NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	137-58-6
Chemical Name	Lidocaine
Substance ID	m-nite-137-58-6_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 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).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible,	- -	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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (blood, nervous system, cardiovascular system)	Danger	H370	P308+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).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, cardiovascular system, blood)	Danger	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)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

To GHS Information