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MMitngion. DC 20460
Pesticide
Fact Sheet
Name of Chemical: v™™ o3
Reason for Issuance:
Date Issued: December 1, 1984
Fact Sheet Number: 42
1. Description of chemical;
Generic name: Cholecalciferol, Activated 7-dehydrocholesterol,
oleovitamin 03, 9,10-secocholesta-5,7,10(19)-
trien-3B-ol [NEW CHEMICAL]
Common name:
Trade name: vitamin 03
EPA Shaughessy code: 208700
Chemical Abstracts Service (CAS) number: 434-16-2
Year of initial registration: 1984
Pesticide type: rodenticide
Chemical family: sterol
D.S. and foreign producers: Phillips-Duphar (Netherlands)
Active ingredient
Bell Laboratories (Madison, Wl)
Formulated product
2. use patterns and formulations;
Application sites: in and around buildings, inside of
transport vehicles
Pest species: norway rats, roof rats, and house mice
Type of formulations: granular (0.075% bait)
Type and method of application: topical, hand application
Application rates: 2-8 ot./15-30 ft. (rats)
1/4-1 oi./8-12ft. (mice)
Usual carriers: Confidential Business information
3. Science findings:
Summary science statement:
Adequate studies are available to assess the acute toxico-
logical hazards of technical and formulated vitamin 03.
No toxicological hazards of concern were identified.
Available studies indicate that vitamin 03 is of low toxicity
to birds; studies on fish are inapplicable because vitamin 03
is virtually insoluble in water. The registration of this
new active ingredient is conditioned on submittal of
additional efficacy data by January 1976.
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Chemical characteristics :
Technical Vitamin Dj is a solid resin. The empirical
formula is C 27 H 44 0, and the molecular weight is 384.62.
The melting point is is 84—85°C. Vitamin D 3 is practically
soluble in water, soluble in the usual organic solvents,
and slightly soluble in vegetable oils.
Toxicological characteristics :
Currently available toxicology studies on Vitamin D 3
are as follows:
— Oral LD 50 in rats: 352 mg/kg and 42 mg/kg for males and
619 mg/kg for females.
- Dermal LD 50 in rabbits: >2000 mg/kg.
— Primary dermal irritation: not reauired because
technical is a solid resin.
- Primary eye irritation: not required because technical
is a solid resin.
— Inhalation L.C 50 : not required because technical is a
solid resin.
- Acute, 60—day, Delayed Toxicity Study in rats: Acute
dose, equal to accidentai exposure, produced no
elevated serum calcium levels and no abnormal long
bone growth in young rats.
— Teratology in rats: not required because technical
is a solid resin and Vitamin D 3 , is a dietary
supplement in the adult fema.le diet.
Adequate studies are available to assess the acute toxi-
cological effects of Vitamin D 3 . No toxicological hazards
of concern have been identified in the studies reviewed
for this new pesticide.
Physiological and biochemical behavioral characteristics :
The registrant submitted a volume on the metabolism and
function of Vitamin D 3 . However, because Vitamin D3
is a non—food use, is applied topically, and in small
amounts, we did not review this submission of such
imformat ion.
Enviroi ental characteristics :
Because of the use pattern of this chemical (in and around
buildings and inside of transport vehicles, we did not
request any enviorninenal fate data.
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Ecological characteristics :
Based on studies available to assess hazards to wildlife
and aquatic organisms, Vitamin D 3 is characterized as being
of low toxicity to birds. Because the chemical is virtually
insoluable in water, we requested no aquatic toxicity data.
Results of currently available studies are as follows:
— avian oral LD 50 : >2000 mg/kg (mallard duck)
— avian dietary LCSO: 4000 ppm (mallard duck)
2000 ppm (bobwhite quail)
— fish LC 50 : not required because technical is virtually
insoluable in water.
— aquatic invertebrate LC 50 : not required because
technical is virtually insoluable in water.
Product Performance characteristics :
Because the Agency had suspended the efficacy requirements
for this type of product, the company did not complete
all the pre—suspension data. Subsequently, the Agency
notified the company that it had re—instituted these data.
The company will have a reasonable period of time (until
January 1, 1986) to supply the missing laboratory and field
data.
4. Summary of regulatory position and rationale :
The Agency has placed the one registered formulation
in Toxicity Category III (CAUTION) and has classified
this use pattern (in and around buildings and inside of
transport vehicles for norway rats, roofs rats, and
house mice) as wUnclassifiedu. Such a product can
be sold over—the—counter. The Agency has not identified
a potential for adverse effects for man or the environment,
based on the submitted toxicology and fish and wildlife
data. Because of re—institution of the efficacy data
requirements, the registration will be conditioned on the
submittal of additional, acceptable laboratory and field
efficacy data within fourteen months.
5. Summary of major data gaps :
—LD—50 tests on target species
—Laboratory, choice—test, efficacy data
for target species
—Field efficacy data
All studies are to be submitted to the Agency by January 1, 1986.
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6. Contact Pe ŕnat EPA
William H. Miller
Product Manager (16)
Registration Division (TS—767C)
Insecticide—Rodenticide Branch
Environmental Protection Agency
Washington, DC 20460
Tel. No. (703) 557—2600
Disclaimer: The information presented in this Chemical
Information Fact Sheet is for informational purposes only
and may not be used to fulfill data requirements for
pesticide registration and reregistration.
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