Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0458
2. Registrant Information.
Registrant Reference Number: 2012BS260 - US0029010
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.
19-OCT-12
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
11-JUL-12
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. 11556-107
Product Name:
- 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).
On July 10/2012, a 100 lb, Angus bovine who's age is unknown in good condition with no known concomitant medical conditions was accidentally given an overdose of CyLence Pour-On insecticide topically. Exact amount not known.
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
Other
2. Type of animal affected
Cow / Vache
3. Breed
Angus
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
100
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
12. How long did the symptoms last?
Unknown / Inconnu
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?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On July 11/2012, the bovine died. No necropsy performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Low level of information. Product has wide safety margin. Acute oral LD50 in rat is 500mg/kg BW. That means calf would have to ingest 2.25 L of product to reach LD50 concentration, even though overdose reported, unlikely such high dose. No typical signs of toxicity (ataxia, vomiting, diarrhea, seizure). In spite close time of onset, other causes more probable. Product connection is unlikely.