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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	50-29-3
Chemical Name	1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane [DDT]
Substance ID	H28-B-029, C-040B
Classification year (FY)	FY2016
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2014 FY2006
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)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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	- -	-	-	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	- -	-	-	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 and oxygen (but not fluorine) which are 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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on an LD50 value of 250 mg/kg (JMPR (1967), ACGIH (2001)) for rats, this substance was classified in Category 3. The category was revised in accordance with the revision of the GHS classification guidance for the Japanese Government. Besides, based on expert judgment, JMPR and ACGIH were preferentially adopted as the information source of LD 50 values.
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	The following 4 values have been reported as LD50 values for rats: 1,000 mg/kg (IPCS, PIM 127 (1992)), 1,931 mg/kg (HSDB (Access on June 2016)), 2,500 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), ACGIH (7th, 2001)), and 250 mg/kg - 3,000 mg/kg (PIM (1992)). One corresponds to Category 3, one to Category 4, one to "Not Classified" (Category 5 in UN GHS classification), and one to Category 3-"Not Classified." The LD50 value of 300 mg/kg (ATSDR (2002), HSDB (Access on June 2016)) was reported for rabbits and corresponds to Category 3. This substance was classified in Category 3, to which the most of the reported values correspond.
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	Not classified	- -	-	-	In dermal exposure to volunteers (EHC 9 (1979)), skin exposure in humans (IPCS, PIM 127 (1992)) and workers handling this substance (ATSDR (2002)), except in a small proportion in which slight skin irritation was observed, there was no finding which suggests damaging action to the skin. Therefore this substance was classified as "Not Classified." Besides, the information on rabbits (PATTY (4th, 1994)) adopted in the previous classification could not be confirmed in the latest edition (PATTY (6th, 2012)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In humans, rare instances have been reported of ocular irritation following contamination of the eye by powders containing DDT (IPCS, PIM 127 (1992)). In addition, in humans exposed to DDT, mild eye irritation caused by direct contact of DDT with the eye was recognized (ATSDR (2002)). Therefore this substance was classified in Category 2B.
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	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	As for in vivo data, there are reports that a dominant lethal test in rats is positive, dominant lethal tests in mice are positive and negative, a mouse spot test is negative, a chromosomal aberration test using spermatocytes of mice is positive, a chromosomal aberration test using bone marrow cells of rats is negative, a chromosomal aberration test using bone marrow and spleen cells of mice is positive, and a DNA damage test using the liver of rats is positive (ATSDR (2002), EHC 9 (1979), IARC 53 (1991), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), JMPR (2000)). As for in vitro, bacterial reverse mutation tests are negative, a mouse lymphoma test and gene mutation tests using mammalian cell are positive and negative, chromosomal aberration tests are positive and negative (ATSDR (2002), IARC 53 (1991), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), EPA Summary (1987)). From the above, this substance was classified in Category 1B according to the GHS classification guidance for the Japanese government.
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	On the basis of limited evidence in humans and sufficient evidence in experimental animals, IARC raised the classification of the carcinogenicity of this substance from previous Group 2B (IARC Suppl. 7 (1987)) to Group 2A in its latest assessment (IARC 113 (in prep., Access on June 2016), IARC Press Release No. 236 (Access on June 2016)). More specifically, it is reported that epidemiological studies have found positive associations between exposure to DDT and non-Hodgkin lymphoma (NHL), testicular cancer, and liver cancer (IARC Press Release No. 236 (Access on June 2016)). As for experimental animals, in tests by oral administration to rats and mice, increases in liver tumors were reported, and increased incidences of pulmonary carcinoma and malignant lymphoma were also reported in mice (IARC 53 (1991)). From the above, this substance was classified in Category 1B for this hazard class. Besides, as the results of classifications by other organizations, ACGIH has classified this substance in A3 (confirmed animal carcinogen: corresponding to Category 2) (ACGIH (7th, 2001)), the EPA in B2 (possible human carcinogen: corresponding to Category 1B) (IRIS (1987)), and NTP in R (NTP RoC (13th, 2014)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	As for humans, the relationship between the level of this substance and its metabolites in blood and the placenta and premature births and spontaneous abortion, the relationship of the level of DDE (the main metabolite of this substance) in mother's milk with hyporeflexia of infants (PATTY (6th, 2012)), and the relationship of high concentrations of this substance and DDE (other substances also detected) in breast milk to congenital hypothyroidism (EHC 241 (2011)) and so on have been reported. However, neither of these can be considered to be conclusive. As for experimental animals, there are descriptions that, in multi-generation studies, increased mortality was seen among pups of mice (33 mg/kg/day) and sexual maturation (puberty) occurred earlier in the pups of dogs (10 mg/kg/day); adverse effects on male reproductive parameters and hormone levels in juvenile male animals exposed to this substance were observed at or above 50 mg/kg/day, 10days; this substance has a weak agonist effect on estrogen receptors; DDE, a metabolite, has an antagonist effect on androgen receptors; and in many tests in which DDE was administered during the periods of pregnancy and lactation, antiandrogenic activity (decreased weights of accessory reproductive organs such as the prostate and seminal vesicles) was observed in male child animals (EHC 241 (2011)). In addition, there is a description that gavage administration of this substance to neonate mice on postnatal day 10 resulted in findings of neurodevelopmental toxicity such as a change in acetylcholine receptor density in the cerebral cortex, increased spontaneous motor activity, and deterioration of the ability to habituate to surroundings (EHC 241 (2011)). As described above, the effects on reproductive functions in humans are not clear, but in experimental animals, it is clear that developmental effects occur in the endocrine system, the nervous system, etc. Therefore, this substance was classified in Category 1B for this hazard class.
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In humans, as the effects of acute toxicity due to ingestion of this substance by accident or suicide attempt, headache, dizziness, etc. are observed at the beginning, followed by nausea, vomiting, diarrhea, etc. and when ingested in large quantities, tremors, convulsions, and unconsciousness are characteristics. In addition, sweating, an increase in intratracheal secretions, hyperthermia, and dyspnea may occur; or even death may occur as a result of the breathing paralysis and ventricular fibrillation (Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), IARC 53 (1991), ACGIH (7th, 2001)). Therefore this substance was classified in Category 1 (nervous system). Besides, in the previous classification, on the basis of a report (ATSDR (2002)) that an effect on the liver observed after oral intake at a dose within the guidance value range for Category 1 in experimental animals, this substance was classified in Category 1 (liver). The classification was revised because the effect was only an increase in enzyme activity, which is an index of liver function impairment.
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, immune system), Category 2 (nervous system, endocrine system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There is no report which indicates effects in humans. There are reports that any adverse effects such as liver function failure were not observed in the workers exposed at an average dosage of 0.25 mg/kg/day for 25 years (JMPR (1984), Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002)), that no changes in liver function were observed in workers exposed to 0.05?0.25 mg/kg/day, and that volunteers who ate 0.31?0.61 mg/kg/day for 21 months showed no effects on the nervous system (JMPR (2000)). As for experimental animals, in a 14-day repeated dose toxicity test using rats by dietary administration, at the dose of 12mg/kg/day (converted guidance value: 1.9 mg/kg/day), which corresponds to Category 1, effects on the liver (vacuolized cytoplasm , cell necrosis) were observed (JMPR (2000)); in a 27-week repeated dose toxicity test using rats by dietary administration, at 5 ppm (0.25 mg/kg/day), which corresponds to Category 1, liver damage (hypertrophy of the liver, increases in acidophilic and basophilic granules) was observed (Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), PATTY (6th, 2012), ATSDR (2002)); and in a 78-week repeated dose toxicity test using rats by dietary administration, at 210 ppm (10.5 mg/kg/day), which corresponds to Category 2, effects on the nervous system (tremors) were observed (NTP TR 131 (1978)). Immunotoxicity was examined in a 12-week repeated dose test using mice by dietary administration. At 7.5 mg/kg/day, which corresponds to Category 1, effects on the immune system (changes in the weights of the spleen and liver, depression of humoral immune responses) were observed. Also in a 22-week repeated dose immunotoxicity test using rats by dietary administration, at 50 ppm (2.5 mg/kg/day) or above, which corresponds to Category 1, suppression of cellular and humoral immune responses was observed (JMPR (2000), IARC 53 (1991)). In a 130-month repeated oral dose toxicity test using monkeys, at 20 mg/kg/day, which corresponds to Category 2, effects on the liver (fatty changes) , effects on the nervous system (tremors, histological abnormalities of the central nervous system and the spinal cord) and effects on the endocrine system (uterine leiomyomas and intraductal hyperplasia of the mammary gland, which are considered possible estrogenic effects) were observed (JMPR (2000)). Therefore, this substance was classified in Category 1 (liver, immune system) and Category 2 (nervous system, endocrine system). Besides, in the previous classification, effects on the nervous system observed at a dose slightly exceeding the guidance value range for Category 1 were classified in Category 1, but were classified in Category 2 for this evaluation. In addition, the classification was changed because new information sources were added.
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 = 0.00026 mg/L for fish (Mugil cephalus) (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002)), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1981)), and 266-day NOEC (reproduction) = 0.0004 mg/L for fish (Pimephales promelas) (ECETOC TR91, 2003). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1981)), and 48-hour LC50 = 0.00036 mg/L for crustacea (Daphnia pulex) (EHC 83, 1989). It was classified in Category 1 from the above results.
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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