Little Pro on 2018-02-05 Views: Update:2019-11-16
When you prepare SDSs or GHS labels for a mixture, it happens very often that there is no acute toxicity data for an ingredient or there is no complete acute toxicity data for the ingredient for all 3 routes (oral, dermal and inhalation). In these cases, GHS may require statements like “x % of the mixture consist of ingredient(s) of unknown acute toxicity” in SDSs and on labels. In this article, we will summarize when to label ingredients of unknown acute toxicity under GHS and how.
Since most countries have followed the UN GHS purple book when developing their own regulations and standards for SDSs and labels, we will firstly look at what the UN GHS says about the ingredients of unknown acute toxicity in a mixture.
In the event that an ingredient without any useable information is used in a mixture at a concentration >=1%, the classification should be based on the ingredients with known acute toxicity only, and additional statement(s) should identify the fact that x% of the mixture contains ingredients of unknown acute (oral/dermal/inhalation) toxicity. The competent authority can decide that the additional statements should be communicated on the label or on the SDS or both, or to leave the choice of where to place the statements to the manufacturer/supplier.
What it really means is that:
To answer above question, there are 2 factors to consider. Firstly you need to know the concentration of ingredients of unknown toxicity in your mixture and how you have classified the mixture.
Since it is possible to have ingredients with unknown toxicity for more than one route (e.g., oral, dermal, inhalation), it is recommended that the total concentration of unknown toxicity be calculated for each route separately.
Secondly, you need to check national regulations and standards to see if the statements on ingredients with unknown toxicity should be communicated via SDSs, labels or both.
The table below summarizes the regulatory requirements for EU and USA.
GHS recommends unknown toxicity statement for each route separately (see example below). X should be the sum of the concentration of ingredients of unknown acute toxicity.
To save space on SDSs and labels, above 3 statements may be simplified to 1 statement:
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