Medicines and Related Substances Act, 1965
R 385
Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)RegulationsHazardous Chemical Substances Regulations, 1995Annexure 1Mixed Exposures |
GENERAL
| 45) | The majority of OELs listed in Tables 1 and 2 of Annexure 1 are for single compounds or for substances containing a common element or radical, e.g. tungsten and compounds, and isocyanates. A few of the limits relate to substances commonly encountered as complex mixtures or compounds e.g. white spirit, rubber fume, and welding fume. However, workers are frequently subject to other mixed exposures involving solids, liquids, aerosols or gases. These exposures can arise as a result of work with materials containing a mixture of substances, or from work with several individual substances, simultaneously or successively, in a workshift. Mixed exposures require careful assessment of their health effects and the appropriateness of control standards. The following paragraphs provide a brief summary of the advice on the application of exposure limits in these circumstances. In all cases of doubt, specialist advice should be sought. |
EFFECTS OF MIXED EXPOSURES
| 46) | The ways in which the constituent substances of a mixed exposure interact, vary considerably. Some mixed exposures involve substances that act on different body tissues or organs, or by different toxilogical mechanisms, these various effects being independent of each other. Other mixtures will include substances that act on the same organs, or by similar mechanisms, so that the effects reinforce each other and the substances are additive in their effect. In some cases the overall effect is considerably greater than the sum of the individual effects and the system is synergistic. This may arise from mutual enhancement of the effects of the constituents or because one substance potentiates another, causing it to act in a way which it would not do alone. |
ASSESSMENT AND CONTROL
| 47) | With All types of mixed exposures, it is essential that assessments be based on the concentrations of each of the constituents in air to which workers are exposed. Depending on the nature of the constituents and the circumstances of use, the relative concentrations of the constituents in air may differ considerably from those in the liquid or solid source material. The composition of the bulk material should not be relied on for assessment unless there is good evidence for doing so. |
| 48) | Where mixed exposures occur, the first step is to ensure adequate control of exposure for each individual substance. However, the nature and amount of the other substances in a mixture can influence the level to which it is reasonably practicable to reduce exposure to a substance subject to an OEL-CL. When limits for specific mixtures have been established, they should be used only where they are applicable, and in addition to any relevant individual limits. They should not be extended to inappropriate situations. It is then necessary to assess whether further control is needed to counteract any increased risk from the substances acting in conjunction. Expert assessments for some particular mixed exposures may be available and can be used as guidelines in similar cases. In other cases, close examination of the toxicological data will be necessary to determine which of the main types of interaction (if any) are likely for the particular combination of substances concerned. The various types should be considered in the following order: |
| a) | Synergistic substances: Known cases of synergism and potentiation are considerably less common than the other types of behaviour in mixed exposures. However, they are the most serious in their effects and require the most strict control. They are also the most difficult to assess and wherever there is reason to suspect such interaction, specialist advice should be obtained; |
| b) | Additive substances: Where there is reason to believe that the effects of the constituents are additive, and where the exposure limits are based on the same health effects, the mixed exposure should be assessed by means of the formula- |
here C1, C2, etc. are the time-weighted average (TWA) concentrations of constituents in air and L1, L2, etc are the corresponding exposure limits. The use of this formula is only applicable where the additive substances habe been assigned OELs, and L1, L2, etc. relate to the same reference period in the list of approved OELs. Where the sum of the C/L fractions does not exceed one, the exposure is considered not to exceed the national OELs. If one of the constituents has been assigned an OEL-CL, then the additive effect should be taken into account in deciding the extent to which it is reasonably practicable to further reduce exposure; and
| c) | Independent substances: Where no synergistic or additive effects are known or considered likely, the constituents can be regarded as acting independently. It is then sufficient to ensure compliance with each of the OELs individually. |
| 49) | The above steps provide basic protocol for assessment of mixed exposures. It is open to persons responsible for control of exposure to treat all non-synergistic systems as though they were additive. This avoids the need to distinguish additive and independent systems and can be regarded as the most prudent course, particularly where the toxicity data are scarce or difficult to assess. |
MONITORING MIXED EXPOSURE
| 50) | Further information on monitoring airborne contaminants is given in paragraphs 52 and 53. The number of components of a mixed exposure for which routine air monitoring is required, can be reduced if their relative concentrations can be shown to be constant. This involves the selection of a key or marker, which may be one of the constituents, as a measure of the total contamination. Exposure to the marker is controlled at a level selected so that exposures to all components will be controlled in accordance with the criteria in paragraphs 48(a) and (b). However, if one of the components has been assigned an OEL-CL, the level of the exposure to that substance should always be reduced as far as is reasonably practicable. If this approach is to be used, it should take place under the guidance of suitable specialist advice. |
COMPLICATING FACTORS
| 51) | Several factors that complicate the assessment and control of exposure to individual substances will also affect cases of mixed exposures and will require similar special consideration. Such factors include- |
| a) | exposure to a substance for which there is no established limit or for which an OEL-CL has been set; |
| b) | the relevance of factors such as alcohol, medication, smoking and additional stresses; |
| c) | exposure of the skin to one or more substances that can be absorbed by this route, as well as by inhalation; and |
| d) | substances in mixture may mutually affect the extent of their absorption, as well as their health effects, at a given level of exposure. |
