ANNEX 8 - International occupational safety & health information centre

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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	25	50	0.25
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 7%	1% conc. < 7%	0.1% conc. < 1%
T with R23, R24, R25		concentration 25%	1% conc. < 25%
Xn with R20, R21, R22			concentration 25%

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 10% R39 obligatory	1% concentration < 10% R39 obligatory	0.1% concentration < 1% R40 obligatory
T with R39		concentration 10% R39 obligatory	1% concentration < 10% R40 obligatory
Xn with R40			concentration 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 10% R48 obligatory	1% concentration < 10% R48 obligatory
Xn with R48		concentration 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 10%	5% conc. < 10% R34 obligatory		1% conc. < 5% R36/ R38 obligatory
C with R34		concentration 10% R34 obligatory		5% conc. < 10% R36, R38 obligatory
Xi with R41			concentration 10% R41 obligatory	5% conc. <10% R36 obligatory
Xi with R36, R37, R38				concentration 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 1% R42 obligatory
Xi and R43		concentration 1% R43 obligatory
Xn and R42/43	concentration 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 carsinogenic substances of category 1 or 2	concentration 0.1% R45, R49 obligatory
Xn with R40 for carcinogenic substances of category 3		concentration 1% R40 obligatory
T with R46 for mutagenic substances of category 1	concentration 0.1% R46 obligatory
Xn with R46 for mutagenic substances of category 2		concentration 0.1% R46 obligatory
Xn with R40 for mutagenic substances of category 3		concentration 1% R40 obligatory
T with R61 for substances causing birth defects of category 1 or 2	concentration 0.5% R61 obligatory
Xn with R63 for substances causing birth defects of category 3		concentration 5% R63 obligatory
T with R60 for substances impairing fertility of category 1 or 2	concentration 0.5% R60 obligatory
Xn with R62 for substances possibly impairing fertility of category 3		concentration 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 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 1%	0.2% concentration < 1%	0.02% concentration < 0.2%
T with R23, R24, R25		concentration 5%	0.5% concentration < 5%
Xn with R20, R21, R22			concentration 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 1% R39 obligatory	0.2% concentration < 1% R39 obligatory	0.02% conc. < 0.2% R40 obligatory
T with R39		concentration 5% R39 obligatory	0.5% conc. < 5% R40 obligatory
Xn with R40			concentration 5% 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 5% R48 obligatory	0.5% concentration < 5% R48 obligatory
Xn with R48		concentration 5% 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. 1% R35 obligatory	0.2% concentration < 1% R34 obligatory		0.02% conc. < 0.2% R37 obligatory
C with R34		concentration 5% R34 obligatory		0.5% concentration < 5% R37 obligatory
Xi with R41			conc. 5% R41 obligatory	0.5% concentration < 5% R36 obligatory
Xi with R36, R37, R38				concentration 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 0.2% R42 obligatory
	Xn and R42/43	concentration 0.2% R42/43 obligatory

Table 12. Gaseous preparations; carcinogenic/mutagenic/teratogenic effects carcinogenic - cancer causing mutagenic - hazards in reproduction teratogenic - non-heritable birth defects
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 0.1% R45, R49 obligatory
Xn with R40 for carcinogenic substances of category 3		concentration 1% R40 obligatory
T with R46 for mutagenic substances of category 1	concentration 0.1% R46 obligatory
Xn with R46 for mutagenic substances of category 2		concentration 0.1% R46 obligatory
Xn with R40 for mutagenic substances of category 3		concentration 1% R40 obligatory
T with R61 for substances causing birth defects of category 1 or 2	concentration 0.2% R61 obligatory
Xn with R63 for substances causing birth defects of category 3		concentration 1% R63 obligatory
T with R60 for substances impairing fertility of category 1 or 2	concentration 0.2% R60 obligatory
Xn with R62 for substances possibly impairing fertility of category 3		concentration 1% R62 obligatory

Table of contents

Updated by AS. Approved by EC. Last update: 30.11.2004.