GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 75-09-2 |
| Chemical Name | Dichloromethane |
| Substance ID | H29-B-064 |
| Classification year (FY) | FY2017 |
| 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 | 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 |
| 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 | Not classified |
- |
- | - | There is no flash point (NFPA (14th, 2010)). Besides, there is the information that combustibility is significantly increased by adding small amount of flammable substance or increased oxygen level in the air, and vapor is explosive (ICSC (J) (2012)). |
| 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 605 deg C (ICSC (J) (2012)). |
| 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 |
- |
- | - | Test methods applicable to low-temperature-boiling liquids are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | There are 5 reports of LD50 values for rats of 2,280 mg/kg (male), 1,410 mg/kg (female), 2,120 mg/kg (male), 1,530-2,524 mg/kg, 1,710-2,250 mg/kg (EHC 164 (1996), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), one case corresponds to Category 4, 2 cases correspond to "Not classified" (Category 5 in UN GHS classification), and 2 cases correspond to Category 4-"Not classified" (Category 5 in UN GHS classification). It was classified as "Not classified" (Category 5 in UN GHS classification) by adopting a category with the largest number of cases. Chemical Substance Hazard Data (CERI) and Environmental Risk Assessment for Chemical Substances Vol. 2 (Ministry of the Environment, 2003) which were used in the previous classification were not adopted because the former is the information source in List 3, and data from the latter is from RTECS, which is the information source listed in List 3. The category was changed from the previous classification by use of the new information sources. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 4 |
 Warning |
H332 |
P304+P340
P261 P271 P312 |
Based on a report of an LC50 value of 15,000 ppm (male) (converted 4-hour equivalent value: 18,371 ppm) in a 6-hour inhalation exposure test with rats (EHC 164 (1996), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), it was classified in Category 4. Besides, the exposure concentration was lower than 90% of the saturated vapor pressure level (574,109 ppm (25 deg C)), so the reference values in units of ppm were applied as vapour without little mist. The category was changed from the previous classification. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
Based on multiple results showing strong or moderate skin irritation in skin irritation tests with rabbits (DFGOT Vol. 1 (2016) (Access on May 2017), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), it was classified in Category 2. |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
Based on reports that in an eye irritation test with rabbits, slight to moderate inflammation occurred within one hour after application of this substance, lacrimation continued for one week, and hyperemia of the conjunctiva, nictating membrane, and eyelid edge continued for up to 2 weeks after application, and that in another eye irritation test with rabbits, moderate irritation was shown and the Primary Irritation Index was 33 (maximum value: 110) (both in DFGOT Vol. 1 (2016) (Access on May 2017)), it was classified in Category 2A. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there are descriptions that no findings showed positive in respiratory sensitization of humans (DFGOT Vol. 1 (2016) (Access on May 2017)), and that there is no indication that this substance is a sensitizer in humans (SIAP (2011)), however, the details are unknown. Therefore, it was classified as "Classification not possible." |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | There is a report that in an LLNA test with mice, when 25 microL of a solution containing 5%, 25%, 100% of this substance in acetone/olive oil (4:1) was applied to the ears of mice, the stimulation indices (SI) were 1.3, 1.5, 1.7 respectively, and that this substance did not show skin sensitization (DFGOT Vol. 1 (2016) (Access on May 2017)). There is a description that there is no finding that this substance is a sensitizer in humans (DFGOT Vol. 1 (2016) (Access on May 2017), SIAP (2011)), but the details are unknown. Therefore, it was classified as "Classification not possible." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. As for in vivo, a mouse dominant lethal test was negative, a Pig-a assay with erythrocytes in mice and a gene mutation test with livers of transgenic mice were negative, a micronucleus test with mouse bone marrow cells was negative, micronucleus tests with peripheral blood was weakly positive, a chromosomal aberration test with bone marrow cells of mice was negative, chromosomal aberration tests with peripheral blood and lung cells were weakly positive, a rat bone marrow chromosomal aberration test was negative, a sister chromatid exchange test with mouse bone marrow cells was negative, a sister chromatid exchange test with mouse lung cells was positive, DNA damage tests with the liver and lungs of rats and mice showed positive and negative results, and unscheduled DNA synthesis tests with the liver of rats and mice were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ATSDR (2000), IARC 110 (2016), ACGIH (7th, 2015), IRIS Tox. Review (2011), Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004)). These weak positive results of in vivo micronucleus tests and chromosomal aberration tests are thought to be due to the species-specific high metabolic rate by glutathione transferase of this substance, and this substance is evaluated as not genotoxic (SIAP (2011)). As for in vitro, bacterial reverse mutation tests were positive, mammalian cell gene mutation tests and mouse lymphoma tests were positive and negative results, a micronucleus assay was negative: chromosomal aberration tests were positive and negative results, and sister chromatid exchange tests were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), IARC 110 (2016), IRIS Tox. Review (2011), Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004), PATTY (6th, 2012), ACGIH (7th, 2015)). |
| 6 | Carcinogenicity | Category 1A |
 Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
As for humans, positive associations were observed between exposure to this substance and cancer of the biliary tract and non-Hodgkin's lymphoma, and IARC concluded that there is limited evidence in humans for carcinogenicity of this substance (IARC 110 (2016)). In addition, Japan Society For Occupational Health (JSOH) reported that there are cases strongly suspected of developing cancer of the biliary tract due to mixed exposures to this substance and 1,2-dichloropropane in Japan, and this substance was classified as an occupational carcinogen Group 2A for carcinogenicity along with the results on experimental animals (described below) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2015)). As for experimental animals, in multiple carcinogenicity studies with mice, an increase in the incidence of tumors in the liver by the oral or inhalation route, and in the lungs etc. by the inhalation route was observed. In multiple carcinogenicity studies with rats, an increase in the incidence of tumors in the skin and mammary glands etc. by the inhalation route was observed. Therefore, IARC concluded that there is sufficient evidence in experimental animals (IARC 100 (2016), OEL Documentations (Japan Society For Occupational Health (JSOH), 2015)). As classification results by other organizations, it was classified in Group 2A by IARC (IARC 110 (2016)), as R by NTP (NTP RoC (14th, 2016)), as L by EPA (IRIS (2011)), in A3 by ACGIH (ACGIH (7th, 2015)), and in Group 2A by Japan Society For Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (2017): Proposal in 2015), respectively. Moreover, as for this substance, based on the Ordinance for Enforcement of the Labor Standards Act., in 2013, Ministry of Health, Labour and Welfare added "cancer of biliary tract due to work involving exposure to this substance" to Appended Table 1-2 (iv) of the Ordinance for Enforcement of the Labor Standards Act (occupational illness list), an illness which is covered by workers' accident compensation (Ministry of Health, Labour and Welfare HP (Access on November 2017)). From the above, it was classified in Category 1A for this hazard class. Besides, the category was changed from the previous classification based on additional information after the previous classification (Category 2). |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
As for reproductive effects in humans, there are the following reports. Eight (20-47 years of age, 0.4-2.9 years of exposure) out of 34 workers who had visited the hospital due to central nervous system dysfunction following occupational exposure to this substance (exposure concentration was unknown, but they had engaged in work, immersing their hands in buckets containing this substance, applying it to parts, and wiping it off) complained of pains in the testis, epididymis and prostate, and were infertile. In 4 of them who cooperated in semen collection, sperm counts and sperm motility counts were clearly low while the proportion of abnormal sperm was high (Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), OEL Documentations (Japan Society For Occupational Health (JSOH), 1999), ATSDR (2000)). After these, results from the environmental measurements by NIOSH showed the average exposure concentration of this substance was 68 ppm (3.3-154.4 ppm), and workers were also exposed to styrene below the permissible concentration (average concentration: 7.2 ppm (1.5-10.4 ppm)) (ATSDR (2000)). On the other hand, there is a report that a decrease in sperm was not observed in four workers who were exposed for more than 3 months to levels of this substance, which were twice as high as in the above report. ATSDR considered that the difference between both report results was not clear as to whether it was attributed to the exposure period (if the exposure period becomes longer, it will be affected) or the result of concomitant exposure to other substances in addition to this substance in the former report (ATSDR (2000)). However, it is considered this substance is dermally absorbed (OEL Documentations (Japan Society For Occupational Health (JSOH), 2005), SIAP (2011)), and in the case of workers who put their hands in buckets containing this substance, it is considered that there is the effect of absorption via the dermal route in addition to the inhalation route; sufficient amounts were absorbed even if the airborne concentrations were half, and therefore, the reproductive effects may have occurred. As for experimental animals, in a two-generation reproduction toxicity study by the inhalation route with rats, no adverse effects were observed in any of the F0 and F1 parental animals, and F1 and F2 offspring even when they were exposed at up to the high dose of 1,500 ppm (5,300 mg/m3) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), SIAP (2011), DFGOT Vol. 1 (2016) (Access on May 2017)). As for fertility in the oral route, there is a report that as a result of administering by drinking water (125 mg/L) to rats for 13 weeks prior to mating, no effects on female fertility, and number of births were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Also, there is a report that as a result of dosing rats by gavage (25-225 mg/kg/day) for 10 days prior to mating, no effects on the fertility were observed at up to the maximum dose of 225 mg/kg/day (DFGOT Vol. 1 (2016) (Access on May 2017)). On the other hand, in developmental toxicity studies with pregnant rats or pregnant mice exposed by inhalation at 1,250 ppm (4,400 mg/m3) during the organogenesis period, an increase in carbon monoxide-haemoglobin (CO-Hb) and an increase in liver weight were observed in the maternal animals in the exposure group in both the rats and mice, but only slight effects (dilation of the renal pelvis, delayed ossification (rats), extra sternum (mice)) were observed in the fetuses (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), DFGOT Vol. 1 (2016) (Access on May 2017), ACGIH (7th, 2015)). Additionally, in a study with pregnant rats dosed by feeding at a maximum of 4.0% during the gestational period, only a decrease in body weight gain in maternal animals and low values of body weight in fetuses were observed at 4.0% (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)). From the above, for humans, there are research studies on infertility with male workers due to occupational exposure to this substance, and there is a report that eight showed infertility and four of these showed sperm reduction. In contrast, it was reported that sperm reduction was not observed in 4 workers exposed to higher concentrations. However, since this substance is absorbed percutaneously, it is considered that in the workers who immersed their hands in buckets, it was absorbed by the percutaneous route in addition to the inhalation route, and thus, reproductive effects might have occurred regardless of airborne concentration. On the other hand, from the results of the animal studies, no evidence on reproductive and developmental effects of this substance in either the inhalation route or oral route was obtained. From the above, adverse effects on male fertility due to occupational exposure to this substance were reported, however, reproductive effects in humans are considered to be limited because of only one report, and reproductive and developmental effects were not detected from animal studies. Based on these, it was classified in Category 2 for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, respiratory organs), Category 3 (narcotic effects) |
Danger Warning |
H370
H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
As for humans, there is a report that as a case of acute inhalation exposure due to an accident during the use of a paint remover containing this substance as the main component, the man who conducted the paint peeling in a place with poor ventilation complained of headaches and chest pains when entering the emergency room; he then developed disorientation, a progressive loss of alertness, an increase in fatigue and lethargy, memory loss, and a loss of time sensation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). In addition, there is a description that in exposure in similar accidents, central nervous system depression, lethargy, eye and respiratory inflammation, and pulmonary edema were observed and sometimes these led to death (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Moreover, there was a report that four workers who were handling an extraction tank of plant ingredient under a poorly ventilated environment showed central nervous system depression, anesthesia, eye irritation, trachea and lung edema before they died (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). In an acute inhalation exposure study with volunteers, there is a report that neurobehavioral effects (confusion in alertness, disorder of complex vigilance tracking behavior) were seen after 1.5-3 hour exposure at 200 ppm, and there is a report that a decrease of the critical fusion frequency detected in visual function tests was seen in 95-min exposure at 300 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). As for experimental animals, it is reported that in a single inhalation exposure test with rats, central nervous system depression, hypothermia, hypotension, convulsions, sensory paralysis, dyspnea, and changes of somatosensory induction were observed. It is reported that in a single inhalation exposure test with mice, reversible coma due to suppression of the central nerves was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EHC 164 (1996)). The effects on experimental animals were observed within the guidance value range for Category 2. From the above, it was classified in Category 1 (central nervous system, respiratory organs), Category 3 (narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, liver, genetic organs (men)) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
As for humans, there are case reports that irreversible damage to the central nervous system with auditory hallucinations and visional hallucinations was observed, and that bilateral temporal lobe degeneration was observed. Also there is a case report of delirium and epileptic seizures. There is a report that gallbladder lesions and enlarged liver were seen (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EHC 164 (1996)). Additionally, there is a report that although the exposure concentration was unknown, eight workers (20-47 years of age, 0.4-2.9 years of exposure) engaged in work immersing their hands in a bucket containing this substance, applying it to parts, and wiping away complained of pains in the testis, epididymis and prostate, and that they became infertile. In the 4 of them who cooperated in the semen collection, sperm counts and sperm motility counts were clearly low, and the proportion of abnormal sperm was high (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004), OEL Documentations (Japan Society For Occupational Health (JSOH), 1999)). As for experimental animals, in a 2-year toxicity test with rats dosed by drinking water, in the groups of 52 mg/kg/day or above in males and in the groups of 58 mg/kg/day or above in females within the guidance value range for Category 2, altered foci and fatty changes in the liver were observed (Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004)). In a one-month continuous inhalation toxicity test (24 hours/day, 7 days/week) with mice, fatty accumulation in the liver, an increase in liver weight and an increase in the blood butyrylcholinesterase level were observed at or above 75 ppm (converted guidance value: 0.35 mg/L) within the guidance value range (vapour) for Category 2. In 100-day continuous inhalation toxicity tests (24 hours/day, 7 days/week) with mice and rats, positive fat stains in the hepatocytes and slight hepatocellular vacuolization were observed at or above 25 ppm (converted guidance value: 0.35 mg/L) within the guidance value range (vapour) for Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). From the above, it was classified in Category 1 (central nervous system, liver, genetic organs (men)). Besides, the category was different from the previous classification because of the addition of the effects on men's genetic organs. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, from the numerical data (viscosity: 0.437 mPa*s (20 deg C), density (specific gravity): 1.3255) listed in HSDB (Access on May 2017), the kinematic viscosity is calculated as 0.33 mm2/sec (20 deg C). |
| 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 = 27 mg/L for crustacea (Daphnia magna) (Canada PSAR: 1993, OECD SIDS: 2011), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 13 % (J-CHECK, 1986)), and 32-day NOEC (body weight) = 82.5 mg/L for fish (Pimephales promelas) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 13 % (J-CHECK, 1986)), and 48-hour LC50 = 27 mg/L for crustacea (Daphnia magna) (Canada PSAR: 1993, OECD SIDS: 2011). From the above results, it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |