GHS Classification Result

Chemical Name：dicyclohexylcarbodiimide
CAS：538-75-0

Result：
ID: 20A2205
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solid Classification not possible - - - - No data available.
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 - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140degC) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases 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).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance does not contain oxygen, fluorine or chlorine.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		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.
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).
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Category 2 Danger H330: Fatal if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P284: Wear respiratory protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P320: Specific treatment is urgent （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		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.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P362: Take off contaminated clothing and wash before reuse. 		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.
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		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.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		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.
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)).
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".
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".
8 Specific target organ toxicity - Single exposure Category 2 (liver, kidney) Warning H371: May cause damage to organs (liver, kidney) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ... 		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).
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.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - No data available.


NOTE:
* 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.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information