Sunday, 3 March 2019

GHS Classification Criteria in A Single Page

GHS Classification Criteria in A Single Page

    
Little Pro on 2016-05-09Views: 25520 Update:2018-10-17
GHS classification criteria are used to determine the nature and the relative severity of the hazard of a chemical substance or mixture.  In this article, we have summarized GHS classification criteria (in GHS rev. 6) for all 29 hazard classes, including 17 physical hazards, 10 health hazards and 2 environmental hazards (see all GHS hazard classes). 
For a substance, you can refer to the table below to determine its GHS classification. For a mixture, it is recommended that you read this article (GHS mixture classification) first.
It should be noted that GHS allows each country to choose their own concentration limits for certain hazard categories. The classification criteria below works for most of countries, but not all countries.
Note: If you wish to quickly search a hazard statement and signal word based on GHS hazard classification and H code, please go to our free hazard statement and signal word finder.
Physical Hazards (17 Hazard Classes)

Explosives

Explosives can be classified as unstable explosives or stable explosives. For stable explosives, there are 6 divisions under GHS (see the table below).
DivisionCharacteristics
1.1Mass explosion hazard
1.2Projection hazard
1.3Fire hazard or minor projection hazard
1.4No significant hazard
1.5Very insensitive substances with mass explosion hazard
1.6Extremely insensitive substances with no mass explosion hazard
Classification as an explosive and allocation to a division is a three-step process
  • Ascertain if the material has explosive effects (Test Series 1 of UN TDG);
  • Acceptance procedure (Test Series 2 to 4 of TDG);
  • Assignment to one of six hazard divisions (Test Series 5 to 7 of UN TDG). 
Explosive properties are usually associated with certain chemical groups (see picture below) that can react to give very rapid increases in temperature or pressure. GHS allows you to classify a substance as non-explosive if there are no functional groups associated with explosive properties in the molecule. If a substance is identified to be a potential explosive, acceptance procedure/testing must be followed to determine right division.
explosive functional group

Flammable Gases (Including Unstable Gases)

The table below summarizes GHS classification criteria for flammable gases (including pyrophoric gases and chemically unstable gases).
TypeCategoryGHS Classification Criteria
Flammable gasesCategory 1Gases, which at 20°C (68°F) and a standard pressure of 101.3 kPa (14.7 psi) that: (a) are ignitable when in a mixture of 13% or less by volume in air; or (b) have a flammable range with air of at least 12 percentage points regardless of the lower flammable limit.
Flammable gasesCategory 2Gases, other than those of Category 1, which, at 20°C (68°F) and a standard pressure of 101.3 kPa (14.7 psi), have a flammable range while mixed in air.
 Pyrophoric gasesCategory 1Flammable gases that ignite spontaneously in air at a temperature of 54°C or below
Chemically unstable gasesCategory AFlammable gases, which are chemically unstable at 20°C (68°F) and a standard pressure of 101.3 kPa
Chemically unstable gasesCategory BFlammable gases, which are chemically unstable at a temperature higher than 20°C (68°F) or a pressure greater than 101.3 kPa

Aerosols

Aerosols are any gas compressed, liquefied or dissolved under pressure within a non-refillable container made of metal, glass or plastic, with or without a liquid, paste or powder. Aerosols should be considered for classification as either a Category 1 or Category 2 Flammable Aerosol if they contain any component classified as flammable according to the GHS criteria for flammable liquids, flammable gases, or flammable solids.
TypeCategoryGHS Classification Criteria
AerosolsCategory 3The concentration of the flammable components ≤ 1% and the heat of combustion is < 20 kJ/g or other spray/foam aerosols.
AerosolsCategory 1The concentration of the flammable components >85% and the heat of combustion is ≥ 30 kJ/g.
Spray AerosolsCategory 1Ignition occurs at a distance >=75cm in an ignition test.
Spray AerosolsCategory 2Ignition occurs at a distance <75cm in an ignition test. However, the heat of combustion is >20kJ/g or ignition distance is >=15cm or the space ignition test shows that the time equivalent <=300s/m3 or the deflation density <300g/m3;
Foam AerosolsCategory 1In the foam test, the flame height is >=20cm and the flame duration >=2s; or the flame height is >=4cm and the flame duration >=7s.
Foam AerosolsCategory 2In the foam test, the flame height is >=4cm and the flame duration >=2s.

Oxidizing Gases

CategoryGHS Classification Criteria
Category 1Gases that cause or contribute to the combustion of other material more than air does. Usually test is not needed. Calculation of oxidizing power can be done according to ISO 10156:2012.

Gases Under Pressure

GHS classification criteria gases under pressure

Flammable Liquids

GHS classification criteria flammable liquids

Flammable Solids

GHS classification criteria flammable solids

Self-reactive Substances

TypeGHS Classification Criteria
AAny self-reactive substance or mixture which can detonate or deflagrate rapidly, as packaged;
BAny self-reactive substance or mixture possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package;
CSelf-reactive substance or mixture possessing explosive properties when the substance or mixture as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion;
DSelf-reactive substance or mixture which in laboratory testing either detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or does not detonate or deflagrate at all and shows a medium effect when heated under confinement;
ESelf-reactive substance or mixture which, in laboratory testing, neither detonates nor deflagrates at all and shows low or no effect when heated under confinement;
FSelf-reactive substance or mixture which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows only a low or no effect when heated under confinement;
GSelf-reactive substance or mixture which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows no effect when heated under confinement and no explosive powder, provided that it is thermally stable and, for liquid mixtures, a diluent having a boiling point greater than or equal to 150°C is used for desensitization;

Pyrophoric Solids

CategoryGHS Classification Criteria
Category 1The solid ignites within 5 mins of coming into contact with air.

Pyrophoric Liquids

CategoryGHS Classification Criteria
Category 1The liquid ignites within 5 mins when added to an inert carrier or exposed to air, or it ignites or chars a filter paper on contact with air within 5 mins.

Self-heating Substances and Mixtures

GHS classification criteria self-heating substances

Substances which on Contact with Water Emit Flammable Gases

GHS classification criteria water-reactive substances

Oxidizing Liquids

GHS classification criteria oxidising liquids
It shall be noted that above ignition test is not necessary to determine whether or not a substance or mixture is oxidizing; examination of its structural formula may provide predictive information. Organic peroxides, for instance, are generally considered as oxidizing. However, the following substances are not considered as oxidizing:
  • Organic substance or mixture that does not contain oxygen, flourine or chlorine; or
  • The substance or mixture contains oxygen, flourine or chlorine and there elements are bonded only to hydrogen or carbon;
  • Inorganic substances that do not contain oxygen or halogen items.

Oxidizing Solids

GHS classification criteria oxidising solids
It shall be noted that above ignition test is not necessary to determine whether or not a substance or mixture is oxidizing; examination of its structural formula may provide predictive information. Organic peroxides, for instance, are generally considered as oxidizing. However, the following substances are not considered as oxidizing:
  • Organic substance or mixture that does not contain oxygen, flourine or chlorine; or
  • The substance or mixture contains oxygen, flourine or chlorine and there elements are bonded only to hydrogen or carbon;
  • Inorganic substances that do not contain oxygen or halogen items.

Organic Peroxides

TypeGHS Classification Criteria
AAny organic peroxide which, as packaged, can detonate or deflagrate rapidly.
BAny organic peroxide possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package.
CAny organic peroxide possessing explosive properties when the substance or mixture as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion;
DAny organic peroxide which in laboratory testing:
  • Detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or
  • Does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or
  • Does not detonate or deflagrate at all and shows a medium effect when heated under confinement.
EAny organic peroxide which, in laboratory testing, neither detonates nor deflagrates at all and shows low or no effect when heated under confinement.
FAny organic peroxide which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows only a low or no effect when heated under confinement as well as low or no explosive power.
GAny organic peroxide which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows no effect when heated under confinement nor any explosive power, provided that it is thermally stable (self-accelerating decomposition temperature is 60°C or higher for a 50 kg package).

Corrosive to Metals

CategoryGHS Classification Criteria
Category 1Corrosion rate on steel or aluminum surfaces exceeds 6.25 mm per year at a test temperature of 55°C.

Desensitized Explosives

GHS classification criteria de-sensitized explosives

Health Hazards (10 Hazard Classes)

Acute Toxicity

Substances are assigned to one of the five toxicity categories on the basis of LD50 (oral, dermal) or LC50 (inhalation).from acute toxicity studies. Some countries/region (i.e, EU) have not adopted acute toxicity category 5.
GHS classification criteria acute toxicity

Skin Irritation/Corrosion

CategoryClassification Criteria
 Category 1 Corrosive
  • Human experience showing irreversible damage to the skin;
  • Structure/activity or structure property relationship to a substance or mixture already classified as corrosive;
  • pH extremes of <=2 and >=11.5 including acid/alkali reserve capacity;
  • Positive results in a valid and accepted in vitro skin corrosion test; or
  • Animal experience or test data that indicate that the substance/mixture causes irreversible damage to the skin following exposure of up to 4 hours.
 Category 2 Irritant
  • Human experience or data showing reversible damage to the skin following exposure of up to 4 hours;
  • Structure/activity or structure property relationship to a substance or mixture already classified as an irritant;
  • Positive results in a valid and accepted in vitro skin irritation test; or
  • Animal experience or test data that indicate that the substance/mixture causes reversible damage to the skin following exposure of up to 4 hours, mean value of ≥ 2.3 < 4.0 for erythema/eschar or for oedema, or inflammation that persists to the end of the observation period, in 2 of 3 tested animals.
 Category 3 Mild Irritant
  • Animal experience or test data that indicates that the substance/mixture causes reversible damage to the skin following exposure of up to 4 hours, mean value of ≥ 1.5 < 2.3 for erythema/eschar in 2 of 3 tested animals.
More info about GHS classification criteria for skin irritation can be found here.

Serious Eye Damage/Eye Irritation

CategoryGHS Classification Criteria
 Category 1 (Causes serious eye damage) 
  • Classification as corrosive to skin; 
  • Human experience or data showing damage to the eye which is not fully reversible within 21 days; 
  • Structure/activity or structure property relationship to a substance or mixture already classified as corrosive; 
  • pH extremes of < 2 and > 11.5 including buffering capacity; 
  • Positive results in a valid and accepted in vitro test to assess serious damage to eyes; or 
  • Animal experience or test data that the substance or mixture produces either (1) in at least one animal, effects on the cornea, iris or conjunctiva that are not expected to reverse or have not reversed; or (2) in at least 2 of 3 tested animals a positive response of corneal opacity ≥ 3 and/or iritis > 1.5, calculated as the mean scores, following grading at 24, 48, and 72 hours 
 Category 2A (Irritant)
  • Classification as severe skin irritant; 
  • Human experience or data showing production of changes in the eye which are fully reversible within 21 days; 
  • Structure/activity or structure property relationship to a substance or mixture already classified as an eye irritant; 
  • Positive results in a valid and accepted in vitro eye irritation test; or 
  • Animal experience or test data that indicate that the substance/mixture produces a positive response in at least 2 of 3 tested animals of: corneal opacity ≥ 1, iritis ≥ 1, or conjunctival edema (chemosis) ≥ 2, calculated as the mean scores, following grading at 24, 48, and 72 hours 
 Category 2B (Mild irritant)
  • Human experience or data showing production of mild eye irritation;
  • Animal experience or test data that indicate that the lesions are fully reversible within 7 days.
More info about GHS classification criteria for eye irritation can be found here.

Respiratory or Skin Sensitization

Category 1 Skin SensitizationCategory 1 Respiratory Sensitization
For substances and tested mixtures:
• If there is evidence in humans that the individual substance can induce sensitization by skin contact in a substantial number of persons, or where there are positive results from an appropriate animal test.
• If any individual skin sensitizer in the mixture has a concentration of:  Subcategory 1B≥ 1.0% Solid/Liquid/Gas or Subcategory 1A≥ 0.1% Solid/Liquid/Gas
For substances and tested mixtures:
• If there is human evidence that the individual substance induces specific respiratory hypersensitivity, and/or Where there are positive results from an appropriate animal test.
• If any individual respiratory sensitizer in the mixture has a concentration of: ≥ 1.0% Solid/Liquid and ≥ 0.2% Gas

Germ Cell Mutagenicity

CategoryCriteria
Category 1AChemicals known to induce or regarded as if they induce heritable mutations in human germ cells
Known to induce heritable mutations –positive evidence from human epidemiological studies.
Mixtures containing ≥ 0.1% of such a category 1A mutagen.
Category 1BChemicals known to induce or regarded as if they induce heritable mutations in human germ cells
Regard as if they induce heritable mutations – positive results from in vivo heritable germ cell or somatic cell mammalian mutagenicity tests, or positive results showing mutagenic effects in the germ cells of humans without demonstration of transmission to progeny.
Mixtures containing ≥ 0.1% of such a category 1B mutagen.
Category 2Chemicals that may induce heritable mutations in human germ cells
Positive evidence obtained from in vivo somatic cell mutagenicity or somatic cell genotoxicity tests in mammals and in some cases with support from in vitro experiments
Mixtures containing ≥ 1% of such a category 2 mutagen.
More info about GHS classification criteria for germ cell mutagenicity can be found here.

Carcinogenicity

CategoryCriteria
Category 1AChemicals known to have carcinogenic potential to humans - largely based on human evidence
Mixtures containing ≥ 0.1% of such a category 1A carcinogen.
Category 1BChemicals presumed to have carcinogenic potential to humans - largely based on animal evidence.
Mixtures containing ≥ 0.1% of such a category 1B carcinogen.
Category 2Suspected human carcinogen - evidence from human and/or animal studies is limited
Mixtures containing ≥ 0.1% of such a category 2 carcinogen. (Note: Some countries have different concentration limits. For example, EU's concentration limit for category 2 carcinogen is 1%).

Reproductive Toxicity

CategoryCriteria
Category 1AKnown human reproductive toxicants
Mixtures containing ≥ 0.1% or ≥ 0.3 % of such a substance. (EU's value is 0.3%).
Category 1B Presumed human reproductive toxicants - largly based on animal studies
Mixtures containing ≥ 0.1% or ≥ 0.3 % of such a substance. (EU's value is 0.3%. USA's value is 0.1%)
Category 2Suspected human reproductive toxicant - Evidence from animal and/or human studies is limited
Mixtures containing ≥ 0.1% or ≥ 3 % of such a substance. (EU's value is 3% while USA's value is 0.1%).
Effects on via lactationEffects on via lactation
Toxicants which may interfere with lactation or which may be present in breast milk and may cause harm to breast-fed children 
Mixtures containing ≥ 0.1% or ≥ 0.3 % of such a substance.

Target Organ Systemic Toxicity - Single Exposure

This provide a means of classifying substances that produce specific, non lethal target organ/systemic toxicity arising from a single exposure. Guidance value from acute toxicity studies are used to determine specific hazard category.
GHS STOT Single Exposure
For mixture, please refer to the table below:
STOT Concentration Limit GHS

Target Organ Systemic Toxicity - Repeated Exposure

This provides a means of classifying substances that produce specific target organ/systemic toxicity arising from repeated exposure that is not specifically addressed elsewhere in the harmonised classification system (GHS).
Standard 90d repeated dose toxicity study serves as the most important study to determine the classification of the specific target organ toxicity of a chemical substance. Since toxicity depends on doses, GHS uses guidance value C to determine the hazard category of specific target organ/systemic toxicity. Guidance value C is defined as test concentration at which there is evidence of significant toxicity and it is not NOAEL.  Guidance value C is usually bigger than NOAEL. Some effects such as body weight change are not regarded as significant toxicity. 
Repeated dose toxicity studies of greater or lesser duration can be used to derive equivalent guidance value by extrapolation. 
CategoryClassification Criteria and Guidance Value
Category 1
Reliable evidence on the substance or mixture (including bridging) of an adverse effect on specific organ/systems or systemic toxicity in humans or animals. May be named for specific organ/system.
For tested substances and mixtures:
  • Guidance value C (oral, rat) ≤ 10 mg/kg bw/d
  • Guidance value C (dermal, rat or rabbit) ≤20 mg/kg bw/d
  • Guidance value C (inhalation, rat, gas) ≤ 50ppm/6h/d
  • Guidance value C (inhalation, rat, vapour) ≤ 0.2 mg/l/6h/d
  • Guidance value C (inhalation, rat, dust/mist/fume) ≤ 0.02mg/l/6h/d
Mixture that lacks sufficient data, but contains Category 1 ingredient: ≥ 1 to ≤ 10% for some authorities; and ≥ 10% for all authorities.
Category 2
Evidence on the substance or mixture (including bridging) of an adverse effect on specific organ/systems or systemic toxicity from animal studies or humans. May be named for specific organ/system.
For substances and tested mixtures:
  • 10<Guidance value C (oral, rat) ≤ 100 mg/kg bw/d
  • 20<Guidance value C (dermal, rat or rabbit) ≤200 mg/kg bw/d
  • 50<Guidance value C (inhalation, rat, gas) ≤ 250ppm/6h/d
  • 0.2<Guidance value C (inhalation, rat, vapour) ≤ 1 mg/l/6h/d
  • 0.02<Guidance value C (inhalation, rat, dust/mist/fume) ≤ 0.2mg/l/6h/d
Mixture that lacks sufficient data, but contains Category 1 ingredient: ≥ 1.0 but ≤ 10% for some authorities and/or contains Category 2 ingredient: ≥ 1.0 or ≥ 10%.

Aspiration Toxicity

GHS classification criteria aspiration toxicity
For mixture, please refer to the table below:
CategoryCriteria
Category 1
Contains >=10% category 1 ingredient and has a kinematic viscosity<=20.5mm2/s (measured at 40 celcius degrees); 
Category 2Contains >=10% category 2 ingredient and has a kinematic viscosity<=14mm2/s (measured at 40 celcius degrees); 
Environmental Hazards (2 Hazard Classes)

Hazardous to Aquatic Environment (Acute/Chronic)

The picture below summarizes environmental hazard classification based on aquatic toxicity data. Lower LC50/EC50/NOEC indicates higher toxicity. Please note that degradation and bio-concentration shall also be taken into account.
GHS classification criteria environmental hazard
For mixture, please refer to the table below. If you do not know what M-factor is and how it is used for environmental hazard classification, please click here.
Concentration limit aquatic hazard
The value of multiplying factor (M-factor) can be found in the table below:
GHS M factor

Hazardous to the Ozone Layer

CategoryCriteria
Category 1
Any of the controlled substances in the annexes to the Montreal Protocol; or any mixture containing at least 1 ingredient listed in the annexes to the Montreal protocal, at a concentration>=0.1%;

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