The Japanese Journal of Antibiotics
Online ISSN : 2186-5477
Print ISSN : 0368-2781
ISSN-L : 0368-2781
SAFETY EVALUATION OF NK 631
ANTIGENICITY, EFFECT ON DELATED HYPERSENSITIVITY, IRRITATIVE EFFECT ON EYE MUCOUS MEMBRANE AND MUTAGENICITY OF PEPLEOMYCIN (NK 631)
FUMINORI ABEAKIKO KOYUHIROSHI INOUETAKUMI YAMASHITAHIKARU EZURAKUNIKO YOSHIZAWAKATSUTOSHI TAKAHASHIOSAMU YOSHIOKAAKIRA MATSUDA
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1978 Volume 31 Issue 12 Pages 859-871

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Abstract
1. Whether NK 631 is antigenic to guinea pigs and rabbits was studied by the methods of active and passive anaphylactic shock tests, SCHULTZ-DALE reaction, passive cutaneous anaphylaxis, OUCHTERLONY, tanned red cell haemagglutination test and test according to the U.S. Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. However, none of the tests proved NK 631 to be antigenic.
2. The immunosuppressive effect of NK 631 was studied by delayed hypersensitivity to picryl chloride in normal and L-1210 tumor bearing mice. Therapeutic dosis of NK 631 was no immunosuppressed but toxic dosis of NK 631 was slightly decreased in ear thickness of delayed hypersensitivity.
3. The acute irritative effect of NK 631 and of bleomycin was studied by single instillation to the rabbit eye mucous membrane with 0.1 ml of either of 10, 33 and 100 mg/ml solution of the drugs in physiological saline.
The irritative effect of NK 631 on the eye mucous membrane at each concentration was slightly severe than that of bleomycin at the same concentration. However, the manifestations were only mild to moderate dilatation of the conjunctival and nictating membrane blood vessels and eye mucous, and recoverd or were mitigated 48 hours after the instillation. No severe changes such as corneal opacity, corneal desquamation, swelling and deaquamation of the conjunctival and nictating membrane were observed.
The histopathological examination revealed no striking changes.
4. Mutagenicity of NK 631 and of bleomycin on Salmonella typhimurium strain TA 100 and TA 98 was studied. It was definitely shown that neither NK 631 nor bleomycin exerted any mutagenic action on either test strains.
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© Japan Antibiotics Research Association
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