TELEPHONE CALL NOTES

PARTICIPANTS:		Bruce K. Bernard (SRA)

				TCVPTF Representative

				Paddy McDonald (CRL)

				Study Director, Inhalation Study

				Elizabeth Donald (CRL, Edinburgh)

				Study Director, Immunotoxicity Study

				James Parker (EPA)

				Product Manager

				Michael Metzger (EPA)

				Chief, Risk Assessment Branch 7, HED

				Paul Chin (EPA)

				Toxicologist, HED

				Yang Yung (EPA)

				HED

 

DATE/TIME:			June 7, 2011

1115 – 1140 (EDT)

SUBJECT:			TCVP Immunotoxicity Study

Background

A combined Immunotoxicity/28-day inhalation study protocol was submitted
to EPA for review; the submission was in response to the data requests
set out in the GENERIC DCI.; the combined concept was rejected by EPA.

EPA provided a written review of the submission; the combined concept
was rejected and a number of additional comments included.

TCVPTF

TCC SRA/CRL(Edinburgh)/EPA

GENERIC DCI/Immunotox & Inhalation Studies

7 June 2011, p. 2

The purpose of this TCC was to clarify those questions regarding the
additional comments.

Topics for this Call

Immunotoxicity Study

Clarification regarding Histopathology and Hematology

EPA stated that neither histopathology nor hematology analyses were
required in this study.

Group Size (animals)

SRA agreed to EPA’s request that the groups size be 10 not 8.

C.	Animal Species

SRA agreed to EPA’s request that the mouse be employed.

NK Assay Data

   

EPA stated that NK data is not required; data based studies are
sufficient to conclude that the immune system is not THE primary target
organ of TCVP.  EPA stated that submission of a formal request to EPA
for a waiver of the NK data is NOT required. 

E.	Route of Administration

EPA stated that either gavage or dietary administration is acceptable
(both require exposure 7 days/week).

TCVPTF

TCC SRA/CRL(Edinburgh)/EPA

GENERIC DCI/Immunotox & Inhalation Studies

7 June 2011, p. 3

F.	Dose Levels

We will be reviewing the available data to determine what doses will be
employed in the study.

G.	Submission of Courtesy Copy of Revised Protocol

SRA offered to submit a courtesy copy of the revised protocol.

 

Inhalation Study

EPA confirmed 5 days/week dosing is satisfactory.

5235 Ragged Point Road, Cambridge, MD 21613-3518

410.228.1400(ph) 410.228.1450(fx) Bernard@sra-intl.com

SRA International, Inc.

