REGTOX/Module 5 1. Globally Harmonized System of Classification and Labeling of Chemicals (GHS) - What is GHS?

What are the essential elements of GSH? Describe shortly the background and the objectives of GHS? Where you can find 'the last updated GHS document prepared by United Nations "the Purple Book" (List also which kind of parts and annexes does it contain)? What does 'a building block approach' mean in implementing of GSH? How is GHS implemented in your home country? a. What is GHS?  The GHS is a system for standardizing and harmonizing the classification and labeling of chemicals. b. What are the essential elements of GSH? The main elements of the GHS are:  Harmonized criteria to classify substances and mixtures according to their health, environmental and physical hazards;  Harmonized hazard communication-including requirements for labeling and safety data sheet. c. Background and objectives of GHS  The GHS was initially developed based on the UN conference on environment and development in 1992 for initiating better and safer use of chemicals in world where great deal of chemicals are produced and transported in a year. It brings common language/symbols among nations in labeling and classification of chemicals based on their hazard level or type. Such approaches include material safety data sheet and easy and easily understandable symbols.  It also facilitates international trade of chemicals and to maintain the existing level of protection to human health and environment.  It informs users about hazardous chemicals and their use through standard symbols and phrases on the packaging labels and also through safety data sheets d. Where you can find 'the last updated GHS document prepared by United Nations "the Purple Book"   It contains 4 parts and 10 annexes.  Parts: classification based on hazard type o Introduction o Health o Physical o Environmental  Annexes: o Annex 1: Allocation of label elements o Annex 2: Classification and labeling summary table o Annex 3: codification of hazard elements o Annex 4: Guidance on preparation of safety data sheet o Annex 5: consumer product labeling based on the likelihood of injury o Annex 6: Comprehensibility testing methodology o Annex 7: Examples of arrangements of GHS label elements

Since the coverage and hazard communication vary by the needs of target audiences. o Substantially Similar Mixtures: slight change in concentration or substitution with toxicologically similar hazard component may not change the toxicity profile of the mixture. If certain block is selected the rules within that block must be complied. In CLP regulation so-called "bridging rules" are introduced as a new approach for classifying of mixtures. the GHS was designed to contain the hazard endpoints and communication tools necessary for application to known regulatory schemes in way it fits all countries and where system covers something that is in the GHS. Countries and organizations can determine which of the building blocks will be applied in different parts of their systems. How is GHS implemented in your home country?  Quality and Standards Authority (QSA) requires manufacturers and importers of chemicals to use standard labeling and classifications such as using symbols and language. o Concentration of Highly Toxic Mixtures: if a mixture is severely hazardous. and implements GHS. Describe (by your own word) the 'bridging principles': What are they? What do they mean in practice? When/Why are they needed?  Bridging rules or principles are those approaches create safety data for untested mixtures if components of the mixtures are tested or test data are available for similar mixtures. the resultant mixture will have equivalent hazard as the original mixture o Batching: under a controlled production process. then a concentrated mixture is also assumed to be severely hazardous o Interpolation within One Toxic Category: Mixtures having component concentrations within a range where the hazards are known are assumed to have those known hazards. f. Then. What does 'a building block approach' mean in implementing of GSH?  The GHS classification and communication requirements can be thought of as a collection of building blocks.e.  http://live. Thus. The principles are: o Dilution: if a mixture is diluted with a diluent of equivalent or lower toxicity. i.unece.html 2. the hazards of the new batch are assumed to be equivalent to the previous batches.o Annex 8: An example of classification in GHS o Annex 9: Guidance on hazard to aquatic environment o Annex 10: Guidance on transformation/dissolution of metals and metal compounds in aqueous media e. that coverage should be consistent. . the bridging rule or principle helps to extend and use the data for untested mixture.

it may be classified as chronic category 1. Chronic category 1: in aquatic environment when the substance is Very toxic to aquatic life with long-lasting (non degradable) effects. unless the propellant affects the hazards upon spraying. However. M-factors are used to derive by the summation method the classification of a mixture in which the substance is present 4.  In practice.272 LD50 = 367. What does the 'multiplying factor (M)' stand for in the classification of preparations? How is it used?     M-factors stand for summation of ingredient effects in classification of preparations or mixtures containing substances that are classified as very toxic (classified as acute category 1 or chronic category 1). =∑ ATE = Acute Toxicity Estimate of ingredients =LD50 N = number of ingredients i = the individual ingredients from 1 to n Ci = concentration of ingredients i (% w/w or % v/v) Therefore = + + + +0 =0. but with significant similarity (toxicological). 18% ingredient B (oral LD50 1300 mg/kg).51 mg/kg. the mixture would be classified as category 4. water. the substance may be classified as Acute category 1. it seems extrapolating data or toxicological profile of one mixture to other. Calculate the LD50 and determine CLP classification for the following mixture: 20% ingredient A (oral LD50 1800 mg/kg). 30% ingredient C (oral LD50 2400 mg/kg). . when the toxicity level is below 1 mg/l in fish and/or Crustacea and/or aquatic plant. 3 % ingredient D (oral LD50 3000 mg/kg). it may not work for all end points.o Aerosols: aerosol and non-aerosolized form of a mixture will have the same toxicity. Acute category 1: for aquatic environment. According to CLP classification. 3.

(300 <LD50 (oral) < 2000 mg/kg but with warning according to ECHA’s Guidance on the Application of the CLP Criteria: Regulation (EC) No 1272/2008 on CLP of substances and mixtures. .