GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 137-58-6 |
| Chemical name | Lidocaine |
| Substance ID | 23A5145 |
| Fiscal year of classification conducted | FY2011 |
| Classifier(s) (Ministries) | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| New/Revised | New |
| Download in Excel format | Excel file |
| Item | Information |
|---|---|
| Guidance used for classification (External link) |
Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government （July, 2010）
Environmental Hazards: UN GHS Document （4th revised edition） |
| Definitions / Abbreviations (Excel file) | Definitions / Abbreviations |
| Model Label by MHLW (External link) | MHLW Website （in Japanese Only） |
| Model SDS by MHLW (External link) | MHLW Website （in Japanese Only） |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable | - | - | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 2 | Flammable gases （including chemically unstable gases） | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Classification not possible | - | - | - | No data. |
| 8 | Self-reactive substances and mixtures | Not applicable | - | - | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Classification not possible | - | - | - | No data. |
| 11 | Self-heating substances and mixtures | Classification not possible | - | - | - | No established test method suitable for solid substances with a melting point of 140 degrees C or lower. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - | Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Not applicable | - | - | - | An organic compound does not contain fluorine or chlorine but contains oxygen which is not chemically bonded to elements other than carbon or hydrogen. |
| 15 | Organic peroxides | Not applicable | - | - | - | An organic compound that does not contain -O-O- structure. |
| 16 | Corrosive to metals | Classification not possible | - | - | - | No established test method suitable for solid substances. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 4 |  |
H302 |
P301+P312 P264 P270 P330 P501 |
From an LD50 value of 317 mg/kg for rats (HSDB (2003)), it was classified in Category 4. |
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - | No data. |
| 2 | Skin corrosion/irritation | Classification not possible | - | - | - |
Lack of data. Besides, there is the information that skin symptoms such as vesicle, burning sensation, exfoliation, and dermatitis which might occur at the site of application during or immediately after treatment with LIDODERM, a patch containing 5% of this substance, are mild and transient (PDR (2009), corresponding to List 1). |
| 3 | Serious eye damage/eye irritation | Classification not possible | - | - | - | No data. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | No data. |
| 4 | Skin sensitization | Category 1 | |
H317 |
P302+P352 P333+P313 P261 P272 P280 P321 P363 P501 |
It was classified in Category 1 because it is listed as a contact allergy substance in Contact Dermatitis (Frosch) (Contact Dermatitis (4th Ed. (2006), corresponding to List 1). |
| 5 | Germ cell mutagenicity | Classification not possible | - | - | - |
The classification is not possible due to no in vivo test data. Besides, a negative in an Ames test was reported as an in vitro test (EMEA (1999)). Furthermore, a negative in a micronucleus test in mice using bone marrow after oral administration of 2,6-dimethylaniline that is a major metabolite of lidocaine was reported (IARC 57 (1993)). |
| 6 | Carcinogenicity | Classification not possible | - | - | - | No data. |
| 7 | Reproductive toxicity | Classification not possible, Additional category: Effects on or via lactation |
H362 |
P308+P313 P201 P260 P263 P264 P270 |
Because it is reported that this substance used as a local anesthetic medicine transfers to milk, and its milk-to-serum concentration ratio is 0.4 in human (PDR (2009)), it was classified in "the additional category for effects on or via lactation." Besides, an epidemiological survey of 947 women exposed during pregnancy reported no increase in the relative risk of malformed babies (Teratogenic (12th, 2007), corresponding to List 2). And an animal test reported that it rapidly crossed the placenta after administration to pregnant guinea pigs and high concentrations were observed in the fetal heart, liver, and brain (HSDB (2003)). But it was classified as Classification not possible in adverse effects on sexual function and fertility, and the development of the offspring due to lack of data. |
|
| 8 | Specific target organ toxicity - Single exposure | Category 1 (blood, nervous system, cardiovascular system) |  |
H370 |
P307+P311 P260 P264 P270 P321 P405 P501 |
Methemoglobinemia following treatment with this substance was reported in humans (IARC 57 (1993)), and there is the information that severe methemoglobinemia might occur especially in patients with heterozygous form of NADH-methemoglobin reductase deficiency (HSDB (2003)). Therefore, it was classified in Category 1 (blood). Furthermore, this substance used as a local anesthetic medicine has toxic signs listed as serious adverse effects such as stupor, tremor, and convulsions (Ethical Pharmaceuticals (2010), corresponding to List 1), and there is a caution about neurologic and psychiatric signs developed by dermal absorption in use of large amounts of cream of this substance (HSDB (2003)). Therefore, it was classified in Category 1 (nervous system). In addition, there is the information that bradycardia, arrhythmia, a drop in blood pressure, respiratory depression, cyanosis, stupor, and rare cardiac arrest are listed as serious adverse effects (Ethical Pharmaceuticals (2010)), and the information that an overdose of this substance causes deaths by ventricular fibrillation, and a large dose leads to cardiac arrest (HSDB (2003)). Therefore, it was classified in Category 1 (cardiovascular system). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, cardiovascular system, blood) | |
H372 |
P260 P264 P270 P314 P501 |
Methemoglobinemia following treatment with this substance was reported in humans (IARC 57 (1993)), and there is the information that severe methemoglobinemia might occur especially in patients with heterozygous form of NADH-methemoglobin reductase deficiency (HSDB (2003)). Therefore, it was classified in Category 1 (blood). An overdose of this substance used as a local anesthetic medicine causes toxic signs mainly in central nervous and cardiovascular systems with increased bold concentrations. Initial signs include anxiety, excitement, visual disorder, tremor, which result in stupor, generalized convulsions, in a serious case, respiratory arrest. There is the information that cardiovascular signs include a drop in blood pressure, decreased myocardial contractile force, ventricular arrhythmia, circulatory collapse, and cardiac arrest (Ethical Pharmaceuticals (2010)). From the above, it was classified in Category 1 (nervous system, cardiovascular system). Besides, there is the information that an infant had two generalized seizures within an hour after applying a 2 % solution of hydrochloride of this substance to gums 5 to 6 times a day for a week (HSDB (2003)). And there is the information that a five-year-old boy had status epilepticus after receiving 7.5 mg/kg/dose of this substance in a 2% solution for five days (HSDB (2003)). |
| 10 | Aspiration hazard | Classification not possible | - | - | - | No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Classification not possible | - | - | - | No data. |
| 11 | Hazardous to the aquatic environment （Long-term） | Classification not possible | - | - | - | No data. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - | This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* Hazard statement or Precautionary statement will show when hovering the mouse over a code of Hazard statement or Precautionary statement. Hazard statement and Precautionary statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. |
Updated date:
|
2016/11/30 Addition of Rationale for the classification |