Biosafety Guidelines For Research On Genetically Modified ...

APPENDIX 4: TOXINS
For work involving toxins that fall under Fifth Schedule of the BATA, prior approval for its
use must be sought from the Ministry of Health.
Fifth Schedule Agents (as of 3 rd January 2006)
1. Botulinum toxins (Types A, B, C, D, E, F and G)
2. Clostridium perfringens toxins
3. Staphylococcal Enterotoxin B
4. Shigatoxins
5. Verotoxins
Section 4.1, Category A(i), of these Guidelines requires that, for work involving the
cloning of genes for toxins (or uncharacterised DNA from organisms that synthesise
toxins for vertebrates) with an LD50 of less than 100 µg/kg, the IBC seek a
recommendation from GMAC before giving approval for work to commence.
Below is a list of a number of toxins with an LD50 of less than 100 µg/kg. The list is not
exhaustive. If it is not known whether a substance should be regarded as toxic, GMAC
advice shall be sought.
SOME TOXINS WITH AN LD50 OF LESS THAN 100 μg/kg *
Abrin
Bacillus anthracis lethal factor
Bordetella pertussis toxin
Cholera - see Vibrio cholerae
Clostridium botulinum toxins
Clostridium perfringens epsilon toxin
Clostridium tetani toxin
Corynebacterium diphtheriae toxins
Escherichia coli heat labile (LT) enterotoxin and LT -like toxin
Oxygen-labile haemolysins such as streptolysin O
Yersinia pestis murine toxins
Pseudomonas aeruginosa exotoxin A
Ricin
Shigella dysenteriae toxin
Staphylococcus aureus determinants A, B and F, alpha and beta toxin, exfoliative toxin
Vibrio cholerae toxin and toxins neutralised by antiserum monospecific for cholera toxin
(e.g. heat labile toxins of E. coli, Klebsiella and other related enterotoxins)
Yersinia enterocolitica heat stable toxin
* Information derived from the NIH Federal Register, Vol 51, No 88, May 1986 (Appendix F) and information provided
by the NIH Office of Recombinant DNA Activities.
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