No effect concentration

Toxicity studies (108—110) estabUshed tolerance levels and degrees of irritations, indicating that the eye is the area most sensitive to fluorine. Comprehensive animal studies (111—113) deterrnined a rat LC q value of 3500 ppm-min for a single 5-min exposure and of 5850 ppm-min for a 15-min exposure. A no-effect concentration corresponded to a concentration-time value of ca 15% of the LC q levels. 

There are insufficient data to conduct a probabilistic estimate of no-effect concentrations. For each of the organotins, the following outlines the reasoning for selection of studies and application of uncertainty factors ... 

For the ecological assessment, risk analysis was based on the traditional PEC/ PNEC ratio (Hazard Quotient) where PEC is the predicted environmental concentration (resulting from chemical analysis) and PNEC the predicted no-effect concentration. Ecological assessment for aquatic species was based on rainbow trout or fathead minnow while terrestrial assessment was based on small rodents like mice rats and rabbits. Exposures associated with HQ<1 were considered negligible. 

McKim, J.M. and D.A. Benoit. 1974. Duration of toxicity tests for establishing no effect concentrations for copper with brook trout (Salvelinus fontinalis). Jour. Fish. Res. Bd. Can. 31 449-452. 

Barber, T.R., D.J. Chappie, D.J. Duda, P.C. Fuchsman, and B.L. Finley. 1998. Using a spiked sediment bioassay to establish a no-effect concentration for dioxin exposure to the amphipod Ampelisca abdita. Environ. Toxicol. Chem. 17 420-424. 

The AEGL-1 concentration was based on a 1-hour (h) no-effect concentration of 8,000 parts per million (ppm) in healthy human subjects (Emmen et al. 2000). This concentration was without effects on pulmonary function, respiratory parameters, the eyes (irritation), or the cardiovascular system. Because this concentration is considerably below that causing any adverse effect in animal studies, an intraspecies uncertainty factor (UF) of 1 was applied. The intraspecies UF of 1 is supported by the absence of adverse effects in therapy tests with patients with severe chronic obstructive pulmonary disease and adult and pediatric asthmatics who were tested with metered-dose inhalers containing HFC-134a as the propellant. Because blood concentrations in this study approached equilibrium following 55 minutes (min) of exposure and effects are determined by blood concentrations, the value of 8,000 ppm was made equivalent across all time periods. The AEGL-1 of 8,000 ppm is supported by the absence of adverse effects in experimental animals that inhaled considerably higher concentrations. No adverse effects were observed in rats exposed at 81,000 ppm for 4 h (Silber and Kennedy 1979) or in rats exposed... 

End point/Concentration/Rationale The highest no-effect concentration of 8,000 ppm for 1 h was used as the basis for the AEGL-1. This concentration is considerably below the threshold for effects in animal studies. For example, anesthetic effects occur at a concentration of approximately 200,000 ppm. 

Intraspecies 1—this no-effect concentration for eight healthy individuals was far below concentrations causing effects in animals. At this low exposure concentration there was no indication of differences in sensitivity among the subjects. This uncertainty factor is supported by the lack of effects in COPD and adult and pediatric asthmatic patients treated with metered-dose inhalers containing HFC-134a as a propellant. 

End point/Concentration/Rationale The no-effect concentration of 40,000 ppm was chosen as the basis for the AEGL-2 because the next higher concentration of 80,000 ppm produced a serious effect. 

Medical questionnaires were not given in the Grabois (1954) study. However, both NIOSH (1976) and ACGIH (1996) reviewed the study. NIOSH (1976) identified 5 ppm as a no-effect concentration using the data for the five plants presented by Grabois (1954). Similar exposures were reported in the studies of Hardy et al. (1950) and Maehly and Swensson (1970). 

Data adequacy The preponderance of data from the key studies support an 8-h noeffect concentration of 1 ppm. The Leeser et al. (1990) study encompassed subjective symptoms as well as extensive medical examinations. The occupational monitoring study of El Ghawabi et al. (1975), in which it is believed that workers inhaling a mean concentration of 8 ppm may suffer mild headaches, supports the safety of the derived values. The values are also supported by a NIOSH (1976) report in which 5 ppm was identified as a no-effect concentration in the Grabois et al. (1954) occupational study. Additional monitoring studies support the values. ... 

The objective is to predict the concentration of the substance below which adverse effects in a particular environmental compartment are not expected to occur, i.e., the predicted no effect concentration (PNEC). However, in some cases, it may not be possible to establish a PNEC, and a qualitative estimation has to be made instead. An assessment factor is applied to... 

Alternative Methods PNEC Predicted no effect concentration... 

The method compares the predicted environmental concentrations (PECs), as indices of exposure, with predicted no effect concentrations (PNECs), as indices of... 

In general, only valid studies were used to derive predicted no effect concentrations (PNECs). Because in some cases only a few valid data were available, studies valid with restrictions have been used based on expert judgement. Invalid or non-assignable studies have not been used. In instances of volatile compounds, valid studies were generally those using closed, flow-through systems, preferably with analytical measurements. 

The risk posed to predators eating contaminated fish is determined by comparing the estimated daily intake (EDI) of fish predators (birds or mammals) with the predicted no-effect concentration in these predatory species. If adequate data are missing, the latter value was estimated from laboratory rodent or meat-eating animals (Table 3.3). 

The assessment of whether a substance presents a risk to the receiving environmental compartment is based on a comparison of the measured or predicted environmental concentration (PEC) of the chemical of concern with the predicted no effect concentration (PNEC) to organisms in the ecosystem. This is briefly discussed in Chapter 7.4. Studies carried out so far, e.g. by Vandepitte and Feijtel [91], show that the risk of anionic surfactants such as LAS, AE and AES for the aquatic environment is low, since the PECs are always lower than the maximum permissible concentrations. 

Environmental risk assessment of substances is nowadays based on an evaluation of exposure pathways and concentrations on the one hand and identification and selection of sensitive endpoints on the other. The concept is operationalised by comparing real or estimated (predicted) exposure concentrations (PEC) with calculated no-effect concentrations (NEC or PNEC, predicted NEC). The comparison can be made by calculating the quotient of exposure and no-effect concentration. If the quotient is less than one, then the substance poses no significant risk to the environment. If the quotient is greater than one, the substance may pose a risk, and further action is required, e.g. a more thorough analysis of probability and magnitude of effects will be carried out. 

No effect concentrations (NEC) for risk characterisation. Several countries and agencies have performed risk assessments for alkylphe-nols (AP) and APEO based on the approaches outlined above. Perhaps the most elaborate has been the assessment carried out by Environment... 

MEC measured environmental concentrations ( ig L ), PNEC predicted no effect concentration, REEmec literature reference for the MEC value, REEnmc literature reference for the PNEC value... 

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