Appendix_3__Sample_APS_Report.pdf

AUDIT OF PATHOLOGY SPECIMENS

(WET TISSUES, BLOCKS, AND SLIDES)

FOR THE CHRONIC GAVAGE

TOXICITY/CARCINOGENICITY STUDY OF

IN MALE AND FEMALE B6C3F1 MICE

CHEMICAL NO.ITDMS NO.:

Conducted by:

Submitted to:

National Institute of Environmental Health Sciences PO Box 12233

Research Triangle Park, NC 27709

Submitted by:

Research Triangle Park, NC 27709

Under Contract No.:

(WET TISSUES, BLOCKS, AND SLIDES)

I. Introduction ......................................................................................................... ;.. 1

A. Study Background

B. Study Duration

C. Audit Dates, Records, and Procedures

II. Audit Findings

A. Wet Tissue Review

1. Inventory for Specimens to be Audited

2. Animal Identifiers in the Residual Tissues

3. Wet Tissue Findings

B. Block and Slide Review

1. Inventory

2. Examination

C. Quantitative Summary

III. List of Attachments

IV. Conflict of Interest Statement

(WET TISSUES, BLOCKS, AND SLIDES)

NTP Testing Facility -

I. Introduction

The pathology specimens (wet tissues, blocks and slides) and related data from the two-year chronic gavage study were audited to assess their quality including accuracy, consistency, completeness and compliance with the standards of the National Toxicology Program (NTP).

A. Study Background

The two-year chronic gavage study was conducted by . The purpose of the study was to characterize the toxicity and carcinogenicity effects in mice of two-year gavage exposure to . The study was designed as follows:

Dose Level (mg/kg) Males Females 0 50 50

62.5 50 50 125 50 50 250 50 50

According to the Pathology Data Review report, liver, glandular stomach, nose, and thyroid gland in both male and female mice, as well as ovary in female mice were designated as organs to be reviewed for all lesions.

B. Study Duration

The dates of exposure entered in the exposure records and dates of scheduled sacrifice entered on the Individual Animal Necropsy Record (IANR) forms are listed in the following table:

Final

SEX DATES OF EXPOSURE

Male Female

C. Audit Dates, Records, and Procedures

DATES OF SCHEDULED

TERMINAL SACRIFICE

The audit was conducted from through at , Research Triangle Park, North Carolina by

The data for this study were recorded on the Toxicology Data Management Systems (TDMS). Individual Animal Necropsy Record (IANR) forms for all animals, Experimental Information System (EIS) and Post Experimental Information System (PElS) reports and other records reviewed are listed on Data Examined During Audit (Form 6-2).

Terminal and moribund sacrifice animals were selected randomly for a 10% sample, five mice per sex from each dose group of the core study including the controls, and two additional follow-up animals as requested in the Pathology Specimen Sampling Plan Memo (PSSPM), dated were selected for use in the review of residual wet tissues, blocks and slides and are listed on Animals Selected for Audit (Form 6-3).

The source and details about the organs with treatment-related effects information used during this audit are summarized on Form 6-5.

The residual wet tissues were reviewed for 40 animals per random 10% selection (wet tissues for the two animals listed in the Pathology Specimen Sampling Plan Memo (PSSPM) were not reviewed) to determine the extent to which: (a) bags were present or accounted for and contained adequate formalin, (b) bag labels contained complete and accurate information, (c) animal identifiers correctly identified individual animals, (d) gross lesions and tissues were trimmed properly, and (e) organs were incised or properly opened at necropsy. During the wet tissue examination, the bag labels were checked to assess the extent to which animal and histology numbers matched the corresponding study laboratory inventory (PEIRPT15). The review was performed by examining the residual wet tissues from each selected animal and comparing the identifiers and gross appearance to tissue bag labels and records of gross and microscopic observations. Untrimmed potential neoplasms in any tissue, as well as possible non-neoplastic changes that were untrimmed in target tissues, were documented as Untrimmed Potential Lesions

(UPL) on the Wet Tissue Review Sheet (Form 6-6) during the audit and listed in the main narrative of this report.

Blocks and slides for the 40 (10%) random sample and two animals per PSSPM were inventoried and reviewed to determine the extent to which: (a) blocks and slides were present or accounted for, (b) labels contained complete and accurate information, (c) blocks were sectioned and corresponding slides prepared properly and (d) blocks were sealed for proper preservation. Blocks and slides were examined for matching, labeling, preservation, and inventory consistencies. A block was considered cut full face when at least 70% of the tissue was present on the corresponding slide (Form 6-7).

II. Audit Findings

A. Wet Tissue Review

1. Inventory for Specimens to be Audited

All original IANR forms, EIS and PElS reports, and other records needed for the audit were present at the NTP Archives (Form 6-2).

Wet tissue bags were reviewed for 40 (10%) mice on the study and were identified by attached labels with computer-generated animal and histology numbers. None of the wet tissue bags had labeling discrepancies. Tissue bags for one (2.5%)* animal had leaking inner or outer bags. The wet tissue bags for all other animals contained properly preserved tissues and had adequate formalin. Individual animals and their discrepancies are recorded on the Wet Tissue Review Sheet (Form 6-6).

*Percentage rounded to tenths of a percent.

2. Animal Identifiers in the Residual Tissues

The mice were identified by tail tattoos as described by the SOP:

Identification of Rodents (RAC. 11-009-01), dated . Copies of this document are available in the NTP Archives and are used during the wet tissue review process.

The animal number printed on the bag label, animal identification code, and findings from the review of individual animal identifiers are recorded on the Wet Tissue Review Sheet (Form 6-6) and summarized by dosage group on Summary of Wet Tissue Inventory, Animal Identification, and Untrimmed Potential Lesions (Form 6-4).

Treatment Group Dosage Level (mg/kg)

Code 1 (Correct - Animal identifiers agree with bag number)

Code 2 (Partially Correct - Animal identifiers are not present or readable, but

The animal identifiers in the residual wet tissues were reviewed for 40 study animals. The two animals listed in the PSSPM were not reviewed. The audit findings are summarized in the following table:

VM LM MM HM VF LF MF HF Total 0 62.5 125 250 0 62.5 125 250

5 5 5 4 4 5 5 5 38

0 0 0 0 0 0 0 0 0 information present agrees with bag number)

Code 3 (Questionable - Animal identifiers are correct, but can

0 0 0 1 1 0 0 0 2 be read as a number other than the bag number)

Code 4 (Unreadable - Animal identifiers are unreadable, not 0 0 0 0 0 0 0 0 0 present, or mutilated)

Code 5 (Incorrect - Animal 0 0 0 0 0 0 0 0 0 identifiers are incorrect)

Total animals examined 5 5 5 5 5 5 5 5 40

The animal numbers for 38 mice were confirmed by reading the tail tattoo identifiers. Two animals had questionable tail tattoo identifiers.

However, an ID cross-check was not necessary because the tail tattoo identifiers were consistent with the identification information on their Individual Animal Necropsy Records. The sex of all animals was confirmed from residual wet tissue.

3. Wet Tissue Findings

Wet tissue examination of the 40 random sample animals from the study groups, excluding the two additional animals requested in the PSSPM, did not reveal any untrimmed potential lesions

All masses appeared to be appropriately trimmed. The two additional animals listed in the PSSPM for Gross-Microscopic and/or Clinical Gross Noncorrelation were not examined. During this review, the slides that should contain tissues that would account for the gross lesions which had not been addressed were present at the NTP Archives and were reviewed. The QA pathologist determined that the review of the wet tissue for those two animals was unnecessary because more than five nodules were visible on the slides.

The wet tissue findings from the review of individual animals are recorded on the Wet Tissue Review Sheets (Form 6-6) and summarized by dosage group on Summary of Wet Tissue Inventory, Animal Identification, and Untrimmed Potential Lesions (Form 6-4).

B. Block and Slide Review

1. Inventory

Blocks and slides were counted for each animal in the random 10% sample of the study groups, as well as for the two additional animals requested in the PSSPM (see I.e.). Results of the block and slide inventory and review are recorded on Block and Slide Inventory and Review Sheet (Form 6-7). The audit counts of the number of blocks and slides present at the NTP Archives for the 42 mice examined agreed with the totals recorded on the study laboratory inventory (PEIRPT15) for each mouse.

2. Examination

Results from examination of blocks and slides recorded for individual animals on the Block and Slide Inventory and Review Sheet (Form 6-7) are summarized in the following table:

Treatment Group VM Dosage Level (mg/kg) 0

'~~bC~S >.···.'r, .' ":

Animals Examined 5

Blocks Examined 61

Blocks/Slide Mismatch 0

Block Missing 0

Blocks Mislabeled 0

Blocks Not Cut Full Face 0

Blocks With Tissues 0 Exposed to Air

I~LI[)ESi' i' .· •••.. ,..i.'.

Slides Examined 62

Slides Missing 0

Slides Mislabeled 0

Slides With Air Bubbles 2

LM

62.5 .i'i.

.'i ... ,ii'

. . .• x. ','

MM HM

125 250 .1., ',i.' '\, .. ' I:'"

6 5

77 60

0 0

0 0

0 0

0 0

2 0 i.'i.

:·,.··.ri n

78 60

0 0

0 0

4 1

VF LF MF HF Total 0 62.5 125 250

I(~!i:. \:;i ... ·'. '::}iL) I"i ','?' ';"·.':;:"'i' 5 5 6 5 42

52 56 70 49 484

0 0 0 0 0

0 0 0 0 0

0 0 0 0 0

0 0 0 0 0

1 0 0 0 3

."i';' •.••. I,"'':: ")):'i .{;',";' li"ii::" .••. i!:,:'ii

54 59 75 50 497

0 0 0 0 0

0 0 0 0 0

0 5 0 3 18

Four blocks (0.8%)* of the 484 examined had holes in the paraffin.

Target organ tissues were affected in one block. Non-target organs were affected in three blocks (one block had a hole that was affecting both target and non-target tissues). Tissues were not affected in one block.

There were air bubbles (AB) beneath the coverslips of 18 of the 497 slides examined (3.6%)*. No tissues were affected on any of the 18 slides that contained air bubbles. These air bubbles did not adversely affect the quality of the slides.

Insufficient mounting media (IMM) was found on 27 of the 497 slides examined (5.4%)*. No tissues were affected on any of the slides.

*Percentage rounded to tenths of a percent.

C. Quantitative Summary

A quantitative summary of findings from the audit of pathology data is presented on Forms 6-1.1 and 6-1.2.

III. List of Attachments

1. Data From Audits of Pathology Specimens (Forms 6-1.1 and 6-1.2)

2. Data Examined During Audit (Form 6-2)

3. Animals Selected for Audit (Form 6-3)

4. Summary of Wet Tissue Inventory, Animal Identification, and Untrimmed Potential Lesions (Form 6-4)

5. Organs with Potential Treatment-Related Effects (Form 6-5)

6. Wet Tissue Review Sheet (Form 6-6)

7. Block and Slide Inventory and Review Sheet (Form 6-7)

8. Pathology Specimen Sampling Plan Memorandum (Attachment A)

IV. Conflict of Interest Statement

This statement is to certify that the personnel listed below participated in the audit of pathology specimens from the Chronic Gavage Toxicity/Carcinogenicity Study of in Male and Female B6C3F1

Mice conducted at and that they have not been involved in the conduct or evaluation of the study prior to the audit. Hence, their participation in the audit poses no apparent or actual conflict of interest. The audit was conducted from through .

Diplomate, ACVP Veterinary Pathologist

Date

FORMS 6-1.1 & 6-1.2

DATA FROM AUDITS OF PATHOLOGY SPECIMENS

CHEMICAL:

SPECIES/STRAIN: B6C3F1 MICE

ROUTE: GAVAGE

AUDIT PARAMETERS

1. Study Laboratory (2 letters)

2. Dates of Terminal Sacrifice

3. APS Start Date

4. APS Draft Report Date

5. Auditor Affiliation (3 letters)

6. Animals in Group

7. Animals in Study

8. Animals Selected for Audit; %, 8+7

9. Animals with WT Present; %, 9+7

10. Animals with Correct WT Bag Labels; %, 10+9

11. Animals with WT Bag Leaking; %, 11 +9

12. Animals with WT Identifiers Checked

13. InitiallD Code 1; %, 13+12

14. InitiallD Code 2; %, 14+12

15 .. lnitiallD Code 3; %, 15+12

16. InitiallD Code 4; %, 16+12

17. InitiallD Code 5; %, 17+12

18. Animals with Residual Wet Tissues Examined; %, 18+9

19. Number of Untrimmed Potential Lesions

20. Animals with UPL's; %, 20+18

21. UPL's in Potential Target Organs

22. Animals with GI Tract Not Opened Adequately; %,22+18

23. Blocks Examined

24. Blocks Missing; %, 24+(24+23)

25. Blocks Mislabeled, %, 25+23

26. Block/Slide Mismatches; %, 26+23

27. Blocks not Cut Full Face; %, 27+23

Form 6-1.1

CHEMICAL/TDMS NO.:

LABORATORY:

Rats

Number %

Mice

Number %

42 10.5%

400* 100.0%

400* 100.0%

2* 0.5%

38 95.0%

0 0.0%

2 5.0%

0 0.0%

0 0.0%

40 10.0%

0 0.0%

0 0.0%

0 0.0%

0 0.0%

0 0.0%

CHEMICAL:

SPECIES/STRAIN: B6C3F1 MICE

ROUTE: GAVAGE

CHEMICAL/TOMS NO.:

LABORATORY:

Rats

Number

AUDIT PARAMETERS

28. Blocks with Tissues Exposed to Air; %, 28+23

29. Blocks with Target Organ Tissues Exposed to Air; %, 29+23

30. Blocks with Non-Target Organ Tissues Exposed to Air; %, 30+23

31. Slides Examined

32. Slides Missing; %, 32+(32+31)

33. Slides Missing without Replacement; %, 33+(32+31)

34. Slides Mislabeled; %, 34+31

35. Slides with Air Bubbles; %, 35+31

36. Slides with Air Bubbles Affecting Target Organ Tissues; %, 36+31

37. Slides with Air Bubbles Affecting Non-target Organ Tissues; %, 37+31

38. Slides with Insufficient Mounting Media (IMM); %, 38+31

39. Slides with Insufficient Mounting Media Affecting Target Organ Tissues; %, 39+31

40. Slides with Insufficient Mounting Media Affecting Non-target Organ Tissues; %, 40+31

41. Slides with Excessive Mounting Media (EMM); %, 41 +31

42. Slides with Excessive Mounting Media Affecting Target Organ Tissues; %,42+31

43. Slides with Excessive Mounting Media Affecting Non-target Organ Tissues; %, 43+31

44. Other:

Footnotes: *Includes data from the initial wet !Issue Inventory conducted at (Archives form No. 7-5) ** One block had target and non-target tissue affected

Form 6-1.2

PAGE20F 2

Mice

Number %

3** 0.6%

1 0.2%

3 0.6%

0 0.0%

0 0.0%

0 0.0%

18 3.6%

0 0.0%

0 0.0%

27 5.4%

0 0.0%

0 0.0%

0 0.0%

FORM 6-2

DATA EXAMINED DURING AUDIT

DATA EXAMINED DURING AUDIT

Page .Lof 1

CHEMICAL: CHEMICAL/TDMS NO.:

LABORATORY: SPECIES/STRAIN: B6C3F1 MICE

DATES OF EXPOSURE: ...:...R:...:;O..::;U...:,.T.=.E;.,..: ...:::.G::....:AV..:..;A...:,.G::..;E=--________ _

PATHOLOGIST: TECHNICIAN(S):

TITLE OF RECORD RECORD DATE

SOP: IDENTIFICATION OF RODENTS (RAC. 11-009-01)

INDIVIDUAL ANIMAL NECROPSY RECORDS

TDMSE SLIDE/BLOCK INVENTORY (PEIRPT15)

FINAL LABORATORY REPORT

DRAFT PEIRPT14

EIS REPORT 02

PATHOLOGY DATA REVIEW

Technician(s)

Form 6-2

FORM 6-3

ANIMALS SELECTED FOR AUDIT

Page _1_ of _1

ANIMALS SELECTED FOR AUDIT

CHEMICAL: CHEMICAL/TOMS NO.:

LABORATORY: SPECIES/STRAIN: B6C3F1 MICE

PATHOLOGIST: TECHNICIAN(S):

ROUTE: GAVAGE

TWO-YEAR STUDY ANIMALS

VM LM MM HM VF LF MF

20 80 107 157 204 254 307

23 83 122 162 210 264 308

24 86 126 163 219 276 325

33 88 134 188 224 278 335

46 90 135* 197 244 291 336

143 344*

* Indicates animal was selected per request in the Pathology Specimen Sampling Plan Memo.

The random numbers were generated as follows: (Please check one)

• A computer-generated random numbers list was developed from a standard formula for calculation of random numbers.

HF

o The random numbers listed was generated from Table A 1 - TEN THOUSAND RANDOMLY ASSORTED DIGITS IN STATISTICAL METHODS, George W. Snedecor and William G. Cochran, The Iowa State University Press: 1967, pp. 543-546.

Technician(s)

Form 6-3

FORM 6-4

SUMMARY OF WET TISSUE INVENTORY,

ANIMAL IDENTIFICATION, AND

UNTRIMMED POTENTIAL LESIONS

SUMMARY OF WET TISSUE INVENTORY, ANIMAL IDENTIFICATION,

AND UNTRIMMED POTENTIAL LESIONS

Page _1_ of_1

CHEMICAL: CHEMICALITDMS NO.:

10 METHOD (EAR, PUNCH/NOTCH, TOE

CLIP, EAR TAG, ETC.): TAIL TATTOO

SPECIES/STRAIN: B6C3F1 MICE

PATHOLOGIST:

GROUP

No. of Animals in Audit

No. of Tissue Bags

No. of Animals with Multiple Tissue Bagsa

No. of Animals with Missing Tissue Bagsb

No. of Animals with Mislabeled Tissue BagsC

No. of Animals for Wet Tissue Examination

No. of Animals with Untrimmed Potential Lesions

No. of Untrimmed Potential Lesions

No. of Tissue Bags Opened 10 Codes:

Code 1 (Correct)

Code 2 (Partially Correct)

Code 3 (Questionable)

Code 4 (Unreadable)

Code 5 (Incorrect) aAnimal No. with multiple bags:

bAnimal No. for each missing bag (with explanation):

cAnimal No. for each mislabeled bag (with explanation):

Technician(s):

Date:

Form 6-4

VM LM

5 5

5 5

0 0

0 0

0 0

5 5

0 0

0 0

5 5

5 5

0 0

0 0

0 0

0 0

ROUTE: GAVAGE

LABORATORY:

TECHNICIAN(S):

MM I HM VF LF MF HF TOTAL

6 5 5 5 6 5 42

6 5 5 5 6 5 42

0 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0

5 5 5 5 5 5 40

0 0 0 0 0 0 0

0 0 0 0 0 0 0

5 5 5 5 5 5 40

5 4 4 5 5 5 38

0 0 0 0 0 0 0

0 1 1 0 0 0 2

0 0 0 0 0 0 0

0 0 0 0 0 0 0

FORM 6-5

ORGANS WITH POTENTIAL TREATMENT-RELATED EFFECTS

ORGANS WITH POTENTIAL TREATMENT-RELATED EFFECTS

CHEMICAL:

LABORATORY:

PATHOLOGIST:

ROUTE: GAVAGE

SEX ORGAN

MALE LIVER

STOMACH,GLANDULAR

NOSE

THYROID GLAND

FEMALE LIVER

STOMACH,GLANDULAR

NOSE

THYROID GLAND

OVARY

CHEMICAL/TDMS NO.:

SPECIES/STRAIN: B6C3F1 MICE

TECHNICIAN(S):

STUDY

PATHOLOGIST

PATHOLOGY DATA

REVIEW

+ = IndIcates the organ was consIdered to have potentIal treatment-related effects

* = The bulk of these tissues were embedded; therefore, few pieces were available for review -= Indicates the organ was not considered to have potential treatment-related effects

Technician(s)

Form 6-5

WET TISSUE REVIEW SHEET

CHEMICAL: CHEMICAUTDMS NO.: SPECIES/STRAIN: B6C3F1 MICE LABORATORY:

PATHOLOGIST: TECHNICIAN(S): ROUTE: GAVAGE DOSE/GROUP/SEX: 0 MG/KGNM/MALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = ID Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable -Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs

Identifier Present

Animal and Number v'

Histology (Read by Reason For Number Auditor) 1.0. Code M F Examination Comments

20 20 1 v' A F

0900020

23 23 1 v' A F

0900023

24 24 1 v' A F

0900024

33 33 1 v' A F

0900033

46 46 1 v' A F

0900046

Technicia Date

Form 6-6

PATHOLOGIST: TECHNICIAN(S): ROUTE: GAVAGE DOSE/GROUP/SEX: 62.5 MG/KG/LM/MALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = ID Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs

Identifier Present

Animal and Number ..;'

Histology (Read by Reason For Number Auditor) 1.0. Code M F Examination Comments

80 80 1 ..;' A F

0900080

83 83 1 ..;' A F

0900083

86 86 1 ..;' A F

0900086

88 88 1 ..;' A F

0900088

90 90 1 ..;' A F

0900090

TeChn Date

CHEMICAL: CHEMICAUTDMS NO.; SPECIES/STRAIN; B6C3F1 MICE LABORATORY;

PATHOLOGIST; TECHNICIAN(S); ROUTE: GAVAGE DOSE/GROUP/SEX; 125 MG/KG/MM/MALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = 10 Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs

Identifier Present

Animal and Number V-

Histology (Read by Reason For Number Auditor) 1.0. Code M F Examination Comments

107 107 1 V- A F

0900107

122 122 1 V- A F

0900122

126 126 1 V- A F

0900126

134 134 1 V- A F

0900134

135 - - - - B WET TISSUE REVIEW WAS NOT PERFORMED; DETERMINED TO BE UNNECESSARY DUE

0900135 TO THE PRESENCE OF MORE THAN FIVE NODULES BEING VISIBLE ON THE SLIDE.

Technician

Date

PATHOLOGIST: TECHNICIAN(S}: ROUTE: GAVAGE DOSE/GROUP/SEX: 125 MG/KG/MM/MALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = 10 Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable. but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct. but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable. not present. or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs

Identifier Present

Animal and Number ,f

Histology (Read by Reason For Number Auditor) 1.0. Code M F Examination Comments

143 143 1 ,f A F

0900143

Technicia

Date

CHEMICAL: CHEMICALfTDMS NO.: SPECIES/STRAIN: B6C3F1 MICE LABORATORY:

PATHOLOGIST: TECHNICIAN(S): ROUTE: GAVAGE DOSE/GROUP/SEX: 250 MG/KG/HM/MALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = 10 Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs Identifier Present

Animal and Number ./

Histology (Read by Reason For Number Auditor) 1.0. Code M F Examination Comments

157 157 1 ./ A F

0900157

162 162 1 ./ A F

0900162

163 163 1 ./ A F

0900163

188 188 1 ./ A INNER BAG LEAKING; REBAGGED DURING WET TISSUE AUDIT.

0900188

197 1967 3 ./ A TAIL TADOO AGREES WITH IDENTIFICATION INFORMATION LISTED ON THE IANR.

0900197

Technician

Date

Form 6-6

I

CHEMICAL: CHEMICALlTDMS NO.: SPECIES/STRAIN: B6C3F1 MICE LABORATORY:

PATHOLOGIST: TECHNICIAN(S): ROUTE: GAVAGE DOSE/GROUP/SEX: 0 MG/KGNF/FEMALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = ID Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs

Identifier Present

Animal and Number ./

Histology (Read by Reason For Number Auditor) I.D. Code M F Examination Comments

204 204 1 ./ A F

0900204

210 210 1 ./ A F

0900210

219 219 1 ./ A F

0900219

224 224 1 ./ A F

0900224

244 2044 3 ./ A TAIL TATTOO AGREES WITH IDENTIFICATION INFORMATION LISTED ON THE IANR.

0900244

TeChnici Date

Form 6-6

CHEMICAL: CHEMICALITDMS NO.: C20006B/20006-04 SPECIES/STRAIN: B6C3F1 MICE LABORATORY:

PATHOLOGIST: TECHNICIAN(S): ROUTE: GAVAGE DOSE/GROUP/SEX: 62.5 MG/KG/LF/FEMALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = ID Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs Identifier Present

Animal and Number ./

Histology (Read by Reason For Number Auditor) I.D. Code M F Examination Comments

254 254 1 ./ A F

0900254

264 264 1 ./ A F

0900264

276 276 1 ./ A F

0900276

278 278 1 ./ A F

0900278

291 291 1 ./ A F

0900291

Technician

Date

Form 6-6

PATHOLOGIST: TECHNICIAN(S): ROUTE: GAVAGE DOSE/GROUP/SEX: 125 MG/KG/MF/FEMALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = ID Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs

Identifier Present

Animal and Number y'

Histology (Read by Reason For Number Auditor) 1.0. Code M F Examination Comments

307 307 1 y' A F

0900307

308 308 1 y' A F

0900308

325 325 1 y' A F

0900325

335 335 1 y' A F

0900335

336 336 1 y' A F

0900336

TeCh Date

Form 6-6

PATHOLOGIST: TECHNICIAN(S): ROUTE: GAVAGE DOSE/GROUP/SEX: 125 MG/KG/MF/FEMALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = ID Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs

Identifier Present

Animal and Number v'

Histology (Read by Reason For Number Auditor) 1.0. Code M F Examination Comments

344 - - - - B WET TISSUE REVIEW WAS NOT PERFORMED; DETERMINED TO BE UNNECESSARY DUE TO

0900344 THE PRESENCE OF MORE THAN FIVE NODULES BEING VISIBLE ON THE SLIDE.

Techniciarr1 Date

CHEMICAL: CHEMICALlTDMS NO.: SPECIES/STRAIN: B6C3F1 MICE LABORATORY:

PATHOLOGIST: TECHNICIAN(S): ROUTE: GAVAGE DOSE/GROUP/SEX: 250 MG/KG/HF/FEMALE

KEY: A = 10% Random Sample; B = Gross-Microscopic Noncorrelation; C = Clinical-Gross Noncorrelation; 0 = 10 Cross Check; E = Data Entry Discrepancy; F = No Comment

1.0. Code Definitions: 1 = Correct - Animal identifiers agree with bag #; 2 = Partially Correct - Animal identifiers are not present or readable, but info present agrees with bag #; 3 = Questionable - Animal identifiers are correct, but can be read as a # other than the bag #; 4 = Unreadable - Animal identifiers are unreadable, not present, or mutilated;

5 = Incorrect - Animal identifiers are incorrect.

Animal Sex Organs Identifier Present

Animal and Number ./

Histology (Read by Reason For Number Auditor) 1.0. Code M F Examination Comments

355 355 1 ./ A F

0900355

365 365 1 ./ A F

0900365

390 390 1 ./ A F

0900390

399 399 1 ./ A F

0900399

400 400 1 ./ A F

0900400

TeChn Date

FORM 6-7

BLOCK AND SLIDE INVENTORY AND REVIEW SHEETS

BLOCK AND SLIDE INVENTORY AND REVIEW SHEET

CHEMICAL: CHEMICALlTDMS NO.: SPECIES/STRAIN: B6C3F1 MICE

PATHOLOGIST:

KEY:

./ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

20 10 10

0900020

23 13 13

0900023

24 11 11

0900024

33 11 11

0900033

Technician

Date

Form 6-7

TECHNICIAN(S): ROUTE: GAVAGE

Audit

AB = Air Bubbles MS = Multiple Slides RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

10 10

13 13

11 11

12 12

NC = No Comment BS = Blood Smear GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 0 MG/KGNM/MALE

REE = Re-embed

Comments I

SL. NO(S). 4,5,6, AND 10 -IMM NOT

AFFECTING TISSUE.

SL. NO(S). 2 AND 5 - AB NOT AFFECTING

TISSUE. SL. NO.4 - IMM NOT AFFECTING

TISSUE.

SL. NO(S). 1,3, AND 4 -IMM NOT

AFFECTING TISSUE.

SL. NO.6 - ORIGINAL AND 1 RC i

PRESENT.

PATHOLOGIST:

KEY:

../ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

46 16 16

0900046

Technic Date

Form 6-7

TECHNICIAN(S): ROUTE: GAVAGE

Audit

AB = Air Bubbles MS = Multiple Slides RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

16 16

NC = No Comment BS = Blood Smear GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 0 MG/KGNM/MALE

REE = Re-embed

Comments

NC

CHEMICAL: CHEMICAUTDMS NO.: SPECIES/STRAIN: B6C3F1 MICE

PATHOLOGIST:

KEY:

./ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

80 13 13

0900080

83 12 12

0900083

86 12 12

0900086

88 11 11

0900088

Technician( s)'

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides

RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

13 13

12 12

12 12

11 11

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear

GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 62.5 MG/KG/LM/MALE

REE = Re-embed

Comments

NC .

NC

NC

SL. NO.6 - IMM NOT AFFECTING TISSUE.

SL. NO. 10 - AB NOT AFFECTING TISSUE.

PATHOLOGIST:

KEY:

v' denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15

Number LAB ARCHIVES

90 11 11

0900090

Technician(~)

Date

Form 6-7

TECHNICIAN(S):

Audit v'

AB = Air Bubbles MS = Multiple Slides RC = Recut Slide

EMM = Excessive Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

11 11

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear GRC = Gross Recut

IMM = Insufficient Mounting Media

Slide/Block Audit Discrepancy v'

LABORATORY:

DOSE/GROUP/SEX: 62.5 MG/KG/LM/MALE

REE = Re-embed

Comments

SL. NO. 4 - IMM NOT AFFECTING

TISSUE. SL. NO.7 - AB NOT AFFECTING

TISSUE. SL. NO.8 - MULTIPLE AB'S NOT

AFFECTING TISSUE. SL. NO(S). 5 AND 9 -

NON-TARGET TISSUE (5-INTESTINE,

9-HARDERIAN GL) EXTENDS BEYOND

COVERSLIP.

PATHOLOGIST:

KEY:

./ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15

Number LAB ARCHIVES

107 12 12

0900107

122 16 16

0900122

126 12 12

0900126

Technician(s)

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides RC = Recut Slide

EMM = Excessive Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

12 12

17 17

12 12

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear

GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 125 MG/KG/MM/MALE

REE = Re-embed

Comments

SL. NO.2 - IMM NOT AFFECTING TISSUE.

I

SL. NO.3 - ORIGINAL AND 1 RC

PRESENT. BLOCK NO.3 - HOLE IN

PARAFFIN AFFECTING NON-TARGET

ORGAN (HEART). SL. NO(S). 2,3, AND 5 -

AB NOT AFFECTING TISSUE.

SL. NO.4 - AB NOT AFFECTING TISSUE.

PATHOLOGIST:

KEY:

v' denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

134 10 10

0900134

135 15 15

0900135

143 12 12

0900143

Technician (s )

Date

Form 6-7

TECHNICIAN(S):

Audit v' v' v'

AB = Air Bubbles

MS = Multiple Slides RC = Recut Slide

EMM = Excessive Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

10 10

15 15

12 12

ROUTE: GAVAGE

NC = No Comment

BS = Blood Smear GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy v' v' v'

LABORATORY:

DOSE/GROUP/SEX: 125 MG/KG/MM/MALE

REE = Re-embed

Comments I

NC

SL. NO(S). 6, 11 AND 12 - IMM NOT

AFFECTING TISSUE. BLOCK NO. 13-

HOLE IN PARAFFIN AFFECTING NON-

TARGET ORGAN (LUNG).

SL. NO.7 - IMM NOT AFFECTING TISSUE.

L

PATHOLOGIST:

KEY:

./ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15

Number LAB ARCHIVES

157 11 11

0900157

162 14 14

0900162

163 12 12

0900163

188 10 10

0900188

Technician(s)

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides

RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

11 11

14 14

12 12

10 10

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear

GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 250 MG/KG/HM/MALE

REE = Re-embed

Comments

NC

NC

SL. NO 2 - AB NOT AFFECTING TISSUE. !

SL. NO.3 - NON-TARGET TISSUE (LUNG)

EXTENDS BEYOND COVERSLIP.

NC I

PATHOLOGIST:

KEY:

-/ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

197 13 13

0900197

Technician(s)

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

13 13

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear

GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 250 MG/KG/HM/MALE

REE = Re-embed

SL. NO. 13 - IMM NOT AFFECTING TISSUE.

PATHOLOGIST:

KEY:

v' denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15

Number LAB ARCHIVES

204 11 11

0900204

210 9 9

0900210

219 11 11

0900219

Technician(s)

Date

Form 6-7

TECHNICIAN(S): ROUTE: GAVAGE

Audit v' v' v'

AB = Air Bubbles

MS = Multiple Slides RC = Recut Slide

EMM = Excessive Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

12 12

9 9

11 11

NC = No Comment

BS = Blood Smear GRC = Gross Recut

IMM = Insufficient Mounting Media

Slide/Block Audit Discrepancy v' v' v'

LABORATORY:

DOSE/GROUP/SEX: 0 MG/KGNF/FEMALE

REE = Re-embed

Comments

SL. NO.3 - CRACKED AND REPAIRED

AT BC. SL. NO.6 - ORIGINAL AND 1 RC

PRESENT.

NC

BLOCK NO.3 - MULTIPLE HOLES IN

PARAFFIN AFFECTING NON-TARGET

ORGAN (HEART) AND TARGET ORGAN

(LIVER).

PATHOLOGIST:

KEY:

-/ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15

Number LAB ARCHIVES

224 10 10

0900224

244 11 11

0900244

Technicia

Date

Form 6-7

TECHNICIAN(S): ROUTE: GAVAGE

Audit

AB = Air Bubbles

MS = Multiple Slides RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

11 11

11 11

NC = No Comment BS = Blood Smear GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 0 MG/KGNF/FEMALE

REE = Re-embed

Comments

SL. NO. 10 - ORIGINAL AND 1 REE

PRESENT. SL. NO.5 - IMM NOT

AFFECTING TISSUE. BLOCK NO.9 -

HOLE IN PARAFFIN NOT AFFECTING

TISSUE.

SL. NO(S). 1,3,4,10, AND 11 -IMM NOT

AFFECTING TISSUE.

PATHOLOGIST:

KEY:

-/ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

254 11 11

0900254

264 11 11

0900264

276 15 15

0900276

Technician(s

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles

MS = Multiple Slides RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

12 12

12 12

16 16

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 62.5 MG/KG/LF/FEMALE

REE = Re-embed

Comments

SL. NO(S). 2, 3, AND 8 - AB NOT AFFECTING

TISSUE. SL. NO.3 - ORIGINAL AND 1 RC

PRESENT.

SL. NO.6 - ORIGINAL AND 1 RC PRESENT.

SL. NO(S). 10 AND 11 - MULTIPLE AB'S NOT

AFFECTING TISSUE.

SL. NO.3 - ORIGINAL AND 1 RC PRESENT.

PATHOLOGIST:

KEY:

-/ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

278 9 9

0900278

291 10 10

0900291

Technician($)

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides RC = Recut Slide

EMM = Excessive Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

9 9

10 10

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 62.5 MG/KG/LF/FEMALE

REE = Re-embed

Comments

PATHOLOGIST:

KEY:

../ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

307 12 12

0900307

308 11 11

0900308

325 12 12

0900325

335 10 10

0900335

Technician($)

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides

RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

12 12

12 12

13 13

10 10

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear

GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 125 MG/KG/MF/FEMALE

REE = Re-embed

Comments

SL. NO(S). 2,8, AND 9 - IMM NOT AFFECTING

TISSUE .

SL. NO.9 - ORIGINAL AND 1 RC PRESENT.

SL. NO(S). 1 AND 2 - IMM NOT AFFECTING

TISSUE .

SL. NO. 10 - ORIGINAL AND 1 REE

PRESENT .

PATHOLOGIST:

KEY:

-/ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15

Number LAB ARCHIVES

336 13 13

0900336

344 12 12

0900344

Technicia

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

15 15

13 13

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 125 MG/KG/MF/FEMALE

REE = Re-embed

Comments

SL. NO(S). 4 AND 6 - ORIGINAL AND 1 RC

PRESENT.

SL. NO.3 - ORIGINAL AND 1 RC PRESENT.

PATHOLOGIST:

KEY:

-/ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15

Number LAB ARCHIVES

355 10 10

0900355

365 9 9

0900365

390 10 10

0900390

399 10 10

0900399

Technici

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

10 10

9 9

10 10

10 10

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear GRC = Gross Recut IMM = Insufficient

Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 250 MG/KG/HF/FEMALE

REE = Re-embed

Comments

SL. NO(S). 7 AND 10 - AB NOT AFFECTING

TISSUE.

SL. NO.3 - AB NOT AFFECTING TISSUE.

NC

PATHOLOGIST:

KEY:

../ denotes agreement with preceding number

X denotes discrepancy present

Animal and Number of Blocks

Histology PEIRPT15 Number LAB ARCHIVES

400 10 10

0900400

Technician(s) 1

Date

Form 6-7

TECHNICIAN(S):

Audit

AB = Air Bubbles MS = Multiple Slides

RC = Recut Slide EMM = Excessive

Mounting Media

Number of Slides

PEIRPT15

LAB ARCHIVES

11 11

ROUTE: GAVAGE

NC = No Comment BS = Blood Smear GRC = Gross Recut

IMM = Insufficient Mounting Media

Slide/Block Audit Discrepancy

LABORATORY:

DOSE/GROUP/SEX: 250 MG/KG/HF/FEMALE

REE = Re-embed

SL. NO.4 - ORIGINAL AND 1 RC PRESENT.

ATTACHMENT A

PATHOLOGY SPECIMEN SAMPLING PLAN

MEMORANDUM

{ -:::z~E.

't,.,..... DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health National Institute of Environmental Health Sciences P. O. Box 12233 Research Triangle Park, NC 27709

Memorandum

Date

From November 19, 2010 NTP Study Patholo~ NTP Pathology /CMPB

Subject Pathology Data Review Approval & Pathology Specimen Sampling Plan

To Pathology Data Coordination Unit

STUDY IDENTIFICATION:

Chronic Gavage

The Pathology Data Review (PDR) for the study listed above has been reviewed and accepted. This study may proceed to the Audit of Pathology Specimens (slide/block and tissue review). The following animals are identified for evaluation during the Audit of Pathology Specimens (slide/block and tissue review).

Sampling Plan for Specimens Review

Number of Animals to be Selected Randomly from Each Treatment Group for Slide/Block and Tissue Reviews:

x 10% Other

X Additional Animals for Slide/Block and Tissue Reviews:

--- Please review all animals on Attachments B & D cc:

(SEE ATTACHMENTD)

PDR APPROVAL I APS SAMPLE PLAN MEMO