NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	538-75-0
Chemical Name	dicyclohexylcarbodiimide
Substance ID	m-nite-538-75-0_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 molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140degC) substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance does not contain oxygen, fluorine or chlorine.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	Based on its rat LD50 of 400 mg/kg (NTP DB (accessed in November 2008) and 1110 mg/kg (both sexes) (Toxicology Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008)), the substance was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Its guinea pig LD50 of 10 ml/kg (conversion value: 9200 mg/kg) (NTP DB (accessed in November 2008)), is considered "Not classified". The substance is labeled with EU Risk Phrase R24 (Toxic in contact with skin).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Its rat LC50 of 159 mg/m3 (0.159 mg/L) for 6 hours (4-hour conversion value: 0.2385 mg/L) falls into Category 2. Since its saturated vapour concentration is 37.65 mg/m3, the state of the substance to which test animals were exposed was estimated to be dust.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	The substance is documented to cause moderate to severe irritation in guinea pigs (GESTIS (accessed in November 2008)) and severe irritation in mice (RTECS (2007)). In the case of guinea pigs, it is documented that massive reddening and moderate formation of edema were observed within 24 hours of application, and the symptoms became better in one week; after two weeks there was only still slight reddening but complete hair loss. Based on these documents, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	Examination of rabbits' eyes after exposure for one hour resulted in slight through to moderate reddening of the lids, nictitating membrane and conjunctiva; after 24 hours there was slight intensification of the reddening and discoloration of the cornea; and after 48 hours moderate reddening, slight edema and injection (of blood vessels) into the iris were observed. 14 days later, changes to the conjunctiva, cornea (opacity) and nictitating membrane were no longer noticeable. The lids were still thickened, sometimes scarred and the surrounding of the eyes was depilated. (GESTIS (accessed in November 2008)). In these observations, since full recovery did not occur 14 days after the application and the substance is labeled with EU Risk Phrase R41 (Risks of serious damage to eyes) (EU-Annex 1 (2008)), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Several human cases (researchers in synthetic studies and pharmaceutical company employees), including those involving patch tests, have been reported (NTP DB (accessed in November 2008)). In addition, this substance is listed as a sensitizing substance by the German Research Foundation (DFG) (List of MAK and BAT value (2007)). Furthermore, the substance is labeled with EU Risk Phrase R43 (EU-Annex 1 (2008)) and thus, it was classified into Category 1 for skin sensitization.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Negative results were documented from micronucleus tests using bone marrow cells of mice that underwent intraperitoneal administration (in vivo mutagenicity tests using somatic cells) (NTP DB (accessed in November 2008)). Based on this description, the substance was classified into "Not classified". Also, in 92-day micronucleus tests using peripheral blood of mice that underwent dermal administration, it was documented that normochromatic erythrocytes slightly but significantly increased, yielding weakly positive results (NTP DB (accessed in November 2008)). In vitro tests, including Ames tests and chromosomal aberration tests using cultured cells, yielded negative results (Toxicology Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) accessed in November 2008)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	In oral administration tests using genetically modified mice (Tg AC hemizygous mice), incidences of squamous cell papilloma increased with increased administration doses (GESTIS (accessed in November 2008)). In contrast, the tests using p53 knockout mice did not show a sign of carcinogenicity (GESTIS (accessed in November 2008)). Because reports on carcinogenicity using animals that are not genetically modified are not available, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	In reproductive study using rats that underwent single administration, effects on preimplantation mortality, postimplantation mortality, and live birth index were documented (NTB DB (accessed in November 2008)). However, since neither information on developmental toxicity of offspring nor testing methods is available, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 2 (liver, kidney)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In single administration tests using rats (OECD TG 401: GLP-compliant), in which 500, 700, 1000, 1400, and 2000 mg/kg were administered, general symptoms such as decreased spontaneous motor activity, bradypnea, and salivation were observed at 700 mg/kg. Livers and kidneys of animals which died from administrations of 1000 or 2000 mg/kg (these doses are equivalent to Category 2 guidance values) underwent histopathological examinations; in these examinations, vacuolation of hepatocytes in the peripheral zone of lobules, and necrosis and internal hemorrhage of Glisson's sheath were observed; and in kidneys, the degeneration of the hyaline droplets within the epithelium of the renal tubules was detected. In addition, it is documented that the renal papilla tubules containing hemoglobin casts were detected in animals that retain dark red urine (Toxicology Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) accessed in November 2008). Based on these documents, the substance was classified into Category 2 (liver, kidney).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In 28-day repeated oral administration tests using rats that were applied with doses of 15, 100, or 500 mg/kg/day, death cases were observed in animal groups treated with 500 mg/kg/day (90-day corrected value: 156 mg/kg/day); according to histopathological examinations, necrosis of hepatocytes surrounding the Glisson's sheath was observed, which suggested that the cause of death was liver damage. General symptoms such as decreased spontaneous motor activity, salivation, and inhibited body weight gain were observed, in addition to increased liver weight, swelling of hepatocytes surrounding the Glisson's sheath and acidophilic cytoplasm, and expansion of the duodenum and thickening of mucosa. Discontinuing administration of the substance, histopathological changes in the liver and duodenum disappeared, and other changes also ceased or shifted toward recovery. Regarding histopathological changes seen in duodenum mucosa, irritating property of the test substance is assumed to be the cause (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008). Under the condition in which this study was conducted, the NOEL was 100 mg/kg/day (90-day correction value: 31 mg/kg/day) for both sexes (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008); and the histopathological changes shown at the doses that were higher than Category 2 guidance values disappeared by discontinuing administration. These observations support that the substances is to be classified into "Not classified" (oral). However, in conclusion, the substance was classified into "Classification not possible" due to lack of data on other administration routes.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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