Lexikon

The information required in technical dossiers is dependant on the annual tonnage of the substance, and is specified in Annexes VI-X of REACH. It includes:

• Registrant details;
• Joint submission details;
• Third party representatives;
• Substance identity;
• Manufacture and use;
• Classification and labelling;
• Guidance on safe use;
• Exposure information (1 to 10 tonne band only);
• (Robust) study summaries reporting on the physiochemical, toxicological, and ecotoxicological properties of the substance;
• Proposals for additional testing;
• Justification to keep commercially sensitive information out of the public domain.

Annex VI specifies the general information which must be provided for all substances regardless of tonnage.

Annexes VII to X give details of the physicochemical, toxicological and ecotoxicological properties that must be provided for each tonnage band.

regulatory toxicology gathers and evaluates existing toxicological information, develops uniform, standardized, comparable methods for testing and evaluating not only the effects but also the fate and behavior of chemical substances both in the environment and in the organisms. Regulatory toxicology means the interpretation and use of toxicity-results for the establishment of effect based quality criteria for food, drinking water, other water uses (e.g. irrigation), animal feed, all environmental compartments, such as air, surface waters, sediments, subsurface waters, soils, depending their use and users (land use) as well as for waste utilization (e.g. sewage sludge utilization on soil). Regulatory toxicology tries to control hazardous substances and materials in a safe matter, ensuring an acceptable risk level, or with other words, a safe exposure.

Regulatory toxicology is the study of the adverse effects of chemicals, not just on humans, but also on all living organisms including plants, animals, fungi and insects. The integration of metabolism, toxicity, pathology and mechanism is playing a much greater role today than ever before. A better understanding of these areas is essential for proper regulation of chemical substances and drugs and every other material, product or waste which contains hazardous chemical substances. It can also play an important role in the development of backup drugs and chemicals. We have to emphasize, that the origin of chemical risk is not only the hazard of a substance, but also the abnormal concentration or presence of a chemical substances at a not proper place and time.

environmental toxicology should serve regulation, scientists should know the concepts of regulation and the way how to fill the gaps with methodologies and information, moreover to advise on the need for their integration into the regulatory decision making.

The importance of regulatory toxicology is highly certified by the regulations on pesticides, biocides, food additives, cosmetics and the regulation of hazardous chemical substances and materials all over the world.

for the in situ or ex situ remediation of hydrocarbons, pesticides, chlorinated substances contaminated soils the altering oxic-anoxic or aerobic-anaerobic treatment is an efficient bioremediation alternative. The steps of the technology application are:

1. Addition of organic soil amendment, zero valent iron, and water to produce anoxic conditions.

2. Periodic tilling of the soil to promote oxic conditions.

3. Repetition of the anoxic-oxic cycle until the desired cleanup goals are achieved.

The addition of DARAMEND® organic amendment, zero valent iron, and water stimulates the biological depletion of oxygen, generating strong reducing anoxic conditions within the soil matrix. The diffusion of replacement oxygen into the soil matrix is prevented by near saturation of the soil pores with water. The depletion of oxygen creates a low redox potential, which promotes dechlorination of organochlorine compounds. A cover may be used to control the moisture content, increase the temperature of the soil matrix and eliminate runon/run off.

The soil matrix consisting of contaminated soil and the amendments is left undisturbed for the duration of the anoxic phase of treatment cycle typically 1-2 weeks. In the oxic phase of each cycle, periodic tilling of the soil increases diffusion of oxygen to microsites and distribution of irrigation water in the soil. The dechlorination products formed during the anoxic degradation process are subsequently removed trough aerobic oxic biodegradation processes, initiated by the passive air drying and tilling of the soil to promote aerobic conditions.

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

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/)

reprotoxic is a chemical substance, which may cause reproductive toxicity. Reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.

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

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

Any condition for or prohibition of the manufacture, use or placing on the market of a substance. The substances restricted under REACH and the conditions of their restrictions are included in Annex XVII of the Regulation.

the area of land and sea, made up of one or more neighbouring river basins together with their associated groundwaters and coastal waters, which is identified under 60/2000/EC, Article 3(1) as the main unit for management of river basins.

European Union Directive 67/548/EEC: Safety advice concerning dangerous substances and preparations. The list was consolidated and republished in Directive 2001/59/EC.

Simple phrases

(S1): Keep locked up

(S2): Keep out of the reach of children

S3: Keep in a cool place

S4: Keep away from living quarters

S5: Keep contents under ... (appropriate liquid to be specified by the manufacturer)

S6: Keep under ... (inert gas to be specified by the manufacturer)

S7: Keep container tightly closed

S8: Keep container dry

S9: Keep container in a well-ventilated place

S10: Keep contents wet

S11: Avoid contact with air

S12: Do not keep the container sealed

S13: Keep away from food, drink and animal foodstuffs

S14: Keep away from ... (incompatible materials to be indicated by the manufacturer)

S15: Keep away from heat

S16: Keep away from sources of ignition - No smoking

S17: Keep away from combustible material

S18: Handle and open container with care

S20: When using do not eat or drink

S21: When using do not smoke

S22: Do not breathe dust

S23: Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer)

S24: Avoid contact with skin

S25: Avoid contact with eyes

S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice

S27: Take off immediately all contaminated clothing

S28: After contact with skin, wash immediately with plenty of ... (to be specified by the manufacturer)

S29: Do not empty into drains

S30: Never add water to this product

S33: Take precautionary measures against static discharges

S35: This material and its container must be disposed of in a safe way

S36: Wear suitable protective clothing

S37: Wear suitable gloves

S38: In case of insufficient ventilation wear suitable respiratory equipment

S39: Wear eye/face protection

S40: To clean the floor and all objects contaminated by this material use ... (to be specified by the manufacturer)

S41: In case of fire and/or explosion do not breathe fumes

S42: During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer)

S43: In case of fire use ... (indicate in the space the precise type of fire-fighting equipment. If water increases the risk add - Never use water)

S45: In case of accident or if you feel unwell seek medical advice immediately (show the label where possible)

S46: If swallowed, seek medical advice immediately and show this container or label

S47: Keep at temperature not exceeding ... °C (to be specified by the manufacturer)

S48: Keep wet with ... (appropriate material to be specified by the manufacturer)

S49: Keep only in the original container

S50: Do not mix with ... (to be specified by the manufacturer)

S51: Use only in well-ventilated areas

S52: Not recommended for interior use on large surface areas

S53: Avoid exposure - obtain special instructions before use

S56: Dispose of this material and its container at hazardous or special waste collection point

S57: Use appropriate containment to avoid environmental contamination

S59: Refer to manufacturer/supplier for information on recovery/recycling

S60: This material and its container must be disposed of as hazardous waste

S61: Avoid release to the environment. Refer to special instructions/safety data sheet

S62: If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label

S63: In case of accident by inhalation: remove casualty to fresh air and keep at rest

S64: If swallowed, rinse mouth with water (only if the person is conscious)

Combinations

(S1/2): Keep locked up and out of the reach of children

S3/7: Keep container tightly closed in a cool place

S3/7/9: Keep container tightly closed in a cool, well-ventilated place

S3/9/14: Keep in a cool, well-ventilated place away from ... (incompatible materials to be indicated by the manufacturer)

S3/9/14/49: Keep only in the original container in a cool, well-ventilated place away from ... (incompatible materials to be indicated by the manufacturer)

S3/9/49: Keep only in the original container in a cool, well-ventilated place

S3/14 Keep in a cool place away from ... (incompatible materials to be indicated by the manufacturer)

S7/8: Keep container tightly closed and dry

S7/9: Keep container tightly closed and in a well-ventilated place

S7/47: Keep container tightly closed and at temperature not exceeding ... °C (to be specified by the manufacturer)

S20/21: When using do not eat, drink or smoke

S24/25: Avoid any inhalation, contact with skin and eyes. Wear suitable protective clothing and gloves

S27/28: After contact with skin, take off immediately all contaminated clothing, and wash immediately with plenty of ... (to be specified by the manufacturer)

S29/35: Do not empty into drains; dispose of this material and its container in a safe way

S29/56: Do not empty into drains, dispose of this material and its container at hazardous or special waste collection point

S36/37: Wear suitable protective clothing and gloves

S36/37/39: Wear suitable protective clothing, gloves and eye/face protection

S36/39: Wear suitable protective clothing and eye/face protection

S37/39: Wear suitable gloves and eye/face protection

S47/49: Keep only in the original container at temperature not exceeding ... °C (to be specified by the manufacturer)

Strategic Approach to International Chemical Management (SAICM) adopted on 6 February 2006 in Dubai.

SAICM supports the achievement of the goal agreed at the 2002 Johannesburg World Summit on Sustainable Development of ensuring that, by the year 2020, chemicals are produced and used in ways that minimize significant adverse impacts on the environment and human health.

Source: http://www.saicm.org/index.php?ql=h&content=home

the silicate minerals make up the largest and most important class of rock-forming minerals, comprising approximately 90 percent of the crust of the Earth. Silicate minerals all contain silicon (silicium in Latin) and oxygen. They are classified based on the structure of their silicate group. The most predominant silicate is quartz (SiO₂). The basic chemical unit of silicates is the (SiO₄) tetrahedron shaped anionic group with a negative four charge (^-4). The central silicon ion has a charge of positive four while each oxygen has a charge of negative two (^-2) and thus each silicon-oxygen bond is equal to one half (1/2) the total bond energy of oxygen. This condition leaves the oxygens with the option of bonding to another silicon ion and therefore linking one (SiO₄) tetrahedron to another and another, etc. Mineralogically, silicate minerals are divided according to structure of their silicate anion into the following groups: nesosilicates (single tetrahedrons), sorosilicates (double tetrahedrons), inosilicates (single and double chains), cyclosilicates (rings), phyllosilicates (sheets), tectosilicates (frameworks).The phyllosilicates (sheet silicates) include the clay minerals. They are one of the primary products of chemical weathering and one of the more abundant constituents of sedimentary rocks. The basic structure of the phyllosilicates is based on interconnected six member rings of SiO₄^-4 tetrahedra that extend outward in infinite sheets. Three out of the 4 oxygen atoms from each tetrahedon is shared with other tetrahedra. This leads to a basic structural unit of Si₂O₅^-2. In case the Si⁺⁴ atom in the middle of the tetradera is replaced by lower valency atoms such as Fe⁺³ or Al⁺³, then more negative bonds become available on the surface of the sheet structured clay minerals (http://en.wikipedia.org). These bonds have primary role in plant nutrient fixation, exchange and supply. Meanwhile these bonds contribute to the sorption of inorganic contaminants, fixing of ions to the surface of the clay mineral, while in case of treatment of contaminated soil to their removal (soil washing, extraction) or even to their stabilisation (soil stabilisation, immobilisation, chemical immobilisation/stabilisation in soil, vitrification). See also fate of inorganic pollutants in soil.

a rotating cultivation technique in which trees are cut down and burned in order to clear land for temporary agriculture; the land is used until its productivity declines at which point a new plot is selected and the process repeats; this practice is sustainable while population levels are low and time is permitted for regrowth of natural vegetation; conversely, where these conditions do not exist, the practice can have disastrous consequences for the environment.

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.

soil bioremediation based on aerobic oxidation means that the soil remediation is based on aerobic biodegradation. The microbiological biodegradation occurs in this case on a high redoxpotential of +0,8-+0,6 Volt. The degrading microorganisms utilise the pollutant as enbergy sources. The source of oxigen is the atmospheric air, soil air, or dissolved oxigen in soil moisture or ground water. If the oxigen-concentration is low, the technologist can increase it by aeration of the soil or the groundwater as well as by adding peroxide substances or other oxigene release compounds ORC to serve as oxigene source for the activation of the aerobic soil microbes.

small size laboratory microcosm prepared from a soil core, an undisturbed part of the soil with original microstructure. SCM is mainly for studying the microscale spatial gradients and processes in the soil.

soil remediation based on aerobic biodegradation is an oxidative process catalysed by microbes. Microbes, mainly bacteria utilise the contaminant as substrate for producing energy. Aerobic bacteria use athmospheric oxigen for the oxidation of the polluting organic compounds and produce inorganic products, such as CO₂, NO₃ and H₂O. This process is also called mineralisation.

When athmospheric oxigen is limited, the biodegradation is catalysed by facultative anaerobic microbes, which use NO₃ for their alternative respiration. In this case the oxidation/mineralisation products from the substrate the contaminant are alcohols or aldehydes.

anaerobic biodegradation of soil contaminants is based on the aternative respiration of soil microorganisms, using oxigen from NO₃^2-, SO₄^2-or CO₂, as hydrogen-acceptor instead of atmospheric oxigen. Paralel to the oxidation of the contaminant energy source in this case, nitrate, sulfate and carbonate are reduced into N₂ via nitrite NO₂⁻, nitric oxide NO, nitrous oxide N₂O, H₂S and CH₄ respectively.

There are some metals which can also be reduced and function as electronacceptor, such as ferric ion Fe³⁺reduction to Fe²⁺ or Fe⁰, manganic ion Mn⁴⁺ reduction to Mn²⁺, selenate SeO₄^2- reduction to selenite: SeO₃^2- and Se⁰, arsenate AsO₄^3- reduction to arsenite: AsO₃^3- or uranyl ion UO₂²⁺ reduction to uranium dioxide UO₂ for the electron transport chain.

The anaerobic biodegradation of xenobiotics needs a microorganism- and metabolism-specific redoxpotential. The soil remedial biotechnology is responsible for ensuring the proper redoxpotential in the soil to control the process and run biodegradation on the optimum.

To control the redoxpotential the technologist should ensure sufficient quantity of nitrate, sulfate or any other electronacceptors in the soil.

solidification/stabilisation (S/S) is a process which physically binds or encloses contaminants within a stabilised mass and is performed both ex situ and in situ. This technology reduces the mobility of hazardous substances and contaminants in the environment through both physical and chemical means.

Ex situ S/S requires excavation of the material to be treated, and the resultant material must be disposed.

In situ S/S uses auger/caisson systems and injector head systems to add binders to the contaminated soil or waste without excavation, and the resultant material is left in place.

solar photovoltaics (PVs) are arrays of cells containing a material, such as silicon, that converts solar radiation into electricity. Today solar PVs are used in a wide range of applications, from residential rooftop power generation to medium-scale utility-level power generation.

The Concentrated Solar Power (CSP) systems use mirrors or reflective lenses to focus sunlight on a fluid to heat it to a high temperature. The heated fluid flows from the collector to a heat engine where a portion of the heat is converted to electricity. Some types of CSP allow the heat to be stored for many hours so that electricity can be produced at night.

a noise caused by a shock wave (a propagating disturbance) that emanates from an aircraft or other object traveling at or above sonic velocity.

a physical technique employing ultrasound to intensely vibrate a sample media in extracting solvent and to maximise solvent/analyte interactions. Abbreviated as SAE, widely used for extracting the contaminants from soil.

a branch of mathematics that deals with collecting, reviewing, summarizing, and interpreting data or information. Statistics are used to determine whether differences between study groups are meaningful.

Strategic Approach to International Chemical Management (SAICM) adopted on 6 February 2006 in Dubai.

SAICM supports the achievement of the goal agreed at the 2002 Johannesburg World Summit on Sustainable Development of ensuring that, by the year 2020, chemicals are produced and used in ways that minimize significant adverse impacts on the environment and human health.

Source: http://www.saicm.org/index.php?ql=h&content=home