillus thuringiensis 

subsp. kurstaki, Strain ABTS-351, 26.55% and Methyl Salicylate, 5.9%), 33 female young adult 

CBA/J mice were tested using the local lymph node assay. Statistically significant increases in 

cell proliferation measurements compared to the vehicle control group were observed at 25%, 

50%, and 100% test concentrations. SIs of > 3.0 were observed at all test concentrations (6.37, 

8.28, and 8.11 for 25%, 50%, and 100% test concentrations, respectively). The positive control 

produced a dermal sensitization response (SI = 10.38) in mice. Under the conditions of this 

study, VBC-60347 produced a dermal sensitization response in mice. (MRID 49343633).

Agency Response: Acceptable

Ecotoxicity

Acute Toxicity 

Ecotoxicity data on methyl salicylate (Table 6.0) show that the compound is slight to practically 

non-toxic to avian species (LD50 > 2,510 mg/kg; LC50 > 5,620 ppm); slight to practically 

nontoxic to fish (LC50 = 26 mg/L and LC50 = 135 mg/L); slight toxicity to aquatic invertebrates 

(LC50 = 38 mg/L); and not phytotoxic. A study on honey bees using the EP showed no toxic 

effect with the 24- and 48-hr LD50 for contact toxicity greater than 125 μg ai/bee. A waiver is 

granted for plant studies 850.4100 (vegetative vigor and seedling emergence) because methyl 

salicylate has significant vapor pressure, resulting in volatilization and rapid losses from 

surfaces, is nontoxic to plants (efficacy studies) and is found in many plants.

Table 6.0 Ecotoxicity Studies 

Studies on Methyl Salicylate Results Reference/MRID

Acute Avian Oral (Bobwhite Quail)

OCSPP 850.2100

LD50 > 1,200 mg/kg

NOEL = 720 mg/kg

49343614

Acute Avian Dietary (Bobwhite Quail)

OCSPP 850.2200

LC50 > 5,620 ppm NOEL = 5,620 ppm 49484401

Daphnia magna

OCSPP 850.1010

48 hr EC50 = 38 mg/ L (95% conf interval 24 

–59 mg/L) NOEL = 24 mg/L

49343618

Bluegill (Lepomis macrochirus)

OCSPP 850.1075

96hr LC50 = 26 mg/L

NOEL = 16 mg/L

49343617
Rainbow Trout (Oncorhynchus mykiss)

OCSPP 850.1075

96hr LC50 =135 mg/L (95% conf interval 23 

– 35 mg/L); NOEL = 9.1 mg/L

49343616

Study on VBC-60347 Results Reference/MRID

Honeybee Acute Toxicity

OCSPP 850.3020

The 24- and 48-hr LD50 for contact toxicity 

was >125 μg ai/bee.

49343639

Waiver Request Results Reference/MRID

Terrestrial Plant Tox.

(Seedling Emergence)

OCSPP 850.4100

Waiver acceptable.

Both ai components are known to promote 

plant health.

49343619

Terrestrial Plant Tox.

(Vegetative Vigor)

OCSPP 850.4100

Waiver acceptable.

Both ai components are known to promote 

plant health.

49343619

Avian Acute Oral (OSCPP 850.2100)

The acute oral LD50 value for northern bobwhite exposed to Methyl Salicylate as a single oral 

dose was calculated to be 1703 mg/kg, with 95% confidence that it was greater than 1200 mg ai

/kg. The no-mortality level was 1200 mg ai/kg. The no-observed-effect level was 720 mg ai/kg 

based on signs of toxicity and a body weight effect observed at the 1200 mg a.i./kg dosage group

(MRID 49343614).

Agency Response: Acceptable

Avian Dietary (OSCPP 850.2200)

The dietary LC50 for northern bobwhite quail exposed the methyl salicylate was determined to be 

greater than 5,620 ppm, the highest concentration tested. The no-treatment related mortality 

concentration and the no-observed-effect concentration were 5,620 ppm. The nominal 

concentrations were 562, 1000, 1780, and 5,620 ppm ai and the estimated daily dietary doses 

were 123, 213, 370, 647, 1,206 mg ai/kg (MRID 49484401).

Agency Response: Acceptable

Fish Acute Toxicity (Rainbow trout) (OSCPP 850.1075)

Rainbow trout (Oncorhynchus mykiss) were exposed for 96 hours under static-renewal 

conditions to five mean measured concentrations of methyl salicylate ranging from 6.3 to 110mg 

ai/L. The 96-hour LC50 value was 35 mg ai/L, with a 95% confidence interval of 23 to 52 mg 

ai/L and the NOEC was 9.1 mg a.i./L.

Agency Response: Acceptable

Fish Acute Toxicity (Bluegill) (OSCPP 850.1075)

Bluegill (Lepomis macrochirus) were exposed for 96 hours under static-renewal conditions to

five mean measured concentrations of methyl salicylate ranging from 3.0 to 106 mg ai/L. The 

96-hour LC50 value was 26 mg ai/L, with a 95% confidence interval of 16 to 106 mg ai/L and the

NOEC was 16 mg ai/L.

Agency Response: Acceptable

Aquatic Invertebrate Acute Toxicity (OSCPP 850.1010)

The cladoceran, Daphnia magna, was exposed for 48 hours under static conditions to five mean 

measured concentrations of methyl salicylate ranging from 5.5 to 117 mg/L. The 48-hour EC50

value was 38 mg methyl salicylate/L and the NOEC was 24 mg methyl salicylate/L.

Agency Response: Acceptable
Honeybee Acute Toxicity (850.3020)

The 48-hr LD50 for oral toxicity was >118 μg VBC-60347/bee. Response of the reference control 

group was appropriate. For the contact exposure, the bees were treated individually by topical 

application of 2 μL of mineral water containing a nominal dose of 7.8, 15.6, 31.3, 62.5, or 125 

μg of product/bee to the thorax and observed for 48 hours. Control bees received 2 μL of mineral 

water or dimethoate in mineral water. Mortality at test end ranged from 2.5% to 15.0% in the test 

material groups compared to 0.0% in the untreated control group, but was likely not-treatment 

related, as there was no dose-response relationship. The 24- and 48-hr LD50 for contact toxicity 

was >125 μg VBC-60347 42/bee (MRID 49343639).

Agency Response: Acceptable

Vegetative Vigor, Seedling Emergence (OCSPP 850.4100; 850.4150)

Valent BioSciences Corp. requests a waiver from the testing requirements for;

Terrestrial Plant Toxicity Seedling Emergence Testing (OCSPP 850.4100) and

Terrestrial Plant Toxicity Vegetative Vigor Testing (OCSPP 850.4150) for Methyl

Salicylate and for VBC-60347, (a liquid formulation of methyl salicylate and Bacillus

thuringiensis subsp. kurstaki strain ABTS-351).

Fellows et al. (1991) using a wind tunnel experiment, found a lower threshold for plant 

phytotoxicity of 1 to 2 ug methyl salicylate/cm2

leaf. Phytotoxicity was transient and began 

resolving within 2 days. Severe plant contact toxicity was observed at levels above 4 ug methyl 

salicylate /cm2 of leaf. Fellows et al. showed that foliar deposited methyl salicylate has an initial 

rapid loss phase with a half-life of 0.9 to 2.4 h on sagebrush, tall- and short-needle pine foliage. 

Methyl salicylate has significant vapor pressure, so volatilization accounts for some rapid losses 

from surfaces with half-lives in terms of hours, and little absorption to organic matter. Exposure 

of non-target seeds is highly unlikely and the development of phytotoxicity would not be

expected. 

Actual VBC-600347 use rates:

Worst case scenario: 4 pints/acre 1 acre = 40,468,564.2 cm2

Product is 6%, at 4 pints ~ 120 g methyl salicylate 

Results in: 2.96 ug methyl salicylate /cm2 (for a planar surface) 

Tomato plant contains 700 - 800cm2 of leaf area

Agency Response: Acceptable
Magnitude of Residues of Methyl Salicylate in Tomato Plants Following Applications 

VBC-60347 (MRID 49484402)

The purpose of this study was to generate magnitude of the residue data for methyl salicylate 

and salicylic acid in/on tomato plants treated at the proposed labeled use rate of 2 pints VBC60347 end use product/A/application at a various time points after a single application. The 

residue data generated in this study will be used to describe the natural levels, and the 

increase and decline of both methyl salicylate and salicylic acid, to establish tolerance 

exemptions for methyl salicylate residues in/on treated tomato in support of its US EPA and 

Canadian PMRA registration.

The residue data produced from the treated plants of this study are appropriate for supporting 

registration of the Methyl Salicylate active ingredient. Samples were analyzed for Methyl

Salicylate and Salicylic Acid residues using well-controlled appropriate methods. Test 

substance applications for this study were consistent and appropriate to obtain good residue 

samples. Plant samples were properly taken and extracted immediately for analysis. No 

unusual weather phenomena, agricultural, or analytical practices were experienced during the 

conduct of this study. 

Endogenous levels of Methyl Salicylate averaged 489 ppb before application of VBC-60347. 

The levels in the leaves increased to an average of 1087 ppb one hour after application of the 

test formulation at the proposed label rate of 2 pints per acre. By four hours after application 

the residue level had decreased to 954 ppb, and by 25 hours the level (560 ppb) had returned 

to the time-0 level. A similar profile was seen for the Salicylic Acid results, except that the 

endogenous levels are lower, and levels in treated plants were also lower throughout the time 

interval. Time-0 values averaged 51 ppb. One-hour after application the levels rose to 246 

ppb but had returned to the background level (30 ppb) by 25 hours after application. There is 

considerable variation within all of this data. This due to plant to plant variation the time-0 

values represent endogenous levels before treatment. However, this data does demonstrate 

the trend of rapid disappearance of methyl Salicylate and no accumulation in the form of 

salicylic acid.

Agency Response: Supplemental
References

Arts, J.H., Droege, S.C., Spanhaak, S., Bloksma, N., Penninks, A.H., Kuper, C.F. 1997. Local 

lymph node activation and IgE responses in brown Norway and Wistar rats after dermal 

application of sensitizing and non-sensitizing chemicals. Toxicology. 117, 2-3: 229-34.

Basketter, D.A., Scholes, E.W. and Kimber, I. 1994. The performance of the local lymph node 

assay with chemicals identified as contact allergens in the human maximization test. Food Chem. 

Toxicol. 32, 543-547.

Hazardous Substances Data Bank (HSDB), Database of the National Library of Medicine's 

TOXNET system (http://toxnet.nlm.nih.gov) on February 17, 2014.

Jenner, P. M., Hagan, E. C., Taylor, J. M., Cook, E. L. & Fitzhugh, O. G. 1964. Fd Cosmet. 

Toxicol.,3, 327

Mayer D. F. 1997. Effects of methyl salicylate on honey bee (Apis mellifera L)

Foraging New Zealand Journal of Crop and Horticultural Science, 25: 291-294

USEPA, 1998. Reregistration, Eligibility Decision (RED): Bacillus thuringiensis. EPA 738-R98-004

Webb, W. K., and W. H. Harisen. 1963. Chronic and subacute toxicology and pathology of 

methyl salicylate in dogs, rats, and rabbits. Toxicol. Appl. Pharmacol. 5:576-587.

MRID Citation Receipt 

Date

49343600

Valent Biosciences Corporation (2014) Submission of Product Chemistry, 

Toxicity, and Fate Data in Support of the Application for Registration of VBC60347. Transmittal of 39 Studies.

20-Mar2014

49343601

Bade, T.; Herrero, M. (2013) Product Identity: Manufacturing Process: Methyl 

Salicylate. Project Number: MESA/12/2013. Unpublished study prepared by 

Valent Biosciences Corporation. 43p.

20-Mar2014

49343602

Marin, J. (2013) Analysis and Certification of Product Ingredients in Five Batches 

of Technical Methyl Salicylate. Project Number: 2412W. Unpublished study 

prepared by PTRL West, Inc. 31p.

20-Mar2014

49343603

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Physical and 

Chemical Characteristics. Project Number: MESA/214/PC. Unpublished study 

prepared by Valent Biosciences Corporation. 33p.

20-Mar2014

49343604

Herrero, M. (2014) Methyl Salicylate Stability to Normal and Elevated 

Temperatures, Metals and Metal Ions, Request for No Further Testing. Project 

Number: MESA/214/PC2. Unpublished study prepared by Valent Biosciences 

Corporation. 26p.

20-Mar2014
49343605

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Acute Oral 

Toxicity Testing. Project Number: MESA/214/01. Unpublished study prepared by 

Valent Biosciences Corporation. 60p.

20-Mar2014

49343606

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Acute Dermal 

Toxicity Testing. Project Number: MESA/214/02. Unpublished study prepared by 

Valent Biosciences Corporation. 125p.

20-Mar2014

49343607

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Acute 

Inhalation Toxicity Testing. Project Number: MESA/214/03. Unpublished study 

prepared by Valent Biosciences Corporation. 137p.

20-Mar2014

49343608

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Primary 

Ocular Irritation Toxicity Testing. Project Number: MESA/214/03. Unpublished 

study prepared by Valent Biosciences Corporation. 14p.

20-Mar2014

49343609

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Primary 

Dermal Irritation Toxicity Testing. Project Number: MESA/214/05. Unpublished 

study prepared by Valent Biosciences Corporation. 142p.

20-Mar2014

49343610

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Dermal 

Sensitization Testing. Project Number: MESA/214/06. Unpublished study 

prepared by Valent Biosciences Corporation. 23p.

20-Mar2014

49343611

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for 90-day Oral 

Toxicity Testing. Project Number: MESA/214/90D, EMEA/MRL/696/99/FINAL. 

Unpublished study prepared by Valent Biosciences Corporation. 108p.

20-Mar2014

49343612

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Pre-Natal 

Developmental Toxicity Testing. Project Number: MESA/214/TER. Unpublished 

study prepared by Valent Biosciences Corporation. 111p.

20-Mar2014

49343613

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Mutagenicity 

Toxicity Testing. Project Number: MESA/214/MU. Unpublished study prepared 

by Valent Biosciences Corporation. 223p.

20-Mar2014

49343614

Hubbard, P.; Beavers, J. (2014) Methyl Salicylate: An Acute Oral Toxicity Study 

with the Northern Bobwhite. Project Number: 529/126. Unpublished study 

prepared by Wildlife International, Ltd. 55p.

20-Mar2014

49343615

Herrero, M. (2014) Methyl Salicylate: Justification for No Further Testing in 

Regard to Avian Dietary Toxicity. Project Number: MESA/1/AD, PNL/SA/19765, 

DE91/012775. Unpublished study prepared by Valent Biosciences Corporation. 

23p.

20-Mar2014

49343616

Brougher, D.; Martin, K.; Gallagher, S.; et al. (2013) Methyl Salicylate: A 96-Hour 

Static-Renewal Acute Toxicity Test with the Rainbow Trout (Oncorhynchus 

mykiss): Final Report. Project Number: 529A/126,

20-Mar2014
529/012813/RBT/96H3/100P/628. Unpublished study prepared by Wildlife 

International, Ltd. 59p.

49343617

Brougher, D.; Bodle, E.; Martin, K.; et al. (2014) Methyl Salicylate: A 96-Hour 

Static Renewal Acute Toxicity Test with the Bluegill (Lepomis macrochirus): 

Final Report. Project Number: 529A/127, 529/042913/BLU/96H3/SUB529. 

Unpublished study prepared by Wildlife International, Ltd. 57p.

20-Mar2014

49343618

Brougher, D.; Martin, K.; Gallagher, S. (2014) Methyl Salicylate: A 48-Hour 

Static Acute Toxicity Test with the Cladoceran (Daphnia magna): Final Report. 

Project Number: 529A/125, 529/032613/DAP/48H1/OECD/OPPTS/100P/601. 

Unpublished study prepared by Wildlife International, Ltd. 56p.

20-Mar2014

49343619

Herrero, M. (2014) Methyl Salicylate: Justification for a Waiver from: Terrestrial 

Plant Toxicity Seedling Emergence Testing: Terrestrial Plant Toxicity Vegetative 

Vigor Testing. Project Number: MESA/1/14, PNL/9818, TD2089. Unpublished 

study prepared by Valent Biosciences Corporation. 178p.

20-Mar2014

49343620

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for: Non-target 

Insect Toxicity Testing: Honey Bee Acute Toxicity. Project Number: 

MESA/214/HBA. Unpublished study prepared by Valent Biosciences 

Corporation. 86p.

20-Mar2014

49343621

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for Residue Data 

Testing. Project Number: MESA/214/01R, PNL/9818, TD/2089. Unpublished 

study prepared by Valent Biosciences Corporation. 519p.

20-Mar2014

49343622

Comb, A. (2013) VBC-60347: Five-Batch Analysis (Chemical and Bioassay). 

Project Number: ZAB0173, VBC/60347. Unpublished study prepared by 

Huntingdon Life Sciences, Ltd. 39p.

20-Mar2014

49343623

Devisetty, B. (2014) VBC-60347: Product Identity, Manufacturing Process, and 

Formation of Unintentional Ingredients. Project Number: VBC/60347/MA. 

Unpublished study prepared by Valent Biosciences Corporation. 70p.

20-Mar2014

49343624

Paterson, K. (2013) VBC-60347: Bioburden Analysis on 5 Batches. Project 

Number: ZAB0174. Unpublished study prepared by Huntingdon Life Sciences, 

Ltd. 16p.

20-Mar2014

49343625 Comb, A. (2013) VBC-60347: Method Validation. Project Number: ZAB0172. 

Unpublished study prepared by Huntingdon Life Sciences, Ltd. 48p.

20-Mar2014

49343626

Comb, A. (2013) VBC-60347: Two Year Storage Stability (Interim Report, Initial 

Data). Project Number: ZAB0175. Unpublished study prepared by Huntingdon 

Life Sciences, Ltd. 59p.

20-Mar2014

49343627

Pointer, C. (2013) VBC-60347: Physico-Chemical Properties. Project Number: 

ZAB0185, 54454/5. Unpublished study prepared by Huntingdon Life Sciences, 

Ltd. 39p.

20-Mar2014

49343628

Durando, J. (2013) VBC-60347: Acute Oral Toxicity Up and Down Procedure in 

Rats. Project Number: 35864, P320/UDP, 130124/4D. Unpublished study 

prepared by Product Safety Laboratories. 28p.

20-Mar2014
49343629

Durando, J. (2013) VBC-60347: Acute Dermal Toxicity Study in Rats. Project 

Number: 35865, 130124/4D, P322/RAT. Unpublished study prepared by Product 

Safety Laboratories. 27p.

20-Mar2014

49343630

Durando, J. (2013) VBC-60347: Acute Inhalation Toxicity Study in Rats. Project 

Number: 35866, 130124/4D, P330. Unpublished study prepared by Product 

Safety Laboratories. 35p.

20-Mar2014

49343631

Durando, J. (2013) VBC-60347: Primary Eye Irritation Study in Rabbits. Project 

Number: 35867, 130124/4D, P324. Unpublished study prepared by Product 

Safety Laboratories. 30p.

20-Mar2014

49343632

Durando, J. (2013) VBC-60347: Primary Skin Irritation Study in Rabbits. Project 

Number: 35868, 130124/4D, P326. Unpublished study prepared by Product 

Safety Laboratories. 30p.

20-Mar2014

49343633

Durando, J. (2013) VBC-60347: Local Lympth Node Assay (LLNA) in Mice. 

Project Number: 35869,130124/4D, P327. Unpublished study prepared by 

Product Safety Laboratories. 39p.

20-Mar2014

49343634

Herrero, M. (2014) VBC-60347: Justification for No Further Testing in Regard to 

Avian Acute Oral Toxicity. Project Number: MESA/1F/AD, PNL/SA/19465, 

DE91/012775. Unpublished study prepared by Valent Biosciences Corporation. 

21p.

20-Mar2014

49343635

Herrero, M. (2014) VBC-60347: Justification for No Further Testing in Regard to 

Avian Dietary Toxicity. Project Number: MESA/2F/AD, PNL/SA/19465, 

DE91/012775. Unpublished study prepared by Valent Biosciences Corporation. 

22p.

20-Mar2014

49343636

Herrero, M. (2014) VBC-60347: Justification for No Further Testing in Regard to 

Fish Acute Toxicity. Project Number: MESA/1F/AF, MESA/1F/AD. Unpublished 

study prepared by Valent Biosciences Corporation. 49p.

20-Mar2014

49343637

Herrero, M. (2014) VBC-60347: Justification for No Further Testing in Regard to 

Aquatic Invertebrate Acute Toxicity. Project Number: MESA/1DA/AD. 

Unpublished study prepared by Valent Biosciences Corporation. 49p.

20-Mar2014

49343638

Herrero, M. (2014) Justification for a Waiver from Terrestrial Plant Toxicity 

Seedling Emergence Testing Terrestrial Plant Toxicity Vegetative Vigor Testing 

with VBC-60347 (Containing Methyl Salicylate (MeSa). Project Number: 

MESA/1/14, PNL/SA/19465, DE91/012775. Unpublished study prepared by 

Valent Biosciences Corporation. 178p.

20-Mar2014

49343639

Verge, E. (2013) Final Report: VBC-60347 - Acute Oral and Contact Toxicity to 

the Honeybee, Apis Mellifera L. under Laboratory Conditions. Project Number: 

S13/03504, S13/03504/L1. Unpublished study prepared by Eurofins 

Agroscience Services EcoChem GmbH. 45p.

20-Mar2014

49435400

Valent BioSciences Corporation (2014) Submission of Product Chemistry and 

Toxicity Data in Support of the Application for Registration of VBC-60347 

Biological Insecticide Emulsifiable Suspension and the Petition for Tolerance of 

Methyl Salicylate. Transmittal of 5 Studies.

25-Jul2014

49435401

Herrero, M. (2014) VBC-60347: Miscibility - Request for No Further Testing. 

Project Number: MESA/214/M. Unpublished study prepared by Valent 

BioSciences Corporation. 4p.

25-Jul2014
49435402

Herrero, M. (2014) Methyl Salicylate: Particle Size - Request for No Further 

Testing. Project Number: MESA/214/PS. Unpublished study prepared by Valent 

BioSciences Corporation. 11p.

25-Jul2014

49435403

Nair, A.; Lopez, J. (2014) Methyl Salicylate pH Measurements. Project Number: 

MESA/214/PH. Unpublished study prepared by Valent BioSciences Corporation. 

5p.

25-Jul2014

49435404

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for 90-Day 

Inhalation Toxicity Testing. Project Number: MESA/214/90DINH. Unpublished 

study prepared by Valent BioSciences Corporation. 40p.

25-Jul2014

49435405

Herrero, M. (2014) Methyl Salicylate: Scientific Justification to Use Current Data 

to Satisfy the Biochemical Pesticide Registration Requirements for 90-Day 

Dermal Toxicity Testing. Project Number: MESA/214/90DD. Unpublished study 

prepared by Valent BioSciences Corporation. 184p.

25-Jul2014

49484400

Valent BioSciences Corporation (2014) Submission of Toxicity and Residue 

Data in Support of the Application for Registration of VBC-60347. Transmittal of 

2 Studies.

09-Oct2014

49484401

Hubbard, P.; Schutt, W.; Beavers, J.; et al. (2014) Methyl Salicylate: A Dietary 

LC50 Study with the Northern Bobwhite. Project Number: 529/129, 

529/072414/QLC/100P/401. Unpublished study prepared by Wildlife 

International Limited. 80p.

09-Oct2014

49484402

Heiman, D. (2014) Magnitude of Residues of Methyl Salycilate in Tomato Plants 

Following Applications of VBC-60347. Project Number: MESA/TLRD/LG/001. 

Unpublished study prepared by Valent Biosciences Research Center. 40p.

09-Oct2014

49586400

Valent BioSciences Corporation (2015) Submission of Product Chemistry Data 

in Support of the Application for Registration of Methyl Salicylate. Transmittal of 

2 Studies.

12-Mar2015

49586401

Richard, K. (2014) Preliminary Analysis of Technical Methyl Salicylate. Project 

Number: 546G822. Unpublished study prepared by EPL Bio-Analytical Services 

(EPL-BAS). 71p.

12-Mar2015

49586402

Herrero, M. (2015) Product Identity Manufacturing Process: Methyl Salicylate. 

Project Number: MESA/03/2015. Unpublished study prepared by Valent 

BioSciences Corporation. 168p.

12-Mar2015