Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6292

2. Registrant Information.

Registrant Reference Number: 2013CK063

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

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

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

Domestic Animal

4. Date registrant was first informed of the incident.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

11-JUL-13

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.       PMRA Submission No.       EPA Registration No. 11556-107

Product Name: CyLence Pour-On Insecticide

• Active Ingredient(s)
  • CYFLUTHRIN
    • Guarantee/concentration 1 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

8

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).

On 26 Jun 2013 a 6 month old, 500 pound, intact male, Angus bovine, was noted having pyrexia due to an abscess on the foot and shoulder. His temperature was 105. On 10-Jul-2013, the calf was administered 8 ml of CyLence Pour-On Insecticide (Cyfluthrin) once topically by the owner. After product application the calf was taken to the veterinary clinic for the concomitant medical conditions. While at the clinic the veterinarian lanced the affected abscessed areas.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Aberdeen Angus

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

500

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 11 Jul 2013 the calf passed away. No necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Would not expect fatal outcome related to the product without showing any sign of pyrethroid toxicity. This produt has a wide margin of safety and is of topical action. The calf received topically 0.4 mg active ingredient per kg body weight. The oral LD 50 is 500 mg/kg bw. The calf had a concomitant medical condition that most likely was the cause of his demise, particularly considering the high fever and ongoing abscess. Although no necropsy was performed a product relation can be excluded.