Presentation on theme: "This presentation is intended for use by trainers with a working knowledge of the GHS and older labelling and classification systems in Australia."— Presentation transcript:
This presentation is intended for use by trainers with a working knowledge of the GHS and older labelling and classification systems in Australia
The Globally Harmonized System of Classification and Labelling of Chemicals This presentation is released under the Creative Commons Attribution 3.0 Australia Licence and may be reused and redistributed free of charge. For more information see
Part 2: Classifying Hazardous Chemicals to the GHS The relationship between the GHS, the ADG Code and the NOHSC Approved Criteria
4 What is classification? Where do I get information to help me classify Cut-off limits Practical Example classifications Single chemical Mixtures Questions (feel free to ask at any time). Part 2: Classifying chemicals according to the GHS (1 hour)
5 What this workshop will teach you This session is aimed at providing you with the information to enable you to re- classify chemicals which have a classification under the older Australian Regulatory frameworks to the requirements of the GHS under the WHS legislation. In order to gain the most from this session, you need to have a basic understanding of the GHS, its hazard classes, pictograms and other labelling elements and previous regulatory frameworks for chemical classification. What this workshop won’t teach you Epidemiological assessments, weight of evidence classifications or interpreting data from animal or other studies to obtain a classification. Bridging principles for classifying mixtures. Although classification of mixtures is discussed, bridging principles for the classification of health effects of mixtures will not be. They can be complex and their usefulness is not always clear
6 What you will need for this workshop A copy of: Guidance on the Classification of Hazardous Chemicals Under the WHS Regulations and Code of Practice: Labelling of Workplace Hazardous Chemicals, or Code of Practice: Preparation of Safety Data Sheets for Hazardous Chemicals, or Classification and labelling for workplace hazardous chemicals poster and Acute toxicity hazard categories and ATE values from GHS – table in GHS text optionally the GHS, 3 rd Revised Edition (The Purple Book).
7 Classification What is classification? The systems used prior to GHS are based on two separate (but related), systems. Dangerous Goods - ADG Code, 7th Edition Physical hazards, acute toxicity, corrosion and environmental hazards Hazardous Substances - NOHSC approved criteria (AC) Health hazards Also included physical hazards and environmental hazards Classification is the process of determining the intrinsic physical, health and environmental hazards of a chemical. The GHS provides pre-defined hazard classes and appropriate sub-categories. Obtaining correct classification is important – for labelling and SDS. Label and safety data sheet follow. It is also a requirement under the WHS Regulations
8 There is close alignment of most GHS classes with the ADG Code and the AC. GHS physical hazards are (almost) the same as the ADG Code. GHS health hazards have a great deal of overlap with the AC. Because this close alignment exists, the classification of chemicals under the ADG Code and the AC can be translated to a GHS classification. (Re)-Classification If you have actual data on a chemical, it should be used for classification. Guidance on the Classification of Hazardous Chemicals under the WHS Regulations Provides a translation for most ADG Code / AC to GHS classes.
9 Converting ADG Code GHS classification e.g. Class 3 Flammable Liquids & Division 4.1 Flammable Solids The transport classification can be found on the safety data sheet in section 14. A substance or mixture with an ADG classification is (essentially) already classified for GHS physical hazards.
10 Conversion of Approved Criteria GHS Classification e.g. R23 Toxic by inhalation Acute toxicity - inhalation R-phrase to H-statement conversion GHS health hazards have a broadly similar scope to the Approved Criteria There are some differences to be aware of.
11 Some issues with health hazards translation Not all of the end-points for classification are the same and there is some overlap. Always check for data on SDS on toxicological information (usually section 11). Become familiar with the Acute Toxicity table in the GHS (p. 109) Cat. 1 Cat. 2 Cat. 3 Cat. 4 T, R23 T+, R26 Xn, R20 GHS App. Crit. Acute toxicity (vapours) - inhalation
12 Environmental Hazard Classification e.g. R50/53 Acute/chronic aquatic toxicity Environmental classification can usually be found in the SDS (sections 14 and 15).
13 GHS Hazard Classes The WHS Regulations refers specifically to the 3 rd revision of the GHS All hazard classes except the following are included in the WHS Regulations: Acute toxicity – oral/dermal/inhalation: Category 5 Skin corrosion/irritation: Category 3 Serious eye damage/irritation: Category 2B Aspiration hazard: Category 2 Flammable gases: Category 2 Acute hazard to the aquatic environment: Categories 1 – 3 (all) Chronic hazard to the aquatic environment: Categories 1 – 4 (all) Hazardous to the ozone layer However, can use these hazard classes and associated label elements if they do not cast doubt upon the correct classification. Building block approach.
14 Supplementary Australian Hazard Classes In addition to the GHS Hazard Classes, several additional classification have been adopted in Australia. AUH001 – Explosive when dry AUH006 – Explosive with or without contact with air AUH014 – Reacts violently with water AUH018 – In use may form flammable/explosive vapour/air mixture AUH029 – Contact with water liberates toxic gas AUH031 – Contact with acid liberates toxic gas AUH032 – Contact with acid liberates very toxic gas AUH044 – Risk of explosion if heated under confinement AUH066 – Repeated exposure may cause skin dryness and cracking AUH070 – Toxic by eye contact AUH071 – Corrosive to the respiratory tract Criteria found in the Classification Guide Appendices E&F and Codes of Practice for Labelling and Safety Data Sheets There are no labelling elements associated with these hazards Most of these categories are also in the Approved Criteria (except AUH070 and AUH071)
15 Classification Where can I get the information to allow re-classification? For the majority of chemicals currently used in Australia, a classification under the ADG / AC will likely already exist. Labelling Safety data sheets – relevant information to consult includes: R-phrases / hazard symbols Transport information (Dangerous Goods Classification / UN numbers) Physical and chemical properties mp / bp / fp / pH / LEL and UELs, etc. Toxicological information LD 50 / LC 50 for oral / dermal / inhalation routes of exposure Carcinogenicity / mutagenicity information Sensitisation / skin and eye corrosion / target organs, etc. Ecological information (for environmental hazards) Reactivity / stability data (may assist with non-GHS hazard classes)
16 Overseas classifications Beware: there are some differences in the “building blocks” between some countries. Classification Where can I get the information to allow re-classification?
17 Classification Where can I get the information to allow re-classification? Online database and tools are also available to assist you in classifying workplace hazardous chemicals. Chemical suppliers’ websites Annex VI to CLP (http://esis.jrc.ec.europa.eu)http://esis.jrc.ec.europa.eu Online translation tools (e.g. HSIS (http://hsis.safeworkaustralia.gov.au)http://hsis.safeworkaustralia.gov.au eChemportal (http://www.echemportal.org)http://www.echemportal.org GREAT (http://great.cla.gov.tw/ENG/index.aspx)http://great.cla.gov.tw/ENG/index.aspx Further information available on our website:
18 Classification – Single substances – and (some) mixtures Process for classification using translation of R-phrase to H-statement Chemical needing classification Gather all information available Does the chemical have a classification under ADG/AC or (EU dir)? Classify the chemical Is testing data available? Can’t classify. Need further information to proceed. Classify the chemical Use translation tables to derive classifications Possibly not hazardous
19 Classification of mixtures For mixtures the translation process will provide adequate classification in the majority of cases – if cut-off limits are not a problem. The translation of physical hazards should be straightforward. However, changes to some cut-off concentrations and the way in which chemicals in some categories contribute to the classification may affect some cases. Beware! If the GHS cut-off limit is lower than its equivalent in the AC, direct translation could result in non-classification. If the GHS cut-off limit is higher than its equivalent in the AC, direct translation could result in over-classification. Specified cut-off limits in HSIS do not apply under WHS Regulations! You need to be aware of the cut-off limits under the GHS vs. the AC.
20 Classification of mixtures Cut-off limit comparison reproductive toxicity Cut-off limits and special instructions can be found in each health hazard chapter of the GHS. Further, the WHS Regulations implements some specific cut-off concentrations. These changes are detailed Schedule 6 of the WHS Regulations or in Appendix G of the Classification Guidance Document Follow the decision logic in each chapter of the GHS.
21 Classification of mixtures Mixtures not classified under AC which would be under GHS You need to be aware of the cut-off limits under the GHS vs. the AC. Manufacturer should be able to supply the information needed to classify properly.
22 Classification of mixtures Acute Toxicity Estimate To estimate the toxicity of components in a mixture, the GHS provides a formula Where: ATEmix = Acute toxicity estimate of mixture ATE i = Acute toxicity estimate of ingredient C i = concentration of ingredient n = number of ingredients from 1 to i Only need to consider components which are greater than 1 % w/w, unless it is known there is a health effect at a lower level.
23 Classification of mixtures (where cut-offs are close) Process for classification Mixture needing classification Gather all information available Test data on similar mixtures? Classify the mixture – according to cut- off limits Is testing data available? Can bridging principles be applied? Classify the mixture Is hazard data available for some or all components? Use known and/or derived GHS classification of individual components Can’t classify mixture – contact supplier to obtain more information Classify the mixture
24 Classification examples 9 examples of reclassifying substances or mixtures according to the GHS For each example, provide label elements: Hazard classes and categories; Signal word; Pictograms; Hazard statements. Use reference materials to assist you assigning the label elements. Return for discussion and answer session
25 Classification – Single substances Example 1: pH Indicator A laboratory chemicals supplier is re-classifying its products to the GHS. The regulatory compliance officer extracted the following salient data on its classification. What would the classification be under the GHS? Provide the associated signal words, pictograms and H-statements? Transport information: Div. 6.1 PG III Risk phrases: R25 – Toxic if swallowed R40 – Limited evidence of a carcinogenic effect Other useful information: LD 50 oral – rat – 200 mg/kg mp = 111°C Data from SDS / LabellingGHS Classification Acute toxicity: Cat. 3 (oral, dermal, inhalation?) Acute toxicity – Oral: Cat. 3 Carcinogenicity: Cat. 2 Acute toxicity – Oral: Cat. 3
26 Classification Example 1: pH Indicator: Answer GHS Classification Acute toxicity – Oral: Cat. 3 Carcinogenicity: Cat. 2 Signal Word: DANGER H301 Toxic if swallowed H351 Suspected of causing cancer Pictograms: + WARNING
27 Classification A manufacturer of a solid disinfecting chemical agent is re-classifying from ADG/AC to comply with the requirements of the GHS under the WHS Regulations. The following ADG/AC classification information is available. What would the classification of this compound be under the GHS? Transport information: Div 5.1 PG II Risk phrases: R8 – contact with combustible material may cause fire R22 – harmful if swallowed R50/53 – very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment Other useful information: LD 50 oral – rat – 1090 mg/kg Oxidising solids: Cat. 2 No translation possible (but covered by DG classification) Acute toxicity – Oral: Cat. 4 Acute aquatic toxicity: Cat. 1 Chronic aquatic toxicity: Cat.1 Acute toxicity – Oral: Cat. 4 Data from SDS / LabellingGHS Classification Example 2: Disinfecting agent
28 Classification Example 2: Disinfecting agent: Answer GHS Classification Oxidising solids: Cat. 2 Acute toxicity – Oral: Cat. 4 Signal Word: DANGER H272 May intensify fire; oxidiser H302 Harmful if swallowed Pictograms: Acute aquatic toxicity: Cat. 1 Chronic aquatic toxicity: Cat. 1 H410 Very toxic to aquatic life with long lasting effects H400 Very toxic to aquatic life H410 Very toxic to aquatic life with long lasting effects
29 Classification Div. 6.1 (3) PG II R45 – may cause cancer R23/24/25 – toxic by inhalation, in contact with skin and if swallowed R10 – flammable R34 – causes burns R43 – may cause sens. by skin contact LD 50 oral – rat – 90 mg/kg LC 50 inhalation (4h) – rat – 3.1 mg/L Probably carcinogenic to humans bp = 115°C / fp 32°C Acute toxicity: Cat. 2 (plus Flammable liquid) Carcinogenicity: Cat.1B Acute toxicity – Inhalation: Cat. 2 (use vapour) Flammable liquids: Cat. 3 Acute toxicity – Oral: Cat. 3 Acute toxicity – Inhalation: Cat. 3 Data from SDS / LabellingGHS Classification Example 3: Plastics starting material A safety officer at a plastics manufacturer is reviewing the classifications of its products and raw materials to comply with the GHS requirements of the WHS Regulations. After extracting the necessary information from the SDS and labelling, this chemical was reclassified. What should the classification be? Skin corrosion: Cat. 1B Skin sensitisation: Cat. 1 Acute toxicity – Dermal/Oral: Cat. 3
30 Classification Example 3: Plastics starting material: Answer GHS Classification Carcinogenicity: Cat. 1B Acute toxicity – Inhalation: Cat. 3 Acute toxicity – Dermal: Cat. 3 Acute toxicity – Oral: Cat. 3 Flammable liquids: Cat. 3 Skin corrosion: Cat. 1B Skin sensitisation: Cat. 1 Signal Word: DANGER H350 May cause cancer H301+H311+H331 Toxic if inhaled, if swallowed and in contact with skin H226 Flammable liquid and vapour H314 Causes severe skin burns and eye damage H317 May cause an allergic skin reaction Pictograms: Precedence rules for pictograms See Codes of Practice
31 Classification DG Classification – Div. 3 PG II R45 – may cause cancer R46 – may cause heritable genetic damage R48/23/24/25 – toxic: danger of serious damage to health through prolonged exposure through inhalation, in contact with skin and if swallowed R65 – harmful: may cause lung damage if swallowed R11 – highly flammable R36/38 – irritating to eyes and skin LD 50 oral – rat – 2990 mg/kg LC 50 inhalation – rat – 447 mg/l LD 50 dermal – rabbit – 8263 mg/kg bp = 80°C / fp = -11°C In vivo test shows mutagenic effect Known to cause cancer in humans Flammable liquids: Cat. 2 Carcinogenicity: Cat. 1A Germ cell mutagenicity: Cat. 1B Aspiration hazard: Cat. 1 Acute toxicity – Oral: Not classified Acute toxicity – Inhalation: Not classified Acute toxicity – Dermal: Not classified Data from SDS / LabellingGHS Classification Example 4: Bulk supply of solvent A solvent supplier provides delivery of solvents in drums of 200 L in volume. These drums are transported directly to workplaces on pallets in a truck. How should this solvent be classified and labelled? Flammable liquid: Cat. 2 Eye irritation: Cat. 2A / Skin irritation: Cat. 2 STOT Repeated Exposure: Cat. 1
32 Classification GHS Classification Flammable liquids: Cat. 2 Carcinogenicity: Cat. 1A Germ cell mutagenicity: Cat. 1B STOT – Repeated Exposure: Cat. 1 Aspiration hazard: Cat. 1 Eye irritation: Cat. 2A Skin irritation: Cat. 2 Signal Word: DANGER H225 Highly flammable liquid and vapour H350 May cause cancer H340 May cause genetic defects H372 Causes damage to organs through prolonged or repeated exposure H304 May be fatal if swallowed and enters airways H315 Causes serious eye irritation H319 Causes skin irritation Pictograms: Example 4: Bulk supply of solvent: Answer DG label required for transport
33 Classification DG Classification – Div. 2.3 (8) R10 – flammable R23 – toxic by inhalation R34 – causes burns R50 – very toxic to aquatic organisms LC 50 inhalation – rat – 2000 ppmV LEL – 15 % v/v / UEL – 25 % v/v Acute toxicity (gas) (Sub. risk – corrosive) Flammable gases: Cat. 2 (Not classified) Acute toxicity – Inhalation: Cat. 3 Data from SDS / LabellingGHS Classification Example 5: Compressed gas A gas manufacturer is re-classifying its products to accord with the GHS. The following data for the gas is known. The product is supplied in cylinders. How would you classify this gas according to the GHS? Acute aquatic toxicity: Cat. 1 Acute toxicity – Inhalation: Cat. 3 Skin corrosion: Cat. 1B Gases under pressure: Compressed gas Flammable gases: Cat. 2 (Not classified)
34 Classification GHS Classification Gases under pressure: Compressed gas Acute toxicity – Inhalation: Cat. 3 Skin corrosion: Cat. 1B Acute aquatic toxicity: Cat. 1 Signal Word: DANGER H280 Contains gas under pressure; may explode if heated H331 Toxic if inhaled H314 Causes severe skin burns and eye damage H400 Very toxic to aquatic life Pictograms: Example 5: Refrigeration gas: Answer
35 Classification DG Classification – Div. 6.1 PG II R61 – may cause harm to the unborn child R24 – toxic in contact with skin R28 – very toxic if swallowed R44 – risk of explosion if heated under confinement R50/53 – very toxic to the aquatic environment, may cause long-term adverse effects in the aquatic environment Acute toxicity: Cat. 2 Reproductive toxicity: Cat. 1B Data from SDS / LabellingGHS Classification Example 6: Herbicide How would this herbicide be classified and labelled according to the GHS given the information below on its classification under the ADG and AC? No GHS equivalent – AUH044 Acute toxicity – Oral: Cat. 2 Acute toxicity – Dermal: Cat. 2 Presumed human reproductive toxicant LD 50 oral – rat – 26 mg/kg LD 50 dermal – rat – 150 mg/kg Acute/chronic aquatic toxicity: Cat. 1 Acute toxicity – Dermal: Cat. 3
Signal Word: DANGER H300+H310 Fatal if swallowed or in contact with skin H360 May damage the unborn child H410 Very toxic to aquatic life with long- lasting effects Pictograms: 36 Classification GHS Classification Acute toxicity – Dermal: Cat. 2 Acute toxicity – Oral: Cat. 2 Reproductive toxicity: Cat. 1B Acute aquatic toxicity: Cat. 1 Chronic aquatic toxicity: Cat. 1 Example 6: Herbicide: Answer AUH044 Risk of explosion if heated under confinement
37 Classification of mixtures Example 7: Alcohol:water solution The following mixture is a commercially-available rinsing solution used for cleaning scientific instruments. It is a 50:50 mixture of an alcohol and water. How would this be classified and labelled under the GHS? DG Classification – Class 3 PG II R10 – flammable R36 – irritating to eyes R67 – vapours may cause drowsiness No toxicity data on SDS fp 22°C No boiling point data on mixture itself Bp of alcohol is 82-83°C Data from SDS / Labelling Flammable liquids: Cat. 2 Eye irritation: Cat. 2A GHS Classification STOT – Single Exposure: Cat. 3
38 Classification of mixtures Examples of classification using translation tables GHS Classification Flammable liquid: Cat. 2 Eye irritation: Cat. 2A STOT – Single exposure: Cat. 3 Signal Word: DANGER H225 Highly flammable liquid and vapour H319 Causes serious eye irritation H336 May cause drowsiness or dizziness Pictograms: Example 7: Alcohol : water solution Concentration of the alcohol is well above the suggested cut-off limit for STOT-SE 3. In this case, we can just translate the classification from ADG/AC to GHS with confidence. Cut-off limits only apply to health hazards in the context of the WHS Regulations.
39 Classification of mixtures A ready-for-bottling herbicide preparation is being supplied from the manufacturing plant to the bottling plant. It will be stored in bulk containers in the plant’s warehouse for a few weeks until it is processed. In order to meet the WHS requirements for storage, the preparation requires labelling in accordance with the regulations prior to it being bottled for consumer use. The active insecticide is present at 0.4 %w/w. What will the GHS classification be? What would happen if the classification was directly translated from its classification under the previous schemes? DG Classification – Not classified Not classified as a hazardous substance Data from SDS / Labelling Not classified GHS Classification The SDS provides information on individual ingredients and their proportions. This allows a classification to be derived by retrieving data on hazardous components. Example 8: Insecticide preparation Care must be taken to take into account the cut-off limits of the GHS. Some cut-off limits are lower under GHS. If we were to directly translate, this preparation would have no classification. Would this be correct?
40 Classification of mixtures GHS Classification To classify this mixture, the GHS classifications and toxicology information can be obtained from the active ingredient’s SDS. Other components: (99.6 %w/w) Not classified as hazardous Acute Toxicity – component below 1 %w/w, so no need to consider. Apply other cut-off limits in GHS / Regulations to ascertain the classification. Breaches cut-off for Reproductive toxicity: Cat. 1 Pyroglusinate: (0.4 %w/w) R60/61: May impair fertility; May harm the unborn child R20/21/22: Harmful by inhalation, in contact with skin or if swallowed R48/20/22: Danger of serious damage to health by prolonged exposure through inhalation and if swallowed. LD 50 – oral = 1620 mg/kg; LC 50 – inhalation = 1260 mg/m 3 ; LD 50 – dermal = 2000 mg/kg
41 Classification of mixtures GHS Classification Reproductive toxicity: Cat. 1 Signal Word: DANGER H360 May damage fertility or the unborn child Pictogram(s): Always pay attention to cut-off limits. If GHS cut-off is lower than AC possible non-classification If GHS cut-off is higher than AC possible under-classification
42 Classification of mixtures The following data relates to a rust-removing preparation. According to the SDS, the material is classified as a hazardous substance under the AC but there is no dangerous goods classification. What issues could you face classifying this mixture? What would you do to classify this material to the GHS and what would its classification be? DG Classification – Not classified R36 – Irritating to eyes R52 – harmful to aquatic organisms R53 – may cause long term adverse effects in the aquatic environment Data from SDS / Labelling Not classified Serious eye irritation: Cat. 2A Acute/Chronic aquatic toxicity: Cat. 3 GHS Classification The SDS provides information on individual ingredients and their proportions. This allows a classification to be derived by retrieving data on hazardous components. Example 9: Rust-removing preparation Care must be taken when reclassifying mixtures with corrosive components. Cut-off concentrations are significantly different versus the AC Is this classification correct?
43 Classification of mixtures GHS Classification To classify this mixture to the GHS, individual GHS classifications and toxicology information can be obtained from individual components’ SDSs. Acid component 2: (9.95 %w/w) Acute toxicity – Oral: Cat.4 (LD 50 = 1950 mg/kg) Skin corrosion: Cat. 1B / Serious eye damage: Cat. 1 STOT – SE: Cat. 3 Need to calculate ATE using formula in GHS text – see Cut-off for Skin Corr. 1B is ≥5% and ≥3% for Eye Dam. 1 Surfactants: (20 %w/w) Not classified as a hazardous chemical/env. hazard (can ignore for classification) Acid component 1: (9.95 %w/w) Eye irritation: Cat. 2A / Skin irritation: Cat. 2 Acute/chronic aquatic toxicity: Cat. 3
44 Classification of mixtures GHS Classification Skin corrosion: Cat. 1B Acute/Chronic aquatic toxicity: Cat. 3 Signal Word: DANGER H314 Causes severe skin burns and eye damage H402 + H412 Harmful to aquatic life with long lasting effects Pictogram(s): Serious eye irritation: Cat. 2A Acute/Chronic aquatic toxicity: Cat. 3 Signal Word: WARNING H314 Causes serious eye irritation H402 + H412 Harmful to aquatic life with long lasting effects Pictogram(s): If direct translation of R-phrases was used:
45 Classifying mixtures Gather as much information as you can – where test data is available, use it. Most mixtures should be able to be re-classified using direct translations of R- phrases to H-statement. However, where components are close to cut-off concentrations, re-classifying sometimes may involve a few extra steps. If this is not possible, obtain the individual classifications (GHS or AC/ADG) of each component and derive the overall classification from there. Contact the supplier/manufacturer/importer for extra information if necessary. The decision logic in each chapter of the GHS text can help greatly.