The IOMC organisations: a source of chemical safety information.

The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC) was established in 1995 as a mechanism to co-ordinate the efforts of Inter-governmental Organisations in promoting the sound management of chemicals. The seven participating organisations are the United Nations Environment Programme (UNEP), the International Labour Organisation (ILO), the United Nations Food and Agriculture Organisation (FAO), the World Health Organisation (WHO), the United Nations Industrial Development Organisation (UNIDO), the United Nations Institute for Training and Research (UNITAR), and the Organisation of Economic Cooperation and Development (OECD). Members consult on the planning, programming, implementation and monitoring of activities undertaken jointly or individually, and help ensure that programmes are mutually supportive, complementary and avoid duplication of efforts, thus meeting the overall needs of the users more efficiently and effectively. To deal with technical work, the IOMC established smaller thematic groups in the main programme areas of Agenda 21's Chapter 19. One such group promotes information exchange work. Within this IOMC framework, the seven organisations have developed approaches and products to help customers find chemical safety information, as well as improving modalities of access to these data. These mechanisms come in addition to and complement the extensive information products and databases developed and provided by the individual organisations. This article presents an overview of the role of each organisation, an introduction to its electronic information products and tools, and a discussion of the products of this joint effort.

Biological standardization of potency testing of diphtheria-tetanus-pertussis vaccines.

Active protection tests were introduced for the potency testing of the toxoid components of the DTP vaccine. The standardization of these tests is described, with special attention on WHO requirements. A freeze-dried, adsorbed DTP vaccine was prepared for use under tropical or subtropical conditions. The potency testing of the components of this vaccine is presented in this paper.

Preparation and laboratory testing of plain and aluminum hydroxide-adsorbed cholera vaccines used in a field trial in Indonesia.

TWO TYPES OF CHOLERA VACCINE WERE PREPARED: a plain vaccine and an aluminium hydroxide-adsorbed vaccine, by using the Inaba NIH 35A3 and Ogawa NIH 41 serotypes of Vibrio cholerae. For cultivation, a solid medium was used and the cultures were inactivated with 0.02% thiomersal and by heating for 1 hour at 56 degrees C. The final vibrio concentration of the vaccines was adjusted to 16 x 10(9) vibrios/ml (equal proportions of the two serotypes). The antigenicity of the vaccines was assessed by the active mouse protection test and by the antibody production test, i.e. by determinating the vibriocidal antibodies in the sera of immunized mice. The results of the active mouse protection test showed that the antigenicity of the Inaba and Ogawa components of both vaccines met the WHO Requirements. The antigenicity of the Inaba component of both vaccines was about the same. The antigenicity of the Ogawa component of the plain vaccine appeared to be somewhat higher than that of the adsorbed vaccine. In the antibody production test, the adsorbed vaccine elicited a higher and longer-lasting immune response than the plain vaccine.

Factors influencing the stability of acid-precipitated polyvalent Bordetella pertussis bulk suspensions.

According to the statistical analysis of the potency values of acid precipitated polyvalent bulk suspensions of Bordetella pertussis, the potency of suspensions decreased below 8 IU/30 IOU during storage for 5 to 9.8 years. The average annual decrease over a 13-year period was 2.03 IU/30 IOU. The periodicity in the decrease of potency values was assumed to be connected with changes in the quality of the casein hydrolysate ingredient of the medium. Periodic functions employed to approach potency values with limits of 1 SD falling within the range of 64--156% indicated that the potency decreased below 8 IU/30 IOU after 9 years.

Standardization of housedust allergen in human skin test trials.

Standardization was carried out by comparison of Bencard and our own ('Human') housedust allergens in human skin test trials. The dose response curves on hypersensitive patients were parallel, linear, and there was no difference between preparations according to the variance analysis. The relative potency was 1.33 compared to the Bencard allergen. 95% confidence limits were 0.29-2.37. The correlation coefficient evaluated from all data was 0.90. Our experience suggests that human skin test trials seem to be a simple and convenient method for the standardization of housedust allergens. According to the results of analysis of factorials, data suitable for standardization can be obtained if the area of both the wheal and flare as different parameters are recorded 10 and/or 20 minutes after the intradermal injections.

Potency of PPD preparations derived from M. tuberculosis and M. bovis.

No significant difference was found between the biological activity of PPD-preparations derived from M. tuberculosis and M. bovis, although the latter was more potent. In potency tests performed in guinea-pigs, the use of difference mycobacteria as sensitizing agents had no influence on the result of the assay. We could not demonstrate a significantly greater potency of homologous versus heterologous PPD. Evaluation of the 95 p.c. fiducial limits established in the course of variance analysis suggested a greater reliability of reading at 48 than at 24 hrs after allergen application. It also seems possible that the results of the potency assays of PPDs derived from different mycobacterium strains are greatly influenced by the level of the working dilutions employed.

Stability of mammalian tuberculin PPD.

Six lots of PPD prepared in 1937 met the requirements when tested in guinea pig potency assay in 1974. Reading of the skin reactions at 48 hr gave more consistent results than the 24 hr reading. Data were evaluated by analysis of variance and by a quick method developed for the estimation of identity of the standard and the test preparation. Although less sensitive than the analysis of variance, the quick method has been found suitable for estimation of the potency of tuberculin preparations.

A quick method for the estimation of the potency of tuberculin purified protein derivative in guinea pig.

By the statiscal analysis of the data the linear regression equation and standard deviation of the dose response function of the Hungarian Reference Purified Protein Derivative of Tuberculin (HR--PPD) have been determined. From the values of reaction diameters of the HR-PPD and of their standard deviation a diagram was plotted that can be used to estimate the identity of test material by comparison with the reference preparation. The diagram meets the condition that the limits of the standard deviation of the reference and test materials together are wider than the predetermined limits of +/-20%. The inaccurate titrations can be detected with its help at once. Using the diagram, the potency of test material can be promptly estimated in the biological assay of tuberculin made in guinea pig.

Comparison of antigen-type immunosorbents prepared by different ways.

7 types of IgG-containing immunosorbents were compared from different respects by using them for adsorption of antibodies. The human IgG was insolubilized by ethylchlorophormate and glutaraldehyde, thereafter it was bound to activated agarose and polyacrylamide gels and 3 new types of polyacrylamide immunosorbent were prepared by polymerizing the acrylamide in the protein solution and by coupling the protein to the matrix by different ways. Using batch technique, the ethylchlorophormate, the glutaraldehyde and some of the new polyacrylamide immunosorbents proved to be useful, but in almost every respect the immunosorbent prepared from Sepharose gel was the best.

Stability of BCG vaccine (intravesical) Theracys/BCG therapeutic ImmuCyst and its importance in clinical efficacy.

The manufacture of Therapeutic BCG can and should be a controlled process, to ensure adequate treatment doses are received by CIS patients. Standardization of production methods and CFU potency testing methods are essential to ensure continued successful treatment of CIS. Stability data can be used to validate assumptions about Therapeutic BCG potency used in clinical trials. Accelerated heat degradation studies of Therapeutic BCG should not be used for predictions of shelf life, but can be used for comparative purposes.

Evaluation of clinical data in bladder cancer immunotherapy with Connaught BCG (ImmuCyst).

Treatment of superficial bladder carcinoma in situ with Connaught BCG (ImmuCyst) significantly increased complete response rate and extended the disease-free interval when compared with Doxorubicin (DOX) chemotherapy. In 54 patients treated with ImmuCyst, 74% showed complete response compared with 42% of 60 patients treated with DOX. The median disease-free time was 48.2 months for BCG and 5.9 months for DOX treatment. Types and severity of adverse reactions were similar for both treatments and within tolerable ranges.

Demonstration of non-capsulated Haemophilus influenzae in the tissues of the respiratory tract in atopic and non-atopic subjects by means of an immunofluroescence technique.

The use of an immunofluorescence method for demonstration of non-capsulated H. influenzae colonization and penetration in the tissues of the respiratory tract seems to be a useful and convenient laboratory method. However, in in the tissues of the lower respiratory tract H. influenzae in our materials could not be demonstrated.

[Pancreatic pseudocysts and fistulas]. / False chisturi si fistule pancreatice.

The authors present false pancreatic cysts and fistulae that have been encountered inthe practice of the I-st Clinic of Surgery from Tg-Mures over a period of 10 years (between 1964 ans 1979). The author's personal cases are presented and the rarity of this type of disturbances is stressed. A total of 14 cases are described, of which 8 were false pancreatic cysts and 6 were false pancreatic fistulae. The major complications that occurred in the cases with false pancreatic cysts the most severe was the intra-cyst haemorrhage, that was encountered in 2 patients (of which one developed severe shock), and peritonitis, following rupture of the cyst in the peritoneal cavity. The 6 pancreatic fistulae have developed following surgery (3 cases), trauma (one case), and acute pancreatitis (2 cases). The treatment of the false cysts consisted in the external drainage (two emergencies), and cyst-gastrectomy. Pancreatic fistulae have benefited from fistulo-gastrostomy (two cases), while the remaining 4 patients were treated conservatively. Only one death was recorded in this group of patients.

Changes in the tendency of lymphocytes to undergo blastic transformation in the postoperative period, in immune-stimulated and untreated colonic tumour patients.

A study was made of the blastic transformation of lymphocytes in the postoperative period in colonic tumour patients: 23 who had been immune-stimulated by vaccination, and 28 who had not been vaccinated. The immune reactivity decreased significantly in the majority of the cases; however, the deterioration of the immune status affected 68% of the nonvaccinated group, but only 48% of the vaccinated group. The data indicate that the vaccination primarily averted the deterioration of the defence ability in the early postoperative period in patients with a normal preoperative immune activity. An evaluable change in the immune reactivity did not occur in the 6-10 preoperative days following vaccination. Three months postoperatively, the number of patients giving a normal immune reaction was three-fold in the vaccinated than in the non-vaccinated group.

[Investigation of house-dust allergy in children (author's transl)]. / Beitrag zur Hausstaub-Allergie bei Kindern.

Authors were studying the relationship between the history data, the diagnostic difficulties, the skin tests and ventilatory functions after provocative inhalation and specific IgE positivity in connection with 40 cases of bronchial asthma. The most important feature of the treatment is the specific hyposensibilisation, which was performed by a depot house-dust preparation, manufactured by the Vaccine Producing Institute "Human", Budapest. Full success was given in 61,1% of the treated asthmatics.

[Hepatic suppurations requiring segmented or atypical hepatectomies]. / Supuratii hepatice care au necesitat hepatectomii reglate sau atipice

Following studies of cases with hepatic suppurations the authors indicate the necessity for regular or atypic hepatectomies. The extension of the suppurative process in the liver made necessary the ligature of the great sagital vein and the authors show, on the basis of anatomic and topographical data (hepatic segmentation), that it is necessary to extend the hepatectomy to the IV-th para-median segment. The authors also present the indications for bi-segmental right hepatectomy in segments VII-VI as well as of the total left regulated hepatectomy.