|
LLNA
SCREENING PROTOCOL MODIFIED OECD TG-429 * |
| |
(Includes
n=4 mice/group @ 3 concentrations of Test Article plus Vehicle
Control group; Historical Positive Control) Pooled Nodes
from each group. Modified OECD TG429 does not include irritation/systemic
toxicity Pre-Screen test.
|
|
*This
is intended only as the most basic screening assay; dermal
(ear) irritation will be assessed during the test; there
will not be an irritation pre-screen unless requested on
Protocol. (Not recommended for new chemicals or mixtures
without previous dermal irritation and sensitization data) |
|
|
|
LLNA
STANDARD EPA/OECD PROTOCOL+ Basic Irritation Pre-Screen** |
| |
(OECD TG-429 and OPPTS 870.2600 compliant. Includes n=5 mice/group, Concurrent 25% HCA Positive Control; Vehicle Control + 3 concentrations of Test Article, n=5/group) Basic Dermal Irritation/Toxicity Pre-Screen |
| |
Quantity:
2-3 Test Articles (As Above) |
| |
|
LLNA REGULATORY EPA/OECD Protocol
+Full Irritation/Toxicity Pre-Screen** |
| |
(OECD TG 429 and OPPTS 870.2600 compliant. Includes Quantitative Range Finding irritation screen + 3 concentrations per TA in main study with Positive and Vehicle Controls n=5/group) |
|
|
Quantity:
2-3 Test Articles (As Above) |
| |
|
**OPPTS
870.2600 and OECD TG429 guidelines specify that "an
irritation pre-study should be performed under identical
conditions as the main test in order to determine the
maximum (irritation threshold) test concentration."
Basic Range finding Pre-Screen is 6 mice at 3
concentrations. See below for a more comprehensive quantitative
range-finder test for suspected or known irritants.
Quantitative
Range-Finder: If no mouse ear irritation data is available
or provided, a quantitative range finder using 12 mice
with n=2 at 6 concentrations (100%, 50%, 25%, 10%, 5%,
2.5%) should be performed first, these will allow proper
choice of test concentrations for the main LLNA study.
If the Test Article is irritating, a second range-finder
at lower doses (1%, 0.5%, 0.25%, 0.1%, 0.05%, etc.) may
be necessary.
|
|
Options: |
|
A) |
Basic Dermal Irritation
Pre-Screen: n=2 mice at 100%, 50%, 25% (for Non-Irritants) |
|
B) |
Quantitative Dermal Irritation
Pre-Screen:(Ear Swelling) Range-Finder with n=2 mice @6
concentrations (e.g. 100%, 50%, 25%, 10%, 5%, 2.5%) |
|
C) |
Immunophenotyping: %B220,
CD3, CD4, CD8, I-Ak (MHC), CD69, CD25, CD44 + CD62lo+
lymph node cells |