Lexikon

see pyroclastics

the repeated dose toxicity comprises the general toxicological effects occurring as a result of repeated daily exposure to a substance for a part of the expected lifespan (sub-acute or sub-chronic exposure) or for the major part of the lifespan (chronic exposure).

These general toxicological effects include effects on body weight and/or body weight gain, absolute and/or relative organ and tissue weights, alterations in clinical chemistry, urinalysis and/or haematological parameters, functional disturbances in the nervous system as well as in organs and tissues in general, and pathological alterations in organs and tissues as examined macroscopically and microscopically. Besides this information on possible adverse general toxicological effects, repeated dose toxicity studies may also provide other information on e.g. reproductive toxicity or carcinogenicity or may identify specific manifestations of toxicity such as e.g., neurotoxicity, immunotoxicity, endocrine-mediated effects...

The objectives of assessing repeated dose toxicity are to evaluate:

• whether repeated exposure of humans to a substance has been associated with adverse toxicological effects; these human studies potentially may also identify populations that have higher susceptibility;
• whether repeated administration of a substance to experimental animals causes adverse toxicological effects; effects that are predictive of possible adverse human health effects;
• the target organs, the potential cumulative effects and the reversibility of the adverse toxicological effects;
• the dose-response relationship and the threshold for any of the adverse toxicological effects observed in the repeated dose toxicity studies;

Source: REACH

reproducibility is the variation arising using the same measurement process among different instruments and operators, and over longer time periods.

It can be distinguished from repeatability, which is the variation arising when all efforts are made to keep conditions constant by using the same instrument and operator, and repeating during a short time period.

reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. As a short name "reprotox" is also used. Those chemical substances which may cause reproductive toxicity are reprotoxic substances.

Reproductive Toxicity is differentiated into:
– adverse effects on sexual function and fertility;
– adverse effects on development;
– effects on or via lactation. (REACH)

Animal tests include evaluating the effects of prenatal exposure on pregnant animals and their offspring [OECD Test Guideline (TG) 414]. This test is usually performed with female rats and rabbits. The test substance is administered orally, the pregnant animals are killed just prior to delivery, and the fetuses are examined for toxic effects. A one-generation reproduction toxicity study (OECD TG 415) in rats or mice is used to evaluate toxic effects on male and female reproduction. Males and females are dosed orally before mating, and females during pregnancy. A two-generation reproduction toxicity study (OECD TG 416) continues dosing with the test substance to the first generation offspring. OECD TG 421 (Reproductive/Developmental Toxicity Screening Assay) uses male and female rats with the test substance administered orally for 4-9 weeks. Pathological effects are determined by daily observation, necropsy, and microscopic histopathology.

The Organisation for Economic Cooperation and Development (OECD) adopted two draft proposals for new reproductive/developmental toxicity TGs in October 2007. Draft Proposal 426,

An ICCVAM-NICEATM workshop reviewed the Frog Embryo Teratogenesis Assay: Xenopus (FETAX) as a potential alternative for assessing developmental toxicants. The method was deemed not ready for validation, so recommendations were made for its continued development.

The ECVAM Scientific Advisory Committee (ESAC) "endorsed three in vitro methods for embryotoxicity testing as scientifically validated" (ESAC Statements, May 1, 2002):

• Embryonic stem cell test for embryotoxicity
• Micromass embryotoxicity assay
• Whole rat embryo embryotoxicity assay

The ESAC recommended these in vitro methods as ready for regulatory acceptance but acknowledged they cannot replace the animal tests. However, when used as part of a testing strategy, they could contribute to reducing animal use. (Source: http://www.alttox.org/ttrc/toxicity-tests/repro-dev-tox/)

reproductive toxicity is of obvious high concern because the continuance of the human species is dependent on the integrity of the reproductive cycle. It is characterised by multiple diverse endpoints, such as impairment of male and female reproductive functions or capacity (fertility), induction of non-heritable harmful effects on the progeny (developmental toxicity) and effects on or mediated via lactation.
The objectives of assessing reproductive toxicity are to establish:

• whether exposure of humans to the substance of interest has been associated with reproductive toxicity;
• whether, on the basis of information other than human data, it can be predicted that the substance will cause reproductive toxicity in humans;
• whether the pregnant female is potentially more susceptible to general toxicity;
• the dose-response relationship for any adverse effects on reproduction.

Source: REACH

a Socio Economic Assessment and Analysis (SEA) may include the following elements:

1. Impact of a granted or refused authorisation on the applicant(s), or, in the case of a proposed restriction, the impact on industry (e.g. manufacturers and importers). The impact on all other actors in the supply chain, downstream users and associated businesses in terms of commercial consequences such as impact on investment, research and development, innovation, one-off and operating costs (e.g. compliance, transitional arrangements, changes to existing processes, reporting and monitoring systems, installation of new technology, etc.) taking into account general trends in the market and technology.
2. Impacts of a granted or refused authorisation, or a proposed restriction, on consumers. For example, product prices, changes in composition or quality or performance of products, availability of products, consumer choice, as well as effects on human health and the environment to the extent that these affect consumers.
3. Social implications of a granted or refused authorisation, or a proposed restriction. For example job security and employment.
4. Availability, suitability, and technical feasibility of alternative substances and/or technologies, and economic consequences thereof, and information on the rates of, and potential for, technological change in the sector(s) concerned. In the case of an application for authorisation, the social and/or economic impacts of using any available alternatives.
5. Wider implications on trade, competition and economic development (in particular for SMEs and in relation to third countries) of a granted or refused authorisation, or a proposed restriction. This may include consideration of local, regional, national or international aspects.
6. In the case of a proposed restriction, proposals for other regulatory or non-regulatory measures that could meet the aim of the proposed restriction (this shall take account of existing legislation). This should include an assessment of the effectiveness and the costs linked to alternative risk management measures.
7. In the case of a proposed restriction or refused authorisation, the benefits for human health and the environment as well as the social and economic benefits of the proposed restriction. For example, worker health, environmental performance and the distribution of these benefits, for example, geographically, population groups.
8. An SEA may also address any other issue that is considered to be relevant by the applicant(s) or interested party.

Source: REACH regulation

soil acidification is a process whereby soil becomes acid (pH < 7) because acid parent material is present or in regions with high rainfall, where soil leaching occurs. Acidification can be accelerated by human activities such as the use of fertilisers, deposition of industrial and vehicular pollutants.

species of Community interest means species which, within the territory referred to in Article 2, are:

(i) endangered, except those species whose natural range is marginal in that territory and which are not endangered or vulnerable in the western palearctic region; or

(ii) vulnerable, i.e. believed likely to move into the endangered category in the near future if the causal factors continue operating; or

(iii) rare, i.e. with small populations that are not at present endangered or vulnerable, but are at risk. The species are located within restricted geographical areas or are thinly scattered over a more extensive range; or

(iv) endemic and requiring particular attention by reason of the specific nature of their habitat and/or the potential impact of their exploitation on their habitat and/or the potential impact of their exploitation on their conservation status.

Such species are listed or may be listed in Annex II and/or Annex IV or V;

Source: Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31992L0043:EN:html

see engineering sciences

see teratogenic effect

see toxic effect, toxicity

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

waste incineration is a disposal method that involves combustion of waste material. Incineration and other high temperature waste treatment systems are sometimes described as "thermal treatment". Incinerators convert waste materials into heat, gas, steam and ash.

Incineration is carried out both on a small scale by individuals and on a large scale by industry. It is used to dispose of solid, liquid and gaseous waste. It is recognized as a practical method of disposing of certain hazardous waste materials (such as biological medical waste). Incineration is a controversial method of waste disposal, due to issues such as emission of gaseous pollutants.

Incineration is common in countries such as Japan where land is more scarce, as these facilities generally do not require as much area as landfills. Waste-to-energy (WtE) or energy-from-waste (EfW) are broad terms for facilities that burn waste in a furnace or boiler to generate heat, steam and/or electricity. Combustion in an incinerator is not always perfect and there have been concerns about micro-pollutants in gaseous emissions from incinerator stacks. Particular concern has focused on some very persistent organics such as dioxins, furans, PAHs,... which may be created within the incinerator and afterwards in the incinerator plume which may have serious environmental consequences in the area immediately around the incinerator. On the other hand this method or the more benign anaerobic digestion produces heat that can be used as energy.

Source: http://en.wikipedia.org/wiki/Waste_management

water scarcity and drought are different phenomena although they are liable to aggravate the impacts of each other. In some regions, the severity and frequency of droughts can lead to water scarcity situations, while overexploitation of available water resources can exacerbate the consequences of droughts. Therefore, attention needs to be paid to the synergies between these two phenomena, especially in river basins affected by water scarcity.

Water scarcity occurs where there are insufficient water resources to satisfy long-term average requirements. It refers to long-term water imbalances, combining low water availability with a level of water demand exceeding the supply capacity of the natural system.

Water availability problems frequently appear in areas with low rainfall but also in areas with high population density, intensive irrigation and/or industrial activity. Large spatial and temporal differences in the amount of water available are observed across Europe.

Beyond water quantity, a situation of water scarcity can also emerge from acute water quality issues (e.g. diffuse or point source pollutions) which lead to reduced fresh/clean water availability.

Currently the main way of assessing Water Scarcity is by means of the Water Exploitation Index (WEI) applied on different scales (i.e. national, river basin). The WEI is the average demand for freshwater divided by the long-term average freshwater resources. It illustrates to which extent the total water demand puts pressure on the available water resource in a given territory and points out the territories that have high water demand compared to their resources.

The maps attached as links show the WEI for the European river basins in 2000 and for a forecasted scenario in 2030.