GHS Classification Result

Chemical Name：Diethylstilbestrol
CAS：56-53-1

Result：
ID: 21A3734
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 Classification not possible - - - - Classification is not possible since no data are available though there are chemical groups (unsaturated bond) present in the molecule associated with 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） Not classified - - - - Based on a LD50 value of >3 g/kg for rats (HSDB (2003)), the substance was classified into "Not classified".
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. As relevant information, there are reports that contact can irritate the skin (HSFS (2002)) and of local irritation of skin (SITTIG (5th, 2008)).
3 Serious eye damage/eye irritation Classification not possible - - - - No data available. As relevant information, there are reports that contact can irritate the eyes (HSFS (2002)) and of local irritation of eye (SITTIG (5th, 2008)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects 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 a positive result in an in vivo mouse micronucleus test (bone marrow) by 26-week oral administration via diet (NTP DB (access on Oct. 2009)), the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of positive chromosomal aberration tests (CHO cell) (NTP DB (access on Oct. 2009), IARC vol. 21 (1979)), a negative chromosomal aberration test (human leucocyte) (IARC vol. 21 (1979)), negative SCE tests (NTP DB (access on Oct. 2009), IARC vol. 21 (1979)), negative bacteria mutation tests (NTP DB (access on Oct. 2009), IARC vol. 21 (1979)); and positive gene mutation tests (NTP DB (access on Oct. 2009), IARC vol. 21 (1979)).
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 vol. 100A (2008), suppl. 7 (1987)), the substance was classified into Category 1A.
7 Reproductive toxicity Category 1A Danger H360: May damage fertility or the unborn child 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 ... 		Since there are epidemiological reports that the substance taken during pregnancy was shown to be causally associated with an increase in vaginal and cervical clear-cell adenocarcinoma in daughters (IARC vol. 21 (1979)) and that in utero exposure of females is associated with increased incidences of congenital anomalies, including cardiovascular and limb defects, and structural abnormalities in the cervicovaginal area and/or uterine cavity (HSDB (2003)), the substance was classified into Category 1A. From animal tests, male progeny developed granulomas in the epididymis and testis and female progeny developed neoplasms on the cervix and vagina in a hamster test where the substance was administered by intragastric tube during gestation (IARC vol. 21 (1979)). Oral administration to pregnant monkeys resulted in vaginal ridging and/or cervical hooding in offspring (IARC vol. 21 (1979)). In mouse oral tests, increased pituitary weight and unclear estrus cycle in female offspring and atrophy of the epididymides and prostate in male offspring were observed (NTP DB Report#RACB830`46 (access on Oct. 2009)). It was also reported that a decreased fertility index was attributed to the reproductive toxicity to males (NTP DB Report #RACB83094 (access on Oct. 2009)).
8 Specific target organ toxicity - Single exposure Category 2 (systemic toxicity) Warning H371: May cause damage to organs (systemic toxicity) 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 ... 		From information under the Adverse Reactions section of the package insert of Phosphestrol (diethylstilbestrol diphosphate), there are the following reports; significant adverse reactions: thrombosis (coronary thrombosis, cerebral thrombosis, limb thrombosis, etc.), myocardial infarction, cardiac failure; other adverse reactions: palpitation, jaundice, liver dysfunction, hypercalcemia, sodium retention or fluid retention, dyslipidemia, headache, abnormal sensation, (unknown incidence) dizziness, psychiatric disorder relapse, nausea, vomiting, anorexia, diarrhea, abdominal pain, rash, itching, burning sensation or numbness in anal area, itching, burning sensation or numbness around the genital area, malaise, impotence, chest pressure, urethral stricture, fever, edema, and proteinuria. Since it is unclear whether they are acute effects, the substance was classified into Category 2 (systemic toxicity). In HSDB (2003), following drug warnings are reported; "Nausea and vomiting are an initial reaction" and "Acute toxicity: nausea and vomiting, abdominal cramps, headache".
9 Specific target organ toxicity - Repeated exposure Category 1 (cardiovascular system), Category 2 (liver, systemic toxicity) Danger
Warning 		H372: Cause damage to organs through prolonged or repeated exposure (cardiovascular system)
H373: May cause damage to organs through prolonged or repeated exposure (liver, 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 ... 		From information under the Adverse Reactions section of the package insert of Phosphestrol (diethylstilbestrol diphosphate), there are the following reports; significant adverse reactions: thrombosis (coronary thrombosis, cerebral thrombosis, limb thrombosis, etc.), myocardial infarction, and cardiac failure. Based on the data, the substance was classified into Category 1 (heart). In addition, there are the following reports; other adverse reactions: palpitation, jaundice, liver dysfunction, hypercalcemia, sodium retention or fluid retention, dyslipidemia, headache, abnormal sensation, (unknown incidence) dizziness, psychiatric disorder relapse, nausea, vomiting, anorexia, diarrhea, abdominal pain, rash, itching, burning sensation or numbness in anal area, itching, burning sensation or numbness around the genital area, malaise, impotence, chest pressure, urethral stricture, fever, edema, and proteinuria. Based on the data, the substance was classified into Category 2 (liver, systemic toxicity). In HSDB (2003), the following side effects of drug therapy (estrogen) are reported; elevated blood pressure, headache, nausea, vomiting, vaginal bleeding, thrombotic disorders and decreased glucose tolerance. In addition, delayed toxicity include: gynecomastia in males, breast tenderness, loss of libido, thrombophlebitis, thromboembolism, hepatic injury, sodium retention with edema, hypertension, and changes in menstrual flow.
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） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 2 from its 96h-LC50 = 1.55 mg/L for Crustacea (Nitocra spinipes) (AQUIRE, 2010).
11 Hazardous to the aquatic environment （Long-term） Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 2 since its acute toxicity is Category 2 and LogKow is more than 4 (LogKow = 5.07, PHYSPROP Database, 2009)).


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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