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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4573

2. Registrant Information.

Registrant Reference Number: 2013AM190

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.

13-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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. Unknown

Product Name: CyLence Pour-On

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

One dose of Cylence was applied topically by the owner to one spot on the dorsal midline.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Other / Autre

specify Caprine

3. Breed

Boar goat

4. Number of animals affected

4

5. Sex

Unknown

6. Age (provide a range if necessary )

.12

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Hair loss

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 15-Apr-2013, four 1 to 1.5 month old, Boer Goat (caprine) kids of mixed genders and unknown weights, in good condition with no concomitant medical conditions, were administered an unknown dose of CyLence Pour-On Insecticide (Cyfluthrin) once topically by the owner. This is an off-label use of this product, it is not labeled for use in goats. Approximately 1 hour after application all kids developed scours and application site alpoecia.One kid died later that day of an unknown cause. On 17Apr2013 the 3 other kids died of an unknown cause. No necropsy was performed. No medical intervention was sought.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Off-label use by species. Cyfluthrin is considered moderately toxic for mammals (oral LD50 850 mg/kg in rats). Diarrhoea is a clinical sign of pyrethroid toxicity. But fatal outcome never expected after topical application of product. No data for goats available. No necropsy initiated. No ingestion of product witnessed. No veterinarian consulted. Clinical course inadequate. Finally a product relation was considered to be not assessable.