D1294 | Ambroxol
R
R05CB06 Ambroxol
[R05CB] Mucolytics
[R05C] EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
[R05] COUGH AND COLD PREPARATIONS
[R] Respiratory system
R03CC63 Clenbuterol and ambroxol
[R03CC] Selective beta-2-adrenoreceptor agonists
[R03C] ADRENERGICS FOR SYSTEMIC USE
[R03] DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
[R] Respiratory system
| Toxicity | Dose | Time | Species | Model | Method | Action | Positive criterion | Reference |
|---|---|---|---|---|---|---|---|---|
| MEMBRANE POTENTIAL | > 200 µM | 30 mins | mouse | liver mitochondria | Rh123 fluorescence (excitation 485 nm, emission 535 nm) are recorded using a fluorescence multi-well plate reader (mCICCP (20 µM) treatments was considered as the 100% baseline for ΔΨm loss) | decrease | EC20 | 36 |
| RESPIRATION | > 400 µM | 60 mins | mouse | liver mitochondria | Oxygen consumption was monitored with 50nM MitoXpress ( an oxygen-sensitive phosphorescent dye) using a spectrofluorimeter (Tecan Infinite 200; λExcitation 380nm; λEmission 650nm). Rotenone (2µM) was used as 100% baseline for complex I inhibition. | decrease | EC20 | 36 |
| RESPIRATION | > 200 µM | 60 mins | mouse | liver mitochondria | Oxygen consumption was monitored with 50nM MitoXpress ( an oxygen-sensitive phosphorescent dye) using a spectrofluorimeter (Tecan Infinite 200; λExcitation 380nm; λEmission 650nm). Oligomycin A (1µM) was used as 100% baseline for complex II inhibition. | decrease | EC20 | 36 |
| SWELLING | > 400 µM | 30 mins | mouse | liver mitochondria | swelling assay: Absorbance at 545 nm using a fluorescence multi-well plate reader (CaCl2 (50 µM) was considered as the 100% baseline for the swelling ) | increase | EC20 | 36 |
| Target | Dose | Time | Species | Model | Method | Action | Positive criterion | Reference |
|---|---|---|---|---|---|---|---|---|
| NADH:ubiquinone reductase | > 400 µM | 60 mins | mouse | liver mitochondria | Oxygen consumption was monitored with 50nM MitoXpress ( an oxygen-sensitive phosphorescent dye) using a spectrofluorimeter (Tecan Infinite 200; λExcitation 380nm; λEmission 650nm). Rotenone (2µM) was used as 100% baseline for complex I inhibition. | inhibit | EC20 | 36 |
| Succinate dehydrogenase | > 200 µM | 60 mins | mouse | liver mitochondria | Oxygen consumption was monitored with 50nM MitoXpress ( an oxygen-sensitive phosphorescent dye) using a spectrofluorimeter (Tecan Infinite 200; λExcitation 380nm; λEmission 650nm). Oligomycin A (1µM) was used as 100% baseline for complex II inhibition. | inhibit | EC20 | 36 |
| Cytochrome c | > 400 µM | 30 mins | mouse | liver mitochondria | Cytochrome c release was evaluated using ELISA kit ( 20 µg/ml Alamethicin was used as 100% baseline) | release | EC20 | 36 |
| Pictogram | Signal | Statements | Precautionary Statement Codes |
|---|---|---|---|
 |
Warning |
Aggregated GHS information provided by 3 companies from 2 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies. Reported as not meeting GHS hazard criteria by 1 of 3 companies. For more detailed information, please visit ECHA C&L website Of the 1 notification(s) provided by 2 of 3 companies with hazard statement code(s): H302 (100%): Harmful if swallowed [Warning Acute toxicity, oral] H315 (100%): Causes skin irritation [Warning Skin corrosion/irritation] H319 (100%): Causes serious eye irritation [Warning Serious eye damage/eye irritation] H335 (100%): May cause respiratory irritation [Warning Specific target organ toxicity, single exposure Respiratory tract irritation] Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. |
P261, P264, P270, P271, P280, P301+P312, P302+P352, P304+P340, P305+P351+P338, P312, P321, P330, P332+P313, P337+P313, P362, P403+P233, P405, and P501; (The corresponding statement to each P-code can be found at the GHS Classification page.) |
| Organism | Test type | Route | Dose (normalized dose) | Effect | Source |
|---|---|---|---|---|---|
| guinea pig | LD50 | intraperitoneal | 280mg/kg (280mg/kg) | Arzneimittel-Forschung. Drug Research. Vol. 28, Pg. 889, 1978. | |
| mouse | LD50 | oral | 2720mg/kg (2720mg/kg) | Medicamentos de Actualidad. Vol. 15, Pg. 523, 1979. | |
| mouse | LD50 | oral | 2380mg/kg (2380mg/kg) | behavioral: convulsions or effect on seizure threshold | Oyo Yakuri. Pharmacometrics. Vol. 21, Pg. 281, 1981. |
| mouse | LD50 | intraperitoneal | 268mg/kg (268mg/kg) | Medicamentos de Actualidad. Vol. 15, Pg. 523, 1979. | |
| rat | LD50 | oral | 13400mg/kg (13400mg/kg) | Medicamentos de Actualidad. Vol. 15, Pg. 523, 1979. | |
| dog | LD50 | oral | 500mg/kg (500mg/kg) | Arzneimittel-Forschung. Drug Research. Vol. 28, Pg. 889, 1978. | |
| rabbit | LD50 | intravenous | 64mg/kg (64mg/kg) | Oyo Yakuri. Pharmacometrics. Vol. 21, Pg. 281, 1981. | |
| mouse | LD50 | intraperitoneal | 268mg/kg (268mg/kg) | Arzneimittel-Forschung. Drug Research. Vol. 28, Pg. 889, 1978. | |
| dog | LD50 | intraperitoneal | 125mg/kg (125mg/kg) | Arzneimittel-Forschung. Drug Research. Vol. 28, Pg. 889, 1978. | |
| rabbit | LDLo | intraperitoneal | 400mg/kg (400mg/kg) | Arzneimittel-Forschung. Drug Research. Vol. 28, Pg. 889, 1978. | |
| rabbit | LD50 | oral | 2597mg/kg (2597mg/kg) | Oyo Yakuri. Pharmacometrics. Vol. 21, Pg. 281, 1981. | |
| mouse | LD50 | intravenous | 138mg/kg (138mg/kg) | Arzneimittel-Forschung. Drug Research. Vol. 28, Pg. 889, 1978. | |
| guinea pig | LD50 | oral | 1180mg/kg (1180mg/kg) | Medicamentos de Actualidad. Vol. 15, Pg. 523, 1979. | |
| guinea pig | LD50 | intraperitoneal | 280mg/kg (280mg/kg) | Medicamentos de Actualidad. Vol. 15, Pg. 523, 1979. | |
| rat | LD50 | intraperitoneal | 262mg/kg (262mg/kg) | Oyo Yakuri. Pharmacometrics. Vol. 21, Pg. 281, 1981. | |
| rat | LD50 | subcutaneous | 1489mg/kg (1489mg/kg) | Iyakuhin Kenkyu. Study of Medical Supplies. Vol. 12, Pg. 263, 1981. | |
| mouse | LD50 | intravenous | 138mg/kg (138mg/kg) | Medicamentos de Actualidad. Vol. 15, Pg. 523, 1979. | |
| rat | LD50 | oral | 4203mg/kg (4203mg/kg) | Iyakuhin Kenkyu. Study of Medical Supplies. Vol. 12, Pg. 263, 1981. | |
| rat | LD50 | intravenous | 100mg/kg (100mg/kg) | Oyo Yakuri. Pharmacometrics. Vol. 21, Pg. 281, 1981. | |
| guinea pig | LD50 | oral | 1180mg/kg (1180mg/kg) | Arzneimittel-Forschung. Drug Research. Vol. 28, Pg. 889, 1978. | |
| mouse | LD50 | subcutaneous | 1060mg/kg (1060mg/kg) | Iyakuhin Kenkyu. Study of Medical Supplies. Vol. 12, Pg. 263, 1981. | |
| rat | LD50 | intraperitoneal | 380mg/kg (380mg/kg) | Medicamentos de Actualidad. Vol. 15, Pg. 523, 1979. | |