The Globally Harmonized System of Classification

1
The Globally Harmonized System of Classification
Labelling of Chemicals (GHS)

• Classification of Mixtures

2
Working Definitions (1)

• Mixture
• Mixtures or solutions composed of two or more
  substances in which they do not react.

3
Working Definitions (2)

• Substance
• Chemical elements and their compounds in the
  natural state or obtained by any production
  process.

It includes any additive necessary to preserve
the stability of the product and any impurities
deriving from the process used, but excludes any
solvent which may be separated without affecting
the stability of the substance or changing its
composition.
4
Working Definitions (3)

• Guidance
• Consider the classification of any impurities,
  additives or individual constituents of a
  substance which have been identified, if they
  exceed the cut-off value/concentration limit for
  a given hazard class.

5
Working Definitions (4)

• Alloy
• An alloy is a metallic material, homogeneous on
  a macroscopic scale, consisting of two or more
  elements so combined that they cannot be readily
  separated by mechanical means.
• Alloys are considered to be mixtures for the
  purpose of classification under the GHS.

6
The Use of Cut-off Values/Concentration Limits

• Normally,
• the harmonized cut-off value/ concentration
  limit is to be applied in all jurisdictions.
• However..

7
The Use of Cut-off Values/Concentration Limits
(Cont.)
However, If there is evidence that the hazard of
an ingredient is present below the
cut-off/concentration limit, then classify the
mixture accordingly. Or
8
The Use of Cut-off Values/Concentration Limits
(Cont.)
If there is conclusive data that the hazard of
an ingredient will not be present at a level
above the harmonized cut-off/concentration limit,
then classify the mixture accordingly.
9
Classification Criteria for Mixtures

• Based on the classification criteria for
  substances
• Allows for the use of available data

10
Tier Approach to Classification

• Generally use test data for the mixture, when
  available
• ?
• Use bridging principles, if applicable
• ?
• Estimate hazards based on the known
• ingredient information

11
Bridging Principles

• Dilution
• Batching
• Concentration of Highly Toxic Mixtures
• Interpolation within One Toxic Category
• Substantially Similar Mixtures
• Aerosols

12
Agreed Health and Environmental Criteria for
Mixtures

• Acute Toxicity
• Skin or Respiratory Sensitization
• Germ Cell Mutagenicity
• Carcinogenicity
• Toxic to Reproduction
• Target Organ Systemic Toxicity
• Skin Irritation/Corrosion
• Serious Eye Damage/Eye Irritation
• Aquatic Toxicity Acute and Chronic

13
Acute Toxicity

• Where
• Ci concentration of ingredient i
• ATEi Acute Toxicity Estimate of ingredient i
• ATEmix Acute Toxicity Estimate of mixture
• n ingredients in the mixture and i runs from 1 to
  n

14
Acute Toxicity (Cont.)

• The Acute Toxicity Estimate (ATE)
• The LD50/LC50 where applicable, or
• The appropriate conversion value for
• the results of a range test for an ingredient,
  or
• a classification of the ingredient.

15
Ingredients with Unknown Acute Toxicity
Concentration of unknown ingredients ? 10

• Where
• Ci concentration of ingredient i
• ATEi Acute Toxicity Estimate of ingredient
  i
• ATEmix Acute Toxicity Estimate of the mixture
• n ingredients in the mixture and i runs from 1 to
  n

16
Ingredients with Unknown Acute Toxicity (Cont.)
Concentration of unknown ingredients is gt 10
Where Ci concentration of ingredient i ATEi
Acute Toxicity Estimate of ingredient i ATEmix
Acute Toxicity Estimate of the mixture n
ingredients in the mixture and i runs from 1 to n
17
Skin Corrosion/Irritation
18
Serious Eye Damage/Eye Irritation
19
Skin/Eye Corrosion/Irritation (Cont.)If the
additivity approach does not apply...
20
Skin Sensitization
For the notes, see Chapter 3.4 of the GHS, Table
3.4.1
21
Respiratory Sensitization
For the notes, see Chapter 3.4 of the GHS, Table
3.4.1
22
Classification of Mixtures When Data is Available
for the Complete Mixture

• Mutagenicity,
• Carcinogenicity,
• Reproductive Toxicity,
• Target Organ Systemic Toxicity

23
Mutagenicity
24
Carcinogenicity
25
Carcinogenicity - Hazard Communication
26
Reproductive Toxicity
27
Reproductive Toxicity - Hazard Communication
28
Target Organ Systemic Toxicity (TOST)
29
TOST - Hazard Communication
30
Hazardous to the Aquatic Environment

• Data available for the mixture as a whole
• Classify for acute toxicity based on the
• established cut-offs
• LC50
• EC50
• NOEC
• Water solubility

31
Hazardous to the Aquatic Environment

• Data available for the mixture as a whole
  (Cont.)
• Classify for chronic toxicity based on the
  Summation of Classified Components approach,
  taking into account
• - degradability
• - bio-accumulation

32
Hazardous to the Aquatic Environment (Cont.)

• Sufficient data on similar mixtures
• Apply Bridging Principles

33
Hazardous to the Aquatic Environment (Cont.)

• Aquatic Test or Classification Data available for
  all relevant components?
• Three approaches
• Summation Method
• Additivity Formula
• Combination of Additivity Formula and Summation
  Method
• Two hazard classes Acute and Chronic

34
Hazardous to the Aquatic Environment (Cont.)

• Summation Method
• Add the concentrations of the classified
  components and apply threshold values to classify
  the mixture for acute and chronic hazards,
  respectively.

35
Hazardous to the Aquatic Environment (Cont.)

• Additivity Formula

36
Hazardous to the Aquatic Environment (Cont.)

• Aquatic Test or Classification Data available for
  all relevant components?
• Consider components with acute toxicity data
• 100 ? apply Summation Approach/Additivity
  Formula, classify
• lt100 ? apply Additivity Formula and Summation
  Method, or only Summation Method, classify

37
Hazardous to the Aquatic Environment (Cont.)

• Aquatic Test or Classification Data available
  for all relevant components?
• Consider components with chronic test data and
  apply the Summation Method

38
Hazardous to the Aquatic Environment (Cont.)

• Ingredients with Unknown Aquatic Toxicity
• Consider
• 1) components with acute aquatic toxicity
  data and apply additivity formula, and/or
  summation method
• 2) components classified as acute and apply
  summation method, and
• 3) components classified as chronic and apply
  summation method.

39
Physical Hazards

• It is assumed that mixtures will be tested for
  physical hazards.

40
The Globally Harmonized System of Classification
Labelling of Chemicals (GHS)

• Classification of Mixtures