The GHS The Globally Harmonized System for Hazard Classification and Labelling of Chemicals - PowerPoint PPT Presentation

Gabriel
the ghs the globally harmonized system for hazard classification and labelling of chemicals l.
Skip this Video
Loading SlideShow in 5 Seconds..
The GHS The Globally Harmonized System for Hazard Classification and Labelling of Chemicals PowerPoint Presentation
Download Presentation
The GHS The Globally Harmonized System for Hazard Classification and Labelling of Chemicals

play fullscreen
1 / 39
Download Presentation
The GHS The Globally Harmonized System for Hazard Classification and Labelling of Chemicals
373 Views
Download Presentation

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

- - - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript

  1. The GHSThe Globally Harmonized System for Hazard Classification and Labelling of Chemicals Basic Course

  2. 2. Hazard Classification 2.2 Health and Environmental Hazard Classification

  3. 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)

  4. Hazards covered by the harmonised criteria (Cont.) Environmental effects: • hazardous to the aquatic environment

  5. Classification criteria for simple chemical

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

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

  17. Phenol Has negative report Not classified under respiratory or skin sensitization

  18. 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

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

  20. 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

  21. 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

  22. 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.

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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.

  29. 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

  30. 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

  31. 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)

  32. 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

  33. 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

  34. 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.

  35. 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

  36. Hazards to be covered by the harmonized criteria • Aspiration hazard • Respiratory tract irritation/corrosion • Water activated toxicity • Narcotic effects • Hazardous to the terrestrial environment

  37. 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/