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IPCS

International Programme
on Chemical Safety

CHEMICAL SAFETY TRAINING MODULES

PART II: IDENTIFICATION, CLASSIFICATION AND LABELLING OF CHEMICALS

ANNEX 7.

A. General Classification and Labelling Requirements for Dangerous Substances and Preparations

The assessment of the effects on health is tested using animals. The test substance or preparation can be applied to the animal orally, under the skin or by inhalation. LD50 and LC50 are the parameters to explain the results of different tests so that they are comparable.

LD50 is an abbreviation used for the dose which kills 50% of the test population.

LC50 is an abbreviation used for the exposure concentration of a toxicant lethal to half of the test animals.

Classification to hazard categories can be done by determining the acute toxicity in animals, expressed in LD50 or in LC50 values and using the following limit figures

 Category

LD50 absorbed orally in rat mg/kg bodyweight

LD50 dermal absorption in rat or rabbit mg/kg bodyweight

LC50 absorbed by inhalation in rat, mg/litre par 4 hours

Very toxic

maximum 25

maximum 50

maximum 0.25

Toxic

25 - 200

50 - 400

0.25 - 1

Harmful

200 - 2000

400 - 2000

1 - 5

LD50 and LC50 can be found for many substances and preparations in the literature.

The substances and preparations have also other effects, like flammability. These should be included in the assessment of hazards for final classification.

B. Concentration Limits to be used in applying the Conventional Method of Assessing Health Hazards

Tables 1 - 6. Non-gaseous substances and preparations

Tables 7 - 12. Gaseous substances and preparations

Table 1. Acute lethal effects

 Classification of the substance

Classification of the preparation

 

T+

T

Xn

T+ with R26, R27, R28

concentration ³ 7%

1% £ conc. < 7%

0.1% £ conc. < 1%

T with R23, R24, R25

 

concentration ³ 25%

1% £ conc. < 25%

Xn with R20, R21, R22

   

concentration ³ 25%

conc. = concentration

Table 2. Non-lethal irreversible effects after a single exposure

 Classification of the substance

Classification of the preparation

 

T+

T

Xn

T+ with R39

concentration ³ 10%

R39 obligatory

1% £ concentration < 10%

R39 obligatory

0.1% £ concentration < 1%

R40 obligatory

T with R39

 

concentration ³ 10%

R39 obligatory

1% £ concentration < 10%

R40 obligatory

Xn with R40

   

concentration ³ 10%

R40 obligatory

The R-phrases R20 to R28 are also to be assigned to indicate route of administration or means of exposure.

Table 3. Severe effects after repeated or prolonged exposure

 Classification of the substance

Classification of the preparation

 

T

Xn

T with R48

concentration ³ 10%

R48 obligatory

1% £ concentration < 10%

R48 obligatory

Xn with R48

 

concentration ³ 10%

R48 obligatory

The R-phrases R20 to R28 are also to be assigned to indicate route of administration or means of exposure.

Table 4. Corrosive or irritant effects

 Classification of the substance and/or relevant R-phrase

Classification of the preparation and R-phrase

 

at least C with R35

at least C with R34

at least Xi with R41

at least Xi with R36, R37 R38

C with R35

concentration ³ 10%

5% £ conc. < 10%

R34 obligatory

 

1% £ conc. < 5%

R36/ R38 obligatory

C with R34

 

concentration ³ 10%

R34 obligatory

 

5% £ conc. < 10%

R36, R38 obligatory

Xi with R41

   

concentration ³ 10%

R41 obligatory

5% £ conc. <10%

R36 obligatory

Xi with R36, R37, R38

     

concentration ³ 20%

R36, R37, R38 obligatory, if they apply

Table 5. Sensitizing effects

 Classification of the substance

Classification of the preparation

 

at least Xn and R42

at least Xi and R43

Xn and R42

concentration ³ 1%

R42 obligatory

 

Xi and R43

 

concentration ³ 1%

R43 obligatory

Xn and R42/43

concentration ³ 1%

R42/43 obligatory

 

Table 6. Carcinogenic/mutagenic/teratogenic effects

cancer causing - carcinogenic

hazards in reproduction - mutagenic

non-heritable birth defects - teratogenic

 Classification of the substance

Classification of the preparation

 

at least T

at least Xn

T with R45 or R49 for carcinogenic substances of category 1 or 2

concentration ³ 0.1%

R45, R49 obligatory

 

Xn with R40 for carcinogenic substances of category 3

 

concentration ³ 1%

R40 obligatory

T with R46 for mutagenic substances of category 1

concentration ³ 0.1%

R46 obligatory

 

Xn with R46 for mutagenic substances of category 2

 

concentration ³ 0.1%

R46 obligatory

Xn with R40 for mutagenic substances of category 3

 

concentration ³ 1%

R40 obligatory

T with R61 for substances causing birth defects of category 1 or 2

concentration ³ 0.5%

R61 obligatory

 

Xn with R63 for substances causing birth defects of category 3

 

concentration ³ 5%

R63 obligatory

T with R60 for substances impairing fertility of category 1 or 2

concentration ³ 0.5%

R60 obligatory

 

Xn with R62 for substances possibly impairing fertility of category 3

 

concentration ³ 5%

R62 obligatory

Category 1 Substances proved to be carcinogenic, mutagenic, teratogenic or to impair fertility in humans and animals.

Category 2 Substances which are probably carcinogenic, mutagenic, teratogenic or probably impair fertility based in animal tests or by some other important information.

Category 3 Substances which have tested to be possibly carcinogenic, mutagenic, teratogenic or to impair fertility in animal tests or based on some other important information, and substances which are suspected to have the hazard but more research is needed.

Table 7. Gaseous preparations; acute lethal effects

 Classification of the substance (gas)

Classification of the gaseous preparation

 

T+ with R26

T with R23

Xn with R20

T+ with R26, R27, R28

concentration ³ 1%

0.2% £ concentration < 1%

0.02% £ concentration < 0.2%

T with R23, R24, R25

 

concentration ³ 5%

0.5% £ concentration < 5%

Xn with R20, R21, R22

   

concentration ³ 5%

Table 8. Gaseous preparations; non-lethal irreversible effects after a single exposure

 Classification of the substance (gas)

Classification of the gaseous preparation

 

T+

T

Xn

T+ with R39

concentration ³ 1%

R39 obligatory

0.2% £ concentration < 1%

R39 obligatory

0.02% £ conc. < 0.2%

R40 obligatory

T with R39

 

concentration ³ 5%

R39 obligatory

0.5% £ conc. < 5%

R40 obligatory

Xn with R40

   

concentration ³ 5%

R40 obligatory

The R-phrases R39/23 - 39/28 or R40/20, R40/21, R40/22 are also to be assigned to indicate route of administration or means of exposure.

Table 9. Gaseous preparations; severe effects after repeated or prolonged exposure

 Classification of the substance (gas)

Classification of the gaseous preparation

 

T

Xn

T with R48

concentration ³ 5%

R48 obligatory

0.5% £ concentration < 5%

R48 obligatory

Xn with R48

 

concentration ³ 5%

R48 obligatory

The R-phrases R39/23 - 39/28 or R40/20, R40/21, R40/22 are also to be assigned to indicate route of administration or means of exposure.

Table 10. Gaseous preparations; corrosive or irritant effects

 Classification of the substance (gas)

Classification of the gaseous preparation and R-phrase

 

at least C with R35

at least C with R34

at least Xi with R41

at least Xi with R36, R37 R38

C with R35

conc. ³ 1%

R35 obligatory

0.2% £ concentration < 1%

R34 obligatory

 

0.02% £ conc. < 0.2%

R37 obligatory

C with R34

 

concentration ³ 5%

R34 obligatory

 

0.5% £ concentration < 5%

R37 obligatory

Xi with R41

   

conc. ³ 5%

R41 obligatory

0.5% £ concentration < 5%

R36 obligatory

Xi with R36, R37, R38

     

concentration ³ 5%

R36, R37, R38 obligatory, if they apply to the substances

Table 11. Gaseous preparations; sensitizing effects

 Classification of the substance (gas)

Classification of the gaseous preparation

 

at least Xn and R42

Xn and R42

concentration ³ 0.2%

R42 obligatory

Xn and R42/43

concentration ³ 0.2%

R42/43 obligatory

Table 12. Gaseous preparations; carcinogenic/mutagenic/teratogenic effects

 Classification of the substance (gas)

Classification of the gaseous preparation

 

at least T

at least Xn

T with R45 or R49 for carcinogenic substances of category 1 or 2

concentration ³ 0.1%

R45, R49 obligatory

 

Xn with R40 for carcinogenic substances of category 3

 

concentration ³1%

R40 obligatory

T with R46 for mutagenic substances of category 1

concentration ³ 0.1%

R46 obligatory

 

Xn with R46 for mutagenic substances of category 2

 

concentration ³ 0.1%

R46 obligatory

Xn with R40 for mutagenic substances of category 3

 

concentration ³ 1%

R40 obligatory

T with R61 for substances causing birth defects of category 1 or 2

concentration ³ 0.2%

R61 obligatory

 

Xn with R63 for substances causing birth defects of category 3

 

concentration ³ 1%

R63 obligatory

T with R60 for substances impairing fertility of category 1 or 2

concentration ³ 0.2%

R60 obligatory

 

Xn with R62 for substances possibly impairing fertility of category 3

 

concentration ³ 1%

R62 obligatory

ANNEX 8.

United Nations Classification Recommendation on Transport of Dangerous Goods

1. EXPLOSIVES

1.1. Substances and articles which have a mass explosion hazard

1.2. Substances and articles which have a projection hazard but not a mass explosion hazard

1.3. Substances and articles which have a fire hazard and either a minor blast hazard or a minor projection hazard but not a mass explosion hazard

1.4. Substances and articles which present no significant hazard

1.5. Very insensitive substances which have a mass explosion hazard

1.6. Extremely insensitive articles which do not have a mass explosion hazard

2. GASES

2.1. Flammable gases

2.2 Non-flammable, non-toxic gases

2.3. Toxic gases

3. FLAMMABLE LIQUIDS

4. FLAMMABLE SOLIDS

4.1. Flammable solids

4.2. Substances liable to spontaneous combustion

4.3. Substances which in contact with water emit flammable gases

5. OXIDIZING SUBSTANCES; ORGANIC PEROXIDES

5.1. Oxidizing substances

5.2. Organic peroxides

6. POISONOUS (=TOXIC) SUBSTANCES

6.1. Toxic substances

6.2. Infectious substances

7. RADIOACTIVE MATERIAL

8. CORROSIVE SUBSTANCES

9. MISCELLANEOUS DANGEROUS SUBSTANCES

Continue to Part III: Chemical safety data sheet