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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1996

2. Registrant Information.

Registrant Reference Number: 2167667

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: 160 QUARRY PARK BLVD. SE Suite 200

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

05-JAN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

05-NOV-17

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 72155-80

Product Name: Home Pest plus Germ Killer Indoor & Outdoor Killer RTU (1 Gal)

  • Active Ingredient(s)
    • BETA-CYFLUTHRIN
      • Guarantee/concentration .05 %
    • SODIUM O-PHENYLPHENATE
      • Guarantee/concentration .3 %

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Boxer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

68.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Abdominal distension
    • Symptom - Anorexia
  • General
    • Symptom - Death
    • Symptom - Edema
  • Renal System
    • Symptom - Renal failure
  • Respiratory System
    • Symptom - Coughing

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1/5/2018 Caller reports applying product in his home around the baseboards in the pantry and around the pet bedding on 11/2/2017 or 11/3/2017. Caller and the pet were out of the home for 1 to 2 hours following application. When he came back into the home caller did not smell any odor and did not see any wet areas. On 11/14/2017 the pet began coughing. Caller brought the pet to their veterinarian, and they gave antibiotics. Caller brought the pet home. The pet continued coughing, and stated having abdominal swelling, not wanting to eat, and had hard areas of fluid under the skin on the neck and chest. The pet was seen by the veterinarian again on 11/21/2017. The veterinarian ran blood work, and noted that the pet had kidney failure. The pet had increased weight due to fluid accumulation in the body. The pet was given and unknown kidney medication. On 12/28/2017, the pet passed away at home.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The main active ingredient in this product, Beta-Cyfluthrin (0.05%), affects the nervous system of target species by preventing the closure of voltage-gated sodium channels resulting in excitation. Due to the overall sensitivity that insects have to such an impact, this class of insecticide has a far wider margin of safety in mammals (such as dogs) than in target insects and therefore pose little risk of significant toxicity in canines. Although there does not appear to have been any direct exposure to the product either during or following application, the effects reported in this case do not correlate well to the anticipated toxic effects from direct exposure to a pyrethroid insecticide which may include minimal stomach or digestive tract complaints (following ingestion) or minor, self-limiting skin reactions (occasional) from direct skin contact; renal injury is not part of the known toxic effects from such products, as formulated. The etiology of the effects reported is not clear from the available information provided in the case and there is likely additional diagnostic testing that had been completed by the animal's veterinarian along with their opinions as to suspected pathological processes involved which are also not reported. A necropsy was not reported to have been conducted post-mortem to determine an official likely cause of death. In summary, the effects reported are not correlated with the known toxicological profile of the product and more likely than not, other etiologies are involved in the death of this 11-year-old boxer breed of dog.