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The GHS The Globally Harmonized System for Hazard Classification and Labelling of Chemicals. Basic Course. 2. Hazard Classification 2.2 Health and Environmental Hazard Classification . Hazards covered by the harmonized criteria. Health effects acute toxicity

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the ghs the globally harmonized system for hazard classification and labelling of chemicals

The GHSThe Globally Harmonized System for Hazard Classification and Labelling of Chemicals

Basic Course

hazards covered by the harmonized criteria
Hazards covered by the harmonized criteria

Health effects

  • acute toxicity
  • skin corrosion/irritation
  • serious eye damage/eye irritation
  • respiratory/skin sensitization
  • germ cell mutagenicity
  • reproductive toxicity
  • carcinogenicity
  • specific target organ systemic toxicity (TOST)
hazards covered by the harmonised criteria cont
Hazards covered by the harmonised criteria (Cont.)

Environmental effects:

  • hazardous to the aquatic environment
slide6

LD50 or (Median – Effective Dose) is the amount of a chemical, given all at once, which causes the death of 50% (one half) of a group of test animals. LC50 is the concentration of a chemical in air or of a chemical in water which causes the death of 50%(one half) of a group of test animals.

classification criteria for acute toxicity

Category 1

Category 2

Category 3

Category 4

Category

5

Oral (mg/kg)

5

50

300

2000

5000

Dermal (mg/kg)

50

200

1000

2000

Gases (ppm/4h)

100

500

2500

5000

Vapours (mg/l/4h)

0.5

2.0

10

20

Dusts and Mists (mg/l/4h)

0.05

0.5

1.0

5

Classification criteria for acute toxicity

LD50/LC50

category 4 symbol warning harmful if swallowed category 3 symbol danger toxic in contact with skin

PhenolLD50 oral rat 340-650 mg/kg rat 317 mg/kgmouse 300-427 mg/kgrabbit 400-600 mg/kg LD50 dermal rabbit 630 mg/kg no record other than deathrat 660-670 mg/kg LD50 oral 300-2,000LD50 dermal 200-1,000

Category 4 Symbol Warning Harmful if swallowed

Category 3 Symbol Danger Toxic in contact with skin

classification criteria for skin corrosion irritation

Category 1

Corrosive

Category 2

Irritant

Category 3

Mild Irritant

Destruction of tissue: visible necrosis at least in one animal

Reversible adverse effects in dermal tissue

Mean Draize score >_ 2.3 -< 4.0 for erythema /eschar/edema at least in 2 of 3 animals or

Persistent inflammation

Reversible adverse effects in dermal tissue

Mean Draize score >_ 1.5 -< 2.3 for erythema

/eschar

/edema at least in 2 of 3 animals

Sub Category 1A Exposure< 3 min

Observa-tion < 1 hour

Sub

Category 1B

Exposure < 1 hour

Observa- tion < 14 days

Sub

Category 1C

Exposure < 4hours

Observa-tion < 14

days

Classification criteria for skin corrosion/irritation
slide10

Category 1 is corrosiveCategory 2 is irritant which is graded at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grading on 3 consecutive days after the onset of skin reactions.Category 3 is mild irritant which is graded at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grading on 3 consecutive days after the onset of skin reactions.

category 1 symbol danger causes severe skin burns and eye damage

Phenol Draize rabbit 500 mg/24h;severe rabbit 535 mg open severe Corrosive to skin and eyes. When 5% or 10 % diluted solution was administered, immediate washing of the eyes can lead to corneal opacityCorrosive

Category 1 Symbol Danger

Causes severe skin burns and eye damage

slide14

Category 1

Category 2

Irreversible damage to cornea, iris, conjunctiva within 21 days after exposure at least in one animal

or corneal opacity > 3 and/or

iritis >1.5 at least in 2 of 3 animals:

Reversible irritating effects

corneal opacity: > 1 and/or iritis: > 1 and/or conjunctival redness: > 2 and/or conjunctival oedema (chemosis): > 2 at least in 2 of 3 animals:

Subcategory 2A: irritating

reversible in 21 days

Subcategory

2B: mild irritating

reversible in 7 days

Classification criteria for eye damage / irritation

slide15

Category 1(irreversible effects on the eyes) calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.Category 2 A (irritating to the eyes) calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and fully reverses within an observation period of normally 21 daysCategory 2 B (mildly irritating to the eyes) calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and fully reverses within an observation period of normally 7 days

category 1 symbol danger causes serious eye damage

PhenolDraize rabbit 5 mg/kg;severerabbit 5 mg/ 30S rinse; mildLoss of vision, burn, conjunctiva tumor, corneal opacityIrreversible effect on the eye

Category 1 Symbol Danger

Causes serious eye damage

slide17

Classification criteria for respiratory or skin sensitization

Respiratory Sensitization

Category 1

Evidence of specific respiratory hypersensitivity in humans and/or

Positive results from appropiate animal test

Skin Sensitization

Category 1

Evidence in humans of sensitization by skin contact in a substantial numbers of persons, or

Positive results from appropiate animal test

slide18

Category 1 Respiratory Sensitization May cause allergy or asthma symptoms or breathing difficulties if inhaledCategory 1 Skin Sensitization May cause an allergic skin reaction

phenol has negative report

Phenol Has negative report

Not classified under respiratory or skin sensitization

slide20

Classification criteria for germ cell mutagenicity

Category 1

Known to produce heritable mutations in human germ cells

Category 2

May induce heritable mutations in human germ cells

Positive evidence in: In vivo somatic cell mutagenicity tests in mammals, or

In vivo somatic genotoxicity tests supported by in vitro mutagenicity tests

Sub-category 1A

Positive evidence from epidemiological studies

Subcategory 1B

Positive results in:

In vivo heritable germ cell tests in mammals, or

In vivo somatic cell mutagenicity tests in mammals, combined with some evidence of potential to cause germ cell mutagenicity, or

Test of germ cell mutagenicity tests in humans

category 1 a 1 b may cause genetic defects category 2 suspected of causing genetic defects

Category 1 A & 1 B May cause genetic defectsCategory 2 Suspected of causing genetic defects

category 1 symbol danger may cause genetic defects

PhenolMicroorganism;Salmonella (-S9) 40 micromol/plateChromosomal aberration; hamster (in vitro) positive ovary 2gm/LMutagenicity has been reported in man

Category 1 Symbol Danger

May cause genetic defects

Induces genetic mutation

slide23

Category 1

Know or presumed human reproductive or developmental toxicant

Category 2

Suspected

human reproductive or developmental toxicant

Additional

Category

Effects on or via lactation

Category 1A

Known from human data

Category 1B

Presumed from animal data

Classification criteria for reproductive toxicity

slide24

Category 1 May damage fertility or the unborn child Substances which are known to cause an adverse effect onreproductive ability or capacity or on development in humans and/or evidence from animal studies and/or other information to support capacity to interfere withreproduction in humans.Category 2 Suspected of damage fertility or the unborn childSubstances which are possibly cause an adverse effect on reproductive ability or capacity or on development in humans and/or evidence from animal studies and/or other information to support capacity to interfere with reproduction in humans which is considered not to be a secondary non-specific consequence of the other toxic effects and the evidence is not sufficient to place the substance in Category 1.

category 2 symbol warning suspected of damaging fertility or the unborn child

PhenolIn an experiment where 200 mg/kg was administered abdominally to 12-24 days pregnant rat, decrease in fetal weight was observed.There are reports of teratogenesis and other reproductive effects in animal experimentsSuspected human reproductive or developmental toxicant

Category 2 Symbol Warning

Suspected of damaging fertility or the unborn child

classification criteria for carcinogenicity

Category 1

Known or presumed humans carcinogen on the basis of epidemiological and/or animal data

Category 2

Suspected humans carcinogen

Limited evidence of human and/or animal studies

Subcategory 1A

Known human carcinogen based on human evidence

Subcategory

1B

Presumed human carcinogen based on demonstrated animal evidence

Classification criteria for carcinogenicity
not classified as carcinogenic

PhenolIn an experiment where 5000 ppm was administered orally to 5-6 weeks old B63F1 mice and F 344 rats, increase in tumor growth rate was observed.Development of skin papilloma and skin cancer in a 2-stage mouse skin carcinogenesisIARC Group 3Evidence as carcinogenic is insufficient

Not classified as carcinogenic

slide28

Classification criteria for Specific Target Organ Systemic Toxicity (TOST) single exposure

Category 1

Category 2

Presumed to have the potential to produce significant toxicity

Reliable evidence from humans or epidemiological studies, or

Observation from animal studies

Expert judgment based on weight of evidence including the following guidance values of dose level showing the effects

Presumed to have the potential to be harmful

Observation from animal studies

Expert judgment based on weight of evidence including the following guidance values of dose level showing the effects

slide29

Classification criteria for Specific Target Organ Systemic Toxicity (TOST) repeated exposure

Category 1

Category 2

Presumed to have the potential to produce significant toxicity

Reliable evidence from humans or epidemiological studies, or

Observation from animal studies

Expert judgment based on weight of evidence including the following guidance values of dose level showing the effects

Presumed to have the potential to be harmful

Observation from animal studies

Expert judgment based on weight of evidence including the following guidance values of dose level showing the effects

slide30

For both categories the specific target organ system that has been primarily affected by the classified substance may be identified, or the substance may be identified as a general systemic toxicant.Attempts should be made to determine the primary target organ of toxicity and classify for that purpose e.g. hepatotoxicant, neurotoxicant etc. One should carefully evaluate the data and, where possible, not include secondary effects.

category 1 symbol danger causes central nervous system circulatory system toxicity

PhenolLDL0 child oral 10 mg/kg weakening of the muscles, cyanosis LDL0 oral 14 mg/kg weakening of the muscles, cyanosisPoisoning in man of coma, low body temperature, loss of vascular contraction, myocardial depression, respiratory dyspnea, etc.Reliable evidence from humans or epidemiological studies, orobservation from animal studies

Category 1 Symbol Danger

Causes central nervous system, circulatory system toxicity

slide32

Classification criteria for substances hazardous to the aquatic environment

Acute Category 1

Acute toxicity

< 1 mg/l

Acute Category 2

Acute toxicity

> 1 - < 10 mg/l

Acute Category 3

Acute toxicity

> 10 -< 100 mg/l

Chronic

Category 1

- Acute toxicity

<1mg/l

and

lack of rapid

degradability

and/or

BCF > 500

(or, log Kow > 4)

Chronic

Category 2

- Acute toxicity

> 1 but < 10 mg/l

and

lack of rapid

degradability

and/or

BCF > 500

(or, log Kow > 4)

and

- unless chronic toxicity > 1 mg/l

Chronic

Category 3

- Acute toxicity

> 10 but < 100 mg/l

and

lack of rapid

degradability

and/or

BCF > 500

(or, log Kow > 4)

and

- unless chronic toxicity > 1 mg/l

Chronic

Category 4

- Acute toxicity

> 100 mg/l

and

lack of rapid

degradability

and

BCF > 500

(or, log Kow > 4)

and

- unless chronic toxicity >1 mg/l

bioconcentration bcf
Bioconcentration (BCF)
  • BCF is the proportionately constant relating the concentration of a chemical in the aquatic animal to the concentration in water under equilibrium conditions (values between 0 and infinity, unit of water volume per unit tissue weight)
octanol water partition coefficient kow
Octanol/Water Partition Coefficient (Kow)
  • Kow, measures lipid solubility , is the ratio of the chemical soluble in the solvent octanol over that found in water.
  • The higher Kow, the higher BCF
  • Kow < 1, the chemicals may not easily pass across membrane, due mainly to low lipid solubility; high Kow may become bound to the membrane due to their very high affinity to lipid
slide35

Acute ToxicityCategory 1 Very toxic to aquatic life96 hr LC50 (for fish)48 hr EC50 (for crustacea)72 or 96 hr EC50 (for algae or other aquatic plants)Category 2 Toxic to aquatic life96 hr LC50 (for fish)48 hr EC50 (for crustacea)72 or 96 hr EC50 (for algae or other aquatic plants)Category 3 Harmful to aquatic life96 hr LC50 (for fish)48 hr EC50 (for crustacea)72 or 96 hr EC50 (for algae or other aquatic plant

slide36

Chronic ToxicityCategory 1 Very toxic to aquatic life with long lasting effects96 hr LC50 (for fish)48 hr EC50 (for crustacea)72 or 96 hr EC50 (for algae or other aquatic plants)Category 2 Toxic to aquatic life with long lasting effects96 hr LC50 (for fish)48 hr EC50 (for crustacea)72 or 96 hr EC50 (for algae or other aquatic plants)Category 3 Harmful to aquatic life with long lasting effects96 hr LC50 (for fish)48 hr EC50 (for crustacea)72 or 96 hr EC50 (for algae or other aquatic plant)Category 4 May cause long lasting harmful effects to aquatic lifePoorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility and which are not rapidly degradable.

slide37

Phenol(Fish) EC50(96H) > 1 - < 10 mg/l(Crustacea)EC50(48H) > 10 -< 100 mg/l(Algae) EC50 (4H) > 100 mg/LNo report on bioaccumulative potentialSatisfactory degradability

Category 2 toxic for fish, category 3 harmful for Crustacea and not classified as acute toxicity for algae

Not classified as chronic toxicity

hazards to be covered by the harmonized criteria
Hazards to be covered by the harmonized criteria
  • Aspiration hazard
  • Respiratory tract irritation/corrosion
  • Water activated toxicity
  • Narcotic effects
  • Hazardous to the terrestrial environment
oecd classification criteria
OECD classification criteria
  • OECD Document “Harmonized Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures”
  • Available free at: http://www.oecd.org/ehs/Class/