Lexikon

recombinant DNA technology means the procedure used to join together DNA segments in a cell-free system (an environment outside a cell or organism). Under appropriate conditions, a recombinant DNA molecule can enter a cell and replicate there, either autonomously or after it has become integrated into a cellular chromosome.

Recombinant DNA technology is also called genetic engineering or in vitro DNA recombination.

minimizing waste generation from site remediation by recovering and reprocessing usable products that might otherwise become waste (Source: EUGRIS).

the average composition of red mud is the following:

reference dose is the maximum acceptable oral or dermal dose of a toxic substance. The EPA defines an oral reference dose (abbreviated RfD) as an estimate, with uncertainty spanning perhaps an order of magnitude, of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. http://www.epa.gov/economics/children/basic_info/glossary.htm

Reference doses are chemical specific, i.e. the EPA determines a unique reference dose for every substance it evaluates. Often separate acute and chronic RfDs are determined for the same substance. Reference doses are specific to dietary exposure. When assessing inhalation exposure, EPA uses "Reference concentrations," (RfCs), instead of RfDs. Note that RfDs apply only to non-cancer effects. When evaluating carcinogenic effects, special risk assessment methodology is applied.
RfDs are usually derived from animal studies. Animals (typically rats) are dosed with varying amounts of the substance in question, and the largest dose at which no effects are observed is identified. This dose level is called the "No Observable effect Level," or NOEL. To account for the fact that humans may be more or less sensitive than the test animal, a 10-fold uncertainty factor is usually applied to the NOEL. This uncertainty factor is called the "interspecies uncertainty factor" or Uf_inter. An additional 10-fold uncertainty factor, the "intraspecies uncertainty factor" or Uf_intra, is usually applied to account for the fact that some humans may be substantually more sensitive to the effects of substances than others. Additional uncertainty factors may also be applied. In general:

Frequently, a NOAEL is used in place of a NOEL. If adverse effects are observed at all dose levels tested, then the smallest dose tested, the "Lowest Observed adverse effect Level" or LOAEL, is used to calculate the RfD. An additional uncertainty factor usually applied in these cases, since the NOAEL, by definition, would be lower than the LOAEL had it been observed.

registration is the submission to the Agency of a technical dossier and, if required, a chemical safety report for a substance being manufactured in or imported into the European Union (and in the European Economic Area (EEA) once implemented in these countries). (Source: REACH Glossary)

registration is the submission to the Agency of a technical dossier and, if required, a chemical safety report for a substance being manufactured in or imported into the European Union (and in the European Economic Area (EEA) once implemented in these countries).
Manufacturers or Importers of substances on their own or in preparations or Producers or importers of articles will have in certain circumstances to provide a registration dossier to the European Chemicals Agency according to Articles 10, 11, 12, 17 and 18. It consists of a technical dossier and, when required, a Chemical Safety Report. (Source: REACH Glossary)

REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF

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.

renewable energy is kind of energy which is generated from natural resources such as sun-energy, wind-energy, hydropower, tides, geothermal energy and biomass. These all are naturally replenished sources.

In 2006, about 18% of global final energy consumption came from renewables, with 13% coming from traditional biomass, such as wood-burning and 3% from hydroelectricity. New type renewable resources (biomass, wind, solar, geothermal, and biofuels) accounted for 2.4% and are growing very rapidly. The share of renewables in electricity generation is around 18%, with 15% of global electricity coming from hydroelectricity and 3.4% from new renewables (source: http://en.wikipedia.org/wiki/Renewable_energy).

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/)

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 Committee for risk Assessment (RAC) is an Agency committee that is responsible for preparing the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions and proposals for classification and labelling under the classification and labelling inventory task and any other questions that arise from the operation of this Regulation relating to risks to human health or the environment. The RAC consists of at least one but no more than two members from the nominees of each Member State appointed by the Management Board for a renewable term of three years. The Committee members may be accompanied by advisers on scientific, technical or regulatory matters.

(Source: REACH)

final step in chemical safety assessment, it consists of estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted exposure to a substance. It may include a “risk estimation”, i.e. the quantification of that likelihood. risk characterisation is made for each exposure scenario and for each target population or compartment. (Source: REACH Glossary)

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.

Information provided on substance properties derived from testing (or otherwise), should be supported by sufficient information to show that the results are valid and reliable. Data should be traceable and validated.

REACH refers to study summaries and robust study summaries which it defines as:

Study summary: A summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study.

Robust study summary: A detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report.

A robust study summary is more detailed than a study summary, but even these definitions do not really clearly define the boundary between them. It will be ECHA and the MSCAs during the evaluation process who make the final decision on whether enough information has been provided.

IUCLID 5 contains input fields for (robust) study summaries data. It also asks for a confidence rating in the results of the study. Not all data will carry the same weight. It is also possible to attach the full study to the IUCLID file, but this should be done in addition to completing the data entry fields, not instead of.

Source: http://www.reach-serv.com/index.php?option=com_content&task=view&id=160&Itemid=64

in geology, rock is a naturally occurring solid aggregate of minerals and/or mineraloids. The Earth's outer solid layer, the lithosphere, is made of rock. The scientific study of rocks is called petrology. Petrography is a branch of petrology that focuses on detailed descriptions of rocks. Rocks are classified by mineral and chemical composition, by the texture of the constituent particles and by the processes that formed them. These indicators separate rocks into igneous, sedimentary and metamorphic. igneous rocks are formed when molten magma cools and are divided into two main categories: plutonic igneous rocks and volcanic rocks. sedimentary rocks are formed by deposition of either clastic sediments, organic matter, or chemical precipitates (evaporites), followed by compaction of the particulate matter and cementation during diagenesis. Sedimentary rocks form at or near the Earth's surface. metamorphic rocks are formed by subjecting any rock type (including previously-formed metamorphic rock) to different temperature and pressure conditions than those in which the original rock was formed. These temperatures and pressures are always higher than those at the Earth's surface and must be sufficiently high so as to change the original minerals into other mineral types or else into other forms of the same minerals (e.g. by recrystallisation). Petrographic descriptions start with the field notes at the outcrop and include megascopic description of hand specimens. The macroscopic characters of rocks, those visible in hand-specimens without the aid of the microscope, are very varied. The geologist in the field depends principally on them and they usually serve for a preliminary classification. However, the most important tool for the petrographer is the petrographic microscope. The detailed analysis of minerals by optical mineralogy in thin section and the micro-texture and structure are critical to understanding the origin of the rock. Characteristics observed under the microscope include colour, colour variation under plane polarised light, fracture characteristics of the grains, refractive index and optical symmetry. The more difficult and skilful part of optical petrography is identifying the interrelationships between grains and relating them to features seen in hand specimen, at outcrop, or in mapping. (http://en.wikipedia.org)

Remote Procedure Call

standard phrases relating to the safe use of dangerous chemical substance. For example "Keep container tightly closed" or "avoid contact with skin" or "do not empty into drains". When the current provisions are repealed and GHS enters into force, the S-phrases will be replaced by "precautionary statements". (Source: REACH Glossary).

The S-phrases are enlisted under the entry of "safety advice for the use of dangerous substances".

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)

the safety data sheet is the main tool used in industry for communicating information on the hazard of dangerous substances and preparations through the supply chain. Annex II of REACH is based on the Annex to the safety data sheet Directive (91/155/EEC) and explains what information should be included under each of the 16 safety data sheet headings. (Source: REACH Glossary)

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 scale problem is due to the spatiotemporal (i.e., in space and in time) variability of the systems of interest: statements that concern a particular scale may (and often will) not hold at other scales. Hence, extrapolation of understanding to a larger or to a smaller scale may require additional knowledge at these larger or smaller scales. (Source: EUGRIS)

Scientific Committee on Emerging and Newly Identified Health Risks, one of the scientific committees of the Europian Commission.

It shall provide opinions on questions concerning emerging or newly identified health and environmental risks and on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other community risk assessment bodies.

Examples of potential areas of activity include potential risks associated with interaction of risk factors, synergic effects, cumulative effects, antimicrobial resistance, new technologies such as nanotechnologies, medical devices including those incorporating substances of animal and/or human origin, tissue engineering, blood products, fertility reduction, cancer of endocrine organs, physical hazards such as noise and electromagnetic fields (from mobile phones, transmitters and electronically controlled home environments), and methodologies for assessing new risks. It may also be invited to address risks related to public health determinants and non-transmissible diseases.

http://ec.europa.eu/health/ph_risk/committees/04_SCENIHR/04_SCENIHR_en.htm