3.10. Aspiration hazard
3.10. Aspiration hazard
3.10.1.1. These criteria provide a means of classifying substances or mixtures that may pose an aspiration toxicity hazard to humans.
3.10.1.2. ‘Aspiration’ means the entry of a liquid or solid substance or mixture directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory system.
3.10.1.1. These criteria provide a means of classifying substances or mixtures that may pose an aspiration toxicity hazard to humans.
3.10.1.2. ‘Aspiration’ means the entry of a liquid or solid substance or mixture directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory system.
3.10.1.3. Aspiration hazard means severe acute effects such as chemical pneumonia, pulmonary injury or death occurring after aspiration of a substance or mixture.
3.10.1.4. Aspiration is initiated at the moment of inspiration, in the time required to take one breath, as the causative material lodges at the crossroad of the upper respiratory and digestive tracts in the laryngopharyngeal region.
3.10.1.5. Aspiration of a substance or mixture can occur as it is vomited following ingestion. This has consequences for labelling, particularly where, due to acute toxicity, a recommendation may be considered to induce vomiting after ingestion. However, if the substance/mixture also presents an aspiration toxicity hazard, the recommendation to induce vomiting shall be modified.
3.10.1.6. Specific considerations
3.10.1.6.1. A review of the medical literature on chemical aspiration revealed that some hydrocarbons (petroleum distillates) and certain chlorinated hydrocarbons have been shown to pose an aspiration hazard in humans.
3.10.1.6.2. The classification criteria refer to kinematic viscosity. The following provides the conversion between dynamic and kinematic viscosity:
3.10.1.6.2a Although the definition of aspiration in section 3.10.1.2 includes the entry of solids into the respiratory system, classification according to point (b) in Table 3.10.1 for Category 1 is intended to apply to liquid substances and mixtures only.
3.10.1.6.3.
Aerosol and mist forms of a substance or a mixture (product) are usually dispensed in containers such as self-pressurised containers, trigger and pump sprayers. The key to classifying these products is whether a pool of product is formed in the mouth, which then may be aspirated. If the mist or aerosol from a pressurised container is fine, a pool may not be formed. On the other hand, if a pressurised container dispenses product in a stream, a pool may be formed that may then be aspirated. Usually, the mist produced by trigger and pump sprayers is coarse and therefore, a pool may be formed that then may be aspirated. When the pump mechanism may be removed, and the contents are available to be swallowed then the classification of the substance or mixture shall be considered.
3.10.2. Classification criteria for substances
Table 3.10.1
Hazard category for aspiration toxicity
|
Category |
Criteria |
|
Category 1 |
Substances known to cause human aspiration toxicity hazards or to be regarded as if they cause human aspiration toxicity hazard A substance is classified in Category 1: (a) based on reliable and good quality human evidence or (b) if it is a hydrocarbon and has a kinematic viscosity of 20,5 mm2/s or less, measured at 40 oC. |
Note:
Substances in Category 1 include but are not limited to certain hydrocarbons, turpentine and pine oil.
3.10.3. Classification criteria for mixtures
3.10.3.1. Classification when data are available for the complete mixture
A mixture is classified in Category 1 based on reliable and good quality human evidence.
3.10.3.2. Classification when data are not available for the complete mixture: bridging principles
3.10.3.2.1. Where the mixture itself has not been tested to determine its aspiration toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazard of the mixture, these data shall be used in accordance with the bridging principles set out in section 1.1.3. However, in the case of application of the dilution bridging principle, the concentration of aspiration toxicant(s) shall be 10 % or more.
3.10.3.3. Classification when data are available for all components or only some components of the mixture
3.10.3.3.1.
3.10.3.3.1.1. The ‘relevant ingredients’ of a mixture are those which are present in concentrations ≥ 1 %.
3.10.3.3.1.2. A mixture is classified as Category 1 when the sum of the concentrations of Category 1 ingredients is ≥ 10 % and the mixture has a kinematic viscosity ≤ 20,5 mm2/s, measured at 40 °C.
3.10.3.3.1.3. In the case of a mixture which separates into two or more distinct layers, the entire mixture is classified as Category 1 if in any distinct layer the sum of the concentrations of Category 1 ingredients is ≥ 10 %, and it has a kinematic viscosity ≤ 20,5 mm2/s, measured at 40 °C.
3.10.4. Hazard Communication
3.10.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.10.2.
3.10.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.10.2.
Table 3.10.2
Aspiration toxicity label elements
|
Classification |
Category 1 |
|
GHS Pictogram |
|
|
Signal Word |
Danger |
|
Hazard Statement |
H304: May be fatal if swallowed and enters airways |
|
Precautionary Statement Prevention |
|
|
Precautionary Statement Response |
P301 + P310 P331 |
|
Precautionary Statement Storage |
P405 |
|
Precautionary Statement Disposal |
P501 |
