Lexikon
according to REACH A substance fulfils the toxicity criterion when:
– the long-term no-observed effect concentration (Noec) for marine or freshwater organisms is less than 0,01 mg/l, or
– the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or
– there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.
toxic substances are those natural or man-made chemical substances, which are toxic for living organisms, including members of the ecosystem and humans.
Toxic substances can be inroganis or organic substances. Inorganic ones are mainly toxic metals, like arsenic, cadmium, lead, copper, chromium, nikkel, zinc, and their compounds.
Organic toxic substances are of natural origin or man-made ones (xenobiotica). The natural toxic substances maybe bacterial toxins, toxins or drugs of fungal, plant, insect or other animal origin. Other part of the toxic substances are designed and produced for the purpose of killing or inhibiting organisms or groups of organisms. These are desinficients, antimicrobial agents, antibiotics, pesticides, biological weapons, etc. These man-made toxic substances may effect not only the target group of organisms with their primary effect, but by discharging them into the environment any other organism, including man is endangered by mutagenic or reprotoxic effects, by immun- and endocrine disrupting effect, or sensitizing effects. The users of the environment, including man, cannot efficiently prevent themselves from these adverse effects, because we often do not know about the presence of these substances in the environment, we cannot predict their interaction with other substances or environmental compounds, and we do not know their long term effects.
See also toxic effect, toxicity, toxic metals, toxicity tests
the testing of physico-chemical characteristics of chemical substances is regulated by the COUNCIL REGULATION (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
(1) Pursuant to Regulation (EC) No 1907/2006, test methods are to be adopted at Community level for the purposes of tests on substances where such tests are required to generate information on intrinsic properties of substances.
(2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances laid down, in Annex V, methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations. Annex V to Directive 67/548/EEC has been deleted by Directive 2006/121/EC of the European Parliament and of the Council with effect from 1 June 2008.
(3) The test methods contained in Annex V to Directive 67/ 548/EEC should be incorporated into this Regulation.
(4) This Regulation does not exclude the use of other test methods, provided that their use is in accordance with Article 13(3) of Regulation 1907/2006.
(5) The principles of replacement, reduction and refinement of the use of animals in procedures should be fully taken into account in the design of the test methods, in particular when appropriate validated methods become available to replace, reduce or refine animal testing.
(6) The provisions of this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006
Article 1: The test methods to be applied for the purposes of Regulation 1907/2006/EC are set out in the Annex to this Regulation.
Article 2: The Commission shall review, where appropriate, the test methods contained in this Regulation with a view to replacing, reducing or refining testing on vertebrate animals.
Article 3: All references to Annex V to Directive 67/548/EEC shall be construed as references to this Regulation.
Article 4: This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.
It shall apply from 1 June 2008.
LIST OF METHODS FOR THE DETERMINATION OF TOXICITY
B.1 bis. Acute oral toxicity – fixed dose procedure
B.1 tris. Acute oral toxicity – acute toxic class method
B.2. Acute toxicity (inhalation)
B.3. Acute toxicity (dermal)
B.4. Acute toxicity: dermal irritation/corrosion
B.5. Acute toxicity: eye irritation/corrosion
B.6. Skin sensitisation
B.7. Repeated dose (28 days) toxicity (oral)
B.8. Repeated dose (28 days) toxicity (inhalation)
B.9. Repeated dose (28 days) toxicity (dermal)
B.10. Mutagenicity – in vitro mammalian chromosome aberration test
B.11. Mutagenicity – in vivo mammalian bone marrow chromosome aberration test
B.12. Mutagenicity – in vivo mammalian erythrocyte micronucleus test
B.13/14. Mutagenicity: reverse mutation test using bacteria
B.15. Mutagenicity testing and screening for carcinogenicity gene mutation – saccharomyces cerevisiae
B.16. Mitotic recombination – saccharomyces cerevisiae
B.17. Mutagenicity – in vitro mammalian cell gene mutation test
B.18. Dna damage and repair – unscheduled dna synthesis – mammalian cells in vitro
B.19. Sister chromatid exchange assay in vitro
B.20. Sex-linked recessive lethal test in drosophila melanogaster
B.21. In vitro mammalian cell transformation tests
B.22. Rodent dominant lethal test
B.23. Mammalian spermatogonial chromosome aberration test
B.24. Mouse spot test
B.25. Mouse heritable translocation
B.26. Sub-chronic oral toxicity test repeated dose 90-day oral toxicity study in rodents
B.27. Sub-chronic oral toxicity test repeated dose 90-day oral toxicity study in nonrodents
B.28. Sub-chronic dermal toxicity study 90-day repeated dermal dose study using
Rodent species
B.29. Sub-chronic inhalation toxicity study 90-day repeated inhalation dose studusing rodent species
B.30. Chronic toxicity test
B.31. Prenatal developmental toxicity study
B.32. Carcinogenicity test
B.33. Combined chronic toxicity/carcinogenicity test
B.34. One-generation reproduction toxicity test
B.35. Two-generation reproduction toxicity study
B.36. Toxicokinetics
B.37. Delayed neurotoxicity of organophosphorus substances following acute exposure
B.38. Delayed neurotoxicity of organophosphorus substances 28 day repeated dose study
B.39. Unscheduled dna synthesis (uds) test with mammalian liver cells in vivo
B.40. In vitro skin corrosion: transcutaneous electrical resistance test (ter)
B.40 bis. In vitro skin corrosion: human skin model test
B.41. In vitro 3T3 NRU phototoxicity test
B.42. Skin sensitisation: local lymph node assay
B.43. Neurotoxicity study in rodents
B.44. Skin absorption: in vivo method
B.45. Skin absorption: in vitro method
the expression of toxicity arising from exposure to a substance is a consequence of a chain of events that results in the affected tissues of an organism receiving the ultimate toxicant in amounts that cause an adverse effect. The concentration of the ultimate toxicant at the biological target site depends on the absorption, distribution, metabolism and excretion. According to REACH annexe VIII, the assessment of these processes, i.e. the toxicokinetics behaviour is required from the relevant available information. There is no obligation to generate new data.
Source: REACH
toxicology involves all aspects of the adverse effects of chemical substances on living systems. Those effects which are damaging to either the survival or normal function of any living organism or their communities.
is a measure of the electrical impedance of the skin, as a resistance value in kilo Ohms. A simple and robust method of assessing barrier function by recording the passage of ions through the skin using a Wheatstone bridge apparatus. It is used in skin corrosivity tests, the value of the eletrical impedance gives the damage of the skin disk used int he test treated by the test substance.
a transgenic animal is one that carries a foreign gene that has been deliberately inserted into its genome. The foreign gene is constructed using recombinant DNA methodology. In addition to the gene itself, the DNA usually includes other sequences to enable it
- to be incorporated into the DNA of the host and
- to be expressed correctly by the cells of the host.
Transgenic sheep and goats have been produced that express foreign proteins in their milk.
Transgenic chickens are now able to synthesize human proteins in the "white" of their eggs.
These animals should eventually prove to be valuable sources of proteins for human therapy.
In July 2000, researchers from the team that produced Dolly reported success in producing transgenic lambs in which the transgene had been inserted at a specific site in the genome and functioned well. [More]
Transgenic mice have provided the tools for exploring many biological questions.
An example: Normal mice cannot be infected with polio virus. They lack the cell-surface molecule that, in humans, serves as the receptor for the virus. So normal mice cannot serve as an inexpensive, easily-manipulated model for studying the disease. However, transgenic mice expressing the human gene for the polio virus receptor can be infected by polio virus and even develop paralysis and other pathological changes characteristic of the disease in humans.
Two methods of producing transgenic mice are widely used:
- transforming embryonic stem cells (ES cells) growing in tissue culture with the desired DNA;
- injecting the desired gene into the pronucleus of a fertilized mouse egg.
Source: http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/T/TransgenicAnimals.html
Xenotransplantation
Transplant organs may soon come from transgenic animals. Patients die every year for lack of a replacement heart, liver, or kidney. For example, about 5,000 organs are needed each year in the United Kingdom alone. Transgenic pigs may provide the transplant organs needed to alleviate the shortfall. Currently, xenotransplantation is hampered by a pig protein that can cause donor rejection but research is underway to remove the pig protein and replace it with a human protein.
Nutritional supplements and pharmaceuticals
Milk-producing transgenic animals are especially useful for medicines.
Products such as insulin, growth hormone, and blood anti-clotting factors may soon be or have already been obtained from the milk of transgenic cows, sheep, or goats. Research is also underway to manufacture milk through transgenesis for treatment of debilitating diseases such as phenylketonuria (PKU), hereditary emphysema, and cystic fibrosis.
In 1997, the first transgenic cow, Rosie, produced human protein-enriched milk at 2.4 grams per litre. This transgenic milk is a more nutritionally balanced product than natural bovine milk and could be given to babies or the elderly with special nutritional or digestive needs. Rosie’s milk contains the human gene alpha-lactalbumin. A transgenic cow exists that produces a substance to help human red cells grow.
Human gene therapy
Human gene therapy involves adding a normal copy of a gene (transgene) to the genome of a person carrying defective copies of the gene. The potential for treatments for the 5,000 named genetic diseases is huge and transgenic animals could play a role. For example, the Virtanen Institute in Finland produced a calf with a gene that makes the substance that promotes the growth of red cells in humans.
transgenic animals may be produced as disease models, meaning genetically manipulated animals, which exhibit disease symptoms so that effective treatment can be studied. For example, Harvard scientists made a major scientific breakthrough when they received a U.S. patent (the company DuPont holds exclusive rights to its use) for a genetically engineered mouse, called OncoMouse® or the Harvard mouse, carrying a gene that promotes the development of various human cancers.
transgenic organism is an experimentally produced organism in which DNA has been artificially introduced and incorporated into the organism's germ line.
Physical properties:
Boiling Point: 87 oC at 760 mmHg
Freezing/Melting Point: -86 oC
Specific Gravity/Density:1.5
Solubility (g/100 ml at 20 oC): 0.1
Vapor Pressure: 77.3 mbar at 20 oC
Vapor Density: 4.5 (air=1)
Autoignition Temperature: 410 oC
Explosion Limits: 8-10.5 Vol %
Log P: 2.42
Earlier it was used as anesthetic, but due to its toxicity and potential carcinogenecity its use in the food (e.g. for coffee decaffeination) and pharmaceutical industries has been banned in much of the world. The greatest use of TCE has been as a degreaser for metal parts, which resulted in the contamination of soil and groundwater. As the density of TCE is higher than that of the water, and it is poorly soluble in water, TCE is adsorbed on the soil grains and it is concentrated in the aquifers as a plum called also DNAPL (Dense Non-Aqueous Phase Liquids). TCE is degraded by the soil micobes, therefore the DNAPL contains beside TCE also DCE (dichloroethylene) and VC (vinyl chloride).
As other Voltile Organic Compounds (VOC), TCE causes eye and skin irritation, it is well soluble in the lipids of the organism explaining its neurotoxic effect, transport through the blood-brain barrier and excretion in maternal milk. Breathing large amounts of trichloroethylene may cause impaired heart function, unconsciousness, and death. Breathing it for long periods may cause nerve, kidney, and liver damage. Drinking or breathing high levels of trichloroethylene may cause nervous system effects, liver and lung damage, abnormal heartbeat, coma, and possibly death. Skin contact with trichloroethylene for short periods may cause skin rashes. Some studies of people exposed over long periods to high levels of trichloroethylene in drinking water or in workplace air have found evidence of increased cancer. TCE may be concentrated in inner atmosphere of dwellings above plums. The EPA has set a maximum contaminant level for trichloroethylene in drinking water at 0.005 mg/L or 5 parts of TCE per billion parts water. The Occupational Safety and Health Administration (OSHA) has set an exposure limit of 100 parts of trichloroethylene per million parts of air (100 ppm) for an 8-hour workday, 40-hour workweek. (Source: Agency for Toxic Substances and Deseas Registry, ATSDR, www.atsdr.cdc.gov).
United Nations Convention to Combat Desertification
The objective of the Convention is to combat desertification and mitigate the effects of drought in countries experiencing serious drought and/or desertification, particularly in Africa, through effective action at all levels, supported by international cooperation and partnership arrangements, in the framework of an integrated approach which is consistent with Agenda 21, with a view to contributing to the achievement of sustainable development in affected areas.
Achieving this objective will involve long-term integrated strategies that focus simultaneously, in affected areas, on improved productivity of land, and the rehabilitation, conservation and sustainable management of land and water resources, leading to improved living conditions, in particular at the community level.
Sorce: http://www.unccd.int/convention/text/convention.php
mathematical adjustments for reasons of safety when knowledge is incomplete.
For example, factors used in the calculation of doses that are not harmful (adverse) to people. These factors are applied to the lowest-observed-adverse-effect-level (LOAEL) or the no-observed-adverse-effect-level (NOAEL) to derive a minimal risk level (MRL). Uncertainty factors are used to account for variations in people's sensitivity, for differences between animals and humans, and for differences between a LOAEL and a NOAEL. Scientists use uncertainty factors when they have some, but not all, the information from animal or human studies to decide whether an exposure will cause harm to people.
For the estimation of ecosystem PNEC, the uncertainty factors are determined according to the precisity of the applied tests. The mathematical method which uses these factors between measured and extrapolated data is called factorial extrapolation.
It is also called safety factor.
on the internet you can find several unit converters, which are able to convert physical unites of measure from ones system to an other one, e.g. to the metric system.
On the web-address of http://www.digitaldutch.com/unitconverter/density.htm you can find a converter able to convert area, density, energy, force, length, mass, power, pressure, speed, temperature and volume, bits and bytes.
use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation.
Conditions of use refer to the Operational Conditions and Risk Management Measures (RMM) as described in an Expousre Scenarios.
(Source: REACH Glossary)
ultraviolet light can be detected by suitable photodiodes and photocathodes which can be tailored to be sensitive in different parts of the UV spectrum. Sensitive ultraviolet photomultipliers are also available. These detectors make possible the detection of any levels and changes in levels of UV-light. As such, they can be applied as detectors of many analytical methods as part of spectrometers or coupled with liquid-chromatographs.
substances of Unknown or Variable composition, Complex reaction products or Biological materials. A type of chemical substances within REACH regulation.
A Venturi scrubber is designed to effectively use the energy from the inlet gas stream to atomize the liquid being used to scrub the gas stream. This type of technology is a part of the group of air pollution controls collectively referred to as wet scrubbers. Venturi scrubbers are used to remove very fine dust and mist, and can also remove gases. They rely on high velocity airflow in the scrubber to atomise water and remove particles down into the submicron range.
Venturi scrubbers can have the highest particle collection efficiencies (especially for very small particles) of any wet scrubbing system.
They are the most widely used scrubbers because their open construction enables them to remove most particles without plugging or scaling. Venturis can also be used to absorb pollutant gases; however, they are not as efficient for this as are packed or plate towers.
Venturi scrubbers have been designed to collect particles at very high collection efficiencies, sometimes exceeding 99%. The ability of venturis to handle large inlet volumes at high temperatures makes them very attractive to many industries; consequently, they are used to reduce particulate emissions in a number of industrial applications.
67/548/EEC regulation uses the following riks-phrases for characterisation of the risk of dangerous chemical substances.
Risk Phrases
R1: Explosive when dry
R2: Risk of explosion by shock, friction, fire or other sources of ignition
R3: Extreme risk of explosion by shock, friction, fire or other sources of ignition
R4: Forms very sensitive explosive metallic compounds
R5: Heating may cause an explosion
R6: Explosive with or without contact with air
R7: May cause fire
R8: Contact with combustible material may cause fire
R9: Explosive when mixed with combustible material
R10: Flammable
R11: Highly flammable
R12: Extremely flammable
R14: Reacts violently with water
R15: Contact with water liberates extremely flammable gases
R16: Explosive when mixed with oxidising substances
R17: Spontaneously flammable in air
R18: In use, may form flammable/explosive vapour-air mixture
R19: May form explosive peroxides
R20: Harmful by inhalation
R21: Harmful in contact with skin
R22: Harmful if swallowed
R23: Toxic by inhalation
R24: Toxic in contact with skin
R25: Toxic if swallowed
R26: Very toxic by inhalation
R27: Very toxic in contact with skin
R28: Very toxic if swallowed
R29: Contact with water liberates toxic gas.
R30: Can become highly flammable in use
R31: Contact with acids liberates toxic gas
R32: Contact with acids liberates very toxic gas
R33: Danger of cumulative effects
R34: Causes burns
R35: Causes severe burns
R36: Irritating to eyes
R37: Irritating to respiratory system
R38: Irritating to skin
R39: Danger of very serious irreversible effects
R40: Limited evidence of a carcinogenic effect
R41: Risk of serious damage to eyes
R42: May cause sensitisation by inhalation
R43: May cause sensitisation by skin contact
R44: Risk of explosion if heated under confinement
R45: May cause cancer
R46: May cause heritable genetic damage
R48: Danger of serious damage to health by prolonged exposure
R49: May cause cancer by inhalation
R50: Very toxic to aquatic organisms
R51: Toxic to aquatic organisms
R52: Harmful to aquatic organisms
R53: May cause long-term adverse effects in the aquatic environment
R54: Toxic to flora
R55: Toxic to fauna
R56: Toxic to soil organisms
R57: Toxic to bees
R58: May cause long-term adverse effects in the environment
R59: Dangerous for the ozone layer
R60: May impair fertility
R61: May cause harm to the unborn child
R62: Possible risk of impaired fertility
R63: Possible risk of harm to the unborn child
R64: May cause harm to breast-fed babies
R65: Harmful: may cause lung damage if swallowed
R66: Repeated exposure may cause skin dryness or cracking
R67: Vapours may cause drowsiness and dizziness
R68: Possible risk of irreversible effects
Combinations
R14/15: Reacts violently with water, liberating extremely flammable gases
R15/29: Contact with water liberates toxic, extremely flammable gases
R20/21: Harmful by inhalation and in contact with skin
R20/22: Harmful by inhalation and if swallowed
R20/21/22: Harmful by inhalation, in contact with skin and if swallowed
R21/22: Harmful in contact with skin and if swallowed
R23/24: Toxic by inhalation and in contact with skin
R23/25: Toxic by inhalation and if swallowed
R23/24/25: Toxic by inhalation, in contact with skin and if swallowed
R24/25: Toxic in contact with skin and if swallowed
R26/27: Very toxic by inhalation and in contact with skin
R26/28: Very toxic by inhalation and if swallowed
R26/27/28: Very toxic by inhalation, in contact with skin and if swallowed
R27/28: Very toxic in contact with skin and if swallowed
R36/37: Irritating to eyes and respiratory system
R36/38: Irritating to eyes and skin
R36/37/38: Irritating to eyes, respiratory system and skin
R37/38: Irritating to respiratory system and skin
R39/23: Toxic: danger of very serious irreversible effects through inhalation
R39/24: Toxic: danger of very serious irreversible effects in contact with skin
R39/25: Toxic: danger of very serious irreversible effects if swallowed
R39/23/24: Toxic: danger of very serious irreversible effects through inhalation and in contact with skin
R39/23/25: Toxic: danger of very serious irreversible effects through inhalation and if swallowed
R39/24/25: Toxic: danger of very serious irreversible effects in contact with skin and if swallowed
R39/23/24/25: Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed
R39/26: Very Toxic: danger of very serious irreversible effects through inhalation
R39/27: Very Toxic: danger of very serious irreversible effects in contact with skin
R39/28: Very Toxic: danger of very serious irreversible effects if swallowed
R39/26/27: Very Toxic: danger of very serious irreversible effects through inhalation and in contact with skin
R39/26/28: Very Toxic: danger of very serious irreversible effects through inhalation and if swallowed
R39/27/28: Very Toxic: danger of very serious irreversible effects in contact with skin and if swallowed
R39/26/27/28: Very Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed
R42/43: May cause sensitization by inhalation and skin contact
R48/20: Harmful: danger of serious damage to health by prolonged exposure through inhalation
R48/21: Harmful: danger of serious damage to health by prolonged exposure in contact with skin
R48/22: Harmful: danger of serious damage to health by prolonged exposure if swallowed
R48/20/21: Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin
R48/20/22: Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed
R48/21/22: Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed
R48/20/21/22: Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed
R48/23: Toxic: danger of serious damage to health by prolonged exposure through inhalation
R48/24: Toxic: danger of serious damage to health by prolonged exposure in contact with skin
R48/25: Toxic: danger of serious damage to health by prolonged exposure if swallowed
R48/23/24: Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin
R48/23/25: Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed
R48/24/25: Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed
R48/23/24/25: Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed
R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment
R51/53: Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment
R52/53: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment
R68/20: Harmful: possible risk of irreversible effects through inhalation
R68/21: Harmful: possible risk of irreversible effects in contact with skin
R68/22: Harmful: possible risk of irreversible effects if swallowed
R68/20/21: Harmful: possible risk of irreversible effects through inhalation and in contact with skin
R68/20/22: Harmful: possible risk of irreversible effects through inhalation and if swallowed
R68/21/22: Harmful: possible risk of irreversible effects in contact with skin and if swallowed
R68/20/21/22: Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed
R-Phrases no longer in use
R13: Extremely flammable liquefied gas.
R47: May cause birth defects.
accordibng to REACH, a substance fulfils the very bioaccumulative criterion when:
– the bioconcentration factor is greater than 5 000.
The assessment of bioaccumulation shall be based on measured data on bioconcentration in
aquatic species. Data from freshwater as well as marine water species can be used.
See also bioaccumulative substance, vPvB substances