Cholecalciferol (Vitamin D3) - Chemical Profile 12/84
CHEMICAL FACT SHEET FOR:
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
- 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
- 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.
- Usual carriers: Confidential Business Information
- Efficacy review results: None conducted (see Paragraph 5)
3. SCIENCE FINDINGS
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.
- 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
- Dermal LD50 in rabbits: 2000 mg/kg.
- Primary dermal irritation: not required because technical is a
- Primary eye irritation: not required because technical is a solid
- 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
Because of the use pattern of this chemical (in and around buildings
and inside of transport vehicles) we did not request any environmental
- 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
- fish LC50: not required because technical is virtually insoluble in
- 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
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)
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.