United State* Office of Pesticides and Toxic Sufattanees
Environmental Protection Office of Pesticide Programs (TS-766C)
Agency Washington. DC 20460
«>EPA Pesticide
Fact Sheet
Name of Chemical: CHDORQBENZILATE
Reason for Issuance:
Date Issued: December 30, 1983
Fact Sheet Number: 15
1. Description of the chemical:
- Generic name: ethyl 4,4'-dichlorobenzilate
- Common name: Chlorobenzilate
- Trade name: Acaraben
- EPA Shaughnessy Code: 028801
- Chemical abstracts services 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:
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.
Chemical charcteristics:
- Chlorobenzilate, an Organochlorine compound, is a brownish viscous
liquid with boiling and melting points of 141-142 °C and 35-37 °C,
respectively. The chemical is virtually insoluble in water and
stable at room temperature.
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i xicologica1 characteristics:
— Overall toxicity category III
— Acute OralLI 0 - 960 to 1220 no/kg — Category iii
— Acute Dermal LDj J - greater than 10,200 Tr,/kg- Category IV
— Acute Inhalation LC — Data Gap
— Primary Eye Irritation— Rabbit— Data Gap
- Primary Dermal Irritation - Data Gap
— Dermal Sensitization- Data Gap
— The major rcxites of exposure are believed to be dermal followed by
inhalation.
—Chronic toxicity results:
The chemical is an onxgen.
Data gaps include, teratology and mutagenicity testing.
Using the protective clothing and the use restriction limited
to citrus as required in the Rebuttable Presiznption Against
1 gistration, the lifetime oncogenicity risk u1d be between 0.5 and
7.0 x l06 fran dietary exposure and between 65 and 190 x
10—6 fran applicator exposure. A risk—benefits analysis of
this use pattern indicates the benefits derived frcni
this use outweighes the risks involved.
Physiological arxl Biochemical Behavioral Characteristics:
—Foliar absorption remains a data gap.
—Metaboli n and persistence in plants and animals are data
gsps.
—Pesticidal action: nerve poison.
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.
Environmental characteristics:
— An environmental asses ient can not be made at this time
because there is a lack of the data needed to make this
asses nent.
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Iblerance Asses ient:
— Because all uses of chlorobenzilate are cancelled except citrus,
a recalculation of the Theoretical Maximum Residue O ncentration
(TNRC), Acãeptable Daily Intake (ADI), and Maximum Permissible
Intake (MPI) was undertaken. These values are 0.2859 mg/day/i .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 at this time. Another reas—
ses tent 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.
4. Stmnary 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 ch nical when the data requested in
the Registration Standard Guidance cument is submitted and
reviewed.
— The Agency determined in the Special Review process that chloro-
benzilate end—use products be classified as “Restricted Use” to
reduce exposure to loaders, mixers and applicators. The ch nical
will continue to be classified for “Restricted Use t ’ 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 chloro-
benzilate products for restricted use, and upgrading the protective
clothing requirements, the exposure level and risk u1d 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 chloro-
benzilate.
5. Sunnary of Data Gaps:
The following data gaps were required to be submitted by January of
1987.
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— Mutagenicity testing
— Rat inhalation LC 50 study
— Primary eye irritation study (rabbit)
— Primary dermal irritation study
— Dissipation studies
— bbility studies
— Hydrolysis studies
— Aerobic soil metabolism study
- photodegradat ion studies
— Fish accumulation studies
- Avian oral LL 0 testing
— Avian dietary LC 50
— Avian reproduction studies
— Freshwater fish LC 50
— Acute LCso freshwater invertebrates study
— Acute LC 50 estuarine and marine organi study
— Fish early life stage and aquatic invertebrate life—cycle study
— Fish life—cycle study
These data gaps are required to be subnitted by April of 1984
— Identity of Ingredients
— Stat nt of Caçosition
— Discussion of Formation of Ingredients
- Preliminary Analysis
— Certification of Limits
— Analytical Mettvds for Enforcar nt of Limits
— Physical and themical Characteristics (except melting point & pH)
i ratology study— 2 species by October of 1984
Citrus Fractionation Study— Feb. of 1984 (prcznised April 1, 1984)
Feeding Citrus By—Products to Cattle— Feb. of 1984 (ptxxnised April 1, 1984)
Aerial Applicators Study— Feb. of 1984 (received March, 1984)
Citrus Picker Exposure Study— Feb. of 1984 (received March, 1984)
6. Contact person at EPA
Jay S. Ellenberger
Product Manager (12)
Insect icide— denticide Branch
Registration Division (TS—767C)
Office of pesticide prcx3raJns
Environmental Protection P ency
401 M Street, S.W.
Washington, D.C. 20460
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