### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL

SAFETY AND

POLLUTION PREVENTION

Wednesday, April 20, 2011

MEMORANDUM

Subject: Acute Toxicity Review for EPA Reg. No.: 85808

- R

DP Barcode: D384435

Product Name: Stabicide 71

From: Ian Blackwell, Biologist

Chemistry and Toxicology Team

Product Science Branch

Antimicrobials Division (7510P)

Through: Karen Hicks, Team Leader

Chemistry and Toxicology Team

Product Science Branch

Antimicrob ials Division (7510P)

To: Marshall Swindell, PM 33/ Demson Fuller

Regulatory Management Branch

Antimicrobials Division (7510P)

Applicant: Schulke & Mayr GmbH

FORMULATION FROM LABEL:

Active Ingredient(s) : % by wt.

N , N’

- methylenebis ( 5

- methy l oxazolidin ) (MBO) 99.09

Other Ingredient(s) : 0.91

Total: 100.00

### I BACKGROUND : Schulke & Mayr GmbH has submitted an acute inhalation toxicity study

to support a data gap for their product, “Stabicide 71”. The Chemistry and Toxicology

Team (C TT) conducted a review of 85808

- R on 3/3/2009. The results of that review

were:

Study MRID Number Toxicity Category Status

Acute Oral Toxicity 475972

- 03 III Acceptable

Acute Dermal Toxicity 475972

- 04 II Acceptable

Acute Inhalation Toxicity Waiver Re quest ? Data Gap

Primary Eye Irritation 475972

- 05 I Acceptable

Primary Skin Irritation 475972

- 05 I Acceptable

Dermal Sensitization 475972

- 06 Non

- sensitizer Acceptable

The Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) conducted

th is study. Prof. Dr. Dr. U. Heinrich is the author.



### II RECOMMENDATIONS :

1. CTT grades this study Supplementary. This study is not currently acceptable ; but,

can be upgraded with the addition of more information. CTT needs for the test

facility to answ er or address each of the following:

A. The report does not state whether the test material was tested neat or diluted.

The registrant needs to clarify this.

B. The size of the exposure chamber was not reported.

C. The lab did not conduct the assay by analyzi ng the chamber concentration of the

active ingredient, N, N’

- methylenebis (5

- methyloxazolidin). Instead the report

states, “Formaldehyde was used as the lead compound for analysis.” We do

realize that MBO is a reaction product from paraformaldehyde and 2

- hydroxypropylamine. CTT knows from the Product Chemistry review of 85808

- R, that one method of measuring MBO concentration is by reacting it with

hydroxylamine hydrochloride. The report does not state how the assay went

from measuring the atmospheric a erosol concentration 85808

- R to having

gaseous formaldehyde in the impingers. These things need to be clarified.

D. The test facility did not determine the M ass Median Aerodynamic Diameter

(MMAD) of the aerosol. The report appears to state that due to evap oration of

the aeroso lized product, they could not measure the MMAD. CTT does not

understand why they could determine a test material concentration (mg/L)

, but

, could not determine an MMAD. The lab needs to explain this.

E. As there was an issue with vapor ization of the aerosol, CTT must ask if the lab

intentionally vaporized the test material for testing.The acute toxicity profile for File Symbol 85808

- R is currently:

Study MRID Number Toxicity Category Status

Acute Oral Toxicity 475972

- 03 III Accep table

Acute Dermal Toxicity 475972

- 04 II Acceptable

Acute Inhalation Toxicity 482860

- 02 ? Supplementary

Primary Eye Irritation 475972

- 05 I Acceptable

Primary Skin Irritation 475972

- 05 I Acceptable

Dermal Sensitization 475972

- 06 Non

- sensitizer Acceptab le



### III LABELING :

1. The Signal Word is “DANGER”, based upon the results of the primary eye and skin

irritation studies.

2. Other than the Signal Word, CTT cannot prescribe Precautionary labeling for 85808

-

R. Upon the receipt of supplemental information on the acute inhalation toxicity

study, CTT might be able to complete the acute toxicity profile and prescribe

complete precautionary labeling.**DATA REVIEW FOR ACUTE INHALATION TOXICITY (§81**

**- 3, 870.1300)** 

**Testing Laboratory** : Fraunhofer Institute for Toxicolo gy and Experimental Medicine

(ITEM)

**Author** : Prof. Dr. Dr. U. Heinrich

**Quality Assurance (40 CFR §160.12)** : Included

**Test Material** : Stabicide 71 , (Grotan OX)

**Concentration** : 0.543 and 1.189 mg/L

**Species** : Wistar rats, Crl:WI(WU)

**Weight** : Males= 241.9

- 302.7 g Females= 188.1

- 197.8 g

**Age** : 8

- 10 weeks

**Source** : Charles River Deutschland

**Summary** :



### 1. **LC 50**  

### (mg/L) **Males=** Unknown

**Females=** Unknown

**Combined=** n/a

2. **The estimated LC 50**  

### is Unknown

3. **MMAD:** Not determined **μm**

4. **Toxicity Category: Classification:**  Supplementary

**Procedure (Deviation From §81**

**- 3)**  :

 The lab plann ed to use a 0.05 mg/L exposure dosage; however, this was not used.

**Results** : 

### Reported Mortality

**Exposure Concentration**

**(mg/L) (NUMBER DEATHS/NUM**  **BER TESTED)**

**Males Females**  **Combined**

0.5 43 0/3 0/3 0/6

1. 189 3/3 0/3 3/6 Product Manager : 33 Reviewer : I. Blackwell

MRID No. : 482860

- 02 Study Completion Date : 10/22/2010

Lab Study No. : 02 G 10026**Chamber Atmosphere**

Dose Level MMAD GSD particles < μm

0.543 mg/L ? μm ? μm ?

1.189 mg/L ? μm ? μm ?

Chamber Environment

Chamber Volume ? ?

Airflow 17.6 L/min

. 17.6 L/min.

Temperature 21.3 ± 0.1 o C 21.3 ± 0.1 o C

Relative Humidity 61.2 ± 0.7 % 63.1 ± 0.6 %

**Clinical Observations** : Salivation, stains around mouth, coat soiled, gasping, respiratory

sounds, general condition bad, abdominal breathing.

**Gross Necr opsy Findings**  : Lungs showy areas that were red, partly red, spongy, and/or

glassy.