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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2062

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0014149 (Report 479908)

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

Address: 2920 Matheson Blvd

City: Mississauga

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.

18-APR-18

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. 11556-128

Product Name: advantageII small dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Other (specify)

spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 an unknown date in approximately Nov 2017, four puppies, of unknown signalment, in unknown condition, with no known concomitant medical conditions, were whelped by a female dog that had 1 tube of Advantage II Small Dog (Imidacloprid-Pyriproxyfen) applied topically by the owner approximately 2 weeks prior in Nov 2017.

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

Dog / Chien

3. Breed

unknown

4. Number of animals affected

4

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Weakness
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

16. How was the animal exposed?

Other / Autre

specify the treated animal whelped

17. Provide any additional details about the incident

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

Approximately 15 days post exposure and 1 day after being born, the puppies weakened and died. No known necropsy examination was performed. No further information is expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely: Product was applied to pregnant female dog 2 weeks prior to giving birth. Reported systemic sign of weakness in puppies is rather unspecific and have various other causes. Further reported fatal outcome of death of puppies is not expected after product application, as it is inconsistent with pharmaco-toxicological product 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. No reproductive toxic effects have been observed in rats and no primary embryotoxic or teratogenic toxic effects have been observed during the studies on rats and rabbits. Thus, such adverse effects are not expected. Other unrelated causes are more probable. Though low level of information provided (e.g. health details of born puppies, necropsy not available), considering the safety profile of the product and indirect product exposure, product involvement is deemed unlikely.