Lexikon
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
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)
Remote Procedure Call
a senzitiezer is a dangerous chemical substance that causes a substantial proportion of exposed people or animals to develop an allergic reaction in normal tissue after repeated exposure to the chemical substance. Certain sentisizers have no immediate health effects. But if an organism is exposed to them several times, an allergic reaction may arise. A sensitizer may make an organism sensitive to other chemicals too, often quite suddenly. Typical reactions to sensitizers can include skin disorders such as eczema, respiratory disorders such as asthma, skin irritation (ulticaria), etc. Being under the effect of a sensitizer is also called hypersensitivity.
Sensitization is an immune response. Therefore, some people may be easily sensitized while others may never be affected. Like any allergic response, a reaction to a sensitizer can be fatal in rare circumstances. You can not predict your reaction to sensitizing chemicals, so treat all sensitizers with great respect and follow proper chemical safety and hygiene procedures.
site of Community importance means a site which, in the biogeographical region or regions to which is belongs, contributes significantly to the maintenance or restoration at a favourable conservation status of a natural habitat type in Annex I or of a species in Annex II and may also contribute significantly to the coherence of Natura 2000 referred to in Article 3, and/or contributes significantly to the maintenance of biological diversity within the biogeographic region or regions concerned.
For animal species ranging over wide areas, sites of Community importance shall correspond to the places within the natural range of such species which present the physical or biological factors essential to their life and reproduction;
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
Irritation and corrosion are local effects, i.e. changes occur at the site of first contact of the substance with the skin, eye, or mucous epithelia such as the respiratory tract.
Corrosive substances may destroy living tissues with which they come into contact after single exposure. Irritant substances are non-corrosive substances which, through immediate contact with the tissue under consideration may cause inflammation after single exposure.
Substances that cause irritant effects only after repeated exposure are not classified as irritants. Skin and/or eye irritation refers to the production of fully reversible changes following application of a substance (in the case of eye irritation, when application is performed to the anterior surface of the eye).
Corrosive substances produce irreversible effects such as necrosis through the epidermis and into the dermis, ocular tissue damages or decay of vision.
Chemicals which are classified for respiratory irritation may provoke irritations similar to skin or eye irritations. They may also cause other toxic effects, in relation with interactions with the vegetative nervous system and leading to reflex responses (sneezing, coughing, respiratory symptoms, etc). These effects are reversible. Testing for respiratory irritation is not required under REACH as no validated guidelines are available. Nevertheless, existing and available data that provide evidence of the respiratory irritation potential of a substance should be taken into account.
a sensitiser is an agent that is able to cause an allergic response in susceptible individuals. The allergic reaction occurs if a previous exposure has led to the development of immunity against the substance (i.e. sensitisation step). The effects arise on the occasion of later contact: allergic contact dermatitis, allergic rhinitis, asthma.,etc.
No information requirements are present under REACH for respiratory sensitisation. However, respiratory sensitisers are indicated for harmonised classification and labelling in article 36 of regulation (EC) no 1272/2008.
Source: REACH
(allergic contact dermatitis) is an immunologically mediated cutaneous reaction to a substance. In the human, the responses may be characterised by pruritis, erythema, oedema, papules, vesicles, bullae or a combination of these. In other species the reactions may differ and only erythema and oedema may be seen.
(allergic contact dermatitis) is an immunologically mediated cutaneous reaction to a substance. In the human, the responses may be characterised by pruritis, erythema, oedema, papules, vesicles, bullae or a combination of these. In other species the reactions may differ and only erythema and oedema may be seen.
eczema is broadly applied to a range of persistent skin conditions. These include dryness and recurring skin rashes that are characterized by one or more of these symptoms: redness, skin edema (swelling), itching and dryness, crusting, flaking, blistering, cracking, oozing, or bleeding. Areas of temporary skin discoloration may appear and are sometimes due to healed injuries. Scratching open a healing lesion may result in scarring and may enlarge the rash.
OECD 406/92 Test Guideline is intended primarily for use with guinea pig, but recently mouse models for assessing sensitisation potential have been developed. For the GPMT at least 10 animals in the treatment group and 5 in the control group are used. For the Buehler test, a minimum of 20 animals is used in the treatment group and at least 10 animals in the control group. The test animals are initially exposed to the test substance. Following a rest period, the induction period (10-14 days), during which an immune response may develop, then the animals are exposed to a challenge dose. The GPMT is made during approximately 23-25 days, the Buehler test, during approximately 30-32 days. The concentration of test substance used for each induction exposure should be well-tolerated systemically and should be the highest to cause mild-to moderate skin irritation, for the challenge exposure the highest nonirritant dose should be used. All skin reactions and any unusual findings should be observed and recorded (other procedures may be carried out to clarify doubtful reactions).
The description of the OECD test can be found here.
Soil washing is an ex situ soil or sediment treatment technology. Contaminants sorbed onto fine soil particles are separated from bulk soil in a water-based system on the basis of particle size. The wash water may be augmented with a basic leaching agent, surfactant, or chelating agent or by adjustment of pH to help remove organics and heavy metals. Soils and wash water are mixed ex situ in a tank or other treatment unit. The wash water and various soil fractions are usually separated using gravity settling.
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
The information required to identify a substance is defined in Annex VI, 2, of REACH, and is reproduced in the table below.
If it is not technically possible, or does not appear scientifically necessary to provide certain information, the reasons should be stated.
If you are involved in a joint registration, it is very important that you have agreed ‘sameness’ of your substances, and the information you each provide here should support this. There is no legal definition of "sameness" but any inconsistencies identified by ECHA or MSCAs that suggest your substances are significantly different could lead to requests for further information, or rejection of registration dossiers.
ECHA Technical Guidance: Guidance for identification and naming of substances under REACH
| Annex VI clause | Information requirement |
| 2.1 | Name or other identifier of the substance |
2.1.1 | IUPAC name or other international chemical name |
2.1.2 | Other names, e.g. trade name, abbreviation |
2.1.3 | EC Number |
2.1.4 | CAS name and CAS number |
2.1.5 | Other identity code |
| 2.2 | Information related to molecular and structural Formula |
2.2.1 | Molecular and structural formula (including SMILES notation, if available) |
2.2.2 | Optical activity and typical ratio of (stereo) isomers ( if applicable and appropriate) |
2.2.3 | Molecular weight or molecular weight range |
| 2.3 | Composition |
2.3.1 | Degree of purity |
2.3.2 | Nature of impurities, including isomers and by-products |
2.3.3 | Percentage of (significant) main impurities |
2.3.4 | Nature and order of magnitude (…ppm, …%) of any additives |
2.3.5 | Spectral data (UV,IR,NMR or mass spectrum) |
2.3.6 | High pressure liquid chromatogram, gas chromatogram. |
2.3.7 | Description of the analytical methods or the appropriate bibliographical references fro the identification of the substance and, where appropriate, for the identification of impurities and additives. This information shall be sufficient to allow the methods to be reproduced. |
Source: http://www.reach-serv.com/index.php?option=com_content&task=view&id=160&Itemid=64
sub-surface water, is fresh water located in the pore space of soil and rocks. It is also water that is flowing within aquifers below the water table. Sometimes it is useful to make a distinction between sub-surface water that is closely associated with surface water groundwater and deep sub-surface water in an aquifer sometimes called "fossil water".
Subsurface waters are generally polluted from the unsaturated soil layer beyond. Pipelines, underground containers, surface land-uses are the most frequent pollution sources. The contaminants in the subsurface waters may naturally attenuate due to dilution, chemical reactions or biodegradation. As the redoxpotential in the subsurface waters is relative low anoxic or anaerobic conditions, the biodegradation of pollutants is generally low, needs some enhancement by engineering/biotechnological tools to increase efficiency.
a tablet PC (personal computer) is a tablet-sized computer that also has the key features of a full-size personal computer. A tablet PC is essentially a small laptop computer, equipped with a rotatable touchscreen as an additional input device, and running a standard (or lightly adapted) PC operating system like Windows or Linux.
Source: http://en.wikipedia.org/wiki/Tablet_personal_computer
target quality in environmental management is the desired quality of the environment not posing unacceptable risk on the ecosystem and humans.
Unacceptable risk of chemical substances can be characterised by the risk characterisation ratio, which is the ratio of the predicted environmental concentration PEC and the predicted no effect concentration PNEC of a hazardous chemical RCR=PEC/PNEC. The targeted environmental concentration is smaller than or equal to the "no effect" concentration.