NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	50-06-6
Chemical Name	Phenobarbital
Substance ID	m-nite-50-06-6_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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)	- -	-	-	Containing no chemical groups with explosive properties	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Containing no chemical groups with explosive or self-reactive properties	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing oxygen (but not fluorine and chlorine), with the oxygen bound to carbon and hydrogen (but not to other elements)	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no "-O-O-" structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available	FY2006	GHS Classification Manual （10 Feb, 2006）
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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on the rat LD50 (oral route) value of 162mg/kg (IARC 79 (2001)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Due to the fact that the substance is "solid" according to the GHS definition and inhalation of its gas is not expected.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Skin sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	Based on the absence of data on multi-generation mutagenicity tests and positive data on germ cell mutagenicity tests in vivo (chromosome aberration tests), described in IARC 79 (2001) and NTP DB (Access on May 2006).	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	Due to the fact that the substance is classified as Group 2B by IARC (2001).	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	Based on the evidence of cleft palate and abnormal behaviour of the offspring observed in teratogenicity studies with mice and rats, described in IARC 79 (2001) (though no data are available regarding parental toxicity).	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	Based on the evidence from animal studies including "somnolence" (RTECS (2006)).	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, thyroid), Category 2 (liver, kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	Based on the human evidence: "Sedation is the most common side effect of exposure to phenobarbital in humans. Overdosage of phenobarbital leads to nystagmus and ataxia," "In the patient, T4 level was decreased whereas T3 and TSH responses to thyrotropin-releasing hormone were within the normal range" (IARC 79 (2003)), "A 2-yr-old child developed massive hepatic necrosis caused by an unusual hypersensitivity response to phenobarbital that was prescribed for presumed febrile seizures," "phenobarbital induced a hypersensitivity state consisting of tubulointerstitial nephritis, exfoliative dermatitis and hepatitis" (HSDB (2002)). Also based on the evidence from animal studies: "the liver of the test animal showed an occurrence of moderate to severe hypertrophy of centrolobular hepatocytes," "serum T4 and T3 levels were decreased, whereas TSH production was increased," "mild to moderate follicular hypertrophy of the thyroid gland and moderate hepatocellular hypertrophy occurred" (IARC 79 (2003)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 2. Since the priority rating of the study reporting the effects on the liver and kidneys in humans is 2, these effects are classified into Category 2.	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

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)	Not classified	- -	-	-	It was classified as "Not classified" from 96-hour LC50 = 484 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" because it was not rapidly degradable (a degradation rate by BOD: 0% (Official Bulletin of Economy, Trade and Industry, 2002)), and due to 21-day NOEC = 31 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it was not rapidly degradable (a degradation rate by BOD: 0% (Official Bulletin of Economy, Trade and Industry, 2002)), and due to 96-hour LC50 = 484 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). From the above results, it was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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