GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 75-35-4
Chemical Name 1,1-Dichloroethylene; Vinylydene dichloride
Substance ID R02-B-034-MHLW, MOE
Classification year (FY) FY2020
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   FY2016  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. It was classified as "Not classified."
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Category 1


Danger
H224 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
It was classified in Category 1 based on a flash point of -28 deg C (closed cup) and a boiling point of 32 deg C (NFPA (14th, 2010)).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
8 Self-reactive substances and mixtures Type G
-
-
- - There is a chemical group associated with self-reactive properties, an unsaturated bond, present in the molecule, but because a stabilized one is classified in Class 3, PG I in UNRTDG (UN1303), and it is considered to be not applicable to self-reactive substances and mixtures, hazards of the highest precedence, it was classified in Type G.
9 Pyrophoric liquids Not classified
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 570 deg C (NFPA (14th, 2010)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (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). It was classified as "Not classified."
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing chlorine (but not fluorine or oxygen), which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified."
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16 Corrosive to metals Classification not possible
-
-
- - Classification is not possible because test methods applicable to low-temperature-boiling liquids are not available.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

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
[Rationale for the Classification]
It was classified in Category 4 from (1) - (6).

[Evidence Data]
(1) LD50 for rats: males: 1,500 mg/kg (Patty (6th, 2012))
(2) LD50 for rats: males: 1,510 mg/kg (EHC 100 (1990), MAK (DFG) vol.8 (1997), ATSDR (2019))
(3) LD50 for rats: males: 1,550 mg/kg (EHC 100 (1990), MAK (DFG) vol.8 (1997), IRIS Tox Review (2002), CICAD 51 (2003))
(4) LD50 for rats: 1,510-1,550 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007))
(5) LD50 for rats: males: 1,800 mg/kg, females: 1,500 mg/kg (EHC 100 (1990), ECETOC JACC (1985), IRIS Tox Review (2002), CICAD 51 (2003), ATSDR (2019))
(6) LD50 for rats: males: 2,500 mg/kg (ACGIH (7th, 2001))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Liquid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Category 4


Warning
H332 P304+P340
P261
P271
P312
[Rationale for the Classification]
From (1) - (6), by using data by feeding before exposure, it was classified in Category 4. (7) to (11) were excluded from the evidence because the toxicity of this substance is enhanced by fasting. Besides, because exposure concentrations were lower than 90% of the saturated vapor pressure concentration (789,536 ppm), a reference value in the unit of ppm was applied as a vapor with little mist.

[Evidence Data]
(1) LC50 for rats (4 hours, fed): males: 6,350 ppm (ECETOC JACC (1985), EHC 100 (1990), MAK (DFG) vol.8 (1997), ACGIH (7th, 2001), IRIS Tox Review (2002), ATSDR (2019))
(2) LC50 for rats (4 hours, fed): males: 7,145 ppm, females: 10,275 ppm (ATSDR (2019))
(3) LC50 for rats (4 hours, fed): males: 7,100 ppm, females: 10300 ppm (MAK (DFG) vol.8 (1997))
(4) LC50 for rats (4 hours, fed): 8,600 ppm (MAK (DFG) vol.8 (1997))
(5) LC50 for rats (4 hours, fed): 1,5000 ppm (EHC 100 (1990), ATSDR (2019))
(6) Vapor pressure of this substance: 600 mmHg (25 deg C) (converted value for the saturated vapor pressure concentration: 789,536 ppm) (HSDB (Access on April 2020))

[Reference Data, etc.]
(7) LC50 for rats (4 hours, fasted): males: 415 ppm, females: 6,545 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (2019))
(8) LC50 for rats (4 hours fasted): males: 600 ppm (EHC 100 (1990))
(9) LC50 for rats (4 hours, fasted): males: 2,300 ppm (MAK (DFG) vol.8 (1997))
(10) LC50 for rats (4 hours, fasted): 4,100 ppm (MAK (DFG) vol.8 (1997))
(11) LC50 for rats (4 hours, fasted): 8,000 ppm (MAK (DFG) vol.8 (1997))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (4).

[Evidence Data]
(1) This substance is irritating to the skin when applied to humans and animals, with the irritation disappearing soon. These irritant effects may be due to p-hydroxyanisole, present in the formulations (ATSDR (2019), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), NTP TR582 (2015), ACGIH (7th, 2001), EHC 100 (1990), GESTIS (Access on May 2020), HSDB (Access on May 2020)).
(2) In an in vitro skin corrosion test using the human skin model (EST-1000), the cell viability was 79%, 53% after 3-minute and 60-minute exposure, respectively, and corrosivity was denied (AICIS IMAP (2016)).
(3) Corrosivity was denied for this substance in an in vitro skin corrosion test according to EU Method B.40 (Transcutaneous Electrical Resistance Test, TER) (REACH registration dossier (Access on June 2020)).
(4) In an in vitro skin irritation test using the reconstructed human epidermis model (EpiSkin), the cell viability was 96.6% after 15-minute exposure, it was judged as non-irritant (AICIS IMAP (2016)).

[Reference Data, etc.]
(5) This substance is irritating to the eye, skin, and respiratory tract (Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016), CICAD 51 (2003), GESTIS (Access on May 2020)).
(6) This substance is a moderate irritant of the eye and skin (MAK (DFG) vol.8 (1997)).
(7) This substance is not corrosive but irritating to the skin (AICIS IMAP (2016)).
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
[Rationale for the Classification]
It was classified in Category 2 from (1), (2). The classification result was changed due to new data (1), (2) obtained.

[Evidence Data]
(1) This substance is irritating to the eye, skin, and respiratory tract (Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016), CICAD 51 (2003), GESTIS (Access on May 2020)).
(2) This substance is a moderate irritant of the eye and skin (MAK (DFG) vol.8 (1997)).

[Reference Data, etc.]
(3) In an in vitro eye damage test using the bovine cornea according to OECD TG 437 (BCOP), an in vitro irritation score (IVIS) was 43.9, and it was judged as moderate eye irritant (AICIS IMAP (2016), REACH registration dossier (Access on June 2020)).
(4) This substance is an ocular irritant when applied to humans and animals, with the irritation disappearing soon. These irritant effects may be due to p-hydroxyanisole, present in the formulations (ATSDR (2019), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), NTP TR582 (2015), ACGIH (7th, 2001), EHC 100 (1990), GESTIS (Access on May 2020), HSDB (Access on May 2020)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) In a mouse local lymph node assay (LLNA) according to TG 429, it was judged as negative (AICIS IMAP (2016), REACH registration dossier (Access on June 2020)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
From (1), (2), it was classified as "Not classified" based on expert judgment.

[Evidence Data]
(1) As for in vivo, it is reported that it was negative in dominant lethal tests in rats and mice, negative in micronucleus tests in bone marrow cells and peripheral blood from mice and chromosomal aberration tests in bone marrow cells from mice or rats, and positive in a chromosomal aberration test in Chinese hamster bone marrow cells (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2007), Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016), IARC 119 (2019), ATSDR (2019), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001), ATSDR (1994), CICAD 51 (2003), MAK (DFG) vol.8 (1997), EHC 100 (1990), IRIS Tox Review (2002), IARC 71 (1999), NTP TR582 (2015)). It was reported to be weakly positive in a DNA damage test with the mouse kidney as the target (ATSDR (2019)).
(2) As for in vitro, it is reported that it was positive in a bacterial reverse mutation test, and in test systems in cultured mammalian cells, it was positive in a mouse lymphoma test, negative in a gene mutation test, chromosomal aberration tests gave positive and negative results, and it was positive in a sister chromatid exchange test (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2007), Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016), IARC 119 (2019), ATSDR (2019), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1994), CICAD 51 (2003), MAK (DFG) vol.8 (1997), EHC 100 (2007), EPA IRIS Tox Review (2002), IARC 71 (1999), NTP TR582 (2015)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
From (1) - (3), it was classified in Category 2 based on the latest classification results by other organizations. The classification result was changed based on the latest classification results by other organizations.

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 119 (2019)), Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), proposed in 2018)), A4 by ACGIH (ACGIH (7th, 2001)), Group C (possible human carcinogen) by EPA (IRIS (2002)), Carc.2 in EU-CLP (EU CLP classification (Access on April 2020)), and 3B in MAK (DFG) (DFG List of MAK and BAT Values 2019).
(2) In a carcinogenicity test by 2-year inhalation exposure to this substance of male and female rats, significant increases were seen in the incidences of malignant mesothelioma in males, thyroid adenoma, thyroid adenoma or carcinoma (combined), and mononuclear cell leukemia in females. Although there was no significant difference, increased incidences of renal tubule carcinoma and respiratory epithelium adenoma in the nose were also found in males (NTP TR582 (2015), IARC 119 (2019), Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016)). From the above, it was concluded that there was clear evidence of carcinogenicity of this substance in male rats, and there was some evidence of carcinogenicity in female rats (NTP TR582 (2015)).
(3) In a carcinogenicity test by 2-year inhalation exposure to this substance of male and female mice, significant increases were seen in the incidences of renal tubule adenoma and carcinoma in males, hepatocellular adenoma or carcinoma, and hemangiosarcoma or hemangioma in the liver in females. Although there was no significant difference, increased incidences of hepatocholangiocarcinoma were also found in males and females (NTP TR582 (2015), IARC 119 (2019), Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016)). From the above, it was concluded that there was clear evidence of carcinogenicity of this substance in male and female mice (NTP TR582 (2015)).
(4) In a high-quality cohort research on mortality from lung cancer in workers in a synthetic plastics plant in the USA, no association between lung cancer and exposure to this substance was observed (IARC 119 (2019)).

[Reference Data, etc.]
(5) There was no evidence of carcinogenicity in tests in rats and mice in the oral route. In a test in the inhalation route, there were no treatment-related neoplastic changes in hamsters (IARC 119 (2019)).
(6) In IARC's related assessment, they changed the classification from Group 3 to Group 2B for carcinogenicity based on NTP's carcinogenicity test results in (2), (3), but a minority group opined that a higher classification (Group 2A) was warranted based on the similarity with vinyl chloride (CAS RN 75-01-4, IARC's classification for carcinogenicity: Group 1) (IARC 119 (2019)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 2.

[Evidence Data]
(1) In a developmental toxicity study by inhalation exposure (7 hours/day) of female rats on days 6 to 15 of gestation, at doses at which maternal toxicity (without description) was observed, wavy ribs and delayed ossification of the skull bones were observed in fetuses (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
(2) In a developmental toxicity study by inhalation exposure (7 hours/day) of female rabbits on days 6 to 19 of gestation, at doses at which maternal toxicity (without description) was observed, fetal resorption and an increase in skeletal variations were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
(3) In a developmental toxicity study by inhalation exposure (22 to 23 hours/day) of female mice on days 6 to 16 of gestation, at doses at which no maternal toxicity was observed, delayed ossification was observed in fetuses (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CICAD 51 (2003)).

[Reference Data, etc.]
(4) In a developmental toxicity study by inhalation exposure (22 to 23 hours/day) of female rats on days 6 to 19 of gestation, at doses at which maternal toxicity (a decrease in body weight, death (2/18 animals)) was observed, hydrocephalus of the lateral cerebral ventricle and delayed ossification of the sternebrae were observed in fetuses (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CICAD 51 (2003)). The CICAD 51 (2003) stated that, because of the severe maternal toxicity, this study was not useful for evaluating developmental toxicity.
(5) In a three-generation reproduction toxicity study with rats dosed by drinking water, no reproductive toxicity was observed even at doses of toxicity in parent animals (slight hepatocellular fatty change in the liver, etc.) (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2007), CICAD 51 (2003), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
(6) In a developmental toxicity study with female rats dosed by drinking water on days 6 to 15 of gestation, no effects on maternal toxicity and fetuses were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2007), CICAD 51 (2003), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007).
8 Specific target organ toxicity - Single exposure Category 1 (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
[Rationale for the Classification]
Based on (2) to (4), it was classified in Category 1 (respiratory organs, liver, kidney), and based on (1), it was classified in Category 3 (narcotic effects). The nervous system was included as a specific target organ in the previous classification, but (6), which was considered to be the rationale, was excluded from the rationale because it was not a toxicity effect of this substance itself, and the classification result was changed.

[Evidence Data]
(1) It was reported that after acute inhalation exposure to this substance, humans exhibited symptoms of depression or excitement of the central nervous system, and in serious cases, they became unconscious (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
(2) Multiple acute oral toxicity tests with rats dosed by gavage were carried out, and as effects on the liver, bile canaliculi dysfunction was observed at or above 25 mg/kg (within the range for Category 1); increases in AST and ALT were observed at or above 50 mg/kg (within the range for Category 1); and an increase in urea nitrogen (BUN) was observed at or above 200 mg/kg (within the range for Category 1). As effects on the kidney, an increase in creatinine, and changes in tissues (vacuolation, pigmentation, and necrosis of the tubular epithelium, tubular dilation) were observed at 400 mg/kg (within the range for Category 2) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
(3) In multiple acute oral toxicity tests with mice dosed by gavage, as effects on the kidney, dysfunction of the proximal tubules was observed in about half of the animals within 8 hours after the administration at 200 mg/kg (within the range for Category 1); and as effects on the respiratory organs, at 200 mg/kg (within the range for Category 1), pulmonary edema and hemorrhage were observed, and necrosis and exfoliation of the Clara cells were observed within 24 hours (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
(4) In an acute inhalation toxicity test with rats (4-hour exposure), at 200 to 250 ppm (800 to 1,000 mg/m3) (within the range for Category 1), increases in serum sorbitol dehydrogenase and ornithine carbamoyltransferase activities, and centrilobular necrosis of the hepatocytes were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).

[Reference Data, etc.]
(5) The target organs for acute toxicity after oral or inhalation exposure were the liver, kidney, and the Clara cells of the lung. It was reported that the effects in the liver included an increase in liver enzymes in the serum, severe histopathological damages, including disruption of bile canaliculi, cytoplasmic vacuolization, and hemorrhagic necrosis, an increase in covalent binding of this substance, and a decrease in GSH (CICAD 51 (2003), Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2007)).
(6) In a case in which two persons developed persistent cranial nerve dysfunction while cleaning a tank, which was used for transportation of aqueous dispersion of copolymer of this substance, effects on the trigeminal nerve appeared most, and effects on the occipital auricular nerve, cutaneous nerves of the head, muscles of mastication, ocular muscles, and hypoglossal nerve were also observed. Dichloroacetylene, which was generated by the reaction between this substance and the soap used for cleaning, was considered to be the causative substance (Environmental Risk Assessment for Chemical Substances Vol. 14, (Ministry of the Environment, 2016)).
9 Specific target organ toxicity - Repeated exposure Category 1 (blood, respiratory organs, liver, kidney, reproductive organs (male))


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1) to (4), it was classified in Category 1 (blood, respiratory organs, liver, kidney, reproductive organs (males)).

[Evidence Data]
(1) It was reported that, in the case of humans, liver dysfunction was observed in 27/46 (59%) of workers at a polymerization plant under the exposure of 6 years or less (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1994)).
(2) In a two-year repeated dose toxicity study with rats dosed by drinking water, centrilobular fatty degeneration and swelling of the hepatocytes were observed in females at or above 50 ppm (males: 7 mg/kg/day; females: 9 mg/kg/day, within the range for Category 1) and in males at 200 ppm (males: 20 mg/kg/day; females: 30 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (1994))
(3) In a 14-week inhalation toxicity study with rats (6 hours/day, 5 days/week), at 6.25 to 50 ppm (converted guidance value: 0.017 to 0.132 mg/L, within the range for Category 1), effects on the respiratory organs (atrophy, mineralization, and necrosis of olfactory epithelium, nasal turbinate atrophy, etc.), and effects on the liver (centrilobular cytoplasmic alteration, cytoplasmic vacuolization, etc.) were observed; and at 100 ppm (converted guidance value: 0.26 mg/L, within the range for Category 2), effects on the testis (decreases in sperm motility and sperm count) were observed in addition to the above (NTP TR582 (2015)).
(4) In a 14-week inhalation toxicity study with mice (6 hours/day, 5 days/week), at 25 to 50 ppm (converted guidance value: 0.017 to 0.132 mg/L, within the range for Category 1), effects on the blood (decreases in the erythrocyte counts, hemoglobin concentrations, and hematocrit values), effects on the respiratory organs (respiratory epithelium squamous metaplasia of the larynx), effects on the testis (a decrease in sperm per cauda epididymis), and effects on the kidney (nephropathy, renal tubule necrosis, protein cast) were observed; and at 100 ppm (converted guidance value: 0.26 mg/L, within the range for Category 2), effects on the liver (necrosis of the liver, centrilobular hypertrophy of the hepatocytes) were observed in addition to the above (NTP TR582 (2015)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data. Besides, from (1), kinematic viscosity was calculated as 0.27 mm2/sec at 20 deg C, and kinematic viscosity at 40 deg C was 14 mm2/s or lower, but the other information could not be obtained.

[Reference Data, etc.]
(1) Kinematic viscosity was 0.27 mm2/s at 20 deg C (calculated from viscosity at 20 deg C: 0.33 mPa*s (HSDB (Access on April 2020)) and density (specific gravity) of 1.21 g/cm3 (HSDB (Access on April 2020))).

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 72-hour EbC50 = 9.12 mg/L for algae (Chlamydomonas reinhardtii) (Environmental Risk Assessment for Chemical Substances Vol. 14 (Ministry of the Environment, 2016), CICAD 51, 2003). Besides, data for algae used for classification was by a biomass method and was smaller than any data for crustacea or fish, leading to a stricter category. Therefore, the data was adopted.
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501
If chronic toxicity data are used, then it is classified as "Not classified" because it was not rapidly degradable (a 4-week degradation rate according to OECD TG301D: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1991)) and due to 96-hour EC10 = 240 mg/L for algae (Desmodesmus subspicatus) (CICAD 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 because it was not rapidly degradable (a 4-week degradation rate by BOD, closed bottle method: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1991)) and due to 48-hour EC50 = 11.6 mg/L for crustacea (Daphnia magna) (CICAD 51, 2003).
By drawing a comparison between the above results, it was classified in Category 3.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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