File: 970613_me013_90b_txt_0001.txt
Page: 0001
Total Pages: 1
SUBJECT: STABILITY OF CRYSTALLINE BOTULINUM NEUROTIXIN TYPE A
IN DISTILLED AND NATICK TAP WATER AT 25C
TREATMENT TIME WEIGHT %RESIDUAL RESIDUAL #HUMAN
(hours) PER LD50 (pq) TOXICITY TOXIN PQ/ML MLD/ML(c)
UNDILIUTED(a)
(140ug/ml) 0 70 100 1.40x10^8 285.7
1 116 60.3 8.40X10^7 171.4
24 210 33.3 4.66x10^7 95.0
48 481 14.5 2.03x10^7 41.4
72 525 13.3 1.86x10^7 37.9
96 641 10.9 1.52x10^7 31.0
168 1750 4.0 5.60x10^6 11.4
1:100 (b) 0 70 100.0 1.40x10^6 2.85
distilled water 1 116 60.3 8.44x10^5 1.72
24 245 28.5 3.99X10^5 0.81
48 350 20.0 2.80x10^5 0.57
72 461 15.1 2.11X10^5 0.43
96 569 12.3 1.72X10^5 0.35
168 2708 2.5 3.50x10^4 0.07
1:100 (b) 0 70 100.0 1.40x10^6 2.86
Natick tap water 1 175 40.0 5.60x10^5 1.14
24 525 13.3 1.86x10^5 0.37
48 641 10.9 1.50x10^5 0.30
72 1750 4.0 5.60x10^4 0.11
96 3854 1.8 2.52x10^4 0.05
168 5429 1.2 1.68x10^4 0.03
a. Undilitued toxin contained 140ug crystalline toxin in 1.0ml phospate buffer.
b. Contained 14ug crystalline toxin in 9.9ml water, eitherdistilled or tap.
c. One Human MLD is approximately equal to 7000 Mouse LD5O's
d. One Mouse LD5O equals 70pg.
TABLE 4. STABILITY OF CRYSTALLINE NEUROTOXIN A ON BDU FABRIC AND MRE FOIL.
STABILITY©a (Days) at
SUPPORT TOXIN TEMPERATURE % RELATIVE HUMIDITY
MATERIAL (LD50) (0c) 0% 50% 90%
BDU 300-b 5 14 14 14
45 14 1 1
or-d 62x103-c 5 14 14 14
MRE 45 14 14 14
a. - Toxicity was measured by the mouse assay.
b-After recovery from the material 7 LD50 units were initiallyavailable for the mouse assay.
c-After recovery from the material 10,503 LD50 units were initiallyavailable for the mouse assay.
d-Results apply to both BDU and MRE.
TABLE 5. EFFECTIVE DETOXICANT OF CRYSTALLINE NEUROTOXIN A.
EXPOSURE TEMPERATURE
EXPOSURE TIME ( 0c)
COMPOUND MINUTES 5 25 45
(% residual toxin)
CLOROX
2.63%; pH 10.6 10 NDa NRTb
0.13%; pH 9.95 2 NRT NRT NRT
0.026%; pH 9.7 2 0.02 NRT NRT
HYDROGEN PEROXIDE 10 0.005 NRT NRT
(1.5%; pH 11.2) 20 0.006
60 NRT
ISOPROPYL ALCOHOL 2 0.013 NRT
(35%,pH 8.6) 10 11 NRT
20 14
60 1.3
ROCCAL 10 1.3 NRT NRT
(0.039%; pH 7.8 ) 20 1.5
60 0.02
ROCCAL 2 0.16 0.01 NRT
(0.039%; PH 11.1) 10 +c + NRT
30 + NRT
a Not done.
b NRT=No Residual Toxin. One LD50=70 pg of crystalline neurotoxinexcept for Roccal (pH 11.1) for which a preparation equal to 135 pgwas used.
c A small number of mice survived when inoculated with theundiluted sample.
INEFFECTIVE DETOXIFYING AGENTS a
2% SODIUM BICARBONATE pH 8.9
10% SODIUM SULFITE pH 10.2
0.8% LYSOL pH 7.9
0.6% FORMALIN pH 6.2
3% AMMONIUM HYDROXIDE pH 11.1
0.8M GLYCINE BUFFER, pH 11.1 DESTROYED 98% OF TOXICITY IN 10 MIN AT22C
a CRYSTALLINE NEUROTOXIN A
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