UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, DC 20460 

OFF! E OF CHEMICAL SAFETY AND POLLUTION 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 IDivision 

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

David Bays, Bi9logist 

Risk Assessme11t and Science Support Branch 

Antimicrobials Division 

Demson Fuller, Chemical Review Manager 

Regulatory M~agement Branch I 

Antimicrobials IDivision 

RASSB has reviewed the av~f acute-oral toxicity study submitted by Schulke and Mayr GmbH 

to support registration of StaJlcide 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 LD50 TEST 

I GUIDELINE OPPTS 850.2100 

MRID 489997-01 

CHEMICAL: 3,3-Methlye e-bis(5-methyl-oxazolidine) PC Code No.: 114804 

TEST MATERIAL: Stabic de 71 Purity: 99% ( 4 7.2% total aldehyde) 

CITATION: 

Author: C. Y oungbr 

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 lem 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: supp1rmentai. 

1 
MRID 489997-01 

Major Deficiencies: 

The OCSPP study guideline (850.21 00) for an avian acute oral toxicity study requires 5 test 

concentrations. An LD50 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 METHODS 

Test Organisms: 

Guideline Criteria 

Species J 

A wild waterfowl species, f referably the 

mallard (Anas platyrhynch@s), or an upland 

game bird species, prereraHly the bobwhite 

(Colinus virginianus) 

Age at beginning of test 

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 is rec9mmended. 

Diet was nutritious and appropriate for 

species? 

Feed withheld at least 15 r ours prior to 

dosing? 

2 

Reported Information 

Northern bobwhite 

(Colinus virginianus) 

27 weeks 

Troy Johnson 

(no address or location reported) 

~14 days 

Reported Information 

Yes 

8 h light/16 h dark 

Yes 

Yes 
MRID 489997-01 

Test Design: 

I Guideline Criteria I Reported Information I 

Range finding test? No I 

Definitive Test 1 

Nominal concentrations: At least five, in a Nominal 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 1 0 (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 wef 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 1 4, and at end of and the control group for days 0-3, 3-7, and 

test if extended beyond 14 days? 10-14 

3 
Guideline Criteria 

Control Mortality 

Not more than 10% 

Raw data included? I 

Signs of toxicity (if any) were described? 

II 

. Mortality . . 

No. I 

Dosage (mg Test 

product/kg) Birds 1 2 

m f m f m 

Control 5/sex lo 0 0 0 0 

525 5/sex 0 1 1 1 1 

No. I 

Dosage (mg TeJt 

product/kg) Birds 9 10 

m f m f m 

Control 5/sex 0 0 0 0 0 

525 5/sex 1 1 1 1 1 

Signs of toxicity: I 

MRID 489997-01 

Reported Information 

No mortality 

Yes 

Signs of toxicity and abnormal behavior 

were recorded in addition to mortality 

Cumulative Number Dead 

Study 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 

Cumulative Number Dead 

Study Day 

11 12 13 

14 

Total 

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 wej observed in all treated birds from Days 1 to 6. Abnormal signs 

4 
MRID 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 difference is significant 

(p=O.O 136). 

Body weight 

Quail in the treated group lost lan 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 dontrol quail yielded no observable abnormalities. 

Statistical Results for Morta1lity: 

Method: Not applicable (only one test concentration) 

LDSO: >525 mg ai/kg-bw 

95% CI: Not determiped 

NOAEL: Not determined 

Conclusions: 

Four of 10 quail that received Ia 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