Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8145

2. Registrant Information.

Registrant Reference Number: 2017CP350

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

23-OCT-17

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

21-OCT-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)

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PMRA Registration No. 27582      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

Units: mL

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

Site: Animal / Usage sur un animal domestique

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

A 19 kg , 2 year old male canine beagle with no concomitant medical condition , was applied one tube advantageII large dog once topically by the owner

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Beagle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

19

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Collapse

• Gastrointestinal System
  • Symptom - Drooling

12. How long did the symptoms last?

<=30 min / <=30 min

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

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

On October 21 2017 , a 19 kg , 2 year old male canine beagle with no concomitant medical condition , was applied one tube advantage II large dog once topically by the owner; two hours after application, the dog collapsed and was hypersalivating reaction lasted 10 minutes.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

O - Unclassifiable/unassessable Hypersalivation after suspected ingestion of product. Sign is consistent with distaste reaction. However, reported collapse is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Even on oral exposure, which was suspected, reported sign would not be expected. Time to onset short though. Sign was not verified by a veterinarian and thus misinterpretation of sign cannot be excluded. Overall, prodcut relation is unassessable.