Proposed Registration Decision PRD2026-06, Cholecalciferol, SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait, TC 413 Rodent Bait, and TC 411 BULK

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Pest Management Regulatory Agency
27 March 2026
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2026-6E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for cholecalciferol
• What does Health Canada consider when making a registration decision?
• What is cholecalciferol?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for cholecalciferol

Health Canada's Pest Management Regulatory Agency (PMRA), pursuant to subsection 28(1) of the Pest Control Products Act, is proposing registration for the sale and use of Cholecalciferol Technical, the related end-use products, SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait, and TC 413 Rodent Bait, and the related manufacturing concentrate, TC 411 BULK, all containing the active ingredient cholecalciferol, to control rodent pests indoors and outdoors.

An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of the pest control products are acceptable.

This summary describes the key points of the evaluation, while the Science evaluation of Proposed Registration Decision PRD2026-06, Cholecalciferol, SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait, TC 413 Rodent Bait, and TC 411 BULK provides detailed technical information on the human health, environmental and value assessments of cholecalciferol and related rodenticide products.

What does Health Canada consider when making a registration decision?

The primary objective of the Pest Control Products Act is to prevent unacceptable risks to individuals and the environment from the use of pest control products. Health or environmental risk is considered acceptable^{Footnote 1} if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration. The Act also requires that products have value^{Footnote 2} when used according to the label directions. Conditions of registration may include precautionary measures on the product label to further reduce risk.

To reach its decisions, Health Canada's PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children). They also consider the unique characteristics of organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information on how Health Canada's PMRA regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and pest management portion of Canada.ca.

Before making a final registration decision on cholecalciferol and related rodenticide products, Health Canada's PMRA will consider any written comments received from the public directly related to the proposed decision in this consultation document.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on cholecalciferol and SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait, TC 413 Rodent Bait, and TC 411 BULK, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and Health Canada's response to these comments.

For more details on the information presented in this summary, please refer to the Science evaluation of PRD2026-06.

What is cholecalciferol?

Cholecalciferol is a form of vitamin D, also called vitamin D3, that kills rodents by mobilizing calcium from the bone matrix into the plasma, leading to its subsequent deposition in soft tissues, for example, the kidneys and lungs.

Health considerations

Can approved uses of cholecalciferol affect human health?

Rodenticide products containing cholecalciferol are unlikely to affect your health when used according to proposed label directions.

Potential exposure to cholecalciferol may occur when handling and applying the end-use products. When assessing health risks, two key factors are considered:

• the levels at which no health effects occur, and
• the levels to which people may be exposed.

The dose levels used to assess risks are selected to protect the most sensitive human population (for example, children and nursing mothers). As such, sex and gender are taken into account in the risk assessment. Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose level at which no effects are observed.

In laboratory animals, the technical grade active ingredient cholecalciferol was of high acute toxicity by the oral and dermal routes of exposure and of moderate acute toxicity via the inhalation route; consequently, the signal word and hazard statement "DANGER – POISON" are required on the label of Cholecalciferol Technical. Cholecalciferol was minimally irritating to the eyes and skin and did not cause an allergic skin reaction.

The acute toxicity of the end-use products and manufacturing concentrate containing cholecalciferol was low via the oral and dermal routes of exposure. They are not expected to pose an acute inhalation hazard. They were minimally irritating to the eyes and non-irritating to the skin and did not cause an allergic skin reaction.

In addition to acute toxicity studies, registrant-supplied short-term animal toxicity tests and genotoxicity testing, as well as information from the published scientific literature, were assessed. The critical effects following oral dosing of cholecalciferol are hypercalcemia and hyperphosphatemia, along with associated changes to the adrenal gland and kidney. Overall, cholecalciferol is not considered to be mutagenic.

The toxicology database for cholecalciferol did not contain the full array of studies normally required for pesticide registration. Rationales to waive additional toxicity testing were accepted based on the known hazard profile of vitamin D, stemming from its importance as an essential vitamin required for normal mammalian growth, as well as the exposure scenarios related to the proposed use pattern of the related end-use products (rodenticides), which have risk mitigation measures in place to reduce exposure. Although there were limited toxicity data available, the supporting toxicological database was considered to be adequate for the current assessment.

Occupational risks from handling SELONTRA RODENT BAIT

Occupational risks are not of health concern when SELONTRA RODENT BAIT is used according to the proposed label directions, which include protective measures.

Occupational handlers using the commercial-class product, SELONTRA RODENT BAIT, and workers entering areas where baits have been placed, are prevented from exposure to cholecalciferol residues through label directions. The label for SELONTRA RODENT BAIT specifies that anyone handling the product must wear a long-sleeved shirt, long pants, shoes, socks, and chemical-resistant gloves when handling this product and disposing of dead rodents, unconsumed bait and empty containers.

Taking into consideration the label statements, the risks to workers from exposure to SELONTRA RODENT BAIT are not of health concern when the end-use product is used according to the proposed label directions.

Health risks in residential and other non-occupational environments

Risks in residential and other non-occupational environments are not of health concern when SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait and TC 413 Rodent Bait are used according to the proposed label directions.

Users handling the domestic-class cholecalciferol products, TC 411 Rodent Bait, TC 412 Rodent Bait and TC 413 Rodent Bait, and individuals entering areas where baits have been placed are prevented from exposure to cholecalciferol residues through label statements. The labels specify that anyone handling bait blocks and/or bait stations, or disposing of rodent carcasses, must wear chemical-resistant gloves. Furthermore, when handling TC 411 Rodent Bait, the protective wrapper must not be removed before loading/refilling bait stations.

Children and pets are prevented from coming into direct contact with cholecalciferol residues from either commercial or domestic class products with label statements indicating that bait must be placed in either tamper resistant bait stations or in locations inaccessible to children and pets. Furthermore, the labels specify that all baits contain a bittering agent to reduce a child repeatedly biting or licking a bait in the unlikely event that any is displaced from a bait station.

Taking into consideration mitigating label statements and restrictive packaging, the use of SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait and TC 413 Rodent Bait is not of health concern when the end-use products are used according to the proposed label directions.

Health risks to bystanders

Bystander risks are not of health concern when SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait and TC 413 Rodent Bait are used according to the proposed label directions.

Bystander exposure is considered not to be applicable, as children and/or pets are not allowed in the area during placement/replacement of the bait and/or bait station.

Health risks to bystanders are not of concern when the end-use products are used according to the proposed label directions.

Environmental considerations

What happens when cholecalciferol is introduced into the environment?

When cholecalciferol is used according to label directions, the risks to the environment have been determined to be acceptable.

Cholecalciferol is a vital nutrient essential for the health of animals. However, when formulated as baits at high concentrations, cholecalciferol can become lethal. These baits are used for rodent control, aiming to reduce rodent populations in various environments.

Cholecalciferol rodenticide bait products are strategically deployed both indoors and outdoors and placed within tamper-resistant bait stations, in covered protected areas or in burrows. They are to be kept out of reach of children, pets, livestock, and non-target wildlife species. By using these protective measures, environmental exposure is minimized. The careful placement of bait stations ensures that the baits remain accessible only to rodents while reducing the risk to other animals. Retrieving/proper disposal of unconsumed baits and dead carcasses will minimize the potential for non-target animals to be poisoned from eating baits or carcasses of animals that died from eating cholecalciferol baits. Based on this, significant environmental exposure is not expected. Therefore, when cholecalciferol baits are used in accordance with label directions, environmental risks are acceptable.

Value considerations

What is the value of SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait, and TC 413 Rodent Bait?

These four rodent bait products provide different options for the control of certain rodents with a new mode of action.

SELONTRA RODENT BAIT provides a commercial option to control rats, mice, and meadow voles indoors and outdoors as bulk bait. TC 411 Rodent Bait, TC 412 Rodent Bait, and TC 413 Rodent Bait provide domestic options to control mice (TC 411 Rodent Bait and TC 412 Rodent Bait) or rats (TC 413 Rodent Bait) indoors with either refillable/reusable (TC 411 Rodent Bait) or disposable (TC 412 Rodent Bait and TC 413 Rodent Bait) bait stations.

Measures to minimize risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human health and the environment. These directions must be followed by law.

The key risk-reduction measures being proposed on the labels of Cholecalciferol Technical, SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait, TC 413 Rodent Bait, and TC 411 BULK to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

All risk mitigation measures required in REV2010-17, Risk Mitigation Measures for Eight Rodenticides, are reflected in the proposed labels. These and additional proposed mitigation measures are described below for each product.

The commercial-class product, SELONTRA RODENT BAIT, can only be used by certified pest control operators, farmers or persons authorized in government-approved pest control programs. The workers must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks when handling the product and disposing of dead rodents, unconsumed bait and empty containers. They must also leave the protective wrapper on the bait block whenever handling it. The wrapped bait must be placed in either a tamper-resistant bait station or in locations not accessible to children, pets, livestock or non-target wildlife. The bait contains a bittering agent.

The domestic-class product, TC 411 Rodent Bait, is a soft bait housed in a refillable bait station resistant to tampering by children. It is a locked, refillable/reusable station where the key must be kept out of the reach of children. The bait blocks are individually wrapped and are not to be unwrapped before or during use. Users must wear chemical-resistant gloves when handling the bait station, bait blocks and rodent carcasses.

The instructions include to not place or refill the bait station when people, pets or livestock are present and not to use this product in areas accessible to pets, domestic animals or non-target wildlife. Unwanted bait and/or damaged bait stations, and carcasses must be wrapped and discarded in household garbage. Damaged bait stations are not to be used. The bait contains a bittering agent.

The domestic-class product, TC 412 Rodent Bait, is packaged in individual disposable bait stations that are resistant to tampering by children. The instructions restrict opening the bait stations. Users must wear chemical-resistant gloves when handling the bait station and rodent carcasses. The instructions include to not place the bait station when pets are present and not to use this product in areas accessible to pets, domestic animals or non-target wildlife. Unwanted bait and/or damaged bait stations, and carcasses must be wrapped and discarded in household garbage. Damaged bait stations are not to be used. The bait contains a bittering agent.

The domestic-class product, TC 413 Rodent Bait, is packaged in individual disposable bait stations that are not tamper-resistant. The instructions restrict opening the bait stations. Users must wear chemical-resistant gloves when handling the bait station and rodent carcasses. The instructions include to not place the bait station when people, pets or livestock are present and not to use this product in areas accessible to children, pets, domestic animals or non-target wildlife. Unwanted bait and/or damaged bait stations, and carcasses must be wrapped and discarded in household garbage. Damaged bait stations are not to be used. The bait contains a bittering agent.

Key risk-reduction measures - Environment

• For products with outdoor use only: A precautionary statement informing users of the toxicity of cholecalciferol to non-target small wild mammals and birds.
• A disposal statement for animal carcasses to minimize the potential for secondary poisonings of non-target organisms.

Next steps

Before making a final registration decision on cholecalciferol, SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait, TC 413 Rodent Bait, and TC 411 BULK, Health Canada's PMRA will consider any written comments received from the public that are directly related to this proposed decision, such as comments directed to the Science evaluation, in response to PRD2026-06 up to 30 days from the date of publication (by 26 April 2026) of PRD2026-06. If more time is required to provide comments, a request for an extension of an additional 15 days can be made. Your request must be submitted in writing to the PMRA's Publications Section within the 30-day consultation period.

Please forward all comments to PMRA Publications, through the Public Engagement Portal (Public Engagement Portal forms – Consultation Comment). Health Canada will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and Health Canada's response to these comments.

Other information

When Health Canada's PMRA makes its registration decision, it will publish a Registration Decision on cholecalciferol, SELONTRA RODENT BAIT, TC 411 Rodent Bait, TC 412 Rodent Bait, TC 413 Rodent Bait, and TC 411 BULK (based on the Science evaluation section of PRD2026-06). In addition, the test data referenced in PRD2026-06 will be available for public inspection, upon application, in the PMRA's Reading Room. For more information or if you have questions, please contact the Pest Management Information Service.