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

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

• Basic Course

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2. Hazard Classification 2.2 Health and
Environmental Hazard Classification
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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)

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Hazards covered by the harmonised criteria (Cont.)

• Environmental effects
• hazardous to the aquatic environment

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Classification criteria for simple chemical
Hazard Class Classification Criteria
Physical hazards Classification using numerical data
Acute toxicity Classification using numerical data
Skin corrosion/irritation Classification using numerical data
Serious eye damage/eye irritation Classification using numerical data
Respiratory/Skin sensitization Evaluation of the weight of evidence
Germ cell mutagenicity Evaluation of the weight of evidence
Reproductive toxicity Evaluation of the weight of evidence
Carcinogenicity Evaluation of the weight of evidence
Specific target organ systemic toxicity (TOST) Classification using numerical data with judgment by the expert
Hazardous to the aquatic environment Classification by numerical data
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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.
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Classification criteria for acute toxicity
LD50/LC50
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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
300-2,000 LD50 dermal 200-1,000

• Category 4 Symbol Warning Harmful if swallowed
• Category 3 Symbol Danger Toxic in contact with
  skin

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Classification criteria for skin
corrosion/irritation
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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.
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Phenol Draize rabbit 500 mg/24hsevere
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

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Classification criteria for eye damage /
irritation
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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
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PhenolDraize rabbit 5 mg/kgsevererabbit 5 mg/
30S rinse mildLoss of vision, burn, conjunctiva
tumor, corneal opacityIrreversible effect on
the eye

• Category 1 Symbol Danger
• Causes serious eye damage

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Classification criteria for respiratory or skin
sensitization
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Category 1 Respiratory Sensitization May cause
allergy or asthma symptoms or breathing
difficulties if inhaledCategory 1 Skin
Sensitization May cause an allergic skin reaction
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Phenol Has negative report

• Not classified under respiratory or skin
  sensitization

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Classification criteria for germ cell mutagenicity
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Category 1 A 1 B May cause genetic
defectsCategory 2 Suspected of causing genetic
defects
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PhenolMicroorganismSalmonella (-S9) 40
micromol/plateChromosomal aberration hamster
(in vitro) positive ovary 2gm/LMutagenicity has
been reported in man
Induces genetic mutation

• Category 1 Symbol Danger
• May cause genetic defects

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Classification criteria for reproductive toxicity
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Category 1 May damage fertility or the unborn
child Substances which are known to 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.Category 2
Suspected of damage fertility or the unborn
child Substances 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.
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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 experiments
Suspected human reproductive or developmental
toxicant

• Category 2 Symbol Warning
• Suspected of damaging fertility or the unborn
  child

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Classification criteria for carcinogenicity
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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 carcinogenesisIAR
C Group 3Evidence as carcinogenic is
insufficient

• Not classified as carcinogenic

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

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Classification criteria for substances hazardous
to the aquatic environment
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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)

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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 lt 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

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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
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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.
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Phenol(Fish) EC50(96H) gt 1 - lt 10 mg/l
(Crustacea)EC50(48H) gt 10 -lt 100 mg/l (Algae)
EC50 (4H) gt 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

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Hazards to be covered by the harmonized criteria

• Aspiration hazard
• Respiratory tract irritation/corrosion
• Water activated toxicity
• Narcotic effects
• Hazardous to the terrestrial environment

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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/