Ecotoxicological data

Reliable residue data are generated during the development of an a.i. to support the assessment of the consumer risk (residue data and toxicological data) and the impact on the environment (fate and behavior, efficacy and ecotoxicological data). It is critical that these analytical methods are reliably validated. In the guidance document SANCO/3029/99 rev. 4 (11/07/00), harmonized requirements for the residue analytical method are described. Validated analytical methods are required for the following studies ... 

Ecotoxicological data based on Organization for Economic Cooperation and Development (OECD) guidelines are also required, and the endpoints for aquatic organisms, such as fish, daphnia, algae and aquatic plants, are needed for utilization as part of the risk assessment process. 

Moreover, water quality is to be maintained or restored in such a way that human beings do not suffer any health damage as a result of the pollutant content of the fish they consume. The ecotoxicological data required in order to protect aquatic organisms and fish populations are the so-called No Observed Effect Concentration (NOEC) data. 

Table 4 Safety factors and available ecotoxicological data [1]...

A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data, Regulatory Toxicology and Pharmacology, 1997, 25, 1. 

Ecotoxicological data points out that mixtures of active substances might have different effects than single compounds [108-110], but general knowledge on this issue is still sparse. There are some examples of toxicity studies in literature showing that APIs mixmres may exhibit additive effects leading to toxicity even at low levels [109]. 

JACC Reports (Joint Assessment of Commodity Chemicals) are comprehensive reviews of toxicological and ecotoxicological data on individual chemical substances. 

Van den Brink, P.J., Van den Briiik, N.W., Ter Braak, C.J.F. (2003). Multivariate analysis of ecotoxicological data using ordination Demonstrations of utility on the basis of various examples. Australian Journal of Ecotoxicology, 9 141-156. 

Since one of the main aims of green chemistry is to reduce the use and/or production of toxic chemicals, it is important for practitioners to be able to make informed decisions about the inherent toxicity of a compound. Where sufficient ecotoxicological data have been generated and risk assessments performed, this can allow for the selection of less toxic options, such as in the case of some surfactants and solvents [94, 95]. When toxicological data are limited, for example, in the development of new pharmaceuticals (see Section 15.4.3) or other consumer products, there are several ways in which information available from other chemicals may be helpful to estimate effect measures for a compound where data are lacking. Of these, the most likely to be used are the structure-activity relationships (SARs, or QSARs when they are quantitative). These relationships are also used to predict chemical properties and behavior (see Chapter 16). There often are similarities in toxicity between chemicals that have related structures and/or functional subunits. Such relationships can be seen in the progressive change in toxicity and are described in QSARs. When several chemicals with similar structures have been tested, the measured effects can be mathematically related to chemical structure [96-98] and QSAR models used to predict the toxicity of substances with similar structure. Any new chemicals that have similar structures can then be assumed to elicit similar responses. 

The result of the discriminant analysis is shown in Fig. 5. The industrial activities are represented by ellipses of inertia containing the coordinates of industrial categories on the first factorial plane. All the categories largely overlap each other and show that this set of ecotoxicological data could not allow any linkage between the type of industry and the toxicological pattern. 

The battery of test approach for toxicity testing is now a universally-accepted concept. It has recently been applied in Latin American countries and is presently recognized as a critical tool for the assessment of complex mixtures. Interpretation of hazard by reducing complex ecotoxicological data into a single numerical value (e.g., PEEP index) is generally favoured by decision-makers involved in various facets of environmental regulation. 

Temporal variability and ecotoxicological data extrapolation This section has its focus on temporal variation in population and community structures and related differences in sensitivities, and on the ability of populations and communities to recover from, or adapt to, chemical stress. 

In the environment, chemicals may stress populations at different periods of the year and during different phases of the populations of the development. Consequently, when extrapolating ecotoxicological data, it is important to be aware of the possible temporal variability in sensitivity associated with different life stages. 

Spatial variability and ecotoxicological data extrapolation This section describes the current knowledge and available extrapolation tools with respect to the effect assessment of the same type of stressor in test systems of different sizes, in different types of aquatic ecosystem within a region, and in comparable ecosystems in different geographical regions. 

To what extent can ecotoxicological data be extrapolated from one geographical region to another, and what are the constraints on this extrapolation ... 

Upscaling in environmental risk assessment concerns, amongst other things, the extrapolation of ecotoxicological data derived from laboratory tests and model... 

Increased production levels require additional toxicology and ecotoxicology data to ensure that prolonged exposure effects are understood.10 Today, the ELINCS system is being progressed under European proposals labeled REACH—Registration, Evaluation and Authorization of Chemicals. 

The analysis need not be confined to the estimation of a standard that uses conventional methods of extrapolation (e.g., default assessment factors). It might usefully be accompanied by an analysis of the consequences of exceeding a particular standard. If a standard is proposed that sits within the range of available toxicological or ecotoxicological data or close to the lower limit of experimental data, then we should try to predict what impact an exceedance will have (e.g., excess cancer risk, proportion of species affected, or number of individuals affected). 

Summary of ecotoxicological data requirements used in different jurisdictions for aquatic (surface water) EQS derivation... 

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