GHS

When to Label Ingredients of Unknown Acute Toxicity under GHS and How

Little Pro on 2018-02-05 Views:  Update:2018-08-13

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. 

What Does UN GHS Say?

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:

  • Where an ingredient with unknown acute toxicity is used in a mixture at a concentration >=1% and the acute toxicity estimates (ATE) of the mixture is calculated based on the acute toxicity data of known ingredients only (ATE method), the statement may be required. 
  • The competent authority can decide whether the statement on ingredients of unknown acute toxicity should be communicated via labels or SDSs or both. 

When to Indicate Ingredients of Unknown Acute Toxicity under GHS

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.

  • Total concentration of ingredients of unknown toxicity <1% -> No need
  •  Mixture classified based on mixture test data, not ATE method -> No need

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. 

Regulations Requirements
  • EU CLP
  • When a mixture contains a ‘relevant’ ingredient (i.e. constituting ≥ 1%; CLP Annex I, 3.1.3.3 (a)) for which there is no adequate acute toxicity data then the mixture must be classified on the basis of the ingredients with known toxicity, with an additional statement on the label and in the SDS to indicate that the mixture consists of ‘x percent’ of component(s) of unknown acute toxicity (CLP Annex I, 3.1.3.6.2.2).
  • US HCS
  • Where an ingredient with unknown acute toxicity is used in a mixture at a concentration >= 1% and the mixture is not classified based on testing of the mixture as a whole, a statement that X% of the mixture consists of ingredient(s) of unknown acute toxicity is required on both SDSs and labels.

How to Label Ingredients of Unknown Acute Toxicity

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. 

  • X1% of the mixture consist of ingredient(s) of unknown acute oral toxicity
  • X2% of the mixture consists of ingredient(s) of unknown acute dermal toxicity
  • X3% of the mixture consists of ingredient(s) of unknown acute inhalation toxicity

To save space on SDSs and labels, above 3 statements may be simplified to 1 statement:

  • max(X1, X2, X3)% of the mixture consists of ingredient(s) of unknown acute toxicity

References

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 Tags: Topics - GHSGHS SDS and Labelling

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