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Cholecalciferol (Vitamin D3) - Chemical Profile 12/84

                         CHEMICAL FACT SHEET FOR:
                                 VITAMIN D3
FACT SHEET NUMBER 42
DATE ISSUED: DECEMBER 1, 1984
                       1.  DESCRIPTION OF CHEMICAL
- Generic Name:  Cholecalciferol, Activated 7-dehydrocholesterol.
  oleovitamin D3, 9, 10-secocholeta-5,7,10(19)-trien-3B-ol (NEW
  CHEMICAL)
- Common Name:
- Trade Name:  Vitamin D3
- EPA Shaughnessy Code:  208700
- Chemical abstracts Service (CAS) Number:  434-16-2
- Year of Initial Registration:  1984
- Pesticide Type:  Rodenticide
- Chemical Family:  Sterol
- U.S. and Foreign Producers:  Phillips-Dunphar (Netherlands) - Active
  ingredient; Bell Laboratories (Madison, WI) - 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 oz./15-30 ft. (rats); 1/4-1 oz./8-12 ft.
  (mice)
- Usual carriers:  Confidential Business Information
- Efficacy review results:  None conducted (see Paragraph 5)
                          3.  SCIENCE FINDINGS
Chemical Characteristics
  Technical Vitamin D3 is a solid resin,  The empirical formula is
  C27H44D, and the molecular weight is 384.62.  The melting point is 84-
  85 degrees C.  Vitamin D3 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 D3 are as follows:
  - Oral LD50 in rats: 352 mg/kg and 42 mg/kg for males, and 619 mg/kg
    for females.
  - Dermal LD50 in rabbits:  2000 mg/kg.
  - Primary dermal irritation:  not required because technical is a
    solid resin.
  - Primary eye irritation:  not required because technical is a solid
    resin
  - Inhalation LC50:  not required because technical is a solid resin.
  - Acute, 60-day, delayed toxicity study in rats:  Acute dose, equal to
    accidental 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 D3 is a dietary supplement in the adult female diet.
- Adequate studies are available to assess the acute toxicological
  effects of Vitamin D3. 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 D3. However, because Vitamin D3 is a non-food use, is applied
  topically, and in small amounts, we did not review this submission of
  such information.
Environmental Characteristics
  Because of the use pattern of this chemical (in and around buildings
  and inside of transport vehicles) we did not request any environmental
  fate data.
Ecological Characteristics
- Based on studies available to assess hazards to wildlife and aquatic
  organisms, Vitamin D3 is characterized as being of low toxicity to
  birds. Because the chemical is virtually insoluble in water, we
  requested no aquatic toxicity data.

- Results of currently available studies are as follows:
  - avian oral LD50:  >2000 mg/kg (mallard duck)
  - avian dietary LC50: 4000 ppm (mallard duck), 2000 ppm (bobwhite
    quail)
  - fish LC50:  not required because technical is virtually insoluble in
    water
  - aquatic invertebrate LC50:  not required because technical is
    virtually insoluble in water
Summary Science Statement
  Adequate studies are available to assess the acute toxicological
  hazards of technical and formulated Vitamin D3. No toxicological
  hazards of concern were identified. Available studies indicate that
  Vitamin D3 is of low toxicity to birds; studies on fish are
  inapplicable because Vitamin D3 is virtually insoluble in water. The
  registration of this new active ingredient is conditioned on submittal
  of additional efficacy data by January, 1986.
         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, roof
rats, and house mice) as Unclassified.  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 reinstitution 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
- LD50 tests on target species
- Laboratory, choice-test, efficacy data for target species
- Field efficacy data
- 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 reinstituted these data.  The
  company will have a reasonable period of time (until January 1, 1986)
  to supply the missing laboratory and field data.
NOTE.  All studies are to be submitted to the Agency by January 1, 1986.
                      6.  CONTACT PERSON AT EPA
William H. Miller
Product Manager (16)
Registration Division (TS-767C)
Insecticide-Rodenticide Branch
Environmental Protection Agency
Washington, DC  20460
Telephone: (703) 557-2600
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.