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Subject:
From:
Joy Anderson <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 18 Dec 2006 22:22:57 +0800
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Hi Karyn-grace,
Gentian violet as carcinogenic (not necessarily oral cancer) is what 
is believed in Australia and why it is so hard to get it.

Jack Newman spoke about this on one of his tours in Australia. He 
kindly gave me copies of his two slides with the info about this. The 
study explained below was found in a small library somewhere in the 
US. Jack said that they told him that no-one had ever asked about 
this one before and he was welcome to have it. So it seems that 
no-one had actually gone to the original research they were basing 
the carcinogenicity claim on. One can speculate on who would benefit 
from this 'rumour'...

The slides read as follows:

Final Report

Experiment no. 304
Chronic Toxicity and carcinogenicity Studies of Gentian Violet in Mice
National Center for Toxicological Research
Jefferson, Arkansas 72079
September 1984

Summary of Experiment:

Outline of the experimental method:

* mice were fed 100, 300 or 600 ppm gentian violet in their feeds for 
12, 18, or 24 months (mice generally live about 30 months)

* this amount of gentian violet corresponds to: 100, 250-275, and 500 
mg/kg/week in females 75-100, 225-250, and 450-475 mg/kg/week in 
males (presumably the females ate more)

* mice were killed (sacrificed) and autopsied at: 12 months, 18 
months or 24 months

Conclusion:

* an increased rate of hepatocellular carcinoma was noted in mice fed 
gentian violet (note that the rate in control mice not fed gentian 
violet was not zero).

* females were more susceptible than males

* "almost all the pathology results occurred only by 24 month sacrifice"

* "under the condition of this study, 100 ppm (100 mg/kg/week) 
gentian violet for 12 months could be considered the 'no observed 
effect' dose and time for female mice. For male mice a 'no observed 
effect' level would be 300 ppm (225-250 mg/kg/week) for 18 months.


What should we make of this?

* in large doses, over a very prolonged period of time, gentian 
violet seems to be carcinogenic

* gentian violet 1%, contains 1000 mg gentian violet in 100 ml

* I usually advise mothers to buy 10 ml, which they never use up 
completely, usually using less than half the 10 ml for an entire 
treatment

* 10 ml contains 100 mg gentian violet

* assuming the mother uses 5 ml, and there is complete absorption by 
the baby of the 5 ml, a five kg (11 lb) baby would get 50 mg over 
three or four days, or 10 mg/kg for the entire treatment

* this hardly compares with even the very lowest dose of 75 
mg/kg/week over most of a lifetime

* there were 2 malignant liver neoplasms in the mice who received no 
gentian violet at 18 months, and 4 at 24 months out of 576 animals, 
suggesting an unusual susceptibility to this neoplasm in this strain 
of mice
- primary malignant liver tumours in humans are much less common than 
this, in the absence of cirrhosis
-- 
******************************************************************
Joy Anderson B.Sc. Dip.Ed. Grad.Dip.Med.Tech. IBCLC
Australian Breastfeeding Association counsellor, Nutrition student
Perth, Western Australia.   mailto:[log in to unmask]
******************************************************************

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