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Under section 63 and 63A of the Hazardous Substances and New Organisms Act 1996

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We cannot formally receive or process your application unless you provide all the information requested in the mandatory sections of this form. 2 Section 59(3)(a)(ii) of the HSNO Act allows applicants to apply to the EPA to waive the need to provide information. Name of the substance(s) or generic name of the class of chemicals or products to be re-evaluated.

You must include the description of the hazardous substance and/or HSNO approval(s) to be reevaluated and the proposed change(s). EPA determined tebuconazole should be classified as suspected reproductive toxicity Category 2 based on review of study data. Tell us the application number (APPXXXXXX) of the Basis for Reassessment application for this substance.

The grounds for reassessment have been established as part of the application for reassessment grounds, APP204030. Identify the aspect of the substance description that needs to be changed (substance name, formulation details, hazard classification or any other aspect).

Would you like the Environmental Protection Authority to consider revoking the approval(s) of this substances(s)? If yes, provide evidence to support this proposal

Would you like the Environmental Protection Authority to review or change one or more of the control(s) attached to this substance(s)? If yes, identify the control(s) to be changed, describe what needs to

List and describe any other controls or aspects that may be affected by the proposed change(s)

Is there reasonable cause to believe that there is actual or imminent danger to human health or safety or the environment from the continued use of the substance(s)? If yes, please provide a

Effects of the reassessment

EPA assesses that there will be no change to the impact of the substances on the relationship of Māori and their culture and traditions to their ancestral lands, water, sites, wāhi tapu, valued flora and fauna and other taonga, and therefore these risks will be unchanged in relation to to those identified when the substances were originally approved. EPA considers that there are some positive effects on New Zealand's international obligations associated with the proposed change to the substance hazard classifications in terms of harmonizing chemical classifications with other major jurisdictions. Taking into account the impacts identified above, EPA judged that there was an overall positive effect of making the change to the hazard classifications of the approvals and noted that the classifications will more accurately represent the hazards of the substances compared to those identified in the current one. approvals.

Best practice considerations

What are the industry or best New Zealand practices for the safe management of the substance(s)?

Are there New Zealand standards or Codes of Practice that apply to the management of the substance(s)?

What are the international standards for the safe management of the substance(s)?

Additional Information (optional)

Provide any additional information to support the proposal to change the approval here and indicate how or why it is relevant

Source of supporting information

Please provide an index of your supporting information

Before you submit: checklist

Request for information waiver under section 59 of the HSNO Act

Signature of applicant or person authorised to sign on behalf of applicant

Definitions

Individual components to be reassessed and the list of affected substances containing them

Tebuconazole HSR Acute oral toxicity Category 4, Specific target organ toxicity (repeated exposure) Category 2, Hazardous to terrestrial vertebrates, Hazardous to the aquatic environment acute Category 1, Hazardous to the aquatic environment chronically. Propiconazole HSR Acute oral toxicity Category 4, Eye irritation Category 2, Specific target organ toxicity (repeated exposure) Category 2, Hazardous to terrestrial vertebrates, Hazardous to the aquatic environment acute Category 1, Hazardous to the aquatic environment chronic HSR050 concentration chronic HSR0501. containing 250 g/litre propiconazole. dimethylammonium chloride and 48 g/litre propiconazole. g/litre fenpropimorph and 24.8 g/litre propiconazole.

Table 3: List of affected substances containing both tebuconazole and propiconazole
Table 3: List of affected substances containing both tebuconazole and propiconazole

Approved substances with proposed changes

Skin Sensitization Category 1, Reproductive Toxicity Category 2, Hazardous to the Aquatic Environment Acute Category 1, Hazardous to the Aquatic Environment Chronic Category 16. HSR000596 Specific Target Organ Toxicity (Repeated Exposure) Category 2, Hazardous to the Aquatic Environment Acute Category 1 , Hazardous to the aquatic environment chronic Category 1. Category 2, Specific target organ toxicity (repeated exposure) Category 2, Hazardous to the aquatic environment acute Category 1, Hazardous to the aquatic environment chronic Category 1.

Category 1, Acute Hazardous to the aquatic environment Category 1, Hazardous to the aquatic environment chronic Category 3. Category 1, Specific target organ toxicity (repeated exposure) Category 2, Acute Hazardous to the aquatic environment Category 1, Hazardous to the aquatic environment chronic Category 1. Reproductive toxicity Category 1, Specific target organ toxicity ( repeated exposure) Category 2, Acute Hazardous to the aquatic environment Category 1, Hazardous to the aquatic environment chronic Category 1.

Reproductive toxicity Category 1, Specific target organ toxicity (repeated exposure) Category 2, Hazardous to the aquatic environment acute. Hornet 430SC HSR007675 Specific target organ toxicity (repeated exposure) Category 2, Hazardous to the aquatic environment acute Category 1, Hazardous to the aquatic environment chronic Category 1. Category 2, Hazardous to the aquatic environment acute Category 1, Hazardous to the aquatic environment Category 1.

Category 2, Skin sensitization Category 1, Reproductive toxicity Category 1, Specific target organ toxicity (repeated exposure) Category 1, Hazardous to the aquatic environment chronic Category 2. Reproductive toxicity Category 2, Hazardous to the aquatic environment acute Hazardous to the aquatic environment Category 1 aquatic environment chronic Category 150. Reproductive toxicity Category 2, Specific target organ toxicity (repeated exposure) Category 2, Hazardous to the aquatic environment acute Category 1, Hazardous to the aquatic environment chronic Category 1.

Reproductive toxicity Category 2, Hazardous to terrestrial vertebrates, Hazardous to the aquatic environment acutely Category 1, Hazardous to the aquatic environment chronically Category 1. Reproductive toxicity Category 1, Specific target organ toxicity (repeated exposure) Category 2, Hazardous to terrestrial invertebrates after the water. Reproductive toxicity Category 1, Hazardous to the aquatic environment acute Category 1, Hazardous to the aquatic environment chronic Category 179.

Reproductive Toxicity Category 1, Hazardous to the Aquatic Environment Acute Category 1, Hazardous to the Aquatic Environment Chronic Category 180. Reproductive Toxicity Category 2, Specific Target Organ Toxicity (Repeated Exposure) Category 1, Hazardous to the Aquatic Environment Acute Category 1, Hazardous to the chronic aquatic environment category.

Ecotoxicological and toxicological hazard assessments of the substances

Tebuconazole

The classification is based on the lowest acute oral LD50 of tebuconazole (1700 mg/kg bw in rats and 1615 mg/kg bw in mice). In the second study, it did not cause corneal opacities or iris lesions. In a two-year carcinogenicity study in the rat, there was an increase in C-cell adenomas and carcinomas of the thyroid gland in all treated males and no clear dose-response relationship was observed.

No classification for reproductive and developmental toxicity has been assigned for tebuconazole in the current EPA classification. Thus, embryotoxic/teratogenic findings were not observed in the absence of maternal toxicity in rats. The developmental NOAELs were 30 mg/kg bw/d in the rat, 10 mg/kg bw/d in the rabbit, whereas only a LOAEL of

Based on the effects observed by species (malformations, loss after implantation, resorption) and the absence of overt maternal toxicity, a Classification of Repr. Based on the observed findings in three species (malformations, loss after implantation, resorption) tebuconazole should be classified as reproductive toxicity Category 2 according to the principles GHS. There are reliable acute data available for all three trophic levels, based on this information the lowest relevant acute aquatic toxicity value is an EC50 of 0.1444 mg ai/L for Lemna gibba (7-day, static) based on leaf number.

Based on this endpoint, tebuconazole is classified as Aquatic Acute Hazard Category 1 with an M-factor of 1 according to GHS principles. Based on this endpoint, tebuconazole is classified as Chronically Hazardous to the Aquatic Environment Category 1 with an M-factor of 10 according to GHS principles. This is based on study data indicating an acute 14-day LC50 of 1381 mg ai/kg dry weight for earthworms in the EPA chemical database.

Tebuconazole is currently classified as toxic to terrestrial vertebrates based on study data indicating an acute LD50 of 1555 mg ai/kg bw for bobwhite quail in the EPA's chemical database. Based on this endpoint, tebuconazole is classified as hazardous to terrestrial vertebrates according to the principles of GHS. Tebuconazole is currently not classified based on study data indicating an acute oral LD50 of >83.05 µg ai/bee for honey bees in the EPA's chemical database IUCLID.

Table 2: Carcinogenicity studies of tebuconazole
Table 2: Carcinogenicity studies of tebuconazole

Propiconazole

Māori impact assessment

Māori Impact Assessment (MIA)

Impact Assessment

General comments

Consultation

Impact on the relationship of Māori and their culture and traditions with their environment and taonga

Impact on the maintenance and enhancement of the capacity of people and communities to provide for their own economic, social, and cultural well-being

Treaty of Waitangi principles

Control codes for changes in Table 4 Appendix 2

LAB EPA Labeling Notice 2017 Hazardous Material Labeling Requirements PKG EPA Packaging Notice 2017 Hazardous Material Packaging Requirements SDS EPA Safety Data Sheet Notice 2017 Hazardous Material Safety Data Sheet Requirements. DIS EPA Disposal Notice 2017 Hazardous Material Disposal Requirements HPC-1 EPA Hazardous Property Controls.

Figure

Table 5. Index of supporting information or references  Name or
Table 2. List of affected substances containing either tebuconazole or propiconazole  Active
Table 1. List of individual components to be reassessed.
Table 3: List of affected substances containing both tebuconazole and propiconazole
+7

References

Related documents

Page 3 of 5 Appendix: Controls applying to HSR004351 Hazardous substances and new organisms HSNO default controls Control code EPA Notice Notice / Part description LAB