NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	72-55-9
Chemical Name	1,1-Bis(4-chlorophenyl)-2,2-dichloroethene [p,p'-DDE]
Substance ID	m-nite-72-55-9_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 molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	There is the information that it is combustible (GESTIS (Access on September 2017)), but the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene group) in the molecule, but the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 a report of an LD50 value of 880 mg/kg (ATSDR (2002)) for rats, this substance was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is a description that this substance is irritating to the human eyes at high levels of exposure (ATSDR (2002)). However, it was classified as "Classification not possible" because details were unknown.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There was no in vivo data. As for in vitro, bacterial reverse mutation tests were negative, a mammalian cell mouse lymphoma test was positive, the results of chromosomal aberration tests were positive and negative, and a sister chromatid exchange test was positive (EHC 241 (2011), NTP DB (Access on August 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	In humans, there is a report on a case-control study in which the relationship between 754 cases of testicular germ cell tumors and serum levels of persistent organic pollutants, including DDT (Dichlorodiphenyltrichloroethane: a mixture containing p, p'-DDT and o, p'-DDT) and DDE (Dichlorodiphenyl dichloroethylene: an isomer mixture containing this substance (p, p'-DDE) and a putative metabolite of DDT) was investigated in the United States of America, a strong and significant relationship between serum DDE levels and development of testicular germ cell tumors (RR = 1.71; 95% CI = 1.23-2.38) was observed in the group whose serum DDE level was not less than 0.39 microg/g lipid (EHC 241 (2011)). As for experimental animals, in a carcinogenicity test, where this substance (purity of approximately 95%) was administered by feeding for 78 weeks to rats and mice, and planned slaughtering was performed after an untreated period of 35 weeks for rats and 15 weeks for mice, no carcinogenicity was shown in rats, but an increase in the incidence of dose-related hepatocellular carcinomas was observed in female and male mice (NTP TR131 (1978)). Besides, regarding this study, EPA pointed out that a dose-dependent trend in an incidence of thyroid tumors was observed in female rats (IRIS (1988)). In addition, in a test in which mice of the strain different strain from the one in the above test were dosed by feeding at a dose of 250 ppm of this substance for 130 weeks, an increase in an incidence of hepatocellular carcinoma was observed in both males and females. Moreover, also in a test in which hamsters were dosed by feeding at 500 and 1,000 ppm for 128 weeks, an increase in an incidence of neoplastic nodules of the liver was observed in both sexes (IRIS (1988)). This substance was classified in B2 (Probable human carcinogen) by EPA based on the sufficient evidence of carcinogenicity in the experimental animals (IRIS (1988)). From the above, based on the limited findings in humans, evidence of carcinogenicity in multiple animal species, and classifications by other organizations, it was classified in Category 1B. Besides, as for carcinogenicity of the relevant compound DDT, IARC announced that the classification would be changed from the previous Group 2B to Group 2A (IARC Press release No. 236 (2015)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	As for humans, there are some reports on the following: a relationship between the serum level of this substance and fetal death; an association of the serum level of this substance with reduced gestational age and increased rates of small-for-gestational-age babies; an association between prenatal or early life exposures to this substance and reduced childhood or pubertal growth, etc. However, there were also negative reports, so there were no conclusive effects regarding reproductive and developmental effects by exposure to this substance, and there are conflicting reports also on hypospadias, AGD (anogenital distance) shortening, and cryptorchidism in boys, therefore, it was not possible to draw a conclusion or a negative conclusion was reached (EHC 241 (2011)). As for experimental animals, there are reports that in multiple tests in which pregnant rats were orally dosed (100 mg/kg/day, Gestational Day 14-18), an increase in a frequency of AGD shortening, nipples retention, and hypospadias was observed. Also, there is a report that in a test in which male rats were orally dosed at 100 mg/kg/day from the time of weaning up to 57 days after birth, a delay of sex maturation stage was observed (EHC 241 (2011), ATSDR (2002)). This substance has an anti-androgenic action (EHC 241 (2011)), and effects on male pups are considered to be related to this action. From the above, it is clear that this substance exhibits developmental effects including malformation (hypospadias) in male pups in experimental animals at perinatal or early postnatal exposure, but reproductive and developmental effects in humans are not clear to date. Therefore, this substance was classified in Category 1B.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (thyroid, liver)	Warning	H373	P260 P314 P501	As for experimental animals, there is a report that in a 78-week feeding test with rats (the low dose group (males: 437 ppm, females: 242 ppm), the high dose group (males: 839 ppm, females: 462 ppm)), an increase in mortality rate, follicular cell hyperplasia of the thyroid, and centrilobular necrosis and fatty changes of the livers were observed at or above 437 ppm (converted guidance value: 21.85 mg/kg/day) of males and at or above 242 ppm (converted guidance value: 12.1 mg/kg/day) of females, which were within the guidance value range for Category 2 (NTP TR131 (1978)). From the above, this substance was classified in Category 2 (thyroid, liver).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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 1	Warning	H400	P273 P391 P501	From 96-hour LC50 = 0.00457 mg/L for crustacea (Hyalella azteca) (EPA AQUIRE: 2017, Ding, Y. et al. (2012)), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Appropriate chronic toxicity data were not obtained. Due to being not rapidly degradable (BioWin), and acute toxicity Category 1, it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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