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GB/T 24782-2009: Decision Method of Persistent, Bioaccumulative and Toxic Substances, and Very Persistent and Very Bioaccumulative Substances
GB/T 24782-2009
Decision method of persistent, bioaccumulative and toxic substances, and very persistent and very bioaccumulative substances
ICS 13.300
A80
National Standards of People's Republic of China
Persistence, bioaccumulation and
Toxic substances and high persistence and
Method for determining high bioaccumulative substances
2009-12-15 release
2010-07-01 Implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Management Committee released
Preface
This standard refers to REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) Annex XIII "Confirmation of persistence, bioaccumulation and
Toxic substances and high persistence, standards for highly bioaccumulative substances ", REACH Regulation Guide" Technical Guidelines for Preparing Chemical Safety Assessment
File "R. Chapter 11. "Persistence, Bioaccumulation and Toxic Substances and High Persistence and High Bioaccumulation Assessment", EU Directive 67/548 /
EEC "classification of dangerous substances, packaging, labeling instructions", the relevant technical content and the above documents are exactly the same, in the standard text format by
GB/T 1.1-2000 made editorial changes.
This standard is proposed and centralized by the National Standardization Technical Committee on Hazardous Chemicals Management (SAC/TC251).
This standard is responsible for the drafting unit. AQSIQ import and export chemical safety research center.
This standard participates in the drafting unit. China Institute of Inspection and Quarantine, Sinochem Chemical Standardization Institute, Jiangsu Entry-Exit Inspection and Quarantine Bureau,
Shandong Entry - Exit Inspection and Quarantine Bureau, Jiangxi Entry - Exit Inspection and Quarantine Bureau.
The main drafters of this standard. Sun Xin, Chen Huiming, Wang Xiaobing, Mei Jian, Li Yu, Zhang Jing, Li Lei.
This standard is developed for the first time.
introduction
The European Union enacted legislation on the registration, assessment, authorization and restriction of chemicals (hereinafter referred to as REACH) on June 1,.2007,
And in June 1,.2008 formally implemented. After the implementation of the regulations to enter the EU market chemicals for unified management. For our country
Responding to the EU REACH regulations, developed a series of chemical safety standards, equivalent to the EU REACH regulations related technical content.
This standard refers to the EU REACH Regulation Annex XIII "to confirm the persistence, bioaccumulation and toxic substances and high persistence, high biological
Standard for Chemical Substances, "REACH Regulation Guide" Preparing the Technical Guidebook for Chemical Safety Assessment ". Chapter 11. "Persistence, Bio tired
Integral and Toxic Substances and High Persistence and High Bioaccumulation Assessment ", and EU Directive 67/548/EEC" Classification, Packaging,
Labeling instructions ", the relevant technical content and the file exactly the same, the establishment of a persistent, bioaccumulative and toxic substances and high persistence
And the determination method of high bioaccumulation material.
Persistence, bioaccumulation and
Toxic substances and high persistence and
Method for determining high bioaccumulative substances
1 range
This standard specifies the criteria for determination of persistence, bioaccumulation and toxic substances and high persistence and high bioaccumulative substances.
Chapter 3 and Chapter 4 of this standard apply only to organometallic compounds.
2 terms and definitions
The following terms and definitions apply to this standard.
2.1
Contains ingredients with persistence, bioaccumulation and toxicity characteristics or high persistence and high bioaccumulation characteristics, and the content of the ingredient
To 80% or more of the substance.
2.2
The maximum amount of persistent, bioaccumulative and toxic substances or high persistence and high bioaccumulative substances is X% (or X% to Y%)
Containing one or more ingredients or impurities having persistence, bioaccumulation and toxicity characteristics or high persistence and high bioaccumulative characteristics,
Substances with a single composition or impurity content greater than or equal to 0.1% (but less than 80%). The content may be the maximum content (X%), or it may be
Is the content range (X% ~ Y%), as the case may be.
2.3
Substances or impurities can be degraded or converted into persistent, bioaccumulative and toxic features or highly persistent and highly biologically
Product, and the resulting change or degradation product alone contains more than 0.1% of the total amount of the starting material. Degradation or transformation
The mass fraction of the product may be suitably treated with a mixture of persistence, bioaccumulation and toxicity characteristics or high persistence and high bioaccumulation characteristics
Quality or ingredient content.
3 Determination of persistence, bioaccumulation and toxic substances
The substances satisfying 3.1, 3.2 and 3.3 are persistent, bioaccumulative and toxic substances.
3.1 Persistence
The substance satisfies the persistence criteria when it satisfies any of the following.
a) the half-life in seawater is longer than 60 d;
b) the half-life of fresh water or river water is longer than 40 days;
c) the half-life in marine sediments is longer than 180 d;
d) the half-life of freshwater or river sediments is longer than 120 d;
e) The half-life in the soil is longer than 120 d.
Persistent assessments in the environment will be based on the available half-life data collected under appropriate conditions.
3.2 bioaccumulation
The substance satisfies the bioaccumulation criteria when it is.
Biological enrichment factor (BCF) is higher than.2000.
The bioaccumulation assessment will be based on bioaccumulation data for aquatic organisms. Data from freshwater and marine aquatic species
be usable.
3.3 Toxicity
The substance meets the criteria for toxicity when it satisfies any of the following.
3.3.1 For seawater and freshwater organisms, its long-term no-observed concentration (Noec) is less than 0.01 mg/L.
3.3.2 are classified as carcinogens
3.3.2.1 substances known to have carcinogenic effects on humans.
There is sufficient evidence to determine the relationship between the exposure of a person to the production of a substance and cancer.
3.3.2.2 substances that are considered to be carcinogenic to humans.
There is sufficient evidence that the human body is exposed to a substance that can cause cancer to produce a strong hypothesis, generally based on.
a) appropriate long-term animal studies;
b) other relevant information.
3.3.3 is classified as teratogenic
3.3.3.1 substances known to have teratogenic effects on humans.
There is sufficient evidence to determine the relationship between exposure to a substance and a genetic gene.
3.3.3.2 Substances that should be considered to cause teratogenic effects on humans.
There is sufficient evidence that the human body is exposed to a substance that can cause hereditary genetic damage to the strong hypothesis that is generally based on.
a) appropriate animal studies;
b) other relevant information.
3.3.4 are classified as reproductive toxic substances
3.3.4.1 substances known to have reproductive damage to the human body.
There is sufficient evidence to determine the relationship between human exposure to a substance and reproductive damage.
3.3.4.2 substances that are known to be toxic to humans.
There is sufficient evidence to determine the relationship between the exposure of the human body to the developmental effects of a substance and its offspring.
3.3.4.3 Substances that should be considered to be harmful to humans.
There is sufficient evidence that the human body is exposed to a substance that can cause reproductive damage to the powerful hypothesis is based on.
a) There is clear evidence in animal studies that do not contain toxic effects of reproductive damage, or approximately the same as other toxic effects
Not other toxic effects of secondary non-specific results of reproductive impairment evidence;
b) other relevant information.
3.3.4.4 Substances that should be considered to cause human developmental toxicity.
There is sufficient evidence that the human body is exposed to a substance that can cause a strong hypothesis of developmental toxicity, generally based on.
a) have a clear result in observing the appropriate animal research that does not mark maternal toxicity, or approximately with other toxic effects
The same but not the other toxic effects of secondary non-specific results of evidence;
b) other relevant information.
3.3.4.5 substances that are of concern to human reproduction
Is generally based on.
a) Appropriate animal research results can provide sufficient evidence to prove that there is no toxic effect and cause significant damage to reproductive damage, or
Reproductive damage to secondary non-specific results of approximately the same level of toxicity as other toxic effects but not other toxic effects
Evidence, but the evidence is not sufficient to classify the substance as a substance in 3.3.4.3 and 3.3.4.4;
b) other relevant information.
3.3.4.6 Substances that are of concern due to the potentially toxic effects on humans.
Is generally based on.
a) Appropriate animal research results can provide sufficient evidence that there is no sign of maternal toxicity and cause developmental toxicity.
Or other sub-non-specific results of the same level of toxicity as other toxic effects but not other toxic effects
However, the evidence is not sufficient to classify the substance as a substance in 3.3.4.3 and 3.3.4.4;
b) other relevant information.
3.3.5 There are other signs of chronic toxicity, including.
3.3.5.1 Toxicity. Substances that are inhaled, ingested, or infiltrated into the skin can cause severe, acute or chronic health risks and even lethal.
Products.
Long-term exposure to serious health hazards. serious damage caused by repeated or prolonged exposure by appropriate means (with clear toxicology
A functional disorder or morphological change).
3.3.5.2 Hazardous substances and preparations that cause limited health risks by inhalation, ingestion or infiltration into the skin.
Long-term exposure to serious health hazards. serious damage caused by repeated or prolonged exposure by appropriate means (with clear poison
A functional disorder or morphological change in the sense of.
Substances and preparations are classified as harmful if they are observed to meet the following conditions.
a) rat oral ≤ 50mg/kg (bw/d);
b) Rat or rabbit skin ≤ 100mg/kg (bw/d);
c) Rat inhalation ≤ 0.25mg/L (6h/d).
4 Determination of high persistence and high bioaccumulation
Substances that meet the criteria in the following sections are highly persistent and highly bioaccumulative substances.
4.1 Persistence
The substance satisfies the high persistence criterion when it satisfies any of the following.
a) the half-life of seawater, fresh water or river water is longer than 60 d;
b) the half-life in seawater, freshwater or river sediments is longer than 180 d;
c) The half-life in soil is longer than 180 d.
4.2 High bioaccumulation
The substance satisfies the high bioaccumulation criteria when it is.
Biological enrichment factor (BCF) is higher than 5000.
5 Determination of persistence, bioaccumulation and toxicity or high persistence and high bioaccumulation substances by screening criteria
The existing data of many substances can not determine their persistence, bioaccumulation and toxicity characteristics or high persistence and high bioaccumulation characteristics.
In this case, the so-called screening criteria should be used as alternative information to determine whether the substance satisfies persistence, bioaccumulation and toxicity or high persistence
And high bioaccumulation criteria.
5.1 Persistence, high persistence
5.1.1 Rapid biodegradability test
If the substance can be rapidly degraded, it is determined that it is not a persistent and highly persistent substance.
5.1.2 Enhanced rapid biodegradability test
If the substance can be rapidly degraded, it is determined that it is not a persistent and highly persistent substance.
5.1.3 Inherent biodegradability test
a) Zane-Wylens test
Using the DOC subtraction method in the 7d mineralization rate ≥ 70%, the logarithmic period does not exceed 3d, before the degradation occurred less than 15%, no
To be pre-acclimated inoculation, the determination is not a persistent substance;
b) MITI II test
The use of breathing measurement method (oxygen consumption) within 14d mineralization rate ≥ 70%, logarithmic period does not exceed 3d, without pre-acclimation inoculation, then sentenced
It is not a persistent substance.
Book GB/T 24782-2009
5.1.4 Forecasting model
a) Biowin2 (non-linear model prediction) and Biowin3 (final biodegradation time)
Biodegradation is not fast (probability < 0.5) 1) and the final biodegradation time range is predicted to be ≥ months (value < 2.2)
Long substance
b) Biowin 6 (MITI nonlinear model prediction) and Biowin3 (final biodegradation time)
Biodegradation is not fast (probability < 0.5) 1) and the final biodegradation time range is predicted to be ≥ months (value < 2.2)
Long substance.
5.2 bioaccumulation, high bioaccumulation
5.2.1 Substantive evidence of material enlargement in the food chain
Such as the biological amplification factor (BMF) and gt; 1, it is determined that it is a bioaccumulative or highly bioaccumulative substance.
5.2.2 Determination of octanol-water partition coefficient by test or effective quantitative structure-activity relationship (QSAR)
LogKow ≤ 4.5 (Kow is the molecular hydrophobic constant 2)), then it is determined that it is not bioaccumulative or highly bioaccumulative.
5.3 Toxicity
5.3.1 Short-term aquatic toxicity (algae, daphnia, fish)
a) semi-inhibitory concentration (EC50) or semi-lethal concentration (LC50) ≥ 0.1mg/L, then determine not toxic substances;
b) semi-inhibitory concentration (EC50) or semi-lethal concentration (LC50) < 0.1mg/L, then determine the potential tox...