Pest Management Regulatory Agency
26 July 2013
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2013-16E-PDF (PDF version)
Summary
Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the
Pest Control Products Act and
Regulations, is proposing full registration for the sale and use of Stepanol DX (AS165) N and MTDX-CR, containing the technical grade active ingredient sodium lauryl sulfate, to kill German cockroach adults and nymphs in and around buildings.
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.
This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2013-16, Sodium Lauryl Sulfate provides detailed technical information on the human health, environmental and value assessments of Stepanol DX (AS165) N and MTDX-CR.
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:
Before making a final registration decision on sodium lauryl sulfate, the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2013-16, Sodium Lauryl Sulfate. The PMRA will then publish a Registration Decision on sodium lauryl sulfate, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRA's response to these comments.
For more details on the information presented in this summary, please refer to the Science Evaluation of Proposed Registration Decision PRD2013-16, Sodium Lauryl Sulfate.
Sodium lauryl sulfate, the technical grade active ingredient in the technical product Stepanol DX (AS165) N, is a sodium salt of a long hydrocarbon chain linked to sulfate. Formulated as the end-use product MTDX-CR and used in and around buildings, it kills German cockroach nymphs and adults on contact.
MTDX-CR containing sodium lauryl sulfate is unlikely to affect human health when used according to label directions.
Exposure to sodium lauryl sulfate may occur when applying the end-use product, MTDX-CR, or when people enter a freshly treated site. When assessing health risks, two key factors are considered:
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.
The technical grade active ingredient sodium lauryl sulfateis expected to be slightly acutely toxic by the oral route, moderately acutely toxic by the dermal route, severely irritating to the skin, eyes, and respiratory tract, and is not a skin sensitizer.
Exposure to humans from the commercial use of MTDX-CR is not expected to be of concern due to the precautionary statements present on the end-use product label that are aimed at mitigating exposure.
Dietary risks from sodium lauryl sulfate on food and water are not of concern.
MTDX-CR is not for direct application to food. Also, the end-use product label has precautionary statements not to contaminate food, feed, and water with the end-use product; therefore, dietary exposure to sodium lauryl sulfate from the proposed end-use product use is anticipated to be negligible.
No risk due to exposure from drinking water is anticipated as sodium lauryl sulfate is unlikely to persist in the environment to the extent that it could be consumed in drinking water.
Risks are not of concern when MTDX-CR containing sodium lauryl sulfate is used according to label directions, which include precautionary statements.
MTDX-CR is to be applied by commercial applicators inside and outside buildings.
Occupational exposure is of concern during handling, loading and mixing of MTDX-CR and clean-up activities when workers are exposed to the concentrated form (98% w/w); however, risks from exposure are not anticipated when workers follow label directions which include exposure mitigation measures, such as personal protective equipment (PPE), cautionary, hygiene, and restricted-entry statements on the end-use product label.
The insecticide, MTDX-CR, is proposed to be applied in and around buildings to kill German cockroaches (Blatta germanica). As the application method is a handheld sprayer pump, and the product is applied directly to the target pest, the exposure to non-target organisms is expected to be negligible. The risk to the environment is not expected to be a concern.
MTDX-CR is a non-conventional product which kills German cockroach nymphs and adults on contact, in and around buildings. German cockroaches can be pests in these areas. MTDX-CR is applied directly on German cockroaches. The active ingredient, sodium lauryl sulfate, is a new mode of action for use against cockroaches.
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 being proposed on the label of MTDX-CR to address the potential risks identified in this assessment are as follows.
The signal words "WARNING - POISON," "DANGER - SKIN IRRITANT," and "DANGER - EYE IRRITANT" are required on the principal display panels of the labels of Stepanol DX (AS165) N and MTDX-CR.
Standard hazard and precautionary statements are also required on both the labels to inform workers of the irritation potential of the active ingredient and to caution that it is harmful when swallowed, inhaled or absorbed through the skin.
Based on the hazard profile (for example, likelihood to irritate the respiratory tract and oral mucosa), standard PPE are required for mixers and loaders, for example, long clothing, shoes and socks, waterproof gloves, protective eyewear, and respirator.
A precautionary statement on the end-use product label indicating that the handling, loading/mixing of the end-use product, as well as the clean-up and maintenance activities must be performed in a well-ventilated area is required.
Label statements advising individuals not to allow contact of the products with skin, eyes or clothing and to avoid breathing dust or spray mist are required.
To protect bystanders, label statements are required to instruct that the product must not be applied in a way that it will contact workers or other persons, either directly or through drift, and indoor application of the end-use product in commercial facilities is restricted to vacant areas only.
To protect from postapplication exposure, a label statement is required to restrict entry/re-entry into treated areas until the spray is dried and the areas are thoroughly ventilated.
The end-use product label instructs that workers not contaminate food or feed, and cover food contact surfaces and equipment during treatment or, alternatively clean them thoroughly before reuse.
Before making a final registration decision on sodium lauryl sulfate, the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2013-16, Sodium Lauryl Sulfate. The PMRA will accept written comments on Proposed Registration Decision PRD2013-16, Sodium Lauryl Sulfate up to 45 days from the date of publication of Proposed Registration Decision PRD2013-16, Sodium Lauryl Sulfate. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the Agency's response to these comments.
When the PMRA makes its registration decision, it will publish a Registration Decision on sodium lauryl sulfate (based on the Science Evaluation of Proposed Registration Decision PRD2013-16, Sodium Lauryl Sulfate). In addition, the test data referenced in Proposed Registration Decision PRD2013-16, Sodium Lauryl Sulfate will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).