Mixtures classification categories and criteria
The classification system for mixtures covers the classification categories which are used for substances,meaning categories Acute 1 and Chronic 1 and 2. Inorder to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following assumption is made and is applied where appropriate:
The "relevant ingredients" of a mixture are those which are present ina concentration equal to or greater than 0.1%(bymass) for ingredients classified as Acute and/or Chronic 1 and equal to or greater than 1% for other ingredients, unless there is a presumption (e.g. in the case of highly toxic ingredients) that an ingredient present at less than 0.1% can still be relevant for classifying the mixture for aquatic environmental hazards.
The approach for classification of aquatic environmental hazards is tiered, and is dependent upon the type of information available for the mixture itself and for its ingredients. Elements of the tiered approach include:
(a)Classification based on tested mixtures;
(b)Classification based on bridging principles;
(c)The use of "summation of classified ingredients" and/or an "additivity formula".
Figure 2.2.9.1.10.4.2 below outlines the process to be followed.
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13 Special guidance is provided in Chapter 4.1, paragraph 4.1.2.13 and Annex 9, Section A9.6 of the GHS.
Figure 2.2.9.1.10.4.2: Tiered approach to classification of mixtures for acute and long-termaquatic environmental hazards
Classification of mixtures when toxicity data are available for the complete mixture
When the mixture as a whole has been tested to determine its aquatic toxicity, this information shall be used for classifying the mixture according to the criteria that have been agreed for substances. The classification is normally based on the data for fish, crustacea and algae/plants (see 2.2.9.1.10.2.3 and 2.2.9.1.10.2.4). When adequate acute or chronic data for the mixture as a whole are lacking, "bridging principles" or "summation method" shall be applied (see 2.2.9.1.10.4.4to 2.2.9.1.10.4.6).
The long-term hazard classification of mixtures requires additional information on degradability and in certain cases bioaccumulation. There are no degradability and bioaccumulation data for mixtures as a whole. Degradability and bioaccumulation tests for mixtures are not used as they are usually difficult to interpret, and such tests may be meaningful only for single substances.
Classification for category Acute 1
(a)When there are adequate acute toxicity test data (LC50or EC50) available for the mixture asa whole showing L(E)C50≤ 1mg/l:Classify the mixture as Acute 1 in accordance with Table 2.2.9.1.10.3.1 (a);
(b)When thereare acute toxicity test data (LC50(s) or EC50(s) available for the mixture as awhole showing L(E)C50(s)>1mg/l, or above the water solubility:
No need to classify for acute hazard under ADR.
Classification for categories Chronic 1 and 2
(a)When there are adequate chronic toxicity data (ECxor NOEC) available for the mixture as awhole showing ECxor NOEC of the tested mixture ≤1mg/l:
(i)classify the mixture as Chronic 1 or 2 in accordance with Table 2.2.9.1.10.3.1 (b)(ii)(rapidlydegradable) if the available information allows the conclusion that all relevantingredients of the mixture are rapidly degradable;
(ii)classify the mixture as Chronic 1 or 2 in all other cases in accordance with Table2.2.9.1.10.3.1 (b)(i) (non-rapidlydegradable);
(b)When there are adequate chronic toxicity data (ECxor NOEC) available for the mixture as awhole showing ECx(s) or NOEC(s) of the tested mixture >1mg/l or above the watersolubility:
No need to classify for long-term hazard under ADR.
Classification of mixtures when toxicity data are not available for the complete mixture: bridging principles
Where the mixture itself has not been tested to determine its aquatic environmental hazard, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, thesedata shall be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterising the hazards of the mixture without the necessity for additional testing in animals.
Dilution
Where a new mixture is formed by diluting a tested mixture or a substance with a diluent which has an equivalent or lower aquatic hazard classification than the least toxic original ingredient and which is not expected to affect the aquatic hazards of other ingredients, then the resulting mixture shall be classified as equivalent to the original tested mixture or substance. Alternatively, the method explained in 2.2.9.1.10.4.5 may be applied.
Batching
The aquatic hazard classification of a tested production batch of a mixtureshall be assumed to be substantially equivalent to that of another untestedproduction batch of the same commercial product when producedby or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the aquatic hazard classification of the untestedbatch has changed. If the latter occurs, new classification is necessary.
Concentration of mixtures which are classified with the most severe classification categories (Chronic 1and Acute 1)
If a tested mixtureis classified as Chronic 1and/or Acute 1, and the ingredients of the mixture which are classified as Chronic 1and/or Acute 1are further concentrated, the more concentrated untestedmixture shall be classified with the same classification category as the original testedmixture without additional testing.
Interpolation within one toxicity category
For three mixtures (A, B and C) with identical ingredients, where mixtures A and B have been tested and are in the same toxicity category, and where untested mixture C has the same toxicologically active ingredients as mixtures A and B but has concentrations of toxicologically active ingredients intermediate to the concentrations in mixtures A and B, then mixture C is assumed to be in the same category as A and B.
Substantially similar mixtures
Given the following:
(a)Two mixtures:
(i)A + B;
(ii)C + B;
(b)The concentration of ingredient B is essentially the same in both mixtures;
(c)The concentration of ingredient A in mixture (i) equals that of ingredient C in mixture(ii);
(d)Data on aquatic hazardsfor A and C are available and are substantially equivalent, i.e. theyare in the same hazard category and are not expected to affect the aquatic toxicity of B.
If mixture (i) or (ii) is already classified based on test data, then the other mixture can be assigned the same hazard category.