Evaluation Report ERC2011-04, Ipconazole

This content was archived on June 24, 2013.

Pest Management Regulatory Agency
14 July 2011
ISSN: 1911-8082 (PDF version)
Catalogue number: H113-26/2011-4E-PDF (PDF version)

Summary

Table of Contents

• Registration Decision for Compound Ipconazole
• What Does Health Canada Consider When Making a Registration Decision?
• What Is Ipconazole?
• Health Considerations
• Environmental Considerations
• Value Considerations
• Measures to Minimize Risk
• What Additional Scientific Information Is Being Requested?
• Other Information

Registration Decision for Compound Ipconazole

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the  Pest Control Products Act and  Regulations, has granted conditional registration for the sale and use of Ipconazole Technical Fungicide and Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide and Rancona Apex Fungicide, containing the technical grade active ingredient ipconazole, to protect against seedling and soil-borne diseases on small grain cereals and corn.

An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.

Although the risks and value have been found acceptable when all risk reduction measures are followed, the registrant must submit additional scientific information as a condition of registration.

This summary describes the key points of the evaluation, while the Science Evaluation of Evaluation Report ERC2011-04, Ipconazole provides detailed technical information on the human health, environmental and value assessments of Ipconazole Technical Fungicide and Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide and Rancona Apex Fungicide.

What Does Health Canada Consider When Making a Registration Decision?

The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable 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 when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.

To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children) as well as organisms in the environment (for example, those most sensitive to environmental contaminants). 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 the PMRA regulates pesticides, the assessment process and risk-reduction programs, please refer to the following:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program

What Is Ipconazole?

Ipconazole is a triazole fungicide used to control various fungi species. This active ingredient is used as a seed treatment on small grain cereals and corn to control smuts, bunts, leaf stripe and seed and seedling diseases caused by Fusarium spp., Cochliobolus sativus, Rhizoctonia solani, Rhizopus spp., Cladosporium spp., Aspergillus spp., and Penicillium spp. Ipconazole is classified as a Group 3 fungicide that inhibits sterol biosynthesis in fungi.

Health Considerations

Can Approved Uses of Ipconazole Affect Human Health?

Ipconazole is unlikely to affect your health when used according to label directions.

Potential exposure to ipconazole may occur through the diet (food and water) or when handling and applying the product. When assessing health risks, two key factors are considered:

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

The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). 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 where no effects are observed. The health effects noted in animals occur at doses more than 100-times higher (and often much higher) than levels to which humans are normally exposed when ipconazole products are used according to label directions.

Ipconazole was moderately acutely toxic by the oral route, slightly acutely toxic by the inhalation route and mildly irritating to the eyes. Consequently, the hazard statement "warning poison - eye irritant" was required on the label.

The end-use products, Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide and Rancona Apex Fungicide were of low acute toxicity. Consequently, no hazard statements were required on the product labels.

Ipconazole did not cause cancer in mice and rats, and was not genotoxic. However, there was some concern regarding the dose adequacy to assess cancer in the rat. There was also no indication that ipconazole caused damage to the nervous system. The first signs of toxicity in animals given daily doses of ipconazole over longer periods of time were effects on the non-glandular stomach (also known as the forestomach) in mice and rats, the eyes (lens), prostate, kidney and thymus in dogs and the liver in all species tested. The effects observed in the non-glandular stomach of rodents are not toxicologically relevant to humans. The female reproductive system (ovaries), endocrine organs and immune system were targeted at higher dose levels.

When ipconazole was given to pregnant animals, effects on the developing foetus were observed at doses that were toxic to the mother. However, since effects in the foetus were of a more severe nature than those seen in the mother, the foetus is considered more sensitive to ipconazole than the adult animal.

The risk assessment protects against the above effects by ensuring that the level of human exposure is well below the lowest dose at which these effects occurred in animal tests. Additional factors were applied to the risk assessment to account for the concerns surrounding the adequacy of dosing in the rat-cancer study.

Residues in Water and Food

Dietary risks from food and water are not of concern.

Aggregate dietary intake estimates (food plus water) revealed that the general population and children 3-5 yrs, the subpopulation which would ingest the most ipconazole relative to body weight, are expected to be exposed to less than 1.7% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from ipconazole is not of concern for all population sub-groups. There is no associated cancer risk from the use of ipconazole on corn (field, sweet and pop), wheat, barley, rye, triticale and oats. An aggregate (food plus water) dietary intake estimate for females 13-49 years old used less than 0.25% of the acute reference dose, which is not a health concern.

The  Food and Drugs Act prohibits the sale of adulterated food, that is, food containing a pesticide residue that exceeds the established maximum residue limit (MRL). Pesticide MRLs are established for Food and Drugs Act purposes through the evaluation of scientific data under the Pest Control Products Act. Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.

Residue trials conducted throughout Canada and the United States using ipconazole on wheat, corn, barley, soybean and peanut were acceptable. The MRLs for this active ingredient can be found in the Science Evaluation section of this Evaluation Report.

Occupational Risks From Handling Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide, and Rancona Apex Fungicide

Occupational risks are not of concern when Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide, and Rancona Apex Fungicideare used according to the label directions, which include protective measures.

Workers mixing and loading Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide, and Rancona Apex Fungicide, or treating seed, as well as workers handling and planting freshly treated seed, can come in direct skin contact with the active ingredient, ipconazole, in these products. Therefore, the labels specify that anyone handling Vortex FL Seed Treatment Fungicide or Rancona 3.8 FS Fungicide, contaminated equipment, or corn seed treated with these products, must wear long pants, a long-sleeved shirt and chemical-resistant gloves. The labels also require that closed mixing/loading equipment be used. For Rancona Apex Fungicide, workers handling the product, contaminated equipment or cereal seed treated with this product must wear long-sleeved coveralls over normal work clothing and chemical-resistant gloves. Closed mixing/loading equipment is required and closed cab tractors must be used for planting seed treated with Rancona Apex Fungicide. Taking into consideration these label statements, the number of applications and the expectation of the exposure period for handlers and workers, the risk to these individuals is not a concern.

For bystanders, exposure is expected to be much less than that for workers and is considered negligible. Therefore, health risks to bystanders are not of concern.

Environmental Considerations

What happens when ipconazole and related end-use products are introduced into the environment?

Environmental risks are negligible when Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide and Rancona Apex Fungicide are used according to label directions, which include precautionary label statements concerning seed burial and cleanup of spilled seed.

Ipconazole can enter the environment by dislodging from treated seed surfaces during and after seeding. Ipconazole is persistent in the environment, with soil biodegradation being the primary route of transformation. Ipconazole has low mobility in soil and has low potential to leach to groundwater. Ipconazole is not expected to reach surface waters in any appreciable amounts under the current use pattern, as exposure of surface waters through soil runoff and leaching is expected to be minimal. Some toxicity occurred to laboratory animals exposed to ipconazole; however, the primary environmental risk under the current use pattern is to birds and mammals that may consume treated seed. This risk was determined to be negligible if label statements regarding burial and cleanup of spilled seed are followed. Risk to other terrestrial and aquatic organisms, and non-target plants is negligible based on low potential for exposure to these groups.

Value Considerations

What Is the Value of Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide and Rancona Apex Fungicide?

Vortex FL Seed Treatment Fungicide and Rancona 3.8 FS Fungicide are seed treatments for use on field corn, sweet corn and popcorn to provide protection against seed, seedling and soil-borne diseases. Rancona Apex Fungicide is a reduced-risk fungicide seed treatment used to control diseases on cereals including wheat, barley, oats, rye and triticale.

Vortex FL Seed Treatment Fungicide and Rancona 3.8 FS Fungicide are alternatives to several older chemicals currently used as corn fungicide seed treatments. As seed treatments, the rate per hectare of all of these products is low and application to the seed reduces exposure to non-target organisms compared to foliar pesticide applications. Rancona Apex Fungicide is a liquid seed treatment with a low concentration of active ingredient and is effective at low rates. Cereal diseases can be adequately controlled using Rancona Apex Fungicide.

Measures to Minimize Risk

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

The key risk-reduction measures on the labels of Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide and Rancona Apex Fungicide to address the potential risks identified in this assessment are as follows:

Key Risk-Reduction Measures

Human Health

Because there is a concern with users coming into direct contact with Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide, and Rancona Apex Fungicide on the skin or through inhalation of dusts, anyone handling Vortex FL Seed Treatment Fungicide or Rancona 3.8 FS Fungicide, contaminated equipment, or corn seed treated with these products, must wear long pants, a long-sleeved shirt and chemical-resistant gloves. The labels also require that closed mixing/loading equipment be used. For Rancona Apex Fungicide, workers handling the product, contaminated equipment or cereal seed treated with this product, must wear long-sleeved coveralls over normal work clothing and chemical-resistant gloves. Closed mixing/loading equipment is required and closed-cab tractors must be used for planting seed treated with Rancona Apex Fungicide.

Environment

The use of Vortex FL Seed Treatment Fungicide, Rancona 3.8 FS Fungicide and Rancona Apex Fungicide may pose a risk to birds and mammals that consume significant amounts of treated seed. Precautionary label statements will be added to the product labels to identify and mitigate this risk (namely, burial of treated seed and cleanup of spilled, treated seed).

What Additional Scientific Information Is Being Requested?

Although the risks and value have been found acceptable when all risk-reduction measures are followed, the registrant must submit additional scientific information as a condition of registration. More details are presented in the Science Evaluation of Evaluation Report ERC2011-04, Ipconazole and in the section 12 Notice associated with these conditional registrations. The registrant must submit the following information within the time frames indicated.

Human Health

• A new rat cancer study at higher doses.
• Hormonal measurements in rats after at least 28-days of treatment.
• Toxicology studies being requested by other regulatory authorities.
• Additional supporting data consisting of dust-off studies comparing the dust-off potential of Vortex FL Seed Treatment Fungicide and Rancona 3.8 FS Fungicide on corn, and oats treated with Rancona Apex Fungicide, with that of the formulation and seed used in the surrogate studies used in the risk assessments, or an acceptable rationale, are requested
• Freezer storage stability data.
• Data must be submitted within three years of this registration.

Value

• Three small-scale field, greenhouse and/or lab (Petri plate) trials confirming that Rancona Apex Fungicide is effective in controlling post-emergence damping-off caused by C. sativus on wheat, barley, oats, rye and triticale are required.
• Field trials on each pathogen (one on Fusarium spp. and two on R. solani) demonstrating that Rancona 3.8 FS Fungicide and Vortex FL Seed Treatment Fungicide are effective in controlling seed rot, damping-off and seedling blight caused by soil-borne Fusarium spp. and seed rot and damping-off caused by R. solani on sweet, field, and popcorn are required.
• Data must be submitted within three years of this registration.

Other Information

As these conditional registrations relate to a decision on which the public must be consulted, the PMRA will publish a consultation document when there is a proposed decision on applications to convert the conditional registrations to full registrations or on applications to renew the conditional registrations, whichever occurs first.

The test data cited in Science Evaluation of Evaluation Report ERC2011-04, Ipconazole (namely, the test data relevant in supporting the registration decision) will be made available for public inspection when the decision is made to convert the conditional registrations to full registrations or to renew the conditional registrations (following public consultation). If more information is required, please contact the PMRA's Pest Management Information Service.