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Template For Subchronic Toxicity Study in Rodents

March 2004

Introduction to the Template For Subchronic Toxicity Study in Rodents

Return to Toxicology Template Introduction


Table Of Contents

  1. Identification of Study
  2. Good Laboratory Practice
  3. Executive Summary
  4. Materials and Methods
    1. Test Substance
    2. Test Substance As Administered
    3. Animal Diet
    4. Test Animals
    5. Experimental Design
    6. Body Weight And Feed Intake
    7. Cage-Side Observations
    8. Opthalmological Examination
    9. Hematology
    10. Clinical Chemistry
    11. Urinalysis
    12. Other Tests
    13. Necropsy (Interim Sacrifice)
    14. Necropsy (Terminal)
    15. Gross Pathology Observations
    16. Histopathology Observations
    17. Statistical Methods
  5. Results
    1. Dose Verification
    2. Feed Consumption Changes
    3. Intake Of Test Substance
    4. Feed Efficiency
    5. Body Weight Changes
    6. Cage-Side Observations
    7. Mortality
    8. Opthalmological Examination
    9. Hematology
    10. Clinical Chemistry
    11. Urinalysis
    12. Other Tests
    13. Organ Weights
    14. Gross Pathology Changes Observed
    15. Histopathology Changes Observed
    16. Neurotoxicity
  6. Evaluation And Comment On Study
  7. Summary And Conclusions
    1. Brief Summary Of Major Findings From The Study
    2. Relationship Between Dose And Incidence/Severity Of Lesions Or Abnormalities
    3. Was There A Target Organ?
    4. NOEL
  8. References

Subchronic Toxicity Study in Rodents Template

Date of Submission:

Title of Petition or Notification:

Name and Address of Petitioner or Notifier:

I. Identification of Study[1] 

A. Study File Location:
B. Study Title/Report Number:
C. Name and Address of Testing Facility:
D. Date of Study Report:
E. Dates Study Conducted:
F. Study Objective:
G. Comments:

II. Good Laboratory Practice[2] 

A. Good Laboratory Practice (GLP) Compliance?
B. Quality Assurance (QA) Statement?
C. Availability and Location of Original Data/Specimens/Test Substance:

III. Executive Summary

IV. Materials and Methods

A. Test Substance[3]

  1. CAS name:
  2. Other name(s):
  3. CAS registry number:
  4. Molecular structure: http://www.chemfinder.com[4] /
  5. Purity:
  6. Impurities:
  7. Stability:
  8. Comments:

B. Test Substance As Administered[5] 

  1. Batch/lot number:
  2. Route:
  3. Vehicle used:
  4. Tested adequately for concentration?
  5. Tested for homogeneity?
  6. Tested for stability?
  7. Problems with storage?

C. Animal Diet,

  1. Feed
    1. Type:
    2. Name:
    3. Availability:
    4. Analysis for contaminants:
    5. Comments:
  2. Water
    1. Source:
    2. Availability:
    3. Analysis for contaminants:  
    4. Comments:

D. Test Animals[6] 

  1. Species/strain/substrain:
  2. Sex:
  3. Age range at initiation of study:  
  4. Weight range at initiation of study:
  5. Quarantine/acclimation?
  6. Physical examination times:
  7. Number per cage:   
  8. Environmental conditions:  
  9. Comments:

E. Experimental Design[7] 

1. Targeted dose levels:

Table # [Heading]

test group

conc. in diet
(ppm or mg/kg)

dose to animals
(mg/kg body-weight/day)

number of males

number of females

Control

    

Low

    

Mid

    

High

    

2. Total number of animals:  
3. Duration of study (including recovery period, if any): 
4. Length of exposure to test substance:
5. Were animals randomized?
6. Recovery period:  
7. Comments: 

F.  Body Weight And Feed Intake

1. Parameter examined:

Table # [Heading]

examined

not examined

 Feed Intake*
Feed Spillage*
Water Intake*
Body Weight*
Body Weight Changes*

*These parameters are recommended in REDBOOK for subchronic toxicity studies.

2. Comments:(e.g., list frequency)

G. Cage-Side Observations[8] 

1. Parameter examined: 

Table # [Heading]

examined

not examined

 Appearance*
Abnormal Stool*
Morbidity*
Mortality*
Neurotoxicity Screening (Specify parameters)*, ** 

*These parameters are recommended in REDBOOK for subchronic toxicity studies. Add additional parameters tested.

**The parameters for neurotoxicity screening may include, but are not limited to, the following:

  • Changes in skin, fur, eyes, mucous membranes, gait, posture, and response to handling,
  • Occurrence of secretions/excretions or other evidence of autonomic activity such as lacrimation, piloerection, pupil size change, unusual respiratory pattern,
  • Presence of clonic or tonic seizure,
  • Stereotype behaviors such as excessive grooming and repetitive circling,
  • Bizarre behavior such as self-mutilating and walking backwards,
  • Gross tumor development.

2. Comments: (e.g., list frequency)

H. Opthalmological Examination

  1. Parameter examined:  
  2. Comments: (e.g., list frequency)

I. Hematology[9] 

  1. Fasting duration prior to blood collection:
  2. When in the study were the blood samples collected?  
  3. How were the blood samples drawn?  
  4. Dose groups and number of animals tested:
  5. Parameter examined:  

Table # [Heading]

measurement
related to

examined

not examined

red blood cells

 Hematocrit (Hct)*
Hemoglobin Conc. (Hb)*
Mean Corp. Hb. (MCH)*
Mean Corp. Hb. Conc. (MCHC)* Mean Corp. Volume (MCV)*
Total Erythrocyte Count (RBC)*

white blood cells

 Basophils, Eosinophils* Lymphocytes*
Macrophage/Monocytes*
Neutrophils*
Total Leukocytes (WBC)*

clotting potential

 Activated Partial-Thromboplastin Time*
Clotting Time*
Platelet Count*
Prothrombin Time*

others

 Bone marrow cytology*
Reticulocyte counts*

  *These parameters are recommended in REDBOOK for subchronic toxicity studies. Add additional additional parameters tested.

6. Comments:    

J. Clinical Chemistry[10] 

  1. Fasting duration prior to blood collection:  
  2. When in the study were the blood samples collected?
  3. How were the blood samples drawn?
  4. Dose groups and number of animals tested:
  5. Parameter examined:  

Table # [Heading]

measurement related to

examined

not examined

electrolyte balance Calcium* Chloride*[,]** Phosphorus* Potassium*[,]** Sodium*[,]**
carbohydrate metabolism Glucose*[,]**
liver function:
  A) hepatocellular
  (recommend at
  least 3 out of 5 
  RED BOOK 
  PARAMETERS )
  B) hepatobiliary
  (recommend at
  least 3 out of 5
  RED BOOK
  PARAMETERS)
 Alanine Aminotransferase
(ALT or SGPT)*[,]**
Aspartate Aminotransferase
(AST or SGOT)*
Glutamate Dehydrogenase* Sorbitol Dehydrogenase*
Total Bile Acids*
 Alkaline Phosphatase (ALP)*[,]**
Gamma-Glutamyl Transferase (GGT)*[,]**
Total Bile Acids*
Total Bilirubin*
5' Nucleotidase*
kidney function Creatinine*[,]**
Urea Nitrogen*[,]**

others

(acid/base balance, cholinesterases, hormones, lipids, methemoglobin, and proteins)

 Albumin (A)*
Globulin (G, calculated) or A/G Ratio*
Total Cholesterol*
Cholinesterase*
Total protein*[,]**
Fasting Triglycerides*

*These parameters are recommended in REDBOOK for subchronic toxicity studies. Add additional additional parameters tested.

** These parameters should generally be given priority when adequate volumes of blood samples can not be obtained from test animals.

6. Comments:  

K. Urinalysis[11] 

  1. When were urine samples collected?  
  2. Parameter examined:

Table # [Heading]

examined

not examined

 

Glucose*, Microscopic evaluation for sediment and presence of blood/blood cells*, pH*, Protein*, Specific Gravity*, Volume*

* These parameters are recommended in REDBOOK for subchronic toxicity studies.

3. Comments :

L. Other Tests[12] 

  1. Observations:
  2. Comments:

M. Necropsy (Interim Sacrifice)[13] 

  1. Was there an interim sacrifice?
  2. Dose groups and number of animals:
  3. Organs/Tissues weighed:

Table # [Heading]

examined

not examined

 

Adrenals*, Brain*, Epididymides*, Heart*,
Kidneys*, Liver*, Spleen*, Testes*, Thyroid/parathyroid*, Thymus*, Ovaries*, Uterus*

* These parameters are recommended in REDBOOK for subchronic toxicity studies.

4. Comments:  

N. Necropsy (Terminal)

1. Organs/Tissues weighed:

Table # [Heading]

examined

not examined

 

Adrenals*, Brain*, Epididymides*, Heart*,
Kidneys*, Liver*, Spleen*, Testes*, Thyroid/parathyroid*, Thymus*, Ovaries*, Uterus*

*These parameters are recommended in REDBOOK for subchronic toxicity studies. Add additional additional parameters tested.

2. Comments:  

O. Gross Pathology Observations

  1. Organs/Tissues Examined:
  2. Comments:

P. Histopathology Observations

  1. Organs/Tissues were collected from which dose groups?  
  2. Organs/Tissues were examined from which dose groups?
  3. How were the organs/tissues prepared for histopathology observation?  
  4. Organs/Tissues collected:

Table # [Heading]

system

examined

not examined

digestive

 Salivary Gland*, Esophagus*, Stomach*, Duodenum*, Jejunum*, Ileum*, Cecum*, Colon*, Rectum*, Gall Bladder* (in case of mice), Liver* (middle, left and triangular lobes), Pancreas*

respiratory

 Nasal Turbinates*, Trachea*,
Lung* (with main-stem bronchi)

cardiovascular

 Aorta*, Heart*

reticulo- endothelial/
hematopoietic

 Bone Marrow* (sternum),
Lymph Nodes* (1 related to route of administration, and 1 from a distant location),
Spleen*, Thymus*

urogenital

 Kidneys*, Ovaries* and fallopian tubes*, Corpus Uteri*, Cervix Uteri*, Prostate*, Seminal Vesicle* (if present), Testes*, Urinary Bladder*, Vagina*

neurologic

 Brain* (at least 3 different levels), Spinal-Cervical*,
Spinal-Lumbar*,
Spinal-Midthoracic*,
Sciatic Nerve*,
Harderian Gland* (if present)

glandular

 Adrenals*, Mammary Glands*, Pituitary Glands*, Thyroid/Parathyroid Glands*, Thymus*,
Zymbal's Gland* (if present)

other

 Bone (Femur)*, Eyes*, Skeletal Muscle*, Skin*, Epididymis*

*These parameters are recommended in REDBOOK for subchronic toxicity studies. Add additional additional parameters tested.

5. Comments:

Q. Statistical Methods

1. Methods of statistical analysis:

Table # [Heading]

methods of statistical analysis

parameters tested

  
  
  
  

2. Comments:

V. Results

A. Dose Verification[14] 

1. Were doses verified?

Table # [Heading]

dose group

targeted concentration
 (ppm or mg/kg)

concentrations found in feed
(ppm or mg/kg)

standardDeviation

N*

low

    

mid

    

high

    

* Number of measurements (N)

  1. Verified by:    
  2. Comments:

B. Feed Consumption Changes[15] 

  1. Observations:
  2. Comments:

C. Intake Of Test Substance[16]

1. Observations:

Table # [Heading]

dose group

daily dose
(mg/kg body-weight/day)

control

0

low

 

mid

 

high

 

2. Comments:

D. Feed Efficiency[17] 

  1. Was feed efficiency calculated?
  2. Comments:  

E. Body Weight Changes[18] 

  1. Observations:
  2. Comments:

F.  Cage-Side Observations[19] 

  1. Observations:  
  2. Comments:

G. Mortality[20] 

  1. Observations:  
  2. Comments:

H. Opthalmological Examination

  1. Observations:
  2. Comments:

I. Hematology[21] 

1. Observations:

Table # [Heading]

 SEX males females

DAILY DOSE
 (mg/kg body-weight/day)

0
CONTROL

 

 

 

0
CONTROL

 

 

 

NUMBER OF ANIMALS

        

red blood cells

        
Hematocrit (Hct)

%

        
Hemoglobin Conc. (Hb)

g/L

        
Mean Corp. Hb. (MCH)         
Mean Corp. Hb. Conc. (MCHC)         
Mean Corp. Volume (MCV)

L/L

        
Total Erythrocyte Count (RBC)

10[12]/L

        

white blood cells

        
Basophils         
Eosinophils         
Lymphocytes

10[9]/L

        
Macrophage/
Monocytes
         
Neutrophils

10[9]/L

        

Total Leukocytes (WBC)

10[9]/L

        

clotting potential

        

Activated Partial-Thromboplastin Time

         

Clotting Time

         

Platelet Count

10[9]/L

        

Prothrombin Time

         

others

        

Bone marrow cytology

         

Reticulocyte counts

10[12]/L

        

Specify a method of statistical analysis): * p<0.05, ** p<0.01

2. Comments:

J.  Clinical Chemistry[22] 

1. Observations:

Table # [Heading]

SEX

males

females

DAILY DOSE
 (mg/kg body-weight/day)

0
CONTROL

 

 

 

0
CONTROL

 

 

 

NUMBER OF ANIMALS

        
electrolyte balance        

Calcium

mmol/L

        

Chloride

mmol/L

        

Phosphorus

mmol/L

        

Potassium

mmol/L

        

Sodium

mmol/L

        
carbohydrate metabolism        

Glucose

mmol/L

        

liver function:

A) hepatocellular

        

Alanine Aminotransferase

(ALT or SGPT)

U/L

        

Aspartate Aminotransferase

(AST or SGOT)

U/L

        

Glutamate Dehydrogenase

U/L

        

Sorbitol Dehydrogenase

U/L

        
liver function:
B) hepatobiliary
        

Alkaline Phosphatase (ALP)

U/L

        

Gamma-Glutamyl Transferase (GGT)

U/L

        

Total Bile Acids

mmol/L

        

Total Bilirubin

mmol/L

        

5' Nucleotidase

U/L

        
kidney function        

Creatinine

mmol/L

        

Urea Nitrogen

mg/dL

        
others        

Albumin (A)

g/L

        

Globulin (G, calculated)

g/L

        

A/G Ratio

         

Total protein

g/L

        

Total Cholesterol

mmol/L

        

Fasting Triglycerides

mmol/L

        

Cholinesterase

U/L

        

(Specify statistical method of analysis): * p<0.05, ** p<0.01

2. Comments:

K. Urinalysis[23] 

1. Observations:

Table # [Heading]

SEX

males

females

DAILY DOSE
 (mg/kg body-weight/day)

0
CONTROL

 

 

 

0
CONTROL

 

 

 

NUMBER OF ANIMALS

        

Glucose

mmol/L

        

Microscopic evaluation for sediment and presence of blood/blood cells

         

pH

         

Protein

g/L

        

Specific Gravity

         

Volume

L/time

        

2. Comments:

L.  Other Tests[24] 

  1. Observations:
  2. Comments:

M.  Organ Weights[25] 

1. Observations: 

Table # [Heading]

SEX

males

females

DAILY DOSE
 (mg/kg body-weight/day)

0
CONTROL

 

 

 

0
CONTROL

 

 

 

NUMBER OF ANIMALS

        
BODY WEIGHT (gram)[a]        
BRAIN        

Absolute Weight[a]

gram

        

Per Body Weight[a]

%

        
ADRENALS        

Absolute Weight[a]

gram

        

Per Body Weight[a]

%

        

Per Brain Weight[a]

%

        
EPIDIDYMIDES     

Absolute Weight[a]

gram

    

Per Body Weight[a]

%

    

Per Brain Weight[a]

%

    
HEART        

Absolute Weight[a]

gram

        

Per Body Weight[a]

%

        

Per Brain Weight[a]

%

        
KIDNEYS        

Absolute Weight[a]

gram

        

Per Body Weight[a]

%

        

Per Brain Weight[a]

%

        
LIVER        

Absolute Weight[a]

gram

        

Per Body Weight[a]

%

        

Per Brain Weight[a]

%

        
SPLEEN        

Absolute Weight[a]

gram

        

Per Body Weight[a]

%

        

Per Brain Weight[a]

%

        
TESTES     

Absolute Weight[a]

gram

    

Per Body Weight[a]

%

    

Per Brain Weight[a]

%

    
THYROID and PARATHYROID        

Absolute Weight[a]

gram

        

Per Body Weight[a]

%

        

Per Brain Weight[a]

%

        
THYMUS        

Absolute Weight[a]

gram

        

Per Body Weight[a]

%

        

Per Brain Weight[a]

%

        
OVARIES     

Absolute Weight[a]

gram

    

Per Body Weight[a]

%

    

Per Brain Weight[a]

%

    
UTERUS     

Absolute Weight[a]

gram

    

Per Body Weight[a]

%

    

Per Brain Weight[a]

%

    

a: Group means at the end of terminal necropsy are shown.
(Specify methods of statistical analysis): * p<0.05, ** p<0.01

2. Comments:

N. Gross Pathology Changes Observed[26] 

  1. Observations:
  2. Comments:

O. Histopathology Changes Observed[27] 

1. Observations:

Table # [Heading) 

 

NUMBER OF ANIMALS 
WITH, GROSS, NON-NEOPLASTIC, OR NEOPLASTIC LESIONS

SEX

males

females

DAILY DOSE
 (MG/KG BODY-WEIGHT/DAY)

0
CONTROL

 

 

 

0
CONTROL

 

 

 

NUMBER OF ANIMALS EXAMINED

        
DIGESTIVE SYSTEM        
ORGAN/TISSUE [#]        

GROSS LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

 

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

 

        
RESPIRATORY SYSTEM        
ORGAN/TISSUE [#]        

GROSS LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

 

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

 

        
CARDIOVASCULAR SYSTEM        
ORGAN/TISSUE [#]        

GROSS LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

 

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

 

        
RETICULO-ENDOTHELIAL /HEMATOPOIETIC SYSTEM        
ORGAN/TISSUE [#]        

GROSS LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

 

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

 

        
UROGENITAL SYSTEM        
ORGAN/TISSUE [#]        

GROSS LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

 

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

 

        
GLANDULAR SYSTEM        
ORGAN/TISSUE [#]        

GROSS LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

 

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

(Specify methods of statistical analysis): * p<0.05, ** p<0.01
# Organs/tissues listed under section IV.P.
In general, data at end of dosing period can be shown; however, if there were additional noteworthy findings at earlier timepoints, these should be included.  Note severity of lesions as needed. 

2. Comments:

P. Neurotoxicity[28] 

1. Observations:

Table # [Heading] 

 

NUMBER OF ANIMALS

SEX

males

females

DAILY DOSE
 (MG/KG BODY-WEIGHT/DAY)

0
CONTROL

 

 

 

0
CONTROL

 

 

 

NUMBER OF ANIMALS EXAMINED

        
OBSERVATIONS OF NERVOUS SYSTEM TOXICITY [+]        

OBSERVATION

        

OBSERVATION

        

OBSERVATION

        

 

        
GROSS- AND HISTO-PATHOLOGY CHANGES IN THE NEUROLOGIC SYSTEM [# ]        
ORGAN/TISSUE        

GROSS LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

NON-NEOPLASTIC LESION

        

 

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

NEOPLASTIC LESIONS

        

+ See under section IV.G for the types of observation for nervous system toxicity: List noteworthy findings.  If additional parameters (other than those in the Template) showed noteworthy changes, these should be added to the tables.  In general, include data at the end of the dosing period.  However, if one observes additional noteworthy findings at earlier timepoints, these should be included.  Footnotes should be used as needed to provide additional information about the tests or the results.  Note the severity of the abnormal observations using the following scales; + Mild, ++ Moderate, and +++ Marked or other scales, as appropriate.
# Organs/tissues listed under section IV.P

2. Comments:

VI. Evaluation and Comment on Study[29] 

VII. Summary and Conclusions[30] 

A. Brief Summary Of Major Findings From The Study

B. Relationship Between Dose And Incidence/Severity Of Lesions Or Abnormalities

C. Was There A Target Organ?

D. NOEL

  1. Was there a no observed effect level?
  2. Comments:

VIII. References


End Notes

This section includes some comments that are only relevant when using the Word template. 

[1]Make note of: study file location (Volume, pages), study title/report #, testing facility name, publication dates of study, study objective, and comments, if needed. 

[2]Indicate Yes or No for the Questions A and B. However, please elaborate on the type of GLP compliance (USFDA, OECD, etc.) or make other notations. 

[3]Description of the test substance should be given, including purity, any possible contaminants or impurities, and any potential properties of the test substance that could have affected its integrity. Are there factors that might have affected the actual administered dose, as opposed to the intended dose? 

[4]After you put a blinking cursor on the http address, (CTRL +) left-click once to follow the link and wait.  Enter a chemical name, CAS Number, or molecular formula inside the search window and click 'search' button.  Right-click inside the molecular structure and select 'copy' submenu.  Return to your document and put the cursor underneath item #4 (molecular structure).  Right click to open up the menu options and select 'paste' submenu.  You can drag the structure to any position you want and resize. If preferred, use other methods of depicting the molecular structure. 

[5]Indicate how the test substance was administered and whether any vehicle was used to dissolve/suspend the test substance (e.g., dissolved in corn oil and mixed into the feed).  Also note if there was adequate testing for concentration and homogeneity (appropriate tests with replicates) and whether there were stability tests done.  Was the strength of the test material checked over the period and under the conditions that the feed mix, test article in vehicle, etc., would be stored? 

[6]Note anything that might have affected the study. Use the comments to indicate other factors that might have impacted the study. 

[7]Provide adequate details. Use the comments to indicate additional information about the experimental design.  To change the table, place cursor in the row or column that you wish to modify, then from the 'Table' menu, use 'Select Row' or 'Select Column' to highlight the row or column that you wish to change, and use the 'delete' or 'insert' functions to make your changes. 

[8]Indicate the measurements or observations that were made by highlighting the parameter and dragging the term into the 'Examined' side.  Those parameters not examined will remain in the 'Not Examined' side. Use the comments to indicate when observations were made and any other notable fact. 

[9]Drag and drop to indicate parameters that were examined.  Use comments to indicate other important information. 

[10]Drag and drop to indicate parameters that were examined.  Use comments to indicate other important information. 

[11]Note when urine was collected for testing, the groups that were affected, and drag and drop the parameters that were tested. Make comments on anything considered significant or treatment-related. 

[12]If other tests were conducted, make note of the endpoints considered significant or treatment-related. 

[13]If there was an interim sacrifice (e.g., at 30 or 60 days), make notes on which groups were affected, and the number and sex of the animals that were tested. 

[14]Note whether there was a verification of the doses being administered (by what analytical methodology and in which laboratory). Was this done more than once? Were there adequate data to calculate the actual dose that was administered? 

[15]Note any statistically or biologically significant feed consumption changes. Note feed consumption changes that were not statistically significant (e.g., at low or mid dose) but could indicate a treatment-related trend. 

[16]Considering the level of feed intake and the level of test substance in the feed, what was the dose actually being delivered to the animals? 

[17]Note when feed efficiency was determined; if any changes were observed; if feed efficiency was calculated for all groups or only selected groups; and if calculations were made per group, per cage, or per animal. 

[18]Note any statistically or biologically significant body weight changes. Also note body weight changes that are not statistically significant (e.g., at low or mid dose) but could indicate a treatment-related trend.  You may wish to insert graphs or tables in this section. 

[19]List significant, dose-related abnormal cage-side observations.  For neurotoxicological observations, also use a Table in Section V. P. (see Section IV. G. for parameters). 

[20]For each animal with an unscheduled death, note the group, date of death, and any observations, including lesions observed at necropsy. 

[21]Note findings that were statistically or biologically treatment-related.  Also note changes that were not statistically significant (e.g., at low or mid dose) but could indicate a treatment-related trend.  The comment section is available to explain data findings, if needed. 

[22]Note findings that were statistically or biologically treatment-related.  Also note changes that were not statistically significant (e.g., at low or mid dose) but could indicate a treatment-related trend.  The comment section is available to explain data findings, if needed. 

[23]Note findings that  were statistically or biologically treatment-related.  Also note changes that were not statistically significant (e.g., at low or mid dose) but could indicate a treatment-related trend.  The comment section is available to explain data findings, if needed. 

[24]When other tests were conducted, make note of the tests and any significant treatment-related effects. 

[25]Note findings that were statistically or biologically treatment-related.  Also note changes that were not statistically significant (e.g., at low or mid dose) but could indicate a treatment-related trend.  The comment section is available to explain data findings, if needed. 

[26]Note findings that were statistically or biologically treatment-related.  Also note changes that were not statistically significant (e.g., at low or mid dose) but could indicate a treatment-related trend.  The type of lesion should be noted. The comment section is available to explain data findings, if needed. Also note the findings in Histopathology Section V.O. below. 

[27]Note findings that were statistically or biologically treatment-related.  Also note changes that were not statistically significant (e.g., at low or mid dose) but could indicate a treatment-related trend.  The type of lesion should be noted. The comment section is available to explain data findings, if needed. 

[28]Provide summary tables of all positive effects. In addition, provide an explicit statement as to whether or not the test substance may represent a potential neurotoxic hazard. 

[29]Give your evaluation of the study: what was done well; what the problems were; did the study accomplish what it was supposed to do? 

[30]Summarize the key findings from the study. Was there a dose-effect relationship? Were target organs identified? Was a NOEL achieved for each significant effect/observation? What was the NOEL?  The whole study should be summarized in this section.


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