GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 72-55-9
Chemical Name 1,1-Bis(4-chlorophenyl)-2,2-dichloroethene [p,p'-DDE]
Substance ID H29-A-012
Classification year (FY) FY2017
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link)  
Model SDS by MHLW (External link)  
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
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
-
-
- - There is the information that it is combustible (GESTIS (Access on September 2017)), but the classification is not possible due to no data.
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.
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 <= 140 deg C) 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 is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- - Classification not possible due to lack of data.
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.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
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)).
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)).
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.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
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).
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data.

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


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* 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.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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