Classification and Labelling of Substances for health hazards
Identification of informationen GHS/CLP does not foresee the use of uniform test methods Different test methods - as long as they are scientifically sound and validated according to international procedures New tests on animals shall be avoided wherever possible (in accordance with REACH) All available data shall be evaluated first 2
General information Existing human data (eg: accidental or occupational exposure data, epidemiological studies, clinical studies, ) Ex-vivo methods In-vitro methods In-silico methods (Grouping, Read-across, (Q)SARs) Weight of evidence from several independent d sources of information as a basis for classification Only if this information is not sufficient new animal tests shall be performed 3
CLP-Reg: Pictograms for health hazards Acute toxicity (Categories 1-3) Acute toxicity (Category 4) Respiratory sensitisation Germ cell mutagenicity Skin corrosion Serious eye damage Skin irritation Carcinogenicity Eye irritation Reproductice toxicity it Skin sensitisation STOT, single exposure (Cat. 3) STOT, single & repeated exposure Aspiration hazard DSD: very toxic toxic CMR harmful irritant corrosive 4
CLP-Regulation: Health hazards 10 hazard DSD: classes 9 1. Acute Toxicity 2. Skin corrosion/irritation 3. Serious eye e damage/eye e irritation itation 4. Respiratory or skin sensitisation 5. Gern cell mutagenicity 6. Carcinogenicity 7. Reproductive toxicity 8. STOT single exposure 9. STOT repeated exposure 10. Aspiration hazard 1. Very toxic 2. Toxic 3. Harmful 4. Corrosive 5. Irritant 6. Sensitizing 7. Carcinogenic 8. Mutagenic 9. Toxic for reproduction 5
Acute Toxicity CLP-Reg: Category 1 Category 2 Category 3 Category 4 Warning Fatal Fatal Toxic Harmful LD 50 [mg/kg KG]: 5 25 50 200 300 2000 (values for oral acute toxicity) DSD: Very toxic (T+) Toxic (T) Harmful (Xn) R28 R25 R22 6
Acute Toxicity Category 1 Category 2 Category 3 Category 4 Signal word Warning Hazard statement (oral) H300: Fatal if swallowed H300: Fatal if H301: Toxic if H302: Harmful if swallowed swallowed swallowed Precautionary statement: Prevention Response Storage Disposal P264, 270 P264, 270 P264, 270 P264, 270 P301 + P310, P301 + P310, P301 + P310, P301 + P310, P321, P330 P321, P330 P321, P330 P330 P405 P405 P405 P501 P501 P501 P501 7
Skin corrosion/irritation CLP-Reg : Category 1 Category 2 1A 1B 1C H314: Causes severe skin burns and eye damage Warning H315: Causes skin irritation DSD: Corrosive (C) Irritant (Xi) R35 R34 R38 8
Serious eye damage/eye irritation CLP-Reg: Category 1 Category 2 H318: Causes serious eye damage Warning H319: Causes serious eye irritation DSD: Irritant (Xi) R41 R36 9
Respiratory or skin sensitisation CLP-Reg : Respiratory sensitisation (Category 1) Skin sensitisation (Category 1) DSD: H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled Sensitising (Xn) Warning H317: May cause an allergic skin reaction Sensitising (Xi) R42 R43 10
CMR Classification criteria for CMR properties according to CLP and DSD similar: Category 1 => Category 1A: classification based on positive evidence from human epidemiological studies (no substance classified as cat. 1A so far!) Category 2 => Category 1B: classification based on positive results from in vivo tests Category 3 => Category 2: positive evidence obtained from experiments in mammals and/or in vitro experiments and not sufficiently convincing to place in Cat. 1A or 1B R64 => H362: based on human and animal evidence 11
CMR CLP-Reg : Category 1A Category 1B Category 2 Additional category for effects on and via lactation No pictogram No signal word Warning DSD: Category 1 (T) Category 2 (T) Category 3 (Xn) R64 12
Specific target organ toxicity (STOT), single exposure = non lethal STOT arising from a single exposure to a subst/mix All significant health effects are included if not specifically addressed in another hazard class (e.g. acute toxicity, CMR, ) reversible & irreversible immediate &/or delayed effects significant changes in a single organ or biological system or generalised changes of a less severe nature involving several organs Specific target organ toxicity (STOT), repeated exposure = STOT including lethal effects arising from repeated exposure All significant health effects that can impair function reversible & irreversible; immediate &/or delayed effects significant changes in a single organ or biological system or generalised changes of a less severe nature involving several organs 13
Specific target organ toxicity (STOT), single exposure Category 1 Category 2 Category 3 Warning Warning H370: Causes damage to organs state all organs affected H371: May cause damage to organs State route of exposure if it is conclusively proven that no other routes of exposure cause the hazard H335: May cause respiratory irritation; H336: May cause drowsiness or dizziness
Specific target organ toxicity (STOT), single exposure CLP-Regulation ous Substances Directive STOT, single exposure Categories: Phrases Symbols 1 R39/26 T+ 1 R39/27 T+ 1 R39/28 T+ 1 R39/23 T 1 R39/24 T 1 R39/25 T 2 R68/20 Xn 2 R68/21 Xn 2 R68/22 Xn 3 R37 Xi 3 R67
Specific target organ toxicity (STOT), repeated exposure = specific target organ toxicity (including lethal effects) arising from repeated exposure to a substance/mixture All significant health effects that can impair function reversible & irreversible immediate &/or delayed effects significant changes in a single organ or biological system or generalised changes of a less severe nature involving several organs 16
Specific target organ toxicity (STOT), repeated exposure Category 1 Category 2 Warning H372: Causes damage to organs through prolonged or repeated exposure H373: May cause damage to organs through prolonged or repeated exposure state all organs affected State route of exposure if it is conclusively proven that no other routes of exposure cause the hazard
Specific target organ toxicity (STOT), repeated exposure CLP-Regulation ous Substances Directive STOT, repeated exposure Categories R-Phrases Symbols 1 R48/23 T 1 R48/24 T 1 R48/25 T 2 R48/20 Xn 2 R48/21 Xn 2 R48/22 Xn
Aspiration hazard Classification is based on human cases for some hydrocarbons (e.g. petroleum distillates) and chlorinated hydrocarbons Classification criteria refer to kinematic Viscosity (mm 2 /s) Significant change to old system: CLP-Regulation: classification in Category 1 if kinematic viscosity 20,5 5 mm 2 /s ous Substances Directive: classification with R65 based on kinematic viscosity 7 mm 2 /s Aspiration means the entry of a liquid or solid substance or mixture directly (through the oral or nasal cavity) or indirectly (from vomiting) into the trachea and lower respiratory systems Aspiration toxicity includes severe acute effects such as chemical pneumonia, pulmonary injury or death following aspiration 19
Aspiration hazard CLP-Reg : Category 1 H304: May be fatal if swallowed and enters airways DSD: Harmful (Xn) R65 20
Contact & Information Dr. Sabine Cladrowa Tel.: 01 313 04 5620 office@reachhalpdesk.at chemikalien@umweltbundesamt.at Umweltbundesamt www.umweltbundesamt.at