### 1 Attachment

Hello Paul,

The contract laboratory study directors have review ed the EPA review comments and have amended the stu dy
plans accordingly.

There were just two comments from them which I wish ed to ask for EPA's expedited feedback on, if neces sary (the Ames Test and Chrosome Aberration Test in Huma n Lymphocytes In Vitro ) studies are scheduled to begin
soon). Please see these comments below.

 Ames Test and Chrosome Aberration Test in Human Lym phocytes 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 du e 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 iss ue?



### 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

12/19/2013 file://C:\Users\hnjo\AppData\Local\Temp\notesEB1B65 \~web7496.htm 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 (da y 42 for males; day 4 for post-partum females)

. Due to animal welfare concerns and ethical backgrou nds our standard procedures for blood sampling do n ot involve fasting of animals. Furthermore, our histor ical background data for clinical pathology is all generated from

“non fasted” animals. In view of the above we would like to reco mmend following our standard procedures as they
are reflecting requirements of the relevant UK auth orities 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 in dividual or entity to which it is addressed and may contain information that is privileged, confidential and ex empt from disclosure under applicable law. If you have recei ved 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/LANXE SS on 06/04/2012 09:58 AM -----

Brian,

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

Let me know if you need anything else from me regar ding 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

12/19/2013 file://C:\Users\hnjo\AppData\Local\Temp\notesEB1B65 \~web7496.htm412-809-3709

----- Forwarded by Deborah Vercek/LXESA/USERS/LANXE SS 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 sti pulated in the report .



### (See attached file: EPA approval of WPs from Lanxes s 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 in formation that may be confidential, protected by th e attorney-client or other applicable privileges, or constitutes non-pub lic information. If you are not the designated reci pient, 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

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