IMMUNE RESPONSES COMMONLY ASSOCIATED WITH POTENTIAL IMMUNOTOXIC EFFECTS

Ref: http://www.fda.gov/cdrh/ost/ostggp/immunotox.html#T1

 

IMMUNOTOXIC EFFECTS

IMMUNE RESPONSES

HISTOPATHOLOGY

HUMORAL RESPONSE

CELLULAR RESPONSES

HOST RESISTANCE

OBSERVE FOR SIGNS OF ILLNESS

T-CELLS

NATURAL KILLER CELLS

MACROPHAGES

GRANULOCYTES*

1 HYPERSENSITIVITY

Non-Critical (NC): 

May be needed for adequate safety evaluation, for example when critical tests are positive

Critical (C): 

There is primary importance for  indications of immunotoxicity. 
(IgE in Type I Reactions Only)

C
(Type IV Reactions Only)

Not Applicable or Not Needed

Not Applicable or Not Needed

C

Not Applicable or Not Needed

C

2 INFLAMMATION

C

NC

C

NA

C

C

Not Applicable or Not Needed

C

3 IMMUNOSUPPRESSION

NC

C

C

C

C

C

C

C

4 IMMUNOSTIMULATION

NC

C

C

Not Applicable or Not Needed

NC

Not Applicable or Not Needed

NC

C

5 AUTOIMMUNITY**

C

C

C

Not Applicable or Not Needed

Not Applicable or Not Needed

NC

Not Applicable or Not Needed

C



Any signs of immune system dysfunction will  be recorded even if the observations were not included as part of a formal client’s protocol.