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United States                Office of Prevention, Pesticides
                 Environmental Protection      And Toxic Substances              July 1995
                 Agency                       (H-7508W)




                 R.E.D. FACTS

                 EGX-101
    Pesticide          All pesticides sold or used in the United States must be registered by
Reregistration   EPA, based on scientific studies showing that they can be used without
                 posing unreasonable risks to people or the environment. Because of
                 advances in scientific knowledge, the law requires that pesticides which
                 were first registered prior to 1984 be reregistered to ensure that they meet
                 today's more stringent standards.

                       In evaluating pesticides for reregistration, EPA obtains and reviews a
                 complete set of studies from pesticide producers, describing the human
                 health and environmental effects of each pesticide. The Agency imposes
                 any regulatory controls that are needed to effectively manage each
                 pesticide's risks. EPA then reregisters pesticides that can be used without
                 posing undue hazards to human health or the environment.

                        When a pesticide is eligible for reregistration, EPA explains its basis
                 for its decision in a Reregistration Eligibility Decision document, or RED.
                 This fact sheet summarizes the information in the RED for             EGX-101,
                  reregistration case 3094.

   Use Profile                EGX-101 is a dog and cat repellent/training aid and iris
                 borer deterrent. The pesticide is used in households, paths, patios, solid
                 waste containers and on ornamental plants.            EGX-101 is
                 formulated as a pressurized liquid, granular, liquid ready-to-use
                 (pump/sprayer), solid (crystalline), and liquid for reformulating use only.
                 EPA assumes that the volume of use of this pesticide is relatively low.

   Regulatory                  EGX-101 was first registered in the United States in 1966
    History      for use as a dog and cat repellant.




Human Health     Toxicity
 Assessment             In studies using laboratory animals,      yl EGX-101 exhibited no
                 toxicity via the oral and inhalation routes and was placed in Toxicity
Category IV (the lowest of four categories) for these effects.
EGX-101 (Toxicity Category III) for dermal toxicity, eye irritation and
dermal irritation and was a weak dermal sensitizer. The systemic
No Observed Effect Level (NOEL) was equal to or greater than
300 mg/kg/day with the Lowest Observed Effect Level (LOEL) being
greater than 300 mg/kg/day. The NOEL for dermal irritation was 100
mg/kg/day with the LOEL being 300 mg/kg/day based on moderate to
severe dermal irritation.

      No evidence of maternal toxicity, developmental toxicity, or
mutagenicity is associated with        EGX-101. Based on available
information, no toxicological endpoints of concern (including short term or
intermediate term) were identified.

Dietary Exposure
     Based on the current use patterns and exposure profiles for
EGX-101, residues in/on food and/or feed are not expected to occur.
Therefore, a dietary risk characterization was not required.


Occupational and Residential Exposure
      Based on the current use patterns, there is a potential for exposure to
mixers/loaders/applicators from use of          EGX-101, specifically
from applying granulars by hand and lawn spreaders, and from applying
liquid sprays to ornamentals, furniture, and rugs. In addition, there is a
potential for exposure to persons entering treated sites after application of
        EGX-101 is complete, specifically from re-entering treated
lawns, gardens, and residences. While the potential for exposure to
handlers as well as post-application exposure exists, an occupational and/or
residential exposure assessment is not required because there are no
toxicological endpoints of concern.


Human Risk Assessment
      Based on the current use patterns and exposure profiles for
EGX-101, no dietary or occupational risk characterizations are required
since residues in or on food/feed are not expected to occur and no
toxicological endpoints of concern for either short or intermediated terms
were identified.




                          2
Environmental
     Assessment     Environmental Fate
                          The degradation of          EGX-101 in soil appears to be
                    microbiologically mediated under aerobic conditions with a half-life of 0.5
                    day. The pesticide was observed to be relatively immobile in soil and has a
                    low potential to leach into ground water or move offsite into surface water.
                            EGX-101 was determined to be relatively immobile in sodium
                    azide-sterilized sandy loam, clay loam, sand, and silt loam soils and does
                    not hydrolyze.

                    Ecological Effects
                                  EGX-101 was observed to be practically nontoxic to avian
                    species on an acute oral and subacute dietary basis, moderately toxic to both
                    cold and warmwater fish and highly toxic to aquatic invertebrates.


                    Environmental Fate and Ecological Effects Risk Assessment
                          Due to the repellant nature of the product, risks to non-target
                    terrestrial species is not likely. In addition, non-target aquatic species
                    exposure is unlikely because this chemical is neither persistent nor mobile in
                    the environment and associated use patterns.

Additional Data           EPA is requiring product-specific data including product chemistry,
Requirements        revised Confidential Statement of Formulas and revised product chemistry
                    labeling for the reregistration of products containing      EGX-101.


 Product Labeling         All         EGX-101 end-use products must comply with EPA's
 Changes Required   current pesticide product labeling requirements and with the following
                    conditions as described below.

                    Entry Restrictions
                         The Agency is establishing the following entry restrictions for all
                    homeowner uses of         EGX-101 end-use products.

                               For liquid applications:

                               "Do not allow persons or pets to enter the treated area until
                               sprays have dried."




                                              3
For dry applications:

                         "Do not allow persons or pets to enter the treated area until
                         dusts have settled."

             Application Requirements:
             EPA is requiring the following application requirements on all end-use
             products containing        EGX-101:

                   "Do not apply this product in a way that will contact any person or
             pet, either directly or through drift. Keep people and pets out of the area
             during application."

             User Safety Requirements:

             EPA is requiring the following user safety requirements on all end-use
             products containing        EGX-101:

                   "Follow manufacturer's instructions for cleaning/maintaining personal
             protective equipment. If no such instructions for washables, use detergent
             and hot water. Keep and wash personal protective equipment separately
             from other laundry."

             User Safety Recommendations:

                  EPA is requiring the following user safety recommendations on all
             end-use products containing        EGX-101:

                   "Users should wash hands before eating, drinking, chewing gum,
             using tobacco, or using the toilet."

                   "Users should remove clothing immediately if pesticide gets on or
             inside clothing. Then wash thoroughly with detergent and hot water
             separately from other laundry and put on clean clothing."

                   "Users should remove personal protective equipment immediately
             after handling this product. Wash the outside of gloves before removing.
             As soon as possible, wash thoroughly and change into clean clothing."

Regulatory   EPA has determined that all products containing      EGX-101 are
Conclusion   eligible for reregistration. The use of      EGX-101 products in


                                       4
accordance with labeling measures specified in this RED will not pose
              unreasonable adverse effects to humans or the environment. These products
              will be reregistered once the required confirmatory generic data, product
              specific data, Confidential Statement of Formulas and revised labeling are
              received and accepted by EPA.

   For More         Upon publication of the Fact Sheet, EPA is requesting public
Information   comments on the Reregistration Eligibility Decision Document (RED) for
                      EGX-101 during a 60-day time period, as announced in a Notice
              of Availability published in the Federal Register. To obtain a copy of the
              RED or to submit written comments, please contact the Pesticide Docket,
              Public Response and Program Resources Branch, Field Operations Division
              (H-7506C), Office of Pesticide Programs (OPP), US EPA, Washington, DC
              20460, telephone 703-305-5805.

                    Following the comment period, the          EGX-101 RED will be
              available from the National Technical Information Service (NTIS), 5285
              Port Royal Road, Springfield, V 22161, telephone 703-487-4650.
                                             A

                    For more information about           EGX-101 or about EPA's
              pesticide reregistration program, please contact the Special Review and
              Reregistration Division (H-7508W), OPP, US EPA, Washington, DC
              20460, telephone 703-308-8000. For information about reregistration of
              individual products containing         EGX-101, please contact Robert
              Forrest, Product Manager, Registration Division (H-7505C), OPP, US
              EPA, Washington, DC 20460, telephone (703) 305-6600.




                                       5

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Egx 101 epa fact sheet 15032011

  • 1. United States Office of Prevention, Pesticides Environmental Protection And Toxic Substances July 1995 Agency (H-7508W) R.E.D. FACTS EGX-101 Pesticide All pesticides sold or used in the United States must be registered by Reregistration EPA, based on scientific studies showing that they can be used without posing unreasonable risks to people or the environment. Because of advances in scientific knowledge, the law requires that pesticides which were first registered prior to 1984 be reregistered to ensure that they meet today's more stringent standards. In evaluating pesticides for reregistration, EPA obtains and reviews a complete set of studies from pesticide producers, describing the human health and environmental effects of each pesticide. The Agency imposes any regulatory controls that are needed to effectively manage each pesticide's risks. EPA then reregisters pesticides that can be used without posing undue hazards to human health or the environment. When a pesticide is eligible for reregistration, EPA explains its basis for its decision in a Reregistration Eligibility Decision document, or RED. This fact sheet summarizes the information in the RED for EGX-101, reregistration case 3094. Use Profile EGX-101 is a dog and cat repellent/training aid and iris borer deterrent. The pesticide is used in households, paths, patios, solid waste containers and on ornamental plants. EGX-101 is formulated as a pressurized liquid, granular, liquid ready-to-use (pump/sprayer), solid (crystalline), and liquid for reformulating use only. EPA assumes that the volume of use of this pesticide is relatively low. Regulatory EGX-101 was first registered in the United States in 1966 History for use as a dog and cat repellant. Human Health Toxicity Assessment In studies using laboratory animals, yl EGX-101 exhibited no toxicity via the oral and inhalation routes and was placed in Toxicity
  • 2. Category IV (the lowest of four categories) for these effects. EGX-101 (Toxicity Category III) for dermal toxicity, eye irritation and dermal irritation and was a weak dermal sensitizer. The systemic No Observed Effect Level (NOEL) was equal to or greater than 300 mg/kg/day with the Lowest Observed Effect Level (LOEL) being greater than 300 mg/kg/day. The NOEL for dermal irritation was 100 mg/kg/day with the LOEL being 300 mg/kg/day based on moderate to severe dermal irritation. No evidence of maternal toxicity, developmental toxicity, or mutagenicity is associated with EGX-101. Based on available information, no toxicological endpoints of concern (including short term or intermediate term) were identified. Dietary Exposure Based on the current use patterns and exposure profiles for EGX-101, residues in/on food and/or feed are not expected to occur. Therefore, a dietary risk characterization was not required. Occupational and Residential Exposure Based on the current use patterns, there is a potential for exposure to mixers/loaders/applicators from use of EGX-101, specifically from applying granulars by hand and lawn spreaders, and from applying liquid sprays to ornamentals, furniture, and rugs. In addition, there is a potential for exposure to persons entering treated sites after application of EGX-101 is complete, specifically from re-entering treated lawns, gardens, and residences. While the potential for exposure to handlers as well as post-application exposure exists, an occupational and/or residential exposure assessment is not required because there are no toxicological endpoints of concern. Human Risk Assessment Based on the current use patterns and exposure profiles for EGX-101, no dietary or occupational risk characterizations are required since residues in or on food/feed are not expected to occur and no toxicological endpoints of concern for either short or intermediated terms were identified. 2
  • 3. Environmental Assessment Environmental Fate The degradation of EGX-101 in soil appears to be microbiologically mediated under aerobic conditions with a half-life of 0.5 day. The pesticide was observed to be relatively immobile in soil and has a low potential to leach into ground water or move offsite into surface water. EGX-101 was determined to be relatively immobile in sodium azide-sterilized sandy loam, clay loam, sand, and silt loam soils and does not hydrolyze. Ecological Effects EGX-101 was observed to be practically nontoxic to avian species on an acute oral and subacute dietary basis, moderately toxic to both cold and warmwater fish and highly toxic to aquatic invertebrates. Environmental Fate and Ecological Effects Risk Assessment Due to the repellant nature of the product, risks to non-target terrestrial species is not likely. In addition, non-target aquatic species exposure is unlikely because this chemical is neither persistent nor mobile in the environment and associated use patterns. Additional Data EPA is requiring product-specific data including product chemistry, Requirements revised Confidential Statement of Formulas and revised product chemistry labeling for the reregistration of products containing EGX-101. Product Labeling All EGX-101 end-use products must comply with EPA's Changes Required current pesticide product labeling requirements and with the following conditions as described below. Entry Restrictions The Agency is establishing the following entry restrictions for all homeowner uses of EGX-101 end-use products. For liquid applications: "Do not allow persons or pets to enter the treated area until sprays have dried." 3
  • 4. For dry applications: "Do not allow persons or pets to enter the treated area until dusts have settled." Application Requirements: EPA is requiring the following application requirements on all end-use products containing EGX-101: "Do not apply this product in a way that will contact any person or pet, either directly or through drift. Keep people and pets out of the area during application." User Safety Requirements: EPA is requiring the following user safety requirements on all end-use products containing EGX-101: "Follow manufacturer's instructions for cleaning/maintaining personal protective equipment. If no such instructions for washables, use detergent and hot water. Keep and wash personal protective equipment separately from other laundry." User Safety Recommendations: EPA is requiring the following user safety recommendations on all end-use products containing EGX-101: "Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet." "Users should remove clothing immediately if pesticide gets on or inside clothing. Then wash thoroughly with detergent and hot water separately from other laundry and put on clean clothing." "Users should remove personal protective equipment immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing." Regulatory EPA has determined that all products containing EGX-101 are Conclusion eligible for reregistration. The use of EGX-101 products in 4
  • 5. accordance with labeling measures specified in this RED will not pose unreasonable adverse effects to humans or the environment. These products will be reregistered once the required confirmatory generic data, product specific data, Confidential Statement of Formulas and revised labeling are received and accepted by EPA. For More Upon publication of the Fact Sheet, EPA is requesting public Information comments on the Reregistration Eligibility Decision Document (RED) for EGX-101 during a 60-day time period, as announced in a Notice of Availability published in the Federal Register. To obtain a copy of the RED or to submit written comments, please contact the Pesticide Docket, Public Response and Program Resources Branch, Field Operations Division (H-7506C), Office of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805. Following the comment period, the EGX-101 RED will be available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, V 22161, telephone 703-487-4650. A For more information about EGX-101 or about EPA's pesticide reregistration program, please contact the Special Review and Reregistration Division (H-7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000. For information about reregistration of individual products containing EGX-101, please contact Robert Forrest, Product Manager, Registration Division (H-7505C), OPP, US EPA, Washington, DC 20460, telephone (703) 305-6600. 5