Safety rules for classification、precautionary labelling and precautionary statements of chemicals - Hazardous to the aquatic environment
Some standard content:
ICS13.300
National Standard of the People's Republic of China
GB20602—2006
Safety rules for classification, precauutionary labelling and precautionary statements of chemicals-llazardous to the agualic: environment2006-10-24Promulgated
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Standardization Administration of the People's Republic of China
2008-01-01Implementation
Chapter 4, Chapter 6, Chapter 7, Chapter 8 of this standard GR20602-2006 (Part 1) is mandatory and the rest are recommended. This standard is not equivalent to the Global Harmonized System of Classification and Labelling of Chemicals (IIS). Its relevant technical specifications (hereinafter referred to as Hazardous Chemicals Standardization Technical Committee T21) have been edited and revised according to G1.12. This standard is responsible for drafting the standard: Shandong Exit and Entry Inspection Bureau. Participants in the development of this standard: National Environmental Protection General Chemical Registration Center, China Chemical Standardization Research Institute. Main drafters of this standard: Zhang Shaoyan, Mi Zhenqian, Jun Lidong, Fu Xiao, Tao Chudun. This standard will be implemented in the production field from January 1, 2008: it will be implemented in the circulation field from December 31, 2008, and the transition period for the implementation of the standard is from December 31, 2028. 1 Scope
Chemical classification, warning labels and warning statements Safety regulations Hazards to the aquatic environment
GB 20602—2006
This standard defines the terms and definitions, classification, determination process, categories and warning labels, classification and label elements, and warning statements of chemicals that are hazardous to the aquatic environment. This standard applies to the hazard classification, warning labels and warning statements of chemicals that are hazardous to the aquatic environment in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.
2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For any reference document with an expiration date, all subsequent amendments (excluding revised versions) or revisions are not applicable to this standard. However, parties that have reached an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any reference document without an expiration date, the latest version shall apply to the following standards: United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS); Joint Recommendations on the Transport of Dangerous Goods (Regulations for the Testing of Chemicals); ED Test Methods (IEC 6001-10); 7 (1995) Partition coefficient (n-octanol/water) Vibration method (Standards for Testing of Chemicals 17 (199) Partition coefficient (n-octanol/water) High performance liquid chromatography [PIC) method (Standards for Testing of Chemicals 2) 1 (1984) Algae, long-term inhibition test (Standards for Testing of Chemicals 202 (1931) Egg immobilization test and reproduction test) Standards for Testing of Chemicals 2092) General, acute sex test (01) Standards for Testing of Chemicals 210 (292) Fish, early life stage toxicity test (Standards for Testing of Chemicals 211 (199) T) aphnia Mgn biodegradation test (OCI) Guidelines for Testing of Chemicals 301 (1992) Ready biodegradability FL) Guidelines for Testing of Chemicals 305 (1966) Bioaccumulation: flow-through fish test () Guidelines for Testing of Chemicals 306A (1902) Biodegradability in seawater 3 Terms and definitions, symbols, abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this standard. 3.1.1
Acute aquatic toxicity
Acute aquatic toxicity
refers to the ability of a substance to cause damage to organisms exposed to it in the short term. 3.1.2
Availability
refers to the degree to which a substance can be made soluble and decomposed. For metal availability, it refers to the degree to which the metal ion portion of the metal (M) compound can be decomposed from the rest of the compound (ion). 3.1. 3
Bioavailabilitybioavailahilityur biolngical ailubilityThe process by which a substance is absorbed by organisms and distributed to a certain area in the body. It is related to the physicochemical properties of the substance, the tissue structure of the organism and the mechanics of the organism. GB 20602—2006
Science: Availability is not a necessary condition for the bioavailability of an organism. 3.1.4
Biological accumulation
The final result of the absorption, transformation and elimination of a substance in an organism by all modes of exposure (i.e. air, water, sediment/soil food).
Bioconcentration
The net result of the absorption, transformation and elimination of a substance in an organism by the waterborne route of exposure. 3.1.6
Chronic aquatic toxicity
The potential or actual nature of a substance to cause adverse effects to aquatic organisms during an exposure period relevant to biological life. 3.1.7
Complex mixtures or mulli-component substances or complex substances
A combination of individual substances of different solubility and physical/chemical properties. In most cases, they have a certain degree of chain length change/substitution. 3.1.8 Degradation Degradation Organic molecules become smaller molecules and eventually decompose into carbon dioxide, water and chlorine: 3.2 Symbols The following symbols apply to this standard: E: refers to the concentration of the substance when the effect reaches 0. Er: Growth rate reduction LC (50%) LC (50%) 1D: refers to the concentration of a chemical in the air or water that causes half of the test animals to die if exposed to the chemical once (F..:C or F.. 3.3 Abbreviations The following abbreviations are applicable to this standard. BcFhioomenrationfaru) Bioconcentration factor (HCT) Biochemical ammonia consumption (CD) Chemical ammonia consumption (NHNF) (isetlffertconcemriun no observable effect concentration (ORCN) (organic environmental cooperation and development ... 3.4 Basic elements 3.4.1 The following elements are used in the standard: acute bioreactivity; existing or actual bioaccumulation; degradation of organic chemicals (biological or abiotic); chronic biotoxicity. 3.4.2 Although data from internationally coordinated test methods are preferred, in practice, data from national GB 20602-2006 methods may also be used as long as they are recognized as equivalent: generally established reactivity data for freshwater and various marine species are considered equivalent, and they are preferably obtained according to the principles of good laboratory practice (EP) using () chemical testing criteria or equivalent methods. If such data are not available, classification is based on the best available data. 3.5 Acute aquatic toxicity
Acute aquatic toxicity is generally determined by using fish 9G1, 1.1 () E (D Chemical Test Guidelines 203 or equivalent test guidelines) 4% hEc (E) Chemical Test Guidelines 202 or equivalent test guidelines) and/or 7h or 96h (1) E) Chemical Test Guidelines 201 or equivalent test guidelines) to confirm that these organisms are considered to be representative of all aquatic organisms and the test method is appropriate. Data from other species such as duckweed may also be considered. 3.6 Bioaccumulation Potential || TT || Bioaccumulation potential is usually determined by the octane/water partition coefficient. Usually according to the (ELL) Chemical Test Guidelines-07 or logK.w determined by 117: Although this coefficient indicates the potential for bioaccumulation, the bioaccumulation factor (B(F)) determined by laboratory tests may provide a better measure, in which case the bioaccumulation factor is determined in accordance with UED Test Guideline 5 for Chemicals. 3.7 Rapid degradability
3.7.1 Environmental degradation may be biological, but may be abiotic (e.g. hydrolysis), see 4., 9.3, and rapid biological release (ECI) in this standard. Biodegradability tests \ECD Test Guidelines for Chemicals (AF)\ definitions. The pass levels in these tests can be used as indicators of rapid degradation in most environments. These tests are all freshwater tests, so this includes the results of the (ECL) Test Guidelines for Chemicals 306, which are also suitable for marine environments. If there is no such evidence, the 10I)/CU[) ratio + C.5 can be used as an indicator of rapid degradation
3. 7.2 Non-biological degradation such as initial hydrolysis, non-biological and primary biodegradation, degradation in non-aqueous media and demonstrated rapid degradation in the environment may be taken into account in defining rapid degradation. 3.8 Chronic aquatic toxicity Chronic toxicity data are not as readily available as acute data and test specifications are less standardized: data from the guidelines for the testing of chemicals 21, 22 and 20 are generally accepted: evidence of valid and internationally recognized tests may be used. 4 Classification 4.1 Classification of substances 4.1.1 The classification of substances consists of four acute and four chronic classification categories (Table 1). Acute and chronic categories are used alone: Classification of substances as acute is based on acute data only. E or I. The classification of substances as chronic combines two types of information, acute toxicity information and environmental effects data (gradual degradation and bioaccumulation data). The classification of mixtures as chronic toxicity can be obtained from the test samples of the components. Table 1 Classification of substances hazardous to the aquatic environment
Acute hazard
Category: Acute!
1c-, 1 and
Branch E algae or other aquatic plants
Some potassium-containing substances may be subdivided into acute 1, 1mg, the lowest range of acute 2
L0 Metal: more than 1 h > m+ or
43 h Ft, (crustaceans) more than rg/1. I human more than 1G ~g: 1. Insects or other animals 1 and not more than 1G/
GR 20602—2006
Category: 2 Nature 3
Table 1 (dwarf)
96h (Five species greater than 10 mg/ H > 130g1./or 48 FC (Crustacea) greater than 1 g/L Hill not greater than [℃ R. Li/or 72 or 6rt: Class or aquatic plants) greater than 1 1 and not greater than 1C 1 Some regulatory changes may extend this range by introducing another category, such as 1 (C (0 g4. Other diffuse toxicity
Category: Chronic [
96 h[c. color] m/[,/or
18 EC: residual) 1 mg/1.. and/or
72 h or 2 Ercn: algae or other aquatic plants) 1 mg/ The substance cannot be rapidly degraded and/or kgK.1t unless experimentally determined BrcF is less than 0.01 Category: Chronic 2
6 1 to Class 2" 1 m/I not more than [0 mg/, and/or 18 years old 1 not more than " /. and or
or 6 ErCs; (Class 2 or H other water) less than 1 mR/1. Not less than 1o J/I The substance cannot be rapidly degraded and/or logK.4 (unless experimentally determined BrcF is less than 11 s), except Il = chronic cystic (FC greater than 11 :g/[Category: chronic condition: 3
yh [C (color) greater than 1 g/1. . person 1 g/,/481EC (crustacean grade) greater than 1:mz/L-1 not more than 10mg/L./72 or 361Frt: (algae or other aquatic plants) human -1:10~g/1. and not more than 100 1mg/1 The substance is not rapidly degradable and/or logK.,4 (unless the experiment confirms that HCF is less than 5CO). Unless chronic toxicity Nr)EC greater than 11 mg1. Classification: Reversible 1
There is no limit to acute toxicity below the level of water conditions, and it is not rapidly degradable, logK4. Non-degradable substances with the potential for bioaccumulation can be classified in this category unless there is other scientific evidence to show that classification is not necessary. Such evidence includes an experimentally determined BCF of less than 500, or a chronic toxicity N greater than 1, or evidence of rapid degradation in the environment. 1.2 Substances classified according to the following principles may be classified as "hazardous to the aquatic environment" categories. These principles specify the classification categories and Table 2 summarizes them in a graphical form. Table 2 Classification scheme for substances hazardous to the aquatic environment Classification principles
(a and)
ec.:.oomgl.
(3a and 2b)
Degradability?
Biological rights "
" category 6:
category,
acute!
Classification category
Category:
Vascular 1
1—5—6
(laThr
Push 2:
1. co mg..r
E0.1c. C me/1
lo. t/1-. L(E)C-
1oc mg?t.
No acute toxicity
Classification principles
(2a Fil 2hjt
Table 2 (continued)
Degradability:
Lack of sub-rapid degradability
Vot :-1. 03 ng:.
Bioaccumulation
BCF 5 or book,
If missing 1oRK
GB20602—2006
Classification of inflammation
Acute 2
Class:
Chronic 2
: Unless sugar?
Class:
Busy::+h
Class:
Unless 7
1a: Acute acoustic radiation based on 1. (E) C value (unit: ug/L) of fish, shellfish/or other aquatic plants (or if there is no test data, the C2SAR estimate is yes! Ih: If the wing recruitment FTC - FCa (growth rate) falls to 10 times the level of the next most sensitive species: 1. If classification is based solely on this effect, then it must be determined whether the toxicity represents a difference in toxicity to water plants. If it can be shown that this is not the case, then a professional judgment must be made to determine whether classification is necessary. The classification must be based on LrC. In the case where no FC basis is specified and there is no record of LrC-based classification, the classification must be based on the best available EC-based. 2. Chronic toxicity ranges are based on NOEC values (in g/[) of color or shell or other recognized public toxicity measurement methods. 2b: It is intended that the community-related development of this system =The data on chronic toxicity are included. Lack of rapid degradability is based on lack of rapid degradability or other evidence of lack of rapid degradation: the bioaccumulation potential is based on experimentally determined 203 or, if this value is not available, 10g K4 is used as the basis. K is an appropriate indicator of the bioaccumulation potential of a substance: log values are taken before log values, F values are taken before F values, and "acute toxicity" is high in water. For substances that are not easily degradable (little water degradable), it is shown that acute tests will not provide a true measure of toxicity. 4.1.3 Testing of core inherent hazards to aquatic organisms The acute and chronic toxicity of a substance distinguishes between acute and chronic hazards. Therefore, fixed hazard categories are defined for these two properties, which represent a hierarchy of established hazard levels. The lowest available toxicity value is usually used to define the appropriate hazard category. However, in some cases a weight of evidence approach may be used: acute toxicity data are most readily available and the tests used are most standardized; therefore, these data form the core of the classification system. 4.1.4 Overall toxicity is a key property in determining the following hazard: a substance may be transported in large quantities and may accidentally cause a serious spillage, giving rise to a chronic hazard. Therefore, a hazard category 1F with a minimum 100 mg/kg was established. 4.1.5 For dry packaged substances, chronic toxicity determination must be performed, although 1(E),An acute toxicity greater than 1 mg/1 is also considered to be sufficient for a hazard. It is considered possible that the substance will reach concentrations of 1 mg/1 in the aquatic environment after normal use and handling. However, if the level of the substance is higher than this, the long-term toxicity itself cannot be used to indicate a significant hazard caused by low concentrations that cause an effect within a longer time frame. Therefore, the hazard category is based on sufficient chronic toxicity. However, for many substances, no chronic toxicity data are available and such substances must be evaluated using existing acute toxicity data. The lack of rapid degradability and/or bioaccumulation potential can be combined with acute toxicity to classify the substance as chronic. If the existing chronic toxicity minimum N (E = 1 mg/1), then no chronic hazard category is required. Similarly, 20602—2006
For substances with an IF of 100 mR/1.00, in most cases the toxicity profile is insufficient to justify classification. 4.1.6 Although acute toxicity values and lack of bioaccumulation of rapidly degradable substances are used as the basis for classification into chronic hazard categories, these data constitute a better basis for classification when actual chronic toxicity data are available. 4.1.7 Aquatic toxicity
4.1.7.1 Biota, crustacea and phyla are tested as surrogate species. The tests cover a range of species and classes and the test methods are highly standardized. However, other biota may be used provided that they are equivalent species and test endpoints. Algal growth inhibition tests are not toxic tests but are used as acute values for classification. Such values must generally be based on growth rate inhibition. If only small amounts of the substance are present, no report is indicated. The only thing that can be used is this value. 4.1.7.2 Aquatic toxicity tests This consists of dissolving the test substance in the aqueous medium used and maintaining a constant effective contact concentration for the test during the test.
4.1.8 Bioaccumulation
Bioaccumulation of a substance in aquatic organisms may produce toxic effects over long periods of time, even if the actual water concentration is very low: Bioaccumulation is the partition between octanol and water. There is a lot of scientific literature to support the positive relationship between the partition coefficient of an organic substance and its bioconcentration measured in fish F: the use of a threshold value log K1.5 is only used to identify substances with a real potential for bioaccumulation. The presence of log K1.5 is not sufficient to determine the BCF value, so the measurement of BCF values should always be the first consideration. Fish F values less than 500 are considered to be an indicator of low bioaccumulation levels. 4.1.9 Rapid Degradability
4.1.9.1 Rapidly degradable substances are rapidly removed from the environment and when effects occur, particularly in the case of a spill or a hypothetical event, the substance will only be localized and will not be present for a very short time. Substances that do not degrade rapidly in the environment may remain toxic in water over a wide range of times. One way to demonstrate rapid thermal degradation is to use a biodegradability thermal screening test designed to determine if a substance is "rapidly degradable". Substances that avoid screening tests are likely to survive in the aquatic environment. In the context of "degradable substances", it is not necessarily true that they will not be rapidly degradable in the environment if they do not pass the screening test. This principle adds a new meaning. This principle allows the use of data to show that the substance is indeed biotically or non-biologically degradable in the aquatic environment. Therefore, if degradation can be demonstrated under actual environmental conditions, the definition of "rapid degradability" is obtained. Many degradation data are in the form of degradation products, and these data are not used to define rapid degradation. Some tests measure the most complete biodegradation of a substance, i.e. complete mineralisation. When assessing rapid biodegradability, the above mentioned signs of biodegradation are not limited to this principle unless it can be demonstrated that the degradation does not meet the criteria for classification as hazardous to the aquatic environment: 4.1.9,2 Environmental degradation is either physical or may be sufficient to be positively biodegradable (e.g. aquatic degradation). The principle used also reflects the fact that failure to meet the rapid biodegradability criteria in a () test does not mean that the substance is not rapidly degradable in the actual environment. Therefore, if rapid degradation can be shown in this column, the substance should be considered to be rapidly degradable. If the aquatic product does not meet the criteria for classification as hazardous to the aquatic environment, then hydrolysis can be considered. The following gives a specific definition of rapid degradability. Other evidence of rapid degradation in the environment may also be considered and may be particularly important if the substance inhibits microbial activity at concentrations used in standard tests.
4.1.9.3 A substance may be considered to be rapidly degradable in the environment if the following principles are met. 4.1.9.3.1 If in 28 rapid biodegradation studies the following levels of degradation are achieved: tests based on organic matter decomposition: 70%; tests based on oxygen depletion or oxide generation: theoretical maximum 60%. These biodegradation levels must occur within 10 days after the start of degradation - the degradation starting point is when 10% of the substance has been degraded; or
4. 1.9.3.2 If, in the case of BUD and C(e) data only, the RI5-dOD ratio is not less than 0.5, or 4.1.9.3.3 If there is other convincing scientific evidence that the substance is degradable (biologically and/or abiotically) in the environment to a level greater than 1% in water within 2 years
4.1.10 Inorganic compounds and metals
4.1.10.1 For inorganic compounds and metals, the concept of degradability of the organic compound is generally limited or meaningless: B 20602—2006
Meaning: In general, normal environmental processes can transform the substance and increase or decrease the bioavailability of the substance. Similarly, the use of the substance in batches must be cautious.
4.1.10. 2 Poorly soluble inorganic compounds and metals can produce acute or chronic toxicity in the aquatic environment. This depends on the inherent toxicity of the bioavailable inorganic species and the ratio and dose of the species that may enter the liquid. 4.1.11 Chronic 1
This standard also introduces the concept of "safety net", that is, the existing data do not allow classification under the formal criteria: the principle of precision does not define exceptions. For poorly soluble substances with no proven toxicity, if the substance cannot be rapidly degraded but has the potential for bioaccumulation, then de-classification may be possible. For these and poorly degradable substances, due to the low exposure level and slow uptake by organisms: in short-term tests, no specific assessment of reproducibility may be made. If no long-term effects are confirmed, that is, long-term NFs are water-soluble or 1 tg/L, or rapidly degrade in the environment, then spectrometry is not required. 4.1.12 Use of QSARs Although experimentally derived test data are preferred, if experimental data are not available, then valid aquatic toxicity quantitative structure activity relationships (QSARs) and bK+ may be used in the classification process. If the chemical is well characterized for both its action formula and its properties, then valid QSARs may be used without modifying the design criteria. Reliable calculated biodegradability and K+ values are valuable within this range. QSARs that predict rapid biodegradation are not accurate enough to be used to measure rapid degradation. 4.2 Classification of mixtures
4.2.1 The classification system for mixtures covers all classification categories used for substances, i.e. Acute 1 to Acute 3 and Chronic 1 to Chronic 4. In order to make use of all available data to classify mixtures for aquatic hazards, the following assumption was made and used at the time: The "relevant ingredients" of a mixture are those present in concentrations of 1% or more (mass fraction), unless it can be inferred (e.g. in the case of highly reactive ingredients) that components with concentrations less than 5% may still be relevant for the classification of the mixture for aquatic hazards. 4.2.2 The approach to classification for aquatic hazards is tiered and depends on the type of information available on the mixture itself and on its components. The elements of the tiered approach include: a) classification based on tested mixtures; b) classification based on Classification based on the bridging principle: Use the 'additivity formula' or 'additivity formula' to classify the mixture. Figure 1 summarizes the process to be followed. If commercial test data are available, do you have a sample of similar mixtures to assess the hazard? Use existing hazard data for known components. Use the bridging principle (see 4.2, 4). Apply the same formula (see 4.2.5).5]
Percentage of the components classified as "chronic":
Percentage of the components classified as "eruptive":
Percentage of the components classified as "white":
Percentage of the components classified as "white":
Apply the summation formula (see 1.2.5.2) to convert the 1. (H) C:sc of the subject to the appropriate "acute" category into the addition method and/or the public health standard (see 4.2.5), without using the formula in 4.2.6
Acute/chronic market risk
C State 1.2. 32
Classification as
Acute/Chronic Hazard
Classification as
Acute/Chronic Hazard
Hierarchical Classification of Acute and Chronic Aquatic Hazards of Mixtures GB20602—2006
4.2.3 Classification of mixtures when complete data are available for the mixture. 4.2.3.1 When the mixture as a whole has been tested to determine its aquatic toxicity, it can be classified according to the agreed principles for the classification of substances, but only the acute toxicity will apply, and the classification must be based on the data for fish, crustaceans and algae/plants. Classification of mixtures using IC or EC data for the mixture as a whole cannot be used for the chronic category, because the chronic category requires toxicity data and environmental consequence data, and the mixture as a whole does not have degradability and bioaccumulation data. This criterion cannot be used for the chronic classification because data from degradability and bioaccumulation tests on the mixture cannot be interpreted; these data are only meaningful for a single substance. 4.2.3.2 When there are acute toxicity test data (EL, or EL) for the mixture as a whole, these data, together with information on the chronic toxicity of the components, must be used to complete the classification of the tested mixture as follows. If there are chronic (long-term) NOEC data, these data must also be used.
L of the tested mixture1.0 mg/L No classification is required for acute or chronic hazards 4.2.4 Preparation of mixtures when data are not available for the entire mixture: Principles 4.2.4.1 If the mixture itself has not been tested to determine its environmental hazards, but there are sufficient data on its individual ingredients and similar tested mixtures to characterize the hazards of the mixture, these data may be used according to the following assumptions and corrections. This ensures that the classification process uses the available data to the greatest extent possible to determine the hazards of the mixture, particularly where additional testing in animals is necessary.
4.2.4.2 Dilution
If a mixture is formed by diluting a classified mixture or substance with a diluent which has the same or lower aquatic hazard classification as the least toxic original ingredient and the diluent does not affect the aquatic degradation of the other ingredients, then the mixture may be classified as equivalent to the original mixture or substance. If a mixture is formed by diluting a classified mixture or substance with water or other completely toxic substances, then the aquatic hazard of the mixture can be calculated from the original mixture or substance. 4.2.4.3 Product batches
It is assumed that the aquatic hazard classification of a batch of a complex mixture is effectively the same as that of a second batch of the same product produced by the same manufacturer or under the control of the same manufacturer, unless there is a change in the aquatic hazard classification which would change the aquatic hazard classification of the batch. If the latter occurs, a new classification is required. 4.2.4. 4.2. If a mixture is classified as Chronic 1 and/or Acute 1 and the ingredients of the mixture classified as Chronic 1 and/or Acute 1 are further concentrated, the more concentrated mixture must be classified as an alternate classification to the original mixture without additional testing. 4.5 Appropriation within one toxicity category If mixtures A and B are in the same classification category and the concentration of the toxicologically active ingredient in mixture (A) is between the concentrations of the toxicologically active ingredient in mixtures A and B, mixture (B) is considered to be in the same category as A and B. Note: The concentrations of the ingredients in all three mixtures are the same. 4.2.4.6 Substantially similar mixtures Given the following: Two mixtures: 1) AB. 2) (-13): The concentrations of ingredient 13 in the two mixtures are substantially different: The concentration of ingredient A in mixture (B) is equal to the concentration of ingredient A in mixture 2): GB 20602—2006www.bzxz.net
If the toxicity data of A and B are available and these data are substantially equivalent, i.e. they belong to the same hazard category, H may not affect the water-borne properties of B;
then, if mixture 1) has been characterized by experiments, then it is not necessary to test mixture 2) and the two mixtures can be classified in the same category.
4.2.5 Classification of mixtures when data on all components of the mixture are available or when data on some components are available 4.2.5.1 The classification of a mixture is based on the sum of the classifications of its components, except for the summation method used for the components classified as "acute\ or \chronic\". 4.2.5.5 of this standard provides a detailed description of the additivity method. 4.2.5.2 A mixture can be composed of components classified as acute 1, 2, 3 and/or chronic 1, 2, 3, 4 and with sufficient test data. When there are sufficient toxicity data for more than one component in the mixture, the following additivity formula [see formula (I)] can be used to calculate the combined toxicity of these components, and the calculated toxicity is used to classify this part of the mixture as an acute hazard category. Subsequently, the classification of this part can be used when applying the additivity method.
: - Concentration of component i (mass fraction): LEC component composition (ug/);
number of components, and from 1 to type
IE E for a part of a mixture with an incorrect test value
4.2.5.3 When using the summation formula for a part of a mixture, it is best to calculate the toxicity of that part of the mixture using the active value for each substance in the same species (i.e. color class, water or class A) and then use the highest toxicity (lowest value) obtained (i.e. use the most sensitive of the three species: however, when toxicity values for all components are available in the same species, the active value for each component must be selected in the same way as the active value selected for the substance class, i.e. use the higher toxicity (from the most sensitive test organism). This part of the mixture can then be classified as Class 1, 2 or 3 using the calculated acute toxicity using criteria relevant to the substance in question. 4.2.5.4 If there is more than one method for classifying a mixture, the method that produces the more conservative result must be used. 4.2.5.5 Additive method
4.2.5.5.1 Basic principle
4.2.5.5.1.1 For substances classified in the categories Acute 1/Chronic 1 to Acute 3/Chronic 3, the difference in the resistance to transfer from one inflammatory category to another is a factor of 1G. Therefore, a substance classified in a category with a higher toxicity range may cause the mixture to be classified in a category with a lower toxicity range. Therefore, the calculation within these classification categories needs to consider the contribution of all substances classified in categories Acute 1/Chronic 1 to Acute 3/Chronic 3 simultaneously.
4.2.5.5.1.2 When a mixture contains substances classified in categories Acute 1/Chronic 1 to Acute 3/Chronic 3, the resistance to transfer from one inflammatory category to another is a factor of 1G. Therefore, a substance classified in a category with a higher toxicity range may cause the mixture to be classified in a category with a lower toxicity range. When classifying components of a mixture, attention must be paid to the fact that these components contribute to the toxicity of the mixture even at very low concentrations when their acute toxicity is significantly lower than 1 m/s: small calcitoxic components usually have such high aquatic toxicity, but some other substances such as organometallic compounds also have such high aquatic toxicity. In these cases, the use of normal cut-off values/limits may lead to a downgrading of the mixture. Therefore, as specified in 4.2.5.5.2 Classification procedure
In general, the category of a mixture with a higher severity takes precedence over the category of a mixture with a lower severity, for example, Chronic 1 takes precedence over Chronic 2. Therefore, if the classification result is Chronic 1, the classification procedure is completed. A classification more severe than Chronic 1 is not possible. Therefore no further classification procedure is required.
4.2.5.5.3 Classification for Acute Categories 1, 2 and 3 4.2.5.5.3.1 First, all components classified as Acute are considered. If the sum of these components is greater than 25, the mixture is classified as Overall Category 1. If the result of the calculation is that the mixture is classified as Acute 1, then the classification process is complete: 4.2.5.5.3.2 If the mixture is not classified as Acute 1, then consideration may be given to classifying the mixture as Acute: 2 If 10 times the sum of all ingredients classified as Acute 1 plus the sum of all ingredients classified as Total 2 is greater than 25%, then the mixture is classified as Acute 2. If the result of the calculation is that the mixture is classified as Acute 2, then the classification process is complete: 4.2.5.5.3.3 If the mixture is not classified as Acute 1 or Acute 2, then consideration may be given to classifying the mixture as Acute 3 If 100 times the sum of all ingredients classified as Total 1 plus 10 times the sum of all ingredients classified as Acute 2 plus the sum of all ingredients classified as Acute 3 is greater than 3, then the mixture is classified as Acute 3. 4.2.5.5.3.4 Table 3 Table 3: Acute hazard classification of mixtures based on the addition of the classified ingredients. The acute hazard classification of mixtures based on the addition of the classified ingredients. The sum of the ingredients is
Acute 1X>25%
(M×10×total 1)+Acute 2>2=%
(Mx 10×acute)-(:0×total 2)+Acute 1:21§1M(release factor[),, 4.2.5.3.5,4.2.5.5.4 Chronic Category 1, 2, 3 and 4 classifications. Mixtures classified as
Acute 1
Acute 2
Acute 3
4,2.5.5.4.1 First: All ingredients classified as Chronic 1 should be considered. If the sum of these components is greater than 25%, then the mixture is classified as a Chronic 1 component. If the result of the calculation is that the mixture is classified as Chronic 2, then the classification process is complete. 4.2.5.5.4.2 If the mixture is not classified as Chronic, then the mixture may be considered for classification as Chronic 2. If 10 times the sum of all components classified as Chronic 1 plus the sum of all components classified as Chronic 2 is greater than 25%, then the mixture is classified as Chronic 2. If the result of the calculation is that the mixture is classified as Chronic 2, then the classification process is complete. 4.2.5.5.4.3 If the mixture is not classified as Chronic 1 or Chronic 2,The mixture may be considered for classification as Chronic 3. If 100 times the sum of all ingredients classified as Chronic 1 plus F10 times the sum of all ingredients classified as Chronic 2 plus the sum of all ingredients classified as Chronic 3 is greater than 25%, then the mixture is classified as Chronic 3. 4.2.5.5.4.4 If the mixture is still not classified as Chronic 1, 2 or 3, then the mixture must be considered for classification as Chronic: 4. If the sum of the percentages of components classified as Chronic 1, 2, 3 and 4 is greater than 25%, then the mixture is classified as Chronic. 14.2.5.5.4.5 Table 1 shows the chronic hazard classification of mixtures based on the addition of components classified. Table 4 shows the chronic hazard classification of mixtures based on the addition of components already classified. The sum of components classified as
Diffuse 1 x M point
(M×10x Chronic): Chronic 2 25%
(M×100×Natural 1) (10×Chronic 2) + Chronic 3 > 25% Chronic 1 + Chronic 2 + Chronic 3 + Fluorescent 25%
2M (for magnification), see 1.2.5.5.5, 4.2.5.5.5 Mixtures with highly toxic components are classified as
Chronic 4
Acute Category 1 toxic components can still affect the properties of the mixture at concentrations well below 1m/s. When using the classification additivity method 10
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