PMID- 12884413
OWN - NLM
STAT- MEDLINE
DCOM- 20031028
LR  - 20041117
IS  - 0260-437X (Print)
IS  - 0260-437X (Linking)
VI  - 23
IP  - 4
DP  - 2003 Jul-Aug
TI  - Harmonization of thresholds for primary skin irritation from results of human 
      repeated insult patch tests and laboratory animal skin irritation tests.
PG  - 279-81
AB  - Classification of a chemical or chemical product as a primary skin irritant using 
      laboratory animal tests has been defined rigorously and codified in Consumer 
      Products Safety Commission (CPSC) regulations. However, no regulatory agency, 
      including the CPSC, has defined a primary skin irritant threshold for human 
      repeat insult patch tests (RIPTs) that are typically conducted on products, such 
      as cosmetics, anticipated to come into direct contact with humans. Further more, 
      the protocols for animal and human tests are significantly different, as are the 
      schemes for grading responses. Consequently, comparing the results of one type of 
      test with those from the other type has proved to be difficult. In this short 
      communication, we propose a procedure to harmonize the results from these two 
      types of skin irritation tests and suggest that a score of "5" in animal tests, 
      considering 24-h results on unabraded skin, is equivalent to a score of "3" in 
      human RIPTs.
CI  - Copyright 2003 John Wiley & Sons, Ltd.
FAU - Tardiff, Robert G
AU  - Tardiff RG
AD  - The Sapphire Group, Inc., 3 Bethesda Metro Center, Suite 830, Bethesda, MD 20814, 
      USA.
FAU - Hubner, Richard P
AU  - Hubner RP
FAU - Graves, Carol Gevecker
AU  - Graves CG
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Appl Toxicol
JT  - Journal of applied toxicology : JAT
JID - 8109495
RN  - 0 (Irritants)
SB  - IM
MH  - Animals
MH  - Dose-Response Relationship, Drug
MH  - Guinea Pigs
MH  - Humans
MH  - *International Cooperation
MH  - Irritants/classification/*toxicity
MH  - Patch Tests/*methods/standards
MH  - Rabbits
MH  - Skin/drug effects/pathology
MH  - Skin Irritancy Tests/*methods/standards
EDAT- 2003/07/29 05:00
MHDA- 2003/10/29 05:00
CRDT- 2003/07/29 05:00
PHST- 2003/07/29 05:00 [pubmed]
PHST- 2003/10/29 05:00 [medline]
PHST- 2003/07/29 05:00 [entrez]
AID - 10.1002/jat.917 [doi]
PST - ppublish
SO  - J Appl Toxicol. 2003 Jul-Aug;23(4):279-81. doi: 10.1002/jat.917.