[ascct] OECD call for genetic toxicity data

  • From: Kristie Sullivan <KSullivan@xxxxxxxx>
  • To: "ascct@xxxxxxxxxxxxx" <ascct@xxxxxxxxxxxxx>
  • Date: Tue, 26 Mar 2013 12:58:11 -0400

Dear Colleagues,

I have attached a letter from Nathalie Delrue, Administrator in the Health and 
Safety Division at the OECD. They are requesting specific data related to in 
vitro genetic toxicology tests. I have also pasted the letter below. Please 
note that the deadline to send data is 5 April, and it should be sent to Tim 
Singer from Health Canada.

Please feel free to let me know if you have any questions.

Best wishes,

Dear Colleagues,
This letter is a follow up to the call for data that I sent you in December 
2012 (Letter ENV/EHS/ND/ch/2012.14). At that time I requested that you send 
historical negative control data for the in vitro micronucleus test, (TG 487), 
the in vitro chromosomal aberration test (TG 473) and the in vitro gene 
mutation test (TG 476). I would like to thank all of you who responded to this 
call and sent data. The data collected on TG 473 and 487 have been used by a 
consultant for the Secretariat to perform a statistical analysis and support 
the determination of the optimal number of cells to be scored in these TGs.

The work has not started yet on TG 476 and before it starts, the lead country 
group for the review of genotoxicity Test Guidelines recommended that data be 
gathered on a few cell lines in addition to those for which data were requested 
in December 2012. In particular, for CHO cells, the last call for data was made 
specifically for Hprt data in CHO-WBL cells, and thus excluded other CHO 
variants, such as CHO-K1 and AA8 cells, which have been used extensively for 
conducting Hprt mutation assays. In addition, TG 476 includes Hprt assays 
conducted with other cell lines, like TK6 cells and L5178Y cells, and possibly 
gpt assays conducted with AS52 cells. If you have any negative control or 
solvent control data for assays in these cell lines, we would appreciate your 
contributing it. Finally, if there are additional solvent/negative control data 
for Hprt assays conducted with V79 cells that were not sent in response to the 
first call for data, please take this opportunity to send it to us.

Thus, I’d be very grateful if, in addition to the data you’ve already sent for 
TG 476, you could also provide data on other cell types, as described below 
under “Useful information”. As with the previous data that have been collected, 
the information will be used to determine the average spontaneous mutant 
frequency across multiple laboratories. Ideally individual data (per culture) 
will be needed when cultures are duplicated.

Useful information:
• Experimental conditions such as:
- Cell line and cell variant, and source of the cells
- Treatment duration
- Expression time
- With or without S9
• Individual negative control culture data: as mutations frequencies/ million 

This individual culture data should ideally be in an Excel spreadsheet from 
which it can be extracted for subsequent analyses and can be easy to match up 
with the conditions the study was carried out under such as with or without S9, 
treatment time and cell line.

Some laboratories have quite a significant historical database that could take 
a considerable time to compile. If you are in this situation, feel free to 
limit yourselves to up to the most recent 20 experiments.

Like was done for the previous call for data, Tim Singer will collect the data 
and remove identifying information for those who wish to provide data 
anonymously. Please send tabulated data to Tim Singer at 
Tim.Singer@xxxxxxxxxxx<mailto:Tim.Singer@xxxxxxxxxxx> by 5 April 2013. Your 
help is greatly appreciated.

Kristie Sullivan
Secretary, ASCCT

Attachment: ND 2013-02_call for genotox data.pdf
Description: ND 2013-02_call for genotox data.pdf

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