![]() |
ANNEX 8.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 | ![]() |
![]() |
![]() |
|
Toxic | 25 -200 | 50 - 400 | 0.25 to 1 |
|
Harmful | 200 - 2000 | 400 - 2000 | 1 to 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 ![]() |
1% ![]() |
0.1% ![]() |
|
T with R23, R24, R25 | concentration ![]() |
1% ![]() | |
|
Xn with R20, R21, R22 | 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 ![]() R39 obligatory |
1% ![]() R39 obligatory |
0.1% ![]() R40 obligatory |
|
T with R39 | concentration ![]() R39 obligatory |
1% ![]() R40 obligatory | |
|
Xn with R40 | concentration ![]() 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 ![]() R48 obligatory |
1% ![]() R48 obligatory | |
|
Xn with R48 | concentration ![]() 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 ![]() |
5% ![]() R34 obligatory |
1% ![]() R36/ R38 obligatory | |
|
C with R34 | concentration ![]() R34 obligatory |
5% ![]() R36, R38 obligatory | ||
|
Xi with R41 | concentration ![]() R41 obligatory |
5% ![]() R36 obligatory | ||
|
Xi with R36, R37, R38 | concentration ![]() 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 ![]() R42 obligatory |
|
|
Xi and R43 | concentration ![]() R43 obligatory | |
|
Xn and R42/43 | concentration ![]() R42/43 obligatory |
![]() |
Table 6. Carcinogenic/mutagenic/teratogenic effects
| ||
|
Classification of the substance | Classification of the preparation | |
|
at least T | at least Xn | |
|
T with R45 or R49 for carsinogenic substances of category 1 or 2 | concentration ![]() R45, R49 obligatory |
|
|
Xn with R40 for carcinogenic substances of category 3 | concentration ![]() R40 obligatory | |
|
T with R46 for mutagenic substances of category 1 | concentration ![]() R46 obligatory |
|
|
Xn with R46 for mutagenic substances of category 2 | concentration ![]() R46 obligatory | |
|
Xn with R40 for mutagenic substances of category 3 | concentration ![]() R40 obligatory | |
|
T with R61 for substances causing birth defects of category 1 or 2 | concentration ![]() R61 obligatory |
|
|
Xn with R63 for substances causing birth defects of category 3 | concentration ![]() R63 obligatory | |
|
T with R60 for substances impairing fertility of category 1 or 2 | concentration ![]() R60 obligatory |
|
|
Xn with R62 for substances possibly impairing fertility of category 3 | concentration ![]() 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 propably 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 ![]() |
0.2% ![]() |
0.02% ![]() |
|
T with R23, R24, R25 | concentration ![]() |
0.5% ![]() | |
|
Xn with R20, R21, R22 | concentration ![]() |
![]() |
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 ![]() R39 obligatory |
0.2% ![]() R39 obligatory |
0.02% ![]() R40 obligatory |
|
T with R39 | concentration ![]() R39 obligatory |
0.5% ![]() R40 obligatory | |
|
Xn with R40 | concentration ![]() R40 obligatory | ||
|
The R-phrases R20, R23 or R26 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![]() R48 obligatory |
0.5% ![]() R48 obligatory |
|
Xn with R48 | concentration![]() R48 obligatory | |
|
The R-phrases R20 or R23 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. ![]() R35 obligatory |
0.2% ![]() R34 obligatory |
0.02% ![]() R37 obligatory | |
|
C with R34 | concentration ![]() R34 obligatory |
0.5% ![]() R37 obligatory | ||
|
Xi with R41 | conc. ![]() R41 obligatory |
0.5% ![]() R36 obligatory | ||
|
Xi with R36, R37, R38 | concentration ![]() 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![]() R42 obligatory |
|
Xn and R42/43 | concentration![]() 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 carsinogenic substances of category 1 or 2 | concentration ![]() R45, R49 obligatory |
|
|
Xn with R40 for carcinogenic substances of category 3 | concentration ![]() R40 obligatory | |
|
T with R46 for mutagenic substances of category 1 | concentration ![]() R46 obligatory |
|
|
Xn with R46 for mutagenic substances of category 2 | concentration ![]() R46 obligatory | |
|
Xn with R40 for mutagenic substances of category 3 | concentration ![]() R40 obligatory | |
|
T with R61 for substances causing birth defects of category 1 or 2 | concentration ![]() R61 obligatory |
|
|
Xn with R63 for substances causing birth defects of category 3 | concentration ![]() R63 obligatory | |
|
T with R60 for substances impairing fertility of category 1 or 2 | concentration ![]() R60 obligatory |
|
|
Xn with R62 for substances possibly impairing fertility of category 3 | concentration ![]() R62 obligatory |