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Subject:
From:
Joy Anderson <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 19 Oct 1998 15:19:37 +0800
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Patricia Drazin wrote:
> Some one from austrailia will I hope give the full story but my recollection
>is that is was an austrailian study on rats using does in excess of what
>mothers and babiers are exposed  to.

Hi all,
I was hoping Jack Newman would chime in on this, but I understand he is
currently away. So I thought I would take the liberty of sharing his 2
slides about the study on gentian violet. I took a copy of the text of his
slides while he was here last year. I hope he doesn't mind me sharing this.

He tells the story that he wanted a copy of the study that supposedly
showed that gv was carcinogenic. He finally tracked it down in a small
library somewhere in the US (can't quite recall exactly where). When he
asked if he could obtain a copy, they said that no-one else had ever asked
for this paper, so he may as well have the original, as they didn't really
need it anymore. So much for those banning it checking their sources!!

This is the text of the 2 slides he showed:

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 increase 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, especially in the absence of cirrhosis


******************************************************************
Joy Anderson B.Sc. Dip.Ed. Grad.Dip.Med.Tech. IBCLC
Nursing Mothers' Association of Australia Breastfeeding Counsellor
Perth, Western Australia.   mailto:[log in to unmask]
******************************************************************

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