Section 11: Toxicological Information
Toxicology is the study of the detrimental effects that chemical, physical, or biological agents have on people, animals and the environment.
Section 11 is written primarily for medical professionals, toxicologists and trained occupational health and safety professionals. The information provided here is of a specialist nature and is not necessarily relevant to the understanding of the rest of the safety data sheet.
The information in this section could be based on:
Human studies (case studies, epidemiology, volunteer studies).
Structure-activity relationships (modelling and analysis).
The presence of biologically significant amounts of hazardous materials.
The properties of similar chemical materials.
Verified laboratory (in-vitro; meaning outside the body in an artificial environment) assays.
It can be used by medical personnel to aid in treatment, or by those people who will classify the product or preparations containing the product.
However, the supplier should find some balance between reporting complex toxicological test results and the need to provide clear and concise information which is understandable to downstream users.
They should never simply copy and paste complex terminology from test reports. The language used must reflect a downstream user's (likely not a health and safety or medical professional) ability to comprehend the information.
Anyone reading this section should easily be able to take the following information, without the need for professional medical or health and safety training:
The levels of exposure where ill-effect is felt or noticeable (dose and frequency).
The symptoms that you can expect for the different routes of exposure.
Which organs may be damaged (e.g. target organs, liver, kidney, lungs, etc.).
How severe you can expect the effect to be (e.g. reversibility, mild, severe, etc.).
The most important routes of exposure (e.g. absorption, injection, ingestion, inhalation).
Whether the effect is acute, local, chronic or systemic.
There this information came from (e.g. animal or human studies, testing of similar chemicals).
Information on the toxicokinetics, metabolism and distribution of the product should be detailed.
As has been mentioned in Section 4 of this guide, there are several routes of exposure hazardous substances can use to enter the body. However, the main exposure routes likely to be included in Section 11 are inhalations, ingestion and skin contact.
The supplier of the safety data sheet may include the results of acute animal toxicity studies. Those studies often refer to LD50 (lethal does for 50% of a group in a single exposure) or LC50 (lethal concentration for 50% of a group in a single exposure).
However, these types of test have been made illegal in Europe, because it requires deliberately and lethally dosing animals. The practice is still legal in the United States.
To report the acute effects of a product, European suppliers will now provide an Acute Toxic Estimate (ATE) in this Section, which is estimated from the 'discriminating' dose. ATE's, like the old LD50 value, is usually present as weight or volume of the chemical per kilogram of body weight and LC50 values are exposure concentrations in air or water.
Each value provided here is required to be qualified by an indication of the route of exposure measure and the species of the animal.
Ideally, this section should contain a clear, complete and intelligible description of the potential health effects or symptoms likely to arise during or after exposure to the product and its known by-products. Including even low-level exposures.
All of this information must consistent with any information provided during the registration of the product and its chemical safety report, if applicable, including the classification of the product.
Please note: If Section 11 contains no information or the supplier states that there is 'No available data' you must still take care. A lack information does not mean the product isn't hazardous. You should immediately contact the supplier or a person trained for assessing toxicological information.
Under this subsection, the supplier must include information on each hazard. This is a legal requirement.
When test results are provided here, they must include:
The method of testings.
The species of the animal.
The dose or concentration of the product.
If the supplier has no available test data, they may estimate the hazards using techniques such as Quantitative Structure-Activity Relationships (QSARs), which are an approach designed to find relationships between chemical structure, chemical structure-related properties, and biological activity.
Where suppliers provide QSARs, they make this clear in this subsection. This is important because the data is calculated and not the results of an actual test. Likewise, if there is no available data for a specific hazard, they must also clearly state this fact.
If the product is a substance that is subject to registration, then the supplier should include brief summaries of the information derived from the results of any tests - or alternative means of information gathering - undertaken, including non-animal tests. This is a legal requirement under REACH Annex VII to XI.
The supplier will also provide here any information on the adverse health effects of the product not already listed elsewhere in the safety data sheet.
Under this subsection, the supplier must the data for entire mixture, or for each hazardous substance which contribute to the hazards inherent in the mixture. Under no circumstances should the supplier leave this section blank or state that there is 'No available data' when there is data available for the components of the products.
If the suppliers have no data available then they must assess the toxicity of the mixture by estimation.
Where the suppliers report data from registered components which reference a particular document, the must include references to the relevant information in Section 16, noting the correct citation required by the ECHA. This allows the downstream user to access more information at any time.
11.1. Information on Toxicological Effects
In this subsection, the supplier will provide the above, relevant information in a similar fashion to the table below:
The table will look very similar for singular substances and mixtures. In the case of mixtures, the supplier should make it clear what the data applies to. If it applies to the mixture or a singular component, this should be stated.
Please note: This section is closely linked to and should be read in conjunction with Sections 2, 4, 6, 7, 8, 9, 13, 14 and 15.
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This article was originally published by the team over at Sevron Ltd and has been shared here with full permissions.