GHS Classification Result

Chemical Name：Cyclosporine
CAS：79217-60-0

Result：
ID: 21A3733
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government （March, 2009）

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 solids 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 - - - - No data 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 contains oxygen which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not 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 a LD50 value of 1500 mg/kg for rats (IARC 50 (1990)), the substance was classified into Category 4. [Cyclosporine mixture contains cyclosporine A as a major component, and most of the available data are related to cyclosporine A. Therefore, data for cyclosporine A were mainly used as the basis of classifications for health hazards]
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
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） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Not classified - - - - Based on negative results in a mouse dominant lethal test as well as mouse and hamster bone marrow chromosomal aberration tests and micronucleus test (IARC 50 (1990)), the substance was classified as "Not classified". As relevant information, there is a report of a negative mouse unscheduled DNA synthesis test (IARC 50 (1990)), and, from in vitro mutagenicity tests, there are reports of a negative Ames test and a negative hamster V79 cell HPRT mutation test (IARC 50 (1990)).
6 Carcinogenicity Category 1A Danger H350: May cause cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on the classification of "Group 1" in IARC (IARC 100A (2008), 50 (1990)) and classification of "K" in NTP (NTP ROC 11th, 2004)), the substance was classified into Category 1A. Numerous case reports were published of neoplasms occurring in organ transplant recipients who received only the substance (ciclosporin) and the majority of these neoplasms were lymphomas, commonly of the gastrointestinal tract, but malignancies at other sites have also been seen (IARC 50 (1990)). In animal tests where mice were fed for 78 week and rats were fed for 95 - 105 weeks, mortality was higher in the high-dose group but no increase in the incidence of tumours was observed (IARC 50 (1990)).
7 Reproductive toxicity Category 1A, Additional category: Effects on or via lactation Danger H360: May damage fertility or the unborn child
H362: May cause harm to breast-fed children 		P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P263: Avoid contact during pregnancy/while nursing.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product. 		There is a report that exposure to the substance during pregnancy induced preterm delivery and low birthweight but no significant risk for infant. The substance is not considered to be a teratogen (HSDB (2009), Birth Defects (3rd, 2000)). Foot skeletal malformation, hypospadias and finger flexure in infant were reported (Birth Defects (3rd, 2000)). While there was no teratogenic effect in rat and rabbit tests (IARC vol. 50 (1990), increased resorptions, embryolethaity, fatal and offspring growth retardations were seen in rats and rabbits at maternally toxic doses. Teratogenic effects were observed in a mouse test (Birth Defects (3rd, 2000)). There is evidence of human reproductive toxicity, therefore, the substance corresponds to known human reproductive toxicant and was classified into Category 1A. In addition, based on reports of "the substance has also been detected in breast milk" (IARC vol. 50 (1990)), and "the substance has been reported to pass into breast milk, so mothers should avoid breast-feeding during treatment period" (JAPIC prescription drug book (2010)), the substance was classified as "Effects on or via lactation"
8 Specific target organ toxicity - Single exposure Category 1 (immune system) Danger H370: Causes damage to organs (immune system) P307+P311: IF exposed: 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.
P321: Specific treatment （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on a report that the substance is a powerful immunosuppressive agent usually used in organ transplantation to prevent rejection (JAPIC prescription drug book (2010)), the substance was classified into Category 1 (immune system).
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney, liver, central nervous system, immune system, systemic toxicity) Danger H372: Cause damage to organs through prolonged or repeated exposure (kidney, liver, central nervous system, immune system, systemic toxicity) 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.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		Based on the following reports: the substance is an immunosuppressive agent; significant side effects such as renal dysfunction can occur at high incidence, of which the primary mechanism likely involves the dose-dependent renal vasoconstriction; hepatic disorder (elevated hepatic enzyme and bilirubin level, jaundice) may occur; central nervous system disorder such as reversible posterior leukoencephalopathy syndrome and hypertensive encephalopathy may occur (JAPIC prescription drug book (2010)), the substance was classified into Category 1 (kidney, liver, central nervous system). In addition, there are the following reports related to other significant side effects: serious infectious disease by bacteria or virus including pneumonia, sepsis, urinary tract infection, herpes simplex, herpes zoster can concur; and may rapidly deteriorate under strongly immunosuppressed conditions; acute pancreatitis, thrombotic microangiopathy, rhabdomyolysis may occur; and the probability of developing malignant tumor may increase due to excess immunosuppression (JAPIC prescription drug book (2010)). Since many of these side effects are considered to involve the immune system and some serious systemic disorders are included, the substance was classified into Category 1 (immune system, systemic toxicity). Based on all information, classification is Category 1 (kidney, liver, central nervous system, immune system, systemic toxicity).
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）

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