### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460
OFF! E OF CHEMICAL SAFETY AND POLL U TION PREVENTION



### MEMORANDUM
DATE: December 19 , 2012 SUBJECT: Stabicide 71

- Rfview of Avian Acute-oral Toxicity Study (850.2100) PC Code(s): 114804 

## I DP Barcode(s)/No( s): D407251 Decision No.: 402782 

### I Registration No(s).: 85808

-R Stabicide 71 Petition No(s).: NA 

### I Regulatory Action: Section 3 

### Risk Assess Type: 

### I Case No(s)
. : TXRNo.:NA 

## I CAS No(s): MRID No(s).: 489997

- 01 

## I 40 CFR: None FROM:

THRU:

TO: W. Erickson, Biologist 

# tJ. OLRisk

### Assessmen**~** and Science Support Branch Antimicrobials ID ivision 

## I

# c~ t;/15 Steven Weiss, Branch Chief**~(//..<.A** 

### David Bays, Bi 9logist Risk Assessme 11t and Science Support Branch Antimicrobials Division Demson Fuller, Chemical Review Manager Regulatory**M~agement** 

### Branch I 

### Antimicrobial s IDivision RASSB has reviewed the**av~f** 

### acute
- oral toxicity study submitted by Schulke and Mayr GmbH to support registration of Sta J

lcide 71 for decontamination and control of microorganisms in fuel systems. The DER is atlachel:l. The study is scientifically sound but utilized only one test concentration. Because an LD50 was not determined nor shown to exceed 2000 mg ai/kg

-bw, the study is categorized as Supplemental. The study provides sufficient information to indicate that the proposed product label does not need a precautionary statement for avian toxicity, because the LD50 (>525 mg ai/kg-bw) is greater than the trigger**(~1** 

### 00 mg ai /kg

-bw) for precautionary labeling. )However, in the event that the uses of Stabicide 71 might be expanded to include other use patterns for which RASSB would conduct an ecological risk assessment, a core study would be required. No additional study is needed for the currently proposed fuel preservation use of Stabicide 71 for which only a hazards assessment is needed for birds.



### -·DATA EVALUATION RECORD**~**VIAN SINGLE -DOSE LD 50 TEST 

## I GUIDELINE OPPTS 850.2100 MRID 489997 - 01

CHEMICAL: 3,3

-Methlye e-bis(5

-methyl

- oxazolidine) PC Code No.: 1 14804 TEST MATERIAL: Stabic de 71 Purity: 99% ( 47.2% total aldehyde) CITATION: Author: C. Youngb r Title: Stabicide 1: Acute Oral Toxicity Study in Bobwhite Quail Laboratory: STILLMEADOW, Inc., Sugar Land, TX Date: 16**Nove ber**  2012 Sponsor: Schulke 

## &Mayr GmbH , Norderstedt, Germany Study ID: Lab.**Stud ~**  ID 16778

- 12 PRIMARY**REVIEWE :**  W
. Erickson, Biologist, RASSB/AD Signature: 

# hi**~** Date: 12119/2012 SECONDARY REVIEWER: D. Bays, Biologist, RASSB/AD 

### Signature:

# ~~ Date: 12119/2012 Study Paramaters: 

### Test Organism: Nort l em bobwhite 

### (Co/inus virginianus) Age: 27 weeks Study Duration: 14 days Results Synopsis: LD50: >525 mg ai/kg-bw 95% CI: not determihed NOAEL: not determined Comments: Only one concentration was tested. Mortality was 40%. 

### study classification: supp1 r mentai
. 1

### MRID 489997

-0 1 Major Deficiencies: The OCSPP study guide line ( 850.21 00) for an avian acute oral toxicity study requires 5 test concentrations. An LD 5 0 needs to be determined or shown to exceed 2000 mg ai/kg

-bw. The current test used only one test concentration and did not establish an LD50 nor determine that it exceeds 2000 mg ai/kg

-bw . 

### MATERIALS AND MET H ODS Test Organisms:
Guideline Criteria 

### Species 

# J A wild waterfowl species , f referably the mallard (Anas platyrh y nch @ s), or an upland game bird species, prereraH ly the bobwhite (Colinus virginianus) 

### Age at beginning of te st At least 16 weeks old 

### Supplier Acclimation period At least 15 days



### Test System:
Guideline Criteria 

### Pen facilities adequate? Photoperiod 1 1

0

-h light, 14

-h dark i s rec9mmended
. 

### Diet was nutritious a n d ap propriate for species? Feed w ithheld at lea st 1 5 r ours prior to dosing?

2 Rep orted Information
Northern bobwhite (Colinus virginianus)
27 weeks Troy Johnson (no address or location reported)**~14** days

Reported Inf ormation Yes 8 h light/16 h dark Yes YesMRID 489997-01 Test Design: 

# I Guideline Criteria 

# I Reported Information 

# I

Range finding test? No I Definitive Test 1 Nominal concentrations: A t least five, in a N ominal concentrations: geometric scale, unless LD5 1 0 > 2000 mg ai/ 525 mg ai/kg kg 

# l Controls Water control or vehicle control (if vehicle is Water used) 

### I Number of birds :Qer grouv 10 birds (5 males/5 females) per group 10 (strongly recommended) Vehicle Distilled water, com oil, propylene glycol, Deionized water 1% carboxymethylcelluloser or gum arabic Amount of vehicle :Qer body weight Constant volume/weight % pf body weight, Yes not to exceed 1% (1ml/100g) 1 Observations :Qeriod 

# I 14 days At least 14 days
REPORTED RESULTS 

# I**Guidelin~ Cri** **eria** 

# I Reported Information 

# I

Quality assurance and GIJP compliance statements we f e Yes included in the report? Individual body weights**~easured** at Measured individually on day of dosing beginning of test, on day 14 and at end of (Day 0) and on Days 3, 7, and 14 test if extended beyond 14 days? Mean feed consumption nieasured at Average determined for each dosage group beginning of test, on day 14, and at end of and the control group for days 0

- 3, 3

- 7, and test if extended beyond 14 days? 10

- 14 3Guideline Criteria 

### Control Mortality Not more than 10% 

### Raw data included ? 

# I Signs of toxicity (if any) were described?

II



## . 

# . Mortality
.

No. 

# I

D osage (m g Test p r oduct/kg) B irds 1 

### 2 m f m f m Control 5/sex 

# l o 0 0 0 0 525 5/sex 0 1 1 1 1



### No. 

# I Dos age (mg TeJt product/kg) Birds 9 10 m f m f m Control 5/s ex 0 0 0 0 0

525 5/sex 1 1 1 1 1 

### Signs of toxicity: 

# I MRID 489997-01
R eported Information No mortality
Yes Signs of toxicity and abnormal behavior

were recorded in addition to mortality



### C umulative Number Dead S tudy Day 3 4 5 

### 6 7 

### 8 f m f m f m f m f m f 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1


### C umulativ e Number D ead S tudy Day 

### 11 1 2 1 3 14 Tota l f m f m f m f 0 0 0 0 0 0 0 0/10 1 2 1 2 1 3 1 4/10
Signs of intoxiciation we j observed in all treated birds from Days 1 to 6. Abnormal signs 4MRID 489997 -01 included head shaking, ruffled ! feathers, decreased amount of feces, and birds that were moribund. There were no abnormalities exhibited in surviving birds during the remainder of the study, including the two birds that died on Days 12 and 14
. Feed consumption: The control group consumed a daily average of 10.6 g of feed and the treated group consumed a daily average of only 7.2 g of feed. The study authors reported that this diff erence is significant (p = O.O 136). Body weight Quail in the treated group lost l an average of30 g body weight, whereas the birds in the control group gained an average of 2. · g. According to the authors, this difference was significant (p = O.O 136). Body weights of R_uail in the control group were significantly greater than body weights in the treated groupo Day 3 (p = 0.0162), Day 7 (p = 0
.0018), and Day 14 (p = 0.0093). Necropsy results: Necropsy findings from the tr ated group included loss of body condition, discolored livers, white gel in crop or hemorrhaging of crop, black slurry in gizzard or black liquid in intestines. All necropsies results for the d ontrol quail yielded no observable abnormalities
. Statistical Results for Morta1 lity: Method: Not applicable (only one test concentration) 

### LDSO: >525 mg ai/kg

-bw 95% 

### CI: Not determip ed NOAEL: Not determined Conclusions: Four of 10 quail that received I a single oral dose of Stabicide 71 at 525 mg ai/kg

-bw died by day 14. Body weights, overall weight gain, and food consumption were significantly less in treated birds as compared to the cont;ol birds. Necropsy findings of treated quail included loss ofbody condition, discolored livers, '1'hite gel in crop or hemorrhaging of crop, black slurry in gizzard or black liquid in intestines
. There were no deaths or any abnormalities in the control group. The study is scientifically soup.d but utilized only one test concentration
. Because an LD50 was not determined nor shown to exceed 2000 mg ai/kg

-bw, the study is categorized as Supplemental. 5