Substance classification categories and criteria

Substances shall be classified as "environmentally hazardous substances (aquatic environment)", if they satisfy the criteria for Acute 1, Chronic 1 or Chronic 2, according to Table2.2.9.1.10.3.1. These criteria describe in detail the classification categories. They are diagrammatically summarized in Table 2.2.9.1.10.3.2.

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11 Special guidance on data interpretation is provided in Chapter 4.1 and Annex 9 of the GHS.

12 See Chapter 4.1 and Annex 9, paragraph A9.4.2.2.3 of the GHS.

Table 2.2.9.1.10.3.1: Categories for substances hazardous to the aquatic environment (see Note 1)

 

(a)

Acute (short-term) aquatic hazard

Category Acute 1:(see Note 2)

      96 hr LC50(for fish)

≤ 1 mg/l and/or

      48 hr EC50(for crustacea)

≤ 1 mg/l and/or

      72 or 96hr ErC50(for algae or other aquatic plants)

≤ 1 mg/l (see Note 3)

(b)

Long-term aquatic hazard (see also Figure 2.2.9.1.10.3.1)

 

(i)

Non-rapidly degradable substances (see Note 4) for which there are adequate chronic toxicity data available

Category Chronic 1:(see Note2)

     

Chronic NOEC or ECx (for fish)

≤ 0,1 mg/l and/or

     

Chronic NOEC or ECx (for crustacea)

≤ 0,1 mg/l and/or

     

Chronic NOEC or ECx (for algae or other aquatic plants)

≤ 0,1 mg/l

Category Chronic 2:

     

Chronic NOEC or ECx (for fish)

≤ 1 mg/l and/or

     

Chronic NOEC or ECx (for crustacea)

≤ 1 mg/l and/or

     

Chronic NOEC or ECx (for algae or other aquatic plants)

≤ 1 mg/l

 

(ii)

Rapidly degradable substances for which there are adequate chronic toxicity data available

Category Chronic 1:(see Note2)

     

Chronic NOEC or ECx (for fish)

≤ 0,01 mg/l and/or

     

Chronic NOEC or ECx (for crustacea)

≤ 0,01 mg/l and/or

     

Chronic NOEC or ECx (for algae or other aquatic plants)

≤ 0,01 mg/l

Category Chronic 2:

     

Chronic NOEC or ECx (for fish)

≤ 0,1 mg/l and/or

     

Chronic NOEC or ECx (for crustacea)

≤ 0,1 mg/l and/or

     

Chronic NOEC or ECx (for algae or other aquatic plants)

≤ 0,1 mg/l

 

(iii)

Substances for which adequate chronic toxicity data are not available

Category Chronic 1:(see Note2)

     

96 hr LC50 (for fish)

≤ 1 mg/l and/or

     

48 hr EC50 (for crustacea)

≤ 1 mg/l and/or

     

72 or 96 hr ErC50 (for algae or other aquatic plants)

≤ 1 mg/l (see Note3)

     

and the substance is not rapidly degradable and/or the experimentally determined BCF is ≥ 500 (or if absent the log Kow ≥ 4)  (see Notes 4 and 5)

Category Chronic 2:

     

96 hr LC50 (for fish)

>1 but ≤ 10 mg/l and/or

     

48 hr EC50 (for crustacea)

>1 but ≤ 10 mg/l and/or

     

72 or 96 hr ErC50 (for algae or other aquatic plants)

>1 but ≤ 10 mg/l (see Note3)

     

and the substance is not rapidly degradable and/or the experimentally determined BCF is ≥ 500 (or, if absent the log Kow ≥ 4)  (see Notes 4 and 5)

NOTE 1: The organisms fish, crustacea and algae are tested as surrogate species covering a range of trophic levels and taxa, and the test methods are highly standardized. Data on other organisms may also be considered, however, provided they represent equivalent species and test endpoints.

NOTE 2: When classifying substances as Acute 1 and/or Chronic 1 it is necessary at the same time to indicate an appropriate M factor (see 2.2.9.1.10.4.6.4 ) toapply the summation method.

NOTE 3: Where the algal toxicity ErC50(= EC50(growth rate)) falls more than 100 times below the next most sensitive species and results in a classification based solely on this effect, consideration shall be given to whetherthis toxicity is representative of the toxicity to aquatic plants. Where it can be shown that this is not the case, professional judgment shall be used in deciding if classification shall be applied. Classification shall be based on the ErC50. In circumstances where the basis of the EC50is not specified and no ErC50is recorded, classification shall be based on the lowest EC50available.

NOTE 4: Lack of rapid degradability is based on either a lack of ready biodegradability or other evidence of lack of rapid degradation. When no useful data on degradability are available, either experimentally determined or estimated data, the substance shall be regarded as not rapidly degradable.

NOTE 5: Potential to bioaccumulate, based on an experimentally derived BCF≥ 500 or, if absent, a log Kow≥ 4 provided log Kowis an appropriate descriptor for the bioaccumulation potential of the substance. Measured log Kowvalues take precedence over estimated values and measured BCF values take precedence over log Kowvalues.

Figure 2.2.9.1.10.3.1: Categories for substances long-term hazardous to the aquatic environmentClassify

The classification scheme in Table 2.2.9.1.10.3.2 below summarizes the classification criteria for substances.

Table 2.2.9.1.10.3.2: Classification scheme for substances hazardous to the aquatic environment

Classification categories

Acute hazard

(see Note 1)

Long-term hazard (see Note 2)

Adequate chronic toxicity data available

Adequate chronic toxicity data not available (see Note 1)

Non-rapidly degradable substances

(see Note 3)

Rapidly degradable substances

(see Note 3)

Category: Acute 1

Category: Chronic 1

Category: Chronic 1

Category: Chronic 1

L(E)C50 ≤ 1,00

NOEC or ECx ≤ 0,1

NOEC or ECx ≤ 0,01

L(E)C50 ≤ 1,00 and lack of rapid degradability and/or BCF ≥ 500 or, if absent log Kow ≥ 4

Category: Chronic 2

Category: Chronic 2

Category: Chronic 2

0,1 < NOEC or ECx ≤ 1

0,01 ≤ NOEC or ECx ≤ 0,1

1,00 < L(E)C50 ≤ 10,0 and lack of rapid degradability and/or BCF ≥ 500 or, if absent log Kow ≥ 4

NOTE 1: Acute toxicity band based on L(E)C50values in mg/l for fish, crustacea and/or algae or other aquatic plants (or Quantitative Structure Activity Relationships (QSAR) estimation if no experimental data13).

NOTE 2: Substances are classified in the various chronic categories unless there are adequate chronic toxicity data available for all three trophic levels above the water solubility or above 1mg/l. ("Adequate" means that the data sufficiently cover the endpoint of concern. Generally this would mean measured test data, but in order to avoidunnecessary testing it can on a case by case basis also be estimated data, e.g. (Q)SAR, or for obvious cases expert judgment).

NOTE 3: Chronic toxicity band based on NOEC or equivalent ECxvalues in mg/l for fish or crustacea or other recognized measuresfor chronic toxicity.

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.

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