Document RJagGwXeMrzR95NRor9bYMxRn
INCORPORATED
200 GirardStreet,Suite200, Gaithersburg,MD 20877
301-921-0168
Fax: 301-977-0433
Client:
3M MEDICAL DEPARTMENT
3M CENTER BUILDING 220-2E-02 ST. PAUL, MN 55133-3220
(651) 575-3161 Attention: ANDREW SEACAT
Date Collected: Date Received:
Date Reported:
02/20/1999-02/26/200C 04/18/2000
05/02/2000
Client No. 1492
Study: 6 MONTH PFOS STUDY Species: CYNOMOLGUS
-------------------------------------------------------------------------------
Accession s ec.
Gp Sex Age
No.
IE -------
----------------
* 0098138 I05508M
1
* 0098139 I05519M
1
* 0098140 I05527M
1
* 0098141 I0553OF
1
* 0098142 I05531F
1
* 0098143 I05535F
1
* 0098144 I05544F
1
Mean S.D.
TSH, SI UIU/ML
0.45 0.32 0.42 0.43 0.19 0.59 0.80 -----.457 .195
CHOLEST MG/DL
105 145 143 124 116 171
99 ------
129 25.4
RDL-DIR LDL-DIR VLDL
MG/DL
MG/DL
MG/DL
----------------- -------------
50 72 44 56 47 42 32 ------
53 73 97 68 66 128 65 ------
2 0 2 0 3 1 2 ------
49
78.6
1.4
12.6
25.6
1.1
Group 1
A 0098145 I05514M
2
A 0098146 I05515M
2
A 0098147 I05516M
2
A 0098148 I05521M
2
A 0098149 I05541F
2
A 0098150 I05547F
2
A 0098151 I0555OF
2
Mean S.D.
0.64 0.69 0.49 0.41 0.51 0.43 0.34 ------
.501 .125
115 80 73 67 92 84 82
------
84.7 15.6
43 37 32 34 48 36 25 ------
36.4 7.5
72 41 36 33 40 48 51 ------
45.9 13.1
0 2 5 0 4 0 6 ------
2.4 2.6
Group 2
Reference Range
.2 2.6
101 240
Page 1 +
00
00
00
INCOR ORATED
200 GirardStreet,Suite200, GaithersburgM,D 20877 301-921-0168 Fax: 301-977-0433
Client:
3M MEDICAL DEPARTMENT
3M CENTER BUILDING 220-2E-02 ST. PAUL, MN 55133-3220
(651) 575-3161 Attention: ANDREW SEACAT
Date Collected: Date Received:
Date Reported:
02/20/1999-02/26/200C 04/18/2000
05/02/2000
Client No. 1492
Study: 6 MONTH PFOS STUDY Species: CYNOMOLGUS
----------------------------------------------------------------------------
Accession S ec.
No.
IE
Gp Sex Age
TSH, SI CHOLEST HDL-DIR LDL-DIR VLDL
UIU/ML MG/DL
MG/DL
MG/DL
MG/DL
-------------------------------
A 0098152 I05510M 3
A 0098153 I05518M
3
* 0098154 I05524M
3
* 0098155 I05528M
3
* 0098156 I05532F 3
* 0098157 I05538F 3
* 0098158 I05545F 3
* 0098159 I05548F 3
0.83
0.83 0.54
0.60
0.76
0.46 0.34
0.32 ------
115
98 110
116
91
88
74 74 ------
48
44
37 31
23
32
24 31 ------
66 54 72 76 68 53 50 42 ------
1 0 1 9 0 3 0 1 ------
Mean S.D.
.585
95.8
33.8
60.1
1.9
.207
17
8.8
12
3
Group 3
A 0098160 I05506M 4
* 0098161 105507M
4
* 0098162 I05512M
4
* 0098163 I05534F
4
* 0098164 I05536F 4
* 0098165 I0554OF
4
* 0098166 105551F
4
Mean S.D.
Group 4
0.73 0.72 1.15 1.25 1.75 0.89 0.86
1.05 .368
56 25 27 59 53 57 61 ------
48.3 15.4
14 8
11 16 18 16 22 ------
15
4.6
42 16 16 40 31 41
35 ------
31.6
11.3
0 1 0 3 4 0 4 ------
1.7 1.9
Reference Range
.2 -
101 -
0-
0-
0-
2.6
240
0
0
0
Page 2 +
C,
NCO PORATED
2oo GirardStreet,Suite200, Gaithersburg,MD 20877
301-921-0168
Fax: 301-977-0433
Client:
3M MEDICAL DEPARTMENT
3M CENTER BUILDING 220-2E-02 ST. PAUL, MN 55133-3220
(651) 575-3161 Attention: ANDREW SEACAT
Date Collected: Date Received:
Date Reported:
02/20/1999-02/26/200C 04/18/2000
05/02/2000
Client No. 1492
Study: 6 MONTH PFOS STUDY Species: CYNOMOLGUS
-------------------------------------------------------------------------------
Accession S ec.
Gp Sex Age
No.
TE
---- ------ ---------------
A 0098167 I05533F
4R
A 0098168 I05542F
4R
A 0098169 I05511M
4R
A 0098170 I05522M
4R
Mean
S.D.
TSH, SI CHOLEST HDL-DIR LDL-DIR VLDL
UIU/ML
MG/DL
MG/DL
MG/DL
MG/DL
---------------------------------------
0.85
0.60 0.65 0.93 ------
117
124 89
106 ------
51 50 45 37 ------
61 46 44 68 ------
5 28
0 1 ------
.758
.158
109
15.3
45.8
6.4
54.8
11.6
8.5
13.2
r--oup 4 WK52 RECOVERY
Reference
Range
.2 2.6
101 240
00
00
00
Approved ------ ------------ Date ---7@Z:2/-C
Page 3 of 3
AndrewM. SeacatP,h.D. 3M MedicalDept. 3M Center,Buildinmc2,20-2E-02 St.Paul,MN 55133-3220 Phone: (612)575-3161 FAX: (612)733-1773 e-mail:amseacatl@nu=.com
3/6/2000
PeterJ.Thomford, Ph.D. Study DirectorT,oxicology Covance LaboratoriesInc. 3301 Kinsman Blvd. Madison WI 53704 Phone: 608-241-7202 Fax: 608-242-'-1736
Re: 26-week capsuletoxicitsytudywithperfluorooctanseulfonicacidpotassium salt (PFOS; T-6295) inCynomoigus Monkeys. Covance Study Number: 6329-223,
Peter,
3M requestsinformationfrom the studyrecordsof 6329-223 forthe methods used and thedatesof specifichormone determinationcsonducted by Ani LyticsIncorporated, GaithersburcN,M,. Specificallwye, need more informationon themethods of determinationforT3, T4, freeT3, freeT4 and TSH. An explanationof thezerovaluesfor TSH isrequestedW.hat isthelimitofdetection(LOD) and limitofquantitatio(nLOQ) forTSH inthemethod used,and should thezerovaluesbe replacedwith <LOD or < LOQ. Furthermore,we need tounderstandthe hichT3 valuesreportedfortheday 37 samples(referencea,ppendix6 ofDraftinterimReport from Covance),forwhich theT3 valueswere hiah in alldose groups.The datethatthetestswere performed on each sample isalsorequested.Ani LyticsisbeinCg)copied on thisrequestinordertoexpedite thetransferof information.
Sincerely,
Andrew M. SeacatPh.D. Study Monitor
cc: Dr. SarojDas Ani Lvtics 200 dirardStreet,Suite200 GaithersburcyM,aryland 20877 Telephone No.:301-921-0168 FacsimileNo.: 301-977-0433
INCORPORATED
200 GirardStreet,Suite200,Gaithersburg,MO 20877 301-921-0168 800-237-2815
05 April 2000
Andrew Seacat, Ph.D.
3M Medical Department 3M Center, Building 220-2E-02 St. Paul, MN 55133-3220
Dear Dr. Seacat,
REF: Fax dated 3/20/00 TSH analysis in Cynos
I want to bring to your attention that primate TSH analysis at Ani Lytics, Inc. has always been performed using anti-human TSH polyclonal antibody. During our telephone conversation I told you that as of 1998 all human TSH testing is being done using monoclonal antibody, therefore these test reagents cannot be used in primates. For this reason we initiated an inhouse TSH assay procedure utilizing polyclonal antibody. The reagent source and other information on each of the assays mentioned in your letter along with result reporting policy are inclosed.
As I indicated to you, primates in general have quite low TSH levels. Therefore it will be necessary to increase the specimen volume in the TSH test system. At least 0.5ml but preferably l.Oml ser= will be good.
Sincerely,
Saroi
Das, M.S., Ph.D.
Director
CC: Peter J. Thomford, Ph.D. Study Director, Toxicology Covance Laboratories, Inc. 3301 Kinsman Blvd. Madison, Wl 53704
NCORPORATED
200 Girard Street,Suite 200, Gaithersburg,MD 20877
301-921-0168
800-237-2815
RESULT REPORTING
POLICY
Linear regression accepted.
curve correlation
coefficient
of 0.99 or greater
Results observed over the highest on appropriate dilution.
calibrator
concentration
repeated
Lowest
limit
concentration.
generated based
In some assays
specific.
of quantitation
is the
lowest
calibrator
Values below this concentration are computer
on the standard curve. These values are reported.
the exact calibration range is kit lot number
A zero value indicates that the counts bound for the sample/s same as or close to or > zero standard counts.
were
C-""--"A
ELM
INCORPORATED
200 Girard Street,Suite 200, Gaithersburg,MD 20877
301-921-0168
800-237-2815
ANALYTE:
NonRuman Primate Thyroid Stimulating
Ho=one
(TSH)
PROCEDURE:
Double Antibody RIA Inhouse Procedure
REAGENTS:
Human TSH standard (Ref WHO standard Sigma-Aldrich Inc. Cat. #T-4651
68/38)
Rabbit-anti human TSH (polyclonal) Sigma-Aldrich Inc. Cat. #T-4651
Radiolabeled
HTSH
Covance Laboratories, Inc., Vie=a, VA
CALIBRATION RANGE: 0.4 to 50 mlu/ml. (Low end sensitivity is dependent upon the integrity of the iodinated hormone.)
RESULTS: Computer
curve.
MIU/ml generated
values reported
below low end sensitivity
of the
COMMENT: Overall TSH levels in NHP are extremely low difficult to know if this test offers significant info=ation.
so it is clinical
1 N C PORATED
200 Girard Street,Suite 200, Gaithersburg,MD 20877
301-921-0168
800-237-2815
ANALYTE:
Free T4
PROCEDURE:
Coat-A-Count
RIA
REAGENT SOURCE: Diagnostic Products Corporation, CA.
CALIBRATION RANGE: 0.1 to 10 ng/dl (kit lot # specific)
RESULTS:
ng/dl Computer generated values reported below the standard.
INCORPORATED
200 Girard Street,Suite 200, Gaithersburg,MD 20877
301-921-0168
800-237-2815
ANALYTE:
Total T4
PROCEDURE:
RIA Coated Tube Assay
REAGENT SOURCE:
DPC, CA.
CALIBRATION
RANGE: 1 to 24 ug/dl
RESULTS:
ug/dl Computer generated
values reported below 1 ug/dI.
I N C 0 ORATED
200 Girard Street,Suite 200, Gaithersburg,MD 20877
301-921-0168
800-237-2815
ANALYTE:
Free T3
PROCEDURE:
Coat-A-Count
RIA
REAGENT SOURCE:
DPC, CA.
CALIBRATION RANGE: 0.5 - 42 pg/ml (kit lot # specific)
RESULTS:
pg/ml computer
standard
generated values curve calibrator
reported below the lowest concentration.
INCO PORATED
2oo Girard Street,Suite200, Gaithersburg,MD 20877
301-921-0168
800-237-2815
ANALYTE:
Total T3
PROCEDURE:
Radioinmunoassay
(RIA)
Coated Tube Assay
REAGENT SOURCE:
Diagnostic Products Corporation
(DPC), CA.
CALIBRATION RANGE: 20 to 600 ng/dl
RESULTS:
ng/dl computer generated
values reported below 20 ng/dl