GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 75-35-4 |
| Chemical Name | 1,1-Dichloroethylene [Vinylydene dichloride] |
| Substance ID | H28-B-041, C-056B |
| 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 | 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 | Category 1 |
 Danger |
H224 |
P303+P361+P353
P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Based on a flash point of -25 deg C (closed cup) and a boiling point of 32 deg C (ICSC (2014)), it was classified in Category 1. It is classified in Class 3, PG I (UN1303, stabilized) in UNRTDG. |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Type G |
- |
- | - | Although there is a chemical group associated with self-reactive properties (unsaturated bond) present in the molecule, because a stabilized one is classified in Class 3 (UN 1303), it does not correspond to self-reactive substances and mixtures which is hazard class with the highest precedence. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 570 deg C (HSDB (Access on June 2016)). |
| 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 oxygen or fluorine) 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 liquid substances with a low boiling point are not available. |
| 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 |
There are seven reported LD50 values for rats of about 1,500 mg/kg (ATSDR (1994)), 1,500 mg/kg (EHC 100 (1990), PATTY (6th, 2012), CICAD 51 (2003), IRIS Tox. Review (2002)), 1,510 mg/kg (EHC 100 (1990), ATSDR (1994), DFGOT vol.8 (1997)), 1,510-1,550 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), 1,550 mg/kg (CICAD 51 (2003), IRIS Tox. Review (2002), DFGOT vol.8 (1997), ATSDR (1994)), 1,800 mg/kg (CICAD 51 (2003), IRIS Tox. Review (2002)), 2,500 mg/kg (ACGIH (7th, 2001)). Since 6 reports correspond to Category 4, and one report to "Not classified" (Category 5 in UN GHS classification), it was Classified in Category 4, which has the greatest number of reports. |
| 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 |
There are 21 reports in the range of 415 - 32,000 ppm as rat LC50 values (4 hours). Since 2 reports correspond to Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1994), EHC 100 (1990)), 4 reports to Category 3 (ATSDR (1994), EHC 100 (1990)), 14 reports to Category 4 (NTP TR582 (2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CICAD 51 (2003), IRIS Tox. Review (2002), DFGOT vol.8 (1997), ATSDR (1994), EHC 100 (1990)), and one repot to "Not classified" (EHC 100 (1990)), it was classified in Category 4 which has the greatest number of reports. Since the LC50 values are lower than 90% of the saturated vapor pressure concentration (791,881 ppm), a reference value in the unit of ppm was applied as vapour without mist. The category was revised based on newly obtained information. |
| 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 |
- |
- | - | Skin irritation was observed in the rabbit skin irritation test. However, because 4-methoxyphenol, a polymerization inhibitor added to this substance, may be involved in irritation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), DFGOT vol.8 (1997), EHC 100 (1990), PATTY (6th, 2012)), it was classified as "Classification not possible." |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Moderate irritation with transient corneal injury was observed in a rabbit eye irritation test. However, because the irritating potential of a polymerization inhibitor, 4-methoxyphenol (MEHQ) in this substance is pointed out (EHC 100 (1990), PATTY (6th, 2012)), it was classified as "Classification not possible." |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Although it is described that a skin sensitization test using mouse (LLNA method) was negative (CICAD 51 (2003)), it was judged that the classification is not possible due to no other data. |
| 5 | Germ cell mutagenicity | 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, it was classified as "Classification not possible." As for in vivo, dominant lethal tests in rats and mice were negative, chromosomal aberration tests using bone marrow cells and peripheral blood of mice and bone marrow cells of rats were negative, and a chromosome aberration test in Chinese hamster bone marrow cells was positive (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001), ATSDR (1994), CICAD 51 (2003), DFGOT vol.8 (1997), EHC 100 (2007), EPA IRIS Tox Review (2002), IARC 71 (1999), NTP TR582 (2015)). As for in vitro, bacterial reverse mutation tests were positive, and in cultured mammalian cell tests, a mouse lymphoma test was positive, gene mutation tests were negative, chromosome aberration tests were positive or negative, and a sister chromatid exchange test was positive (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1994), CICAD 51 (2003), DFGOT vol.8 (1997), EHC 100 (2007), EPA IRIS Tox Review (2002), IARC 71 (1999), NTP TR582 (2015)). From the above, although there are many positive in vitro test results, due to mostly negative reports in in-vivo tests, this substance was considered to be not genotoxic in vivo. |
| 6 | Carcinogenicity | Category 1B |
 Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
There was no evidence of carcinogenicity in studies using rats and mice on the oral route. In the study on the inhalation route, there was no treatment-related neoplastic change in hamsters, but in mice, an increase in pulmonary adenoma was observed in males and females, and an increase in kidney adenocarcinomas and mammary gland tumors was observed in males and females, respectively (IARC 71 (1999)). Based on these results etc., IARC classified it in Group 3 (IARC 71 (1999)) and ACGIH in A4 (ACGIH (7th, 2001), on the other hand, EPA classified it in group C (possible human carcinogen: equivalent to Category 2) (IRIS Summary (2002)). After that, NTP performed inhalation carcinogenicity studies and published the results in 2015. That is, as a result of inhalation exposure to rats or mice for 2 years, in rats, malignant mesothelioma, nose and kidney tumors in males, thyroid tumors and mononuclear leukemia in females were obserbved, and in mice, liver tumors in males and females, kidney tumors in males, hemangioma and angiosarcoma in multiple organs in females were observed. It was concluded that there was clear evidence of carcinogenicity in male rats and male and female mice and some evidence in female rats (NTP TR582 (2015)). As described above, because evidence of carcinogenicity was obtained in experimental animals of two species in the latest inhalation exposure study by NTP, it was classified in Category 1B for this hazard class. |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
In a 3-generation reproductive toxicity study using rats by the oral route (drinking water), each generation of F0, F1, and F2 was allowed to give pregnancy/parturition twice, however, even at the doses where liver effect (fatty liver) was observed in F1 and F2 generations (100, 200 ppm), there was no adverse effect on the fertility index and development of the next generation, and it is concluded that there is no reproductive toxicity (EHC 100 (1990), ACGIH (7th, 2001), PATTY (6th, 2012)). On the other hand, in developmental toxicity studies in which pregnant rats or pregnant rabbits were exposed by inhalation during organogenesis period, at doses at which maternal toxicity was observed, delayed ossification and wavy ribs in the rat fetuses, increased embryonic/fetal resorption and skeletal variations in the rabbit fetuses were seen (EHC 100 (1990), ACGIH (7th, 2001), PATTY (6th, 2012)). In addition, it is reported that in an inhalation exposure study in which pregnant animals (rats, mice) were exposed by inhalation during organogenesis period, at a dose at which deaths (mortality rate unknown) were seen in some of the dams, a malformation (hydrocephalus) and increase in early resorptions, and complete embryonic resorptions were observed in fetuses (EHC 100 (1990)). As above, because the embryonic/fetal toxicity which level was not considered to be slight effects was observed at the doses with maternal toxicity, it was classified in Category 2 for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system, respiratory organs, liver, kidney), Category 3 (narcotic effects) |
Danger Warning |
H370
H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
It is reported that humans acutely exposed by inhalation to this substance showed symptoms of depression or excitement of the central nervous system and became unconscious in severe cases (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). In addition, two cases were reported in which humans were acutely exposed by inhalation during cleaning tanks containing this substance and showed persistent damages of trigeminal nerve, hypoglossal nerve, and auditory nerve (ATSDR (1994)). As for laboratory animals, it is reported that a single oral or single inhalation exposure to this substance at doses within the guidance value range for Category 1 caused disruption of bile canaliculi, necrosis of centrilobular hepatocytes, damage of proximal tubules, and pulmonary edema and hemorrhage (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CICAD 51 (2003)). Furthermore, it was reported that in laboratory animals, animals which died from a single inhalation exposure to this substance showed crouching position, dyspnea, coma, and narcosis, resulting in death (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1994)). From the above, it was classified in Category 1 (nervous system, respiratory organs, liver, kidney) and Category 3 (narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (blood, respiratory organs, liver, kidney, genetic organs (men)) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
As for humans, it is reported that liver function disorder was observed in 27/46 (59%) of polymerization plant workers who were exposed for 6 years or less (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1994)). As for laboratory animals, it is reported that in a 2-year repeated dose toxicity study using rats dosed by drinking water, hepatocellular swelling associated with slight midzonal fatty degeneration was observed at 50 ppm (9 mg/kg/day) equivalent to Category 1 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1994)). It is reported that in a 14-week inhalation toxicity study using rats, effects on the respiratory organs (atrophy, mineralization, necrosis of the olfactory epithelium, atrophy of nasal turbinates, etc.) and effects on the liver (centrilobular cytoplasmic alteration, cytoplasmic vacuolization, etc.) at 6.25-50 ppm (converted guidance value: 0.017 - 0.132 mg/L) within the range of Category 1, and in addition to the above, effects on the testes (lowered sperm motility, decreased number of spermatid) at 100 ppm corresponding to Category 2 were observed (NTP TR582 (2015)). It is reported that in a 105-week inhalation toxicity test using rats, the effects on the respiratory organs (atrophy and hyperostosis of turbinate, olfactory epithelium respiratory metaplasia, respiratory epithelial hyperplasia, and chronic active inflammation, etc.) and the liver (inflammation and diffuse fatty change, etc. in the liver) were observed at 25-50 ppm (0.099-0.198 mg/L) which is within the range of Category 1, (NTP TR582 (2015)), and that in a 52-week inhalation toxicity study using mice, renal regressive degeneration, abscess, and nephritis were seen at 10 ppm (0.026 mg/L) equivalent to Category 1 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). It is reported that in a 14-week inhalation toxicity test using mice, the effects on the blood (decreased erythrocyte counts, hemoglobin concentrations, and hematocrit values), effects on the respiratory organs (squamous metaplasia of respiratory epithelium of the larynx), effects on the testis (decreases in total sperm/cauda in epididymis), and effects on the kidney (nephropathy, tubular necrosis and protein cast) at 6.25-50 ppm (converted guidance value: 0.017-0.132 mg/ L) within the range of Category 1, and in addition to the above, effect on the liver (necrosis, centrilobular hepatocyte hypertrophy) at 100 ppm (converted guidance value: 0.26 mg/L) corresponding to Category 2 were observed (NTP TR582 (2015)). It is reported that in a 105-week inhalation toxicity study using mice, effects on the respiratory organs (atrophy and hyperostosis of nasal turbinate, respiratory metaplasia in the olfactory epithelium, etc.) and effects on the kidney (renal tubule hyperplasia) were observed at 6.25-25 ppm (0.025-0.099 mg/L) within the range of Category 1 (NTP TR582 (2015)). As described above, the effect on the liver was observed in humans, and the effects on the haemal system, respiratory organs, liver, kidney and testis were seen from the range of Category 1 in experimental animals. Therefore, it was classified in Category 1 (haemal system, respiratory organs, liver, kidney, genetic organs (men)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. From the numerical data (viscosity: 0.330 mPa*s (20 deg C), density (specific gravity): 1.22 (20/4 deg C)) listed in HSDB (Access on June 2016), the kinematic viscosity is calculated as 0.27 mm2/sec (20/20 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 2 |
- |
H401 |
P273
P501 |
From 72-hour EbC50 = 9.12 mg/L for algae (Chlamydomonas reinhardtii) (CICADs 51, 2003; ECETOC TR91, 2003), it was classified in Category 2. Besides, the data on algae from biomass method was adopted for the classification because it is lower than the data on crustacea or fish, leading to a more hazardous Category. |
| 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 (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)), and 96-hour EC10 = 240 mg/L for algae (Desmodesmus subspicatus) (CICADs 51, 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 3 due to being not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)), and LC50 = 11.6 mg/L for crustacea (Daphnia magna) (CICADs 51, 2003). It was classified in Category 3 by drawing a comparison between the above results. |
| 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. |