New incident report
Incident Report Number: 2009-2450
Registrant Reference Number: 182492
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience, Inc.
Address: Suite 100, 3131 114 Avenue SE
City: Calgary
Prov / State: AB
Country: Canada
Postal Code: T2Z 3X2
Human
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. 28952 PMRA Submission No. EPA Registration No.
Product Name: Spirotetramat Technical
Other (specify)
TCNo
Unknown
Data Subject
Sex: Unknown
Age: Unknown / Inconnu
System
Unknown / Inconnu
Yes
Unknown
Occupational
Other
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
On 2 March 2009, Bayer CropScience Region Americas Industrial Operations Group received information regarding possible spirotetramat dermal sensitization cases at the BCS production plant in (city), (country), where spirotetramat technical grade active ingredient is produced. Spirotetramat technical was shown to be positive for dermal sensitization in regulatory studies in the guinea pig and mouse. In 2004 during the development of spirotetramat, cases of type 4 skin sensitization were seen and proven by patch testing in two R+D personnel who frequently handled technical active ingredient. These findings were included in the registration dossier submitted in 2006 for joint review by AGES, PMRA and US EPA. No additional sensitization cases have been reported by any R+D or field personnel. In 2008 the (city) plant produced spirotetramat in a campaign ending in September. Late in 2008 several workers in the production plant complained about skin symptoms suggestive of a type 4 allergy. Eight possible cases of allergic reactions were identified. Symptoms in all cases involved reddening or rashes on the face and sometimes also on the wrists. Cyclohexanone and epoxy resin, two other known sensitizers, were also in the plant. Since workers involved in the production of spirotetramat could have been exposed to multiple sensitizers, testing is in place for a standard allergy test panel including the other substances as well as spirotetramat.
Moderate
One individual with a known tendency to develop allergies has undergone patch testing, and sensitization to spirotetramat was confirmed. BCS has encouraged the remaining workers to undergo the allergy test, but under local labor agreements in (country) having the test is strictly voluntary. Two workers have refused testing; five cases remain open. Any additional test results will be reported if workers voluntarily agree to undergo the allergy tests.