NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	563-41-7
Chemical Name	Semicarbazide hydrochloride
Substance ID	m-nite-563-41-7_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	Classification not possible	- -	-	-	It contains chemical groups (hydrazine structure) associated with explosive properties in the molecule. Since no test results are available, classification is not possible.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	It contains chemical groups (hydrazine structure) associated with explosive properties in the molecule. Since no test results are available, classification is not possible.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	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)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine which is chemically bonded only to carbon or hydrogen.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on the mouse LD50 value of 225 mg/kg (HSDB (2005)), the substance was classified into Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The classification was concluded as "Not classified" based on the negative results in the micronucleus tests using the bone marrow cells obtained from mice after oral administration or using peripheral blood obtained from mice intraperitoneal administration (in vivo mutagenicity test in somatic cells) (Risk assessment report - Veterinary Medicinal Products (2007), Toxicology Letters (2005)), and in vivo gene mutation test using livers and lungs of transgenic mice by orally administration for 28 days (in vivo mutagenicity test in somatic cells) (Risk assessment report - Veterinary Medicinal Products (2007)). As relevant information, negative results in the UDS test using liver cells by oral administration to rats (Risk assessment report - Veterinary Medicinal Products (2007)). As for in vitro studies, positive results in the Ames test using specific bacterial strain (TA1535 and TA100) (Risk assessment report-Veterinary Medicinal Products (2007)), negative results in the chromosome aberration test using Chinese hamster ovary (CHO) cells (Risk assessment report - Veterinary Medicinal Products (2007)), and positive results in the mouse lymphoma TK assay (Risk assessment report - Veterinary Medicinal Products (2007), HSDB (2005)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	The classification was concluded as "Classification not possible" based on the criterion of "Group 3" by the IARC carcinogenicity assessment (IARC supplement 7 (1987)). As relevant information, increased incidences of lung tumors were noted in the 7-month feeding study in mice. And in the life-time administration study in mice via drinking water, increased incidences of lung tumors in females and of vascular-derived tumors containing angioma and angiosarcoma in both sexes were reported (IARC 12 (1976)). On the other hand, in rats, no evidence to induce any tumors was noted in the examination after the study period that was 78-week dietary administration and consequent 26-week withdrawal (in the high dose group, administration was up to 32 weeks due to animal deaths), although osteoporosis of long bones was observed (The EFSA Journal (2005)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the oral study using pregnant rats, the offspring had facial abnormalities containing micrognathia and cleft palates (IARC 12 (1976)). In the study using pregnant rats administered on days 10 - 16 of gestation, high incidence of resorption in the dam and of cleft palates in the pups were noted (IARC 12 (1976)). In the study using pregnant rats injected intraperitoneally on days 5, 7, 10, 13, or 15 of gestation, abnormalities in the brain, kidney, intestines, or liver were found in fetuses on the 21th day of the gestation period. In the study using pregnant rats injected intraperitoneally during the organogenetic period, high percentage of hydronephrosis appeared in the fetuses. In the other experimental group with pregnant rats injected intraperitoneally throughout gestation, a statistically significant decrease in the number of implantations and live fetuses resulted (HSDB (2005)). The results mentioned above indicate that the substance has teratogenicity for rats, however, there is no description for the general toxicity of parental animals at these doses. Therefore, the substance was classified as Category 2.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (bone)	Warning	H373	P260 P314 P501	In the 90-day feeding study in rats, deformity of the thorax and tail accompanied by enlargement and deformity of the knee joint was observed at the dose level of 500 ppm (40.7 - 44.2 mg/kg/day; corresponded to Category 2 of the guidance values) or higher, and disarrangement of chondrocytes and fissure of cartilage matrix in epiphyseal and articular cartilage were histopathologically evident at all dose levels (18.1 - 70.5 mg/kg/day). These changes were accompanied by proliferation of connective tissue and skeletal deformities at higher doses. The degree of the lesions was potentiated depending on the dose (Food Chemical Toxicology 47 (2009)). Based on the information, the substance was classified as Category 2 (bone). In addition, insufficient calcification of cartilage was also observed in all treatment groups (40 - 140 mg/kg/day) in the 28-day oral dose study in juvenile rats (Food and Chemical Toxicology 47 (2009)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	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 available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2010	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.	FY2010	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.

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