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chlorobenzilate Chemical Fact Sheet 12/84

                       CHEMICAL FACT SHEET FOR CHLOROBENZILATE

FACT SHEET NUMBER:  15

DATE ISSUED:  DECEMBER 30, 1984


                   1.  DESCRIPTION OF CHEMICAL

- Generic Name:  ethyl 4,4'-dichlorobenzilate
- Common Name:  chlorobenzilate
- Trade Name:  Acaraben
- EPA Shaughnessy Code:  028801
- Chemical Abstracts Services (CAS) Number:  510-15-6
- Year of Initial Registration:  1953
- Pesticide Type:  Miticide
- Chemical Family:  Organochlorine compound
- U.S. and Foreign Producers:  Ciba-Geigy, Nippon Kayaku, Japan and
  Makhteshim Beer-Sheva, Israel

                  2.  USE PATTERNS AND FORMULATIONS

- Application sites:  Citrus 
- Types of formulations:  Four pound per gallon emulsifiable concentrate 
- Types and methods of application:  Aerial and ground foliar sprays
  restricted to citrus use only in the States of Arizona, California,
  Florida, and Texas for control of mites. 
- Application rates:  0.75 lb/acre 
- Usual carriers:  water

                      3.  SCIENCE FINDINGS

Chemical Characteristics

- Chlorobenzilate, an organochlorine compound, is a brownish viscous
  liquid with boiling and melting points of 141-142 degrees C and 35-37
  degrees C, respectively. The chemical is virtually insoluble in water
  and stable at room temperature.

Toxicological Characteristics

- Overall toxicity Category III 
- Acute Oral LD50 - 960 to 1220 mg/kg - Category III 
- Acute Dermal LD50 - greater than 10,200 mg/kg - Category IV 
- Acute Inhalation LC50 - Data Gap 
- Primary Eye Irritation - Rabbit - Data Gap 
- Primary Dermal Irritation - Data Gap 
- Dermal Sensitization - Data Gap 
- The major routes of exposure are believed to be dermal followed by
  inhalation.
- Chronic toxicity results:
  - The chemical is an oncogen.
  - Data gaps include chronic feeding studies, teratology, and
    mutagenicity testing.
  - Using the protective clothing and the use restriction limited to
    citrus as required in the Rebuttable Presumption Against
    Registration, the lifetime oncogenicity risk would be between 0.5
    and 7.0 x 10-6 from dietary exposure and between 65 and 190 x 10-6
    from applicator exposure. A risk/benefits analysis of this use
    pattern indicates the benefits derived from this use outweigh the
    risks involved.

Physiological and Biochemical Behavioral Characteristics

- Foliar absorption remains a data gap. 
- Metabolism and persistence in plants and animals are data gaps.
- Pesticidal action:  nerve poison.

Environmental Characteristics

- An environmental assessment cannot be made at this time, because there
  is a lack of the data needed to make this assessment.

Ecological Characteristics

- No data available. Most studies reserved pending review of basic
  product chemistry, environmental fate, toxicology, and residue
  chemistry data. Potential problems related to endangered species are
  unknown.

Tolerance Assessment

- Because all uses of chlorobenzilate are cancelled except citrus, a
  recalculation of the Theoretical Maximum Residue Concentration (TMRC),
  Acceptable Daily Intake (ADI), and Maximum Permissible Intake (MPI)
  was undertaken. These values are 0.2859 mg/day/1.5 kg (3.81% of the
  ADI), 0.125 mg/kg/day and 7.50 mg/day/60 kg, respectively. These
  values are considered provisional, since a data gap exists for a
  chronic feeding study. Another reassessment and recalculation of the
  ADI/MPI will be made when the toxicology data gaps are filled. 
- A food additive tolerance(s) is required for citrus oil. 
- Established tolerances other than citrus and the associated meat, fat,
  and meat byproducts will be revoked in 1984, because all other uses
  were cancelled by the RPAR action.

Summary of Science Statement

- Chlorobenzilate is classified RESTRICTED. 
- Chlorobenzilate met criteria for unreasonable adverse effects due to
  the oncogenicity trigger. 
- Chlorobenzilate is suspected to be contaminated by DDT and/or its
  analogs at or near the limit of detection (by Thin Layer
  Chromatography). The Agency is requesting registrants to do further
  analyses with more sensitive analytical techniques to search for these
  impurities.

           4. SUMMARY OF REGULATORY POSITION AND RATIONALE

- An interim 24-hour reentry interval on citrus crops has been
  established until the Agency receives reentry data.
- The Agency will make a determination as to the continued
  registrability of this chemical when the data requested in the
  Registration Standard Guidance Document is submitted and reviewed.
- The Agency determined in the Special Review process that
  chlorobenzilate end-use products be classified as Restricted Use to
  reduce exposure to loaders, mixers, and applicators. The chemical will
  continue to be classified for Restricted Use until the Agency receives
  data to reevaluate its position.
- The Agency has concluded, via the Special Review process, that by
  limiting the use of chlorobenzilate to citrus, classifying
  chlorobenzilate products for restricted use, and upgrading the
  protective clothing requirements, the exposure level and risk would be
  lowered to acceptable levels. The benefits are determined to exceed
  the risks and the chemical is allowed continued registration, provided
  the following data are submitted and they do not suggest new
  unacceptable toxicological and/or environmental properties of
  chlorobenzilate.

                     5. SUMMARY OF MAJOR DATA GAPS

- The following data gaps were required to be submitted by January of
  1987:
  - Chronic feeding study (one rodent species) 
  - Mutagenicity testing
  - Rat inhalation LC50 study
  - Primary eye irritation study (rabbit)
  - Primary dermal irritation study
  - Dissipation studies
  - Mobility studies
  - Hydrolysis studies
  - Aerobic soil metabolism study
  - Photodegradation studies
  - Fish accumulation studies
  - Avian oral LD50 testing
  - Avian dietary LC50
  - Avian reproduction studies
  - Freshwater fish LC50
  - Acute LC50 freshwater invertebrates study
  - Acute LC50 estuarine and marine organisms study
  - Fish early life stage and aquatic invertebrate life cycle study
  - Fish life cycle study

- These data gaps are required to be submitted by April of 1984:
  - Identity of Ingredients
  - Statement of Composition
  - Discussion of Formation of Ingredients
  - Preliminary Analysis
  - Certification of Limits
  - Analytical Methods for Enforcement of Limits
  - Physical and Chemical Characteristics (except melting point & pH)

- Teratology study - 2 species by October of 1984
- Citrus Fractionation Study - February of 1984 (promised April 1, 1984)
- Feeding Citrus By-Products to Cattle - February of 1984 (promised
  April 1, 1984)
- Aerial Applicators Study - February of 1984 (received March, 1984)
- Citrus Picker Exposure Study - February of 1984 (received March, 1984)

                      6.  CONTACT PERSON AT EPA

Jay S. Ellenberger
Product Manager (12)
Insecticide-Rodenticide Branch
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M Street, S.W.
Washington, DC  20460

Office location and telephone number:

Room 202, Crystal Mall #2
1921 Jefferson Davis Hwy.
Arlington, VA  22202
(703)  557-2386


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.