1 Attachment 

Hello Paul, 

The contract laboratory study directors have reviewed the EPA review comments and have amended the study 

plans accordingly. 

There were just two comments from them which I wished to ask for EPA's expedited feedback on, if necessary 

(the Ames Test and Chrosome Aberration Test in Human Lymphocytes In Vitro) studies are scheduled to begin 

soon). Please see these comments below. 

 Ames Test and Chrosome Aberration Test in Human Lymphocytes In Vitro

As the test item in aqueous media has a very short half-life (5.1 mins at approximately ambient temp) it is possible 

that only the hydrolysis products will be tested due to the study being aqueous-based. However, the test item data 

sheets (submitted by the Sponsor with the test item) consider the test item to be insoluble in water, therefore, if an 

organic solvent is used, is hydrolysis still an issue? 

Fw: HPV 3 Lanxess Study Plans Reviews for CAS 98-09-9 EPA Reviews completed and 

attached 

brian.laplante 

to: 

Paul Campanella 

06/04/2012 10:16 AM 

Cc: 

deborah.vercek 

Hide Details 

From: brian.laplante@lanxess.com 

To: Paul Campanella/DC/USEPA/US@EPA 

Cc: deborah.vercek@lanxess.com 

History: This message has been forwarded. 

EPA approval of WPs from Lanxess Corp.doc

Page 1 of 3

file://C:\Users\hnjo\AppData\Local\Temp\notesEB1B65\~web7496.htm 12/19/2013
 Oral (Gavage) Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity 

Screening Test in the Rat

Overnight fasting of animals is recommended before sampling of blood at the planned sampling dates (day 42 for 

males; day 4 for post-partum females). 

Due to animal welfare concerns and ethical backgrounds our standard procedures for blood sampling do not 

involve fasting of animals. Furthermore, our historical background data for clinical pathology is all generated from 

“non fasted” animals. In view of the above we would like to recommend following our standard procedures as they 

are reflecting requirements of the relevant UK authorities governing the use of laboratory animals. 

Thank you, in advance, for your assistance. We look forward to the Agency's reply. 

Brian T. Laplante, M.S., DABT 

Senior Regulatory Affairs Representative 

LANXESS Corporation 

Phone: 412.809.3583 

Fax: 412.809.1056 

E-mail: brian.laplante@lanxess.com 

CONFIDENTIALITY NOTICE: This email, including any attachments, is intended only for the use of the individual 

or entity to which it is addressed and may contain information that is privileged, confidential and exempt from 

disclosure under applicable law. If you have received this communication in error, please notify the sender 

immediately and delete the original. Any other use of the email by you is prohibited. 

----- Forwarded by Brian Laplante/LXAAS/USERS/LANXESS on 06/04/2012 09:58 AM ----- 

Brian, 

The studies can begin as long as they meet the additional conditions listed in the attachment. 

Let me know if you need anything else from me regarding this matter. 

Thanks, 

Debbie 

Best regards, 

Deborah Vercek 

LANXESS Corporation 

111 RIDC Park West Drive 

Pittsburgh, PA 15275-1112 

Deborah Vercek/LXESA/USERS/LANXESS

05/01/2012 03:48 PM 

To Brian Laplante/LXAAS/USERS/LANXESS@LANXESS

cc Susan VanVolkenburg/MOVNV/USERS/LANXESS@LANXESS

Subject Fw: HPV 3 Lanxess Study Plans Reviews for CAS 98-09-9 EPA Reviews 

completed and attached

Page 2 of 3

file://C:\Users\hnjo\AppData\Local\Temp\notesEB1B65\~web7496.htm 12/19/2013
412-809-3709

----- Forwarded by Deborah Vercek/LXESA/USERS/LANXESS on 05/01/2012 03:46 PM ----- 

Deborah, Attached is a document that evaluates the 7 Test plans that Lanxess submitted. The completed review 

are summarized in a documented completed by an EPA contractor and approved by EPA internal reviewers. You 

can start the testing subject to the conditions stipulated in the report .

(See attached file: EPA approval of WPs from Lanxess Corp.doc)

Paul J. Campanella, Ph.D. 

Chemical Information and Testing Branch 

Chemical Control Division 

U.S. Environmental Protection Agency 

Washington, D.C. 

202-564-8091

 

This e-mail, including any attachments, contains information that may be confidential, protected by the attorney-client or 

other applicable privileges, or constitutes non-public information. If you are not the designated recipient, please notify the 

sender by replying to this message and then delete it from your system without retaining a copy. 

Paul Campanella <Campanella.Paul@epamail.epa.gov>

05/01/2012 03:21 PM 

To deborah.vercek@lanxess.com

cc

Subject HPV 3 Lanxess Study Plans Reviews for CAS 98-09-9 EPA Reviews 

completed and attached

Page 3 of 3

file://C:\Users\hnjo\AppData\Local\Temp\notesEB1B65\~web7496.htm 12/19/2013