PMID- 10737952
OWN - NLM
STAT- MEDLINE
DCOM- 20000427
LR  - 20191025
IS  - 0893-6692 (Print)
IS  - 0893-6692 (Linking)
VI  - 35
IP  - 3
DP  - 2000
TI  - Considerations on photochemical genotoxicity: report of the International 
      Workshop on Genotoxicity Test Procedures Working Group.
PG  - 173-84
AB  - Recent toxicological observations have caused concern regarding the need to test, 
      for example, pharmaceuticals and cosmetic products for photochemical 
      genotoxicity. The objective of this report is to give assistance on how to adapt 
      existing test methods to investigate the potential of light-absorbing compounds 
      to induce genotoxic effects on photoactivation. In general, the Organization for 
      Economic Co-Operation & Economic Development (OECD) draft guideline on in vitro 
      phototoxicity testing served as a basis for consideration. Concomitant exposure 
      of the cells to the test compound and solar simulated light was considered 
      appropriate as the initial, basic test condition. Optimization of the exposure 
      scheme, e.g., a change of the irradiation spectrum, might be indicated depending 
      on the initial test results. Selection of test compound concentrations should be 
      based on results obtained with the dark version of the respective test system but 
      might have to be modified if phototoxic effects are observed. Selection of the 
      irradiation dose has to be performed individually for each test system based on 
      dose-effect studies. The irradiation should induce per se a small, reproducible 
      toxic or genotoxic effect. The report includes a specification of necessary 
      controls, discusses factors that might have an impact on the irradiation 
      characteristics, and gives a rationale for the omission of an external metabolic 
      activation system. It also addresses the question that physicochemical and 
      pharmacokinetic properties might trigger the need to test a chemical for 
      photochemical genotoxicity. Relevant experimental observations are presented to 
      back up the recommendations. The working group did not reach a consensus as to 
      whether a single, adequately perfomed in vitro test for clastogenicity would be 
      sufficient to exclude a photogenotoxic liability or whether a test battery 
      including a gene mutation assay would be needed for product safety testing 
      regarding photochemical genotoxicity.
CI  - Copyright 2000 Wiley-Liss, Inc.
FAU - Gocke, E
AU  - Gocke E
AD  - F. Hoffmann-La Roche Ltd., Basel, Switzerland. elmar.gocke@roche.com
FAU - Muller, L
AU  - Muller L
FAU - Guzzie, P J
AU  - Guzzie PJ
FAU - Brendler-Schwaab, S
AU  - Brendler-Schwaab S
FAU - Bulera, S
AU  - Bulera S
FAU - Chignell, C F
AU  - Chignell CF
FAU - Henderson, L M
AU  - Henderson LM
FAU - Jacobs, A
AU  - Jacobs A
FAU - Murli, H
AU  - Murli H
FAU - Snyder, R D
AU  - Snyder RD
FAU - Tanaka, N
AU  - Tanaka N
LA  - eng
PT  - Congress
PL  - United States
TA  - Environ Mol Mutagen
JT  - Environmental and molecular mutagenesis
JID - 8800109
SB  - IM
MH  - Animals
MH  - Cell Line
MH  - Dose-Response Relationship, Radiation
MH  - Guidelines as Topic
MH  - *Mutagenicity Tests
MH  - Photochemistry
MH  - *Ultraviolet Rays
EDAT- 2000/03/29 09:00
MHDA- 2000/04/29 09:00
CRDT- 2000/03/29 09:00
PHST- 2000/03/29 09:00 [pubmed]
PHST- 2000/04/29 09:00 [medline]
PHST- 2000/03/29 09:00 [entrez]
AID - 10.1002/(SICI)1098-2280(2000)35:3<173::AID-EM4>3.0.CO;2-E [pii]
AID - 10.1002/(sici)1098-2280(2000)35:3<173::aid-em4>3.0.co;2-e [doi]
PST - ppublish
SO  - Environ Mol Mutagen. 2000;35(3):173-84. doi: 
      10.1002/(sici)1098-2280(2000)35:3<173::aid-em4>3.0.co;2-e.