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Ecological certificate for Olympus EndoDis + Olympus EndoAct
Status Nov. 2001
______
Ecological Evaluation
of the
Two components- Disinfection - Product
Olympus EndoDis + Olympus EndoAct
for the setup of endoscopes
in the Endo- Thermo- Disinfector (ETD)
VTB-Ecology / Dr. BergerNovember 2001
Ecological tests are carried out in the ecological institute at Henkel. According to official and international OECD test methods the ecological institute works in accordance with the OECD guideline for "Good Laboratory Practice" (GLP) and is certificated in accordance with ISO 9001 and 14001.
Ecological product evaluation for
Olympus EndoDis + Olympus EndoAct
State November 2001
For evaluation comes a two components- disinfection product for endoscopes under the name “Olympus EndoDis + Olympus EndoAct”. A product of Olympus Optical Co.(Europa) GmbH. The endoscope is work up in a special setup- machine called Endo-Thermo-Disinfector (ETD), a product of Olympus Optical Co. (Europa ) GmbH.
1.0Field of application and characteristics
For chemical- thermo disinfection of endoscopes and accessories in the ETD.
Disinfection product for medical devices according to the medical devices directive (MDD)
2.0 Product composition
Disinfection:
Antimicrobical active substances (peracetic acid, hydrogen peroxide), stabilizer
Activator:
Inorganic salts, alkaline
Ecological evaluation of the ingredients
3.0Olympus EndoDis
3.1Antimicrobical active substances
Disinfecting agents are compounds which are destinated to attack micro-organisms at specified concentrations. On account of this characteristics they also display their microbicidal effect in the OECD tests on "easy and quick biodegradability" (ready biodegradability), thus obstructing their own biodegradation. Therefore, the test result may be falsified in the officially prescribed tests since the result provides no information about a structure-related good or poor degradability. For the test of microbicides on biodegradability, the tests must be modified in order to exclude such selfinhibitions of biodegradation, e.g. through reduction of the test concentrations or addition of the test substance in small portions instead of the usual single portion with a correspondingly increased concentration.
In sewage treatment plants, the organic pollutants are biodegraded by bacteria. These treatment plant bacteria must not be impeded through the disinfectants. Thus, through dilution in sewage, the microbicidal active threshold must never be exceeded in the sewage treatment plant in order to avoid malfunctions in sewage treatment plants and to enable the structure-related possible biodegradation.
The data for biodegradability refer to test concentrations below the threshold for toxic selfinhibition. As for the rest, the mentioned tests correspond to the official regulations adopted by the OECD and the EC, as described there.
Oxygen donor
Peracetic acid is contained as a disinfection component. During application or, at the latest, in sewage it decomposes into acetic acid and hydrogen peroxide, an inorganic oxygen carrier which in sewage completely decomposes into oxygen and water.
The resulting acetic acid is easily and quickly biodegradable into carbon dioxide and water:
Test data
-Degradation into carbon dioxide and water:
According to the internationally valid criteria of the OECD and the test methods used here, these components are classified as easily degradable (terminus technicus: readily biodegradable) since the limiting values determined by the OECD are exceeded.
(Closed Bottle Test and/or Modified OECD Screening Test: EEC-Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Off. J. 196, 16.08.1967, p. 1) and 6th amendment EEC-Directive 84/449/EWG, Annex V, Part C: Biodegradation.)
3.2.Stabilizer
Small quantities of a phosphonic complexing agent (about 0,6 %) are contained which are not biodegradable. In conventional fully biological sewage treatment plants they are partially removed by adsorption onto the sewage sludge. Approx. 90 % are precipitated in sewage treatment plants with a phosphate precipitation stage. The residues entering the waters are subject to slow abiotic decomposition. They are nontoxic for aquatic organisms. They can complex heavy metals, but adsorb strongly at suspended materials and sediments, so that, in contrast to other organic complexing agents, a theoretically possible mobilisation of heavy metals does not occur in practice, and phosphate precipitation stages in sewage treatment plants are not disturbed.
4.0Olympus EndoAct
Sodium hydroxide as alkali agent is contained.
The alkali property of a product requires special evaluation. Alkali ( OH- ions) is neutralized by acids ( H- ions) to harmlessnes under water formation. A damage of a sewage plant is only possible if an surplus of alkali remains. This is not the fact in this case.
Phosphates are contained
Phosphates are nutrients for plants and animals and do thus not only support plant growth in agriculture but also the algae growth in lakes. An excessive phosphate load has a negative influence on the water constitution. Therefore, phosphate consumption should be restricted. However, today in Germany only approx. 7 % of phosphates originate from washing and cleaning agents, the rest results from kitchen waste, feces and fertilisers. A further phosphate reduction in washing and cleaning agents would indeed not solve the eutrophication problem but would help to reduce it. Therefore, because of this problem the phosphate content in this product is kept low: The product contains ca. 0,2 % total P in form of phosphate.
5.0Total pH-value adjustment
The pH-value adjustment of the working solution requires special evaluation. Strongly acid or strongly alkaline sewage can cause damage at the point of discharge into a channel system if it contains concrete as a channel material. Therefore, a pH range is prescribed for sewage discharge, mostly pH 6-10 (e. g. in Germany ATV Arbeitsblatt A 115).
-The two products are used always together. In a 1 % application concentration the working solution of both products has a pH value of 7
Through discharge of the application solutions of this product, the sewage will not exceed the usual limiting values of pH 6 - 10. It constitutes no danger to the channel system.
Overall evaluation
In Germany and in other European countries municipal and commercial sewage is cleaned in biological sewage treatment plants, before it enters into river water. Depending on biodegradability (brake down) or mechanical elimination of substances in the waste water there remains a more or less residual load for the self purification process in the river. For an ecological evaluation therefore information on the biodegradability and elimination are important criteria.
The degradability values of all individual organic components are added up, taking into consideration the proportions in the present product (see individual evaluation). It is then determined which degradation value would be obtained if the product as a whole was tested in an OECD test on ready biodegradability. If the limit for classification as "readily biodegradable" is exceeded, this product is classified as "biodegradable". Consequently, the BOD/COD ratio is > 60 %. However, it is still possible that some individual components contained in small quantities do not attain this limit while others contained in greater quantities exceed this limit to such an extent that they conceal the first-mentioned. Therefore, we also inform about the quantity of these smaller fractions by differentiating the term "biodegradable" in the overall evaluation.
We also provide information if the ingredients are not classified as "readily biodegradable", but are almost as well removable in sewage treatment plants as communal mixed sewage. For these fractions, the BOD/COD ratio is < 60 %.
(Dr. Harald Berger)(Dr. Holger Biering)
Department ofDepartment of
EcologyHospital Hygiene
EDP-like conversion of the ecological expert report. The content is binding even if not signed and stamped.