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bronopol (Myacide B10) Chemical Fact Sheet 4/85





                      CHEMICAL FACT SHEET FOR 
      2-BROM0-2-NITROPROPANE-1,3-DIOL(BRONOPOL) Bactericide

FACT SHEET NUMBER:  32
DATE ISSUED:  AUGUST 2, 1984
DATE UPDATED:  APRIL 5, 1985

                  1. DESCRIPTION OF CHEMICAL

- Generic Name:  2-Bromo-2-nitropropane-1,3-diol
- Common Name:  bronopol - Boots
- Trade Names:  Myacide B10, Myacide AS
- EPA Shaughnessy Code:  216400
- Chemical Abstracts Service (CAS) Number:  52-51-7
- Year of Initial Registration:  1984
- Pesticide Type:  Bactericide
- Chemical Family:  Alcohol
- U.S. and Foreign Producers:  The Boots Co., PLC

              2. USE PATTERNS AND FORMULATIONS

- Application sites:  Pesticide manufacturing facilities and milk
  processing plants.
- Types of formulations:  Crystalline powder, powdered tablets,
  granules, and liquid.
- Types and methods of application:  For formulating use; add directly
  to milk samples that are to be preserved.
- Application rates:  Add 1-2 drops of product to 2 oz. milk sample;
  use 500 mg (granules)/100 ml milk sample, use 2-4 tablets/100 ml milk
  sample.
- Usual carriers:  Water or sodium chloride
- Efficacy data:  N/A

                     3. SCIENCE FINDINGS

Chemical Characteristics:

- Physical state:  White crystalline powder 
- Melting point:  Approximately 130 C 
- Bulk density:  1.10 mg/ml 
- Solubility:  in ethanol, 50%; in water (25 C), 25%; 
  in ethylene glycol, 61%; in chloroform, 0.9%

Toxicological Characteristics:

- Major routes of exposure:  Dermal exposure to bronopol is expected to
  occur when users handle the milk preservation tablets and granules,
  and during the pesticide manufacturing process. 
- Eye irritation:  5% solution strongly irritating, Category I 
- Skin irritation:  A severe irritant, Category I 
- Dermal LD50:  Not specified, Category I 
- Oral LD50 (mg/kg):  Orally administered - male 307 and female 342
  (rat), male-374 and female 327 (mouse); intraperitoneal - male 22.0
  and female 30.2 (rat), male 22.8 and female 34.7 (mouse), Category II 
- Inhalation LC50:  LC50 > 5 mg/L, Category III 
- Dermal sensitization:  Not a skin sensitizer 
- 90-day oral (rat):  No observable effect level, 20 mg/kg/day; lowest
  effect level, 80 mg/kg/day 
- Teratology (rat, dermal):  NOEL > 40 mg/kg/day 
- 13-week (dog):  NOEL = 4 mg/kg/day; LEL = 8 mg/kg/day 
- 2-year oncogenicity study (rat, oral):  NOEL = 10 mg/kg/day; 
  LEL = 40 mg/kg/day. (Did not include tumors.)
- 80-week dermal (mice):  Not oncogenic when applied to the skin of mice
  at concentrations of 0.2 and 0.5% in water:acetone for 80 weeks.

Physiological and Biochemical Behavioral Characteristics:

     As there are no food or other outdoor uses, foliar absorption, 
translocation, mechanism of pesticidal action, metabolism, and 
persistence in plants and animals studies have not been submitted.

Environmental Characteristics:

     As there are no food uses or other outdoor uses, extensive 
environmental fate data have not been submitted to the Agency.  However, 
one hydrolysis study indicates that bronopol appears to hydrolyze slowly 
at acidic or neutral pH conditions.  Bronopol decomposes in aqueous 
solution on exposure to light.  Increases in temperature increase 
decomposition.  Label required to disallow any pesticide waste discharge 
into aquatic environments.

Ecological Characteristics:

- Mallard duck acute oral LD50 = 510 mg/kg
- Freshwater invertebrate (Daphnia magna) 48-hour EC50 = 1.4 mg/L
- Acute LC50, trout = 41.5 (35.9-45.4) ppm
- Avian dietary LC50, quail = 4488 (2518-9827) ppm

Tolerance Assessments:

     The registered uses of bronopol do not include direct application 
to a food or feed crop; therefore, no tolerances have been established 
for this chemical.

Problems Known to Have Occurred with Use of the Chemical:

     None

             4. SUMMARY OF REGULATORY POSITION AND RATIONALE

- There are no use, formulation, manufacturing process, or geographical
  restrictions for bronopol registrations.
- Unique warning statement: Do not discharge into aquatic environments
  unless in accordance with an NPDES permit.

                      5. SUMMARY OF MAJOR DATA GAPS

     None

                      6. CONTACT PERSON AT EPA

John H. Lee
Product Manager 31
Disinfectants Branch
Registration Division (T5-767C)
401 M Street S.W.
Washington, DC 20460
(703) 557-3675

DISCLAIMER:  THE INFORMATION PRESENTED IN THIS CHEMICAL INFORMATION FACT 
SHEET IS FOR INFORMATIONAL PURPOSES ONLY AND NOT TO BE USED TO FULFILL
DATA REQUIREMENTS FOR PESTICIDE REGISTRATION AND REREGISTRATION.