NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	56-53-1
Chemical Name	Diethylstilbestrol
Substance ID	m-nite-56-53-1_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen which is chemically bonded only to carbon or hydrogen.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)	Not classified	- -	-	-	Based on a LD50 value of >3 g/kg for rats (HSDB (2003)), the substance was classified into "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	Based on the classification of "Group 1" in IARC (IARC vol. 100A (2008), suppl. 7 (1987)), the substance was classified into Category 1A.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 1A	Danger	H360	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 2 (systemic)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	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".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (cardiovascular system), Category 2 (liver, systemic)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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)	Category 2	- -	H401	P273 P501	Classified into Category 2 from its 96h-LC50 = 1.55 mg/L for Crustacea (Nitocra spinipes) (AQUIRE, 2010).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Classified into Category 2 since its acute toxicity is Category 2 and LogKow is more than 4 (LogKow = 5.07, PHYSPROP Database, 2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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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