GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 107-06-2
Chemical Name 1,2-Dichloroethane
Substance ID H27-B-062/C-098B_P
Classification year (FY) FY2015
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 FY2009   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
-
-
- - Liquid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Liquid (GHS definition)
6 Flammable liquids Category 2


Danger
H225 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
Based on a flash point of 13 deg C (closed cup), and a boiling point of 83.5 deg C (ICSC (2013)), it was classified in Category 2. Besides, it is classified in Class 3, Subsidiary Risk 6.1, PG II (UN 1184) in UNRTDG.
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
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 classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 440 deg C (ICSC (2013)).
10 Pyrophoric solids Not applicable
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid 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
-
-
- - The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- - No data available. Besides, it is described that it corrodes iron and other metals at elevated temperatures when in contact with water (HSDB (Access on August 2015)).

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 reports of LD50 values for rats of 670 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)), 680 mg/kg (ATSDR (2001), EHC 176 (1995), EHC 62 (1987), IARC 20 (1979), JMPR (1965), JECFA FAS 30), 770 mg/kg (PATTY (6th, 2012), SIDS (2004), ACGIH (7th, 2001), EHC 176 (1995), JMPR (1965)), 794 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), 850 mg/kg (EHC 176 (1995), EHC 62 (1987), JECFA FAS 30 (Access on October 2015)), and 967 mg/kg (SIDS (2004)), it was classified in Category 4.
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on reports of LD50 values for rabbits of 2,800 mg/kg (EHC 176 (1995)), 4,890 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), SIDS (2004)), and 2,800-4,900 mg/kg (EHC 176 (1995)), it was classified as "Not classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
Based on reports of LD50 values (4 hours) for rats of 1,000 ppm (IARC 20 (1979)), and approximately 1,900 ppm (SIDS (2004)), it was classified in Category 3. Besides, since the LC50 values are lower than 90% of the saturated vapor pressure concentration (103,816 ppm), a reference value in the unit of ppm was applied as vapour without mist.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - There is a report that in a Draize test with rabbits, as a result of an application of 0.5 mL of this substance for 4 hours, mild irritation was observed (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). It is concluded in SIDS (2004) that this substance is mildly irritating to the skin (SIDS (2004)). From the above, it was classified as "Not classified" (Category 3 in UN GHS classification).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
There are reports that in Draize tests with rabbits, as a result of an application of 0.1 mL of this substance, mild eye irritation, or no irritation was observed (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). From the above, it 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 Classification not possible
-
-
- - As for in vivo, it was negative in a dominant lethal test with mice, positive in a spot test with mice, negative in micronucleus tests with bone marrow cells and peripheral blood erythrocytes of mice, negative in a mutation test with transgenic rodents, positive in a sister chromatid exchange test with mouse bone marrow cells, positive in comet assays with the liver of rats and with the liver, kidney, stomach, forestomach, lung, urinary bladder, brain, and bone marrow of mice, and positive in DNA binding tests with the liver, kidney, stomach, forestomach, and lung of rats and mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), CICAD 1 (1998), IARC 71 (1997), JECFA FAS 30 (Access on October 2015), ATSDR (2001), SIDS (2004), EHC 176 (1995), NTP DB (Access on October 2015), OECD, Detailed review paper on transgenic rodent mutation assays, ENV/JM/MONO (2009)). As for in vitro, it was positive in all of the following tests: bacterial reverse mutation tests, a gene mutation test, a chromosomal aberration test, and a sister chromatid exchange test with cultured mammalian cells, and a micronucleus test with human lymphocytes (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), CICAD 1 (1998), IARC 71 (1997), JECFA FAS 30 (Access on October 2015), ATSDR (2001), SIDS (2004), NTP DB (Access on October 2015)). From the above, since the mouse spot test, which was considered as positive, was regarded as weakly positive by EHC and as inconclusive by IARC, it is not a definitive finding. In addition, other in vivo positive findings, which were the sister chromatid exchange test, the comet assays, and the DNA binding tests, are not direct findings. Furthermore, since a clearly positive finding which supports classification in Category 2 was not found from the negative finding in the mutation test with transgenic rodents, it was classified as "Classification not possible" according to the GHS classification guidance for the Japanese government.
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
As for humans, IARC summarized multiple cohort studies and case-control studies which targeted a group of workers who had been simultaneously exposed to this substance and other substances such as ethylene oxide and chlorohydrin, and had obviously died of cancers, and the excess risk of lymphohematopoietic tumors in the three cohort studies and the excess risk of pancreatic cancers and gastric cancers in each one of the epidemiological studies were shown. However, IARC pointed out that an excess risk of cancers was not shown in the other cohort studies and cohort case-control studies, and all the cases received combined exposures to multiple chemical compounds, and they concluded that in evaluating the relationship between the exposure limited to this substance and human carcinogenesis, as for available data, the existing epidemiological research reports were inadequate (IARC 71 (1999), NTP RoC (13th, 2014)).
On the other hand, as for experimental animals, in a carcinogenicity test by the oral route with rats or mice, hemangiosarcoma (males and females), squamous cell carcinomas of the forestomach (males), mammary gland adenocarcinomas (females) in rats and malignant lymphomas and bronchioles/alveolar adenomas (males and females), hepatocellular carcinomas (males), adenocarcinomas of the mammary gland and tumors of the endometrium (females) in mice were observed respectively, and IARC classified it in Group 2B because there is sufficient evidence of carcinogenicity in experimental animals (IARC 71 (1999)). Furthermore, also in carcinogenicity studies by the inhalation route with rats and mice, tumor occurrence at multiple sites was observed such as fibroadenoma (males and females), adenomas and adenocarcinomas (females) of the mammary gland, fibromas (males and females) of subcutaneous tissue, mesothelioma of the peritoneum (males) in rats and hepatic hemangiosarcoma (males) and hepatocellular adenomas (females), and bronchioles/alveolar adenomas and carcinomas (females) in mice, and it was proved that this substance showed carcinogenicity in experimental animals even by the inhalation route (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on August 2015)).
As classification results by other organizations other than IARC, it was classified as "R" by NTP in 1981 (NTP RoC (13th, 2014)), in "B2 (probable human carcinogen)" in 1991 by EPA (IRIS Summary (Access on August 2015)), in "2B" by Japan Society of Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (2015)) and in "Carc. 1B" by EU (ECHA SVHC Support Document (2011)), and the EU designated this substance as a Substance of Very High Concern (SVHC) based on this classification result.
From the above, there is no evidence of carcinogenicity in humans, however, in experimental animals, both rats and mice showed tumor occurrence in multiple organs by both the inhalation and oral routes. Therefore, it was classified in Category 1B for this hazard class similarly to EU.
7 Reproductive toxicity Classification not possible
-
-
- - As for reproductive effects in humans, there are reports of the miscarriages and early births due to occupational exposure, however, it was stated that the female workers had received combined exposures to gasoline, dichloromethane, etc. in addition to this substance, therefore, there is no report clearly related to the exposure to this substance alone (DFGOT Vol. 3 (1992), Initial Risk Assessment (NITE, CERI, NEDO, 2005)).
As for experimental animals, in a 2-generation reproductive toxicity test by the oral route with mice and a one-generation reproductive toxicity test by the inhalation route with rats, either at doses of up to 50 mg/kg/day in the former test or at doses of up to 150 ppm (617 mg/m3) in the latter, general toxicity effects and effects on fertility in parent animals of F0 and F1 generation, and effects on growth and survival rate etc. in pups were not observed (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). On the other hand, as for developmental toxicity tests, for the oral route, in an oral dose test by gavage with pregnant rats on day 6-15 of gestation, at the dose (200 mg/kg/day or more), at which suppression of weight gain and deliveries of stillborn pups occurred in the dams, increases in fetal death and absorbed embryos were observed (SIDS (2004), Initial Risk Assessment (NITE, CERI, NEDO, 2005)), but as for an inhalation route, in 2 inhalation exposure tests in which pregnant rats were exposed on day 6-15 of gestation or on day 6-20 of gestation and in an inhalation exposure test in which pregnant rabbits were exposed on day 6-18 of gestation, in all tests, animals were exposed with up to the concentration where maternal toxicity (suppression of weight gain, occurrence of death cases) was evident, but no abnormalities were observed in the fetuses (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
From the above, it was concluded in SIDS that in the reproductive toxicity tests with mice or rats by the oral and inhalation routes, no adverse effects were shown on fertility in the parent animals, and survival rates before and after birth, postnatal growth, and development in pups, and in the developmental toxicity tests with pregnant rats or pregnant rabbits by the oral and inhalation routes, there was no toxicity to the embryo/fetuses at up to the dose at which toxicity occurred in the maternal animals, and as a whole, it is difficult to consider this substance as a reproductive and developmental toxic substance (SIDS (2004)). According to this, it is considered to correspond to "Not classified." However, in the developmental toxicity study by an oral route with pregnant rats, an increase in fetal death was observed at the doses where maternal toxicity occurred (possibly equivalent to Category 2), and in the reproductive toxicity tests with mice or rats by oral and inhalation routes, animals were not dosed at up to the dose where clear general toxic effects occurred in parental animals, and to conclude that there is no reproductive and developmental toxicity, it seemed to be necessary to verify whether the dose to the parent animals was appropriate. In other words, the question remains on the contents of the test to classify as "Not classified," and there is no definitive evidence to allocate the classification category, therefore, it was classified as "Classification not possible" for this hazard class.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, respiratory organs, cardiovascular system, haemal system, liver, kidney, gastrointestinal tract), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
Many human data and experimental animal data on this substance are reported. This substance causes respiratory tract irritation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), ACGIH (7th, 2001)). In the cases of human poisoning, there are reports that by inhalation or ingestion, it caused headache, nausea, vomiting, dizziness, narcotic action, central nervous suppression, tremor, nystagmus, autonomic symptoms, pupillary dilatation, atrophy of cranial nerve cells (atrophy accompanied by nuclear enrichment of the cerebellar Purkinje cell layer), abdominal colic, gastrointestinal disorders, diarrhea, effects on the cardiovascular system (cardiac arrhythmia, epigastric pain, stenosis of the heart, cardiovascular insufficiency, surface punctate hemorrhage of the heart, myocardial degeneration), a decrease in the blood coagulation factor, thrombocytopenia, leukocytosis, respiratory failure, pulmonary congestion, liver damage, hepatocellular necrosis, kidney damage, renal tubular necrosis, urine protein, and cyanosis, and on necropsy in death cases, congestion and bleeding of the major organs, pulmonary edema were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), ACGIH (7th, 2001), DFGOT Vol.3 (1992), PATTY (6th, 2012), OEL Documentations (Japan Society For Occupational Health (JSOH), 1984), CICAD 1 (1998), EHC 176 (1995), IARC 20 (1979), IARC 71 (1997), ATSDR (2001)).
As for experimental animals, by inhalation exposure (at the dose corresponding to Category 1) in rats, there are reports of depression of the central nervous system, lowered body temperature, coma, apnea, pulmonary edema, myocardial degeneration, liver damage, kidney damage, and cyanosis, and from necropsy findings from surviving cases, increases in liver and kidney weight, extension of prothrombin time, reduced phosphatase, increased lipid, congestion, hemorrhagic necrosis of the parenchyma, fatty degeneration in the liver, congestion and bleeding of the kidney, and cortical degeneration, and by oral administration (at the dose corresponding to Category 2) in rats, there are reports of lowered locomotor activity, ataxic gait, and liver damage (fatty degeneration, hemorrhagic necrosis), congestion of intestinal blood vessels etc., kidney damage (renal congestion, hemorrhage, necrosis, interstitial edema, renal tubular dilatation, fatty degeneration of renal tubular epithelium, hypertrophy of renal tubular cells), and lung damage (pulmonary congestion, bleeding, pulmonary edema, pleural effusion) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), ACGIH (7th, 2001), DFGOT vol.3 (1992), PATTY (6th, 2012), SIDS (2004), ATSDR (2001)).
From the above, this substance has effects on the central nervous system, respiratory organs, cardiovascular system, haemal system, liver, kidney, and gastrointestinal tract, in addition to narcotic effects, and it was classified in Category 1 (central nervous system, respiratory organs, cardiovascular system, haemal system, liver, kidney, gastrointestinal tract), Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system, liver, cardiovascular system, thyroid), Category 2 (haemal system, kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
As for humans, it is described that NIOSH in the United States reported that workers exposed to this substance in the airplane factory handling this substance had a high incidence of diseases of the liver and bile duct, neurological symptoms, autonomic imbalance, hyperthyroidism, etc. (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). Also, it is described that increases in autonomic imbalance, neuromuscular disorder, bradycardia, perspiration, fatigue, irritability, insomnia, etc. were reported in workers exposed to this substance at up to 20 mg/m3 for 0.5-5 years (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). Based on these descriptions, the nervous system, liver, cardiovascular system, and thyroid are considered as the target organs by the repeated exposure to this substance in humans.
As for experimental animals, in a 13-week oral dose study by gavage with SD rats, increases in relative liver and kidney weights, and haemal effects (decreases in hemoglobin level and hematocrit value) were observed at 75 mg/kg/day which corresponds to Category 2, and in a13-week oral dose study by gavage with F344 rats, increased weights of the liver and kidney at or above 18-30 mg/kg/day corresponding to Category 2, neurologic symptoms and respiratory symptoms such as tremor, salivation, and respiratory difficulty at the dose which exceeded the range for Category 2, and 90-100% death, cerebellar necrosis, mucosal inflammation of the forestomach, hyperplasia, and necrosis of the thymus at the doses of 240-200 mg/kg/day were observed (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). In contrast, there is a description that in a 13-week study with F344 rats dosed by drinking water, occurrence of toxicity was reduced as compared with gavage administration, however, at 1,000 ppm (86-102 mg/kg/day) which corresponds to Category 2, regeneration of the renal tubular epithelium was observed (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). On the other hand, for the inhalation route, it is described that in a 12-month inhalation exposure study of this substance with rats of 12 months of age, increases in serum ALT, uric acid, and urea nitrogen were observed at or above 50 ppm (converted guidance value: 0.17 mg/L/6 hour/day (corresponding to Category 1)) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). From the results of the tests with the experimental animals above, effects on the nervous system and liver among the candidates of human target organs were confirmed, and other than those, the effects on the kidney and haemal system were observed in the dose range for Category 2.
From the above, it was classified in Category 1 (nervous system, liver, cardiovascular system, thyroid), Category 2 (haemal system, kidney) for this hazard class.
10 Aspiration hazard Classification not possible
-
-
- - This substance is not a hydrocarbon, but it is described that in acute exposure cases in humans, among five case reports of humans who ingested this substance and developed pulmonary edema, one may have been caused by chemical pneumonitis due to aspiration of this substance (ATSDR (2001)). In addition, the calculated kinematic viscosity is 0.68 mm2/sec (20 deg C) from the numerical data (viscosity: 0.84 mPa*s (20 deg C), density (specific gravity): 1.2351 (20 deg C)) listed in HSDB. From the above, it is considered to correspond to "Category 1," however, in the assessment documents after ATSDR, there is only a description that a large amount was swallowed or inhaled, pulmonary edema may occur (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)), it is only described in the latest ICSC as well, that when it is inhaled, it may cause pulmonary edema (ICSC (2013)), and no findings supporting lung damage by aspiration are found. Furthermore, there is no addition of the corresponding hazard statement (H 304) to this hazard class in the EU CLP classification (ECHA SVHC Draft Support Document (Access on August 2015)). From the above, it was classified as "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 3
-
-
H402 P273
P501
From 48-hour LC50 = 12.8 mg/L for crustacea (Artemia salina) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), it was classified in Category 3.
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - Due to being not rapidly degradable (a degradation rate by 2-week BOD = 0%, a degradation rate by TOC = 1.6%, a degradation rate by GC = 1.1% (Official Bulletin of Ministry of International Trade and Industry, 1978)), 72-hour NOEC (r) = 55 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1995)), 21-day NOEC (reproduction) = 1.02 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), Initial Risk Assessment (NITE, CERI, NEDO, 2005)), and 28-day NOEC (GRO, after hatching) = 29 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), it was classified as "Not classified."
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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