GHS Classification Results by the Japanese Government
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 96-33-3 |
| Chemical Name | Methyl acrylate |
| Substance ID | R02-B-020-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 FY2011 |
| 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 |
| 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 2 |
 Danger |
H225 | P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
It was classified in Category 2 based on a flash point of -3 deg C (closed cup) and a boiling point of 80 deg C (NFPA (14th, 2010)). Besides, it is classified in Class 3, PG II in UNRTDG (UN1919). |
| 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 commercially available products, stabilized, are classified in Class 3 in UNRTDG (UN1919) and are considered to be not applicable to self-reactive substances and mixtures, hazards of the highest precedence. Therefore, this substance 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 468 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 oxygen (but not fluorine or chlorine) 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 not possible due to lack of data. |
| 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." |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 3 |
 Danger |
H301 | P301+P310 P264 P270 P321 P330 P405 P501 |
[Rationale for the Classification] It was classified in Category 3 from (1) - (7). [Evidence Data] (1) LD50 for rats: 277 mg/kg (ACGIH (7th, 2014), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009), SIAR (2008), CLH Report (2020), AICIS IMAP (2014), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016)) (2) LD50 for rats: 277-765 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (3) LD50 for rats: 280-420 mg/kg (CLH Report (2020)) (4) LD50 for rats: 300 mg/kg (ACGIH (7th, 2014), OEL Documentations (Japan Society For Occupational Health (JSOH), 2004), CLH Report (2020), AICIS IMAP (2014)) (5) LD50 for rats: 750 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016)) (6) LD50 for rats: 765 mg/kg (SIAR (2008)) (7) LD50 for rats: 768 mg/kg (CLH Report (2020)) |
| 1 | Acute toxicity (Dermal) | Category 4 |
 Warning |
H312 | P302+P352 P362+P364 P280 P312 P321 P501 |
[Rationale for the Classification] It was classified in Category 4 from (1) - (4). [Evidence Data] (1) LD50 for rabbits: 1.3 mL/kg (1,239 mg/kg) (ACGIH (7th, 2014)) (2) LD50 for rabbits: 1,243 mg/kg (ACGIH (7th, 2014), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009), OEL Documentations (Japan Society For Occupational Health (JSOH), 2004)) (3) LD50 for rabbits: 1,250 mg/kg (SIAR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), AICIS IMAP (2014)) (4) LD50 for rats: 1,300 mg/kg (ACGIH (7th, 2014)) |
| 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 3 |
Danger |
H331 | P304+P340 P403+P233 P261 P271 P311 P321 P405 P501 |
[Rationale for the Classification] It was classified in Category 3 from (1) - (7). Besides, because exposure concentrations were lower than 90% of the saturated vapor pressure concentration (113,956 ppm), the reference value in units of ppm was applied as a vapor with little mist. [Evidence Data] (1) LC50 for rats (4 hours): 1,000 ppm (ACGIH (7th, 2014)) (2) LC50 for rats (4 hours): 1,350 ppm (OEL Documentations (Japan Society For Occupational Health (JSOH), 2004), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), ACGIH (7th, 2014), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)) (3) LC50 for rats (4 hours): 1,600 ppm (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)) (4) LC50 for rats (vapor, 4 hours): 5.7 mg/L (1,618.8 ppm) (SIAR (2008), AICIS IMAP (2014)) (5) LC50 for rats (4 hours): 6.5 mg/L (1,846 ppm) (SIAR (2008)) (6) LC50 for rats (4 hours): 750-1,810 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (7) LC50 for rats (nose exposure, 4 hours): < 3,000 mL/m3 (3,000 ppm) (MAK (DFG) (2019)) (8) Vapor pressure of this substance: 86.6 mmHg (25 deg C) (HSDB (Access on April 2020)) (converted value for the saturated vapor pressure concentration: 113,956 ppm) |
| 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 | Category 1 |
 Danger |
H314 | P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501 |
[Rationale for the Classification] It was classified in Category 1 from (1) - (4). [Evidence Data] (1) In a skin irritation test with rabbits according to OECD TG 404, it was judged as highly irritating. Besides, superficial necrosis on the skin was observed in part of animals after 1-hour semi-occlusive or occlusive application, and necrosis was seen in all the animals after 4-hour occlusive application (SIDS (2008), REACH registration dossier (Access on June 2020)). (2) This substance was judged as highly irritating in a skin irritation test (BASF test) by semi-occlusive application to rabbits, and 15 minutes to 20 hours of application led to necrosis and strong edema (SIDS (2008), MAK (DFG) vol.6 (1994), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), REACH registration dossier (Access on June 2020)). (3) This substance irritates the skin and respiratory tract and severely irritates the eye, and causes erythema or pain in contact with the eye or skin (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)). (4) This substance was judged as highly irritating in a skin irritation test with rabbits by a semi-occlusive application of the substance (0.5 mL) equivalent to OECD TG 404, the mean erythema score of 2.17 (maximum 3) and the mean edema score of 2.44 (maximum 4) were reported (AICIS IMAP (2014)). [Reference Data, etc.] (5) It was classified in Skin Irrit. 2 (H315) in EU-CLP classification (EU CLP classification (Access on June 2020)). (6) This substance is a reversible irritant to the skin and mucous membranes (ACGIH (7th, 2014)). |
| 3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 | P305+P351+P338 P280 P310 |
[Rationale for the Classification] It was classified in Category 1 from (1) - (4). [Evidence Data] (1) In an eye irritation test with rabbits (Draize test), an irritation score was 66 (maximum 110), and it was judged as severely irritating (SIDS (2008), MAK (DFG) vol.6 (1994), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), REACH registration dossier (Access on June 2020)). (2) This substance irritates the skin and respiratory tract and severely irritates the eye, and causes erythema or pain in contact with the eye or skin (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)). (3) In an eye irritation test in which this substance (0.1 mL) was applied to the rabbit eye, the mean score at 72 hours after application for corneal opacity, iris, conjunctival redness, and chemosis were 2.33 (maximum 3), 1 (maximum 1), 2 (maximum 2), and 3 (maximum 3), respectively (AICIS IMAP (2014)). (4) This substance was classified in Category 1 in skin corrosion/irritation. [Reference Data, etc.] (5) In an in-vitro eye damage test with the bovine cornea (BCOP) according to OECD TG 437, in vitro irritancy score (IVIS) was 12.55, and Category 1 was denied (REACH registration dossier (Access on June 2020)). (6) This substance is a reversible irritant to the skin and mucous membranes (ACGIH (7th, 2014)). (7) It was classified in Eye Irrit. 2 (H319) in EU-CLP classification (EU CLP classification (Access on June 2020)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| 4 | Skin sensitization | Category 1A |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] Data supporting Category 1, Category 1A, or Category 1B were mixed, but because the Japan Society for Occupational Health (JSOH) classified it in occupational skin sensitizers Group 2 in (1), it was classified in Category 1A according to the GHS classification guidance for the Japanese government. [Evidence Data] (1) This substance was assigned as occupational skin sensitizers Group 2 by the Japan Society for Occupational Health (JSOH) (OEL Documentations (Japan Society for Occupational Health (JSOH), 2010)). (2) As a result of a 2-day application of a 20% solution of this substance to 30 volunteers, irritation reactions were seen in 10, and as for a 2% solution, allergic reactions were observed in 2 out of 22 persons (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)). (3) In a local lymph node assay (LLNA) in mice according to TG 429, it was judged as positive, and EC3 of 19.6% was reported (AICIS IMAP (2014), REACH registration dossier (Access on June 2020)). (4) This substance (1% in petrolatum, 20% in olive oil) produced positive results in a patch test in humans, and cross-sensitization with other acrylates and methacrylates was reported (AICIS IMAP (2014)). (5) It was judged as positive in a skin sensitization test with guinea pigs (split adjuvant test) (REACH registration dossier (Access on June 2020)). (6) It was reported to be positive in skin sensitization tests with guinea pigs (Polak test, modified Draize test, modified maximization test) (SIDS (2008), MAK (DFG) vol.16 (2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), REACH registration dossier (Access on June 2020)). (7) This substance is sensitizing in guinea pigs, with cross-reactivity with other acrylates and related compounds (ACGIH (7th, 2014)). [Reference Data, etc.] (8) It was reported to be negative in a skin sensitization test with guinea pigs (open epicutaneous test) (SIDS (2008), MAK (DFG) vol.16 (2001)). (9) It was classified in Skin Sens. 1 (H317) in EU-CLP classification (EU CLP classification (Access on June 2020)). |
| 5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in two micronucleus tests in bone marrow cells after oral or inhalation administration to mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009), SIDS Dossier (2008), SIAR (2008)). Besides, there is also a report that it was positive in a micronucleus test in bone marrow cells after intraperitoneal administration to another strain of mice, but the test details are unknown, and there was no dose-dependency in increased incidences of micronuclei (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2008)). (2) As for in vitro, it is reported that most bacterial reverse mutation tests gave negative results, and it was negative and positive in gene mutation tests in cultured mammalian cells and positive in a chromosomal aberration test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009), SIDS Dossier (2008), SIAR (2008)). |
| 6 | Carcinogenicity | Category 1B |
 Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] There is no information on carcinogenicity in humans. There are classification results by other organizations as described in (1), and no carcinogenicity was observed in mice, but this substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare. Also, in rats, tumors in the nasal cavity occurred in both males and females, and IARC concluded that there was sufficient evidence in experimental animals for carcinogenicity. From the above, by giving weight to the fact that the Ministry of Health, Labour and Welfare issued the public announcement after discussion by the small committee of hazard evaluation of MHLW from concerns for carcinogenicity in humans, it was classified in Category 1B. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 122 (2019)), A4 by ACGIH (ACGIH (7th, 2001)), Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH)) (proposed in 2004)), and D (not classifiable as to human carcinogenicity) by EPA (IRIS) (IRIS (1990)). (2) This substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act (Notification No. 27, February 7, 2020). (3) In a carcinogenicity test by 104-week inhalation exposure to this substance of male and female rats, tumor formation in the nasal cavity was seen in both males and females, and there was a significant increase in the incidence of squamous cell carcinoma of the nasal cavity found in males. In females, there was squamous cell carcinoma in the nasal cavity, which was not a significant increase, but this was a rare tumor that was not observed in the historical data. From the results, it was concluded that there was clear evidence of carcinogenic activity in male rats, and there was some evidence of carcinogenic activity in female rats (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2017), IARC 122 (2019)). (4) In a carcinogenicity test by 24-month inhalation exposure to this substance of male and female rats, there were significant increases in the incidences of sarcoma of the soft tissue (skin or subcutis) and malignant leukemic tumors (leukemia, lymphoma, lymphosarcoma) in males, and there was a significant increase in the incidence of adenoma of the pituitary gland in females (IARC 122 (2019)). (5) In a carcinogenicity test by inhalation exposure to this substance of male and female mice for 94 weeks (males) or 97 weeks (females), no increase in the incidence of any neoplasm was found in males or females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2017), IARC 122 (2019)). |
| 7 | Reproductive toxicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (3), no reproductive toxicity was observed. Therefore, it was classified as "Not classified." Since the new pieces of information (1) and (3) were obtained, the classification result was changed from the previous classification. [Evidence Data] (1) In a two-generation reproduction toxicity test with rats exposed to this substance in the inhalation route (OECD TG 416), even at doses at which parental toxicity effects (reduced body weight gain, a decrease in food consumption, histopathological damage to the nasal area) were observed, no effect on fertility was observed, but reduced body weight gain was observed in pups (MAK (DFG) (2019)). (2) In a developmental toxicity study by inhalation exposure in female rats on days 6 to 20 of gestation, at doses at which maternal toxicity effects (reduced body weight gain, a decrease in food consumption) were observed, a significant decrease in fetal body weight was observed. In one fetus of the highest dose group, a malformation was observed, which was not considered to be caused by this substance. There was no effect on embryo/fetal mortality or malformations (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), OEL Documentations (Japan Society For Occupational Health (JSOH), 2004), Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009), SIDS (2003), MAK (DFG) (2019)). (3) In a developmental toxicity study by inhalation exposure in female rabbits on days 6 to 28 of gestation, even at doses at which maternal toxicity effects (degeneration and atrophy of the olfactory epithelium) were observed, no developmental effects were observed (MAK (DFG) (2019)). |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (respiratory organs) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
[Rationale for the Classification] Based on (1) and (2), there was information that irritation to the respiratory organs was observed in humans. Based on (3) and (4), there was information that effects on the respiratory organs and lungs were observed in experimental animals at doses within the range for Category 1 and Category 2. Therefore, it was classified in Category 1 (respiratory organs). With the addition of new information sources (1) and (2), the classification result was changed from the previous classification. [Evidence Data] (1) It was reported that in humans exposed by inhalation to this substance at 75 ppm (equivalent to 0.264 mg/L), irritation to the eyes, nose, and lungs was observed (ACGIH (7th, 2014)). (2) It was reported that in humans exposed to this substance at 70 ppm (250 mg/m3) and 140 ppm (500 mg/m3), irritation to the upper respiratory tract and conjunctiva was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (3) In an inhalation exposure test of this substance with rats, mice, and hamsters, inflammation of the eyes and nose, and dyspnea were observed at 1.0 to 10.9 mg/L (within the range for Category 1 to Category 2). At or above 1.9 mg/L (within the range for Category 1), there were death cases, and in the animals that died, dilation and congestion of the heart, and congestion, hyperemia, and edema of the lungs were noted. Mottled lungs were observed in some of the animals at sacrifice (SIDS Dossier (2003)). (4) In an inhalation toxicity test of this substance with rats, dyspnea, diaphragmatic breathing, wheezing, breathing sounds, red and purulent eyes and nose, salivation, sallow skin, piloerection, hyperexcitability, tremor, and poor general condition were observed at 10.8 mg/L (within the range for Category 2) (MAK (DFG) (2019)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] There was information that based on (1) and (2), effects on the respiratory organs were observed in humans, and based on (3) to (5), effects on the respiratory organs were observed in test animals at a dose of Category 1, and it was classified in Category 1 (respiratory organs). In the previous classification, the kidney was also one of the target organs, but no sufficient evidence of effects in humans was obtained. As a result of a review of the information, the classification result was changed from the previous classification. [Evidence Data] (1) Subjective symptoms were examined in 195 workers at a chemical fiber plant, which consisted of 51 people in group A who were exposed at the average exposure concentrations of 21.3 mg/m3 for this substance and 1.0 mg/m3 for acrylic acid (CAS RN 79-10-7), 62 people in group B exposed at 4.7mg/m3 for this substance and 5.2 mg/m3m for acrylic acid, 22 people in group C exposed to only acrylic acid (11.2 mg/m3), and 60 people in control group who were not exposed. As a result, cough, shortness of breath, sputum, and sore throat were observed only in group A exposed mainly to this substance. In addition, in group A, there was also a significantly higher incidence of hyperemia of the pharynx and pulmonary markings observed in a chest X-ray (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009)). (2) In a prospective epidemiological study conducted at an acrylic ester production plant (exposure group: 60 people, control group: 60 people, average age of both groups: 40 years old, average exposure period: 13 years), about 40% in the exposure group had complaints of burning sensations of the eyes and throat, irritative cough, headache, nausea, dizziness, and discomfort in the skin; and increases in triglyceride and monocytes were observed (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009)). (3) In a 90-day inhalation exposure test with rats, irritation to the eyes and nose, dyspnea, and atrophy and necrosis of the olfactory epithelium of the nasal cavity were observed at or above 242 ppm (equivalent to 0.852 mg/L, [converted guidance value: 0.568 mg/L], within the range for Category 2); and tracheitis, pulmonary hyperemia, and bronchopneumonia were observed at 626 ppm (equivalent to 2.2 mg/L [converted guidance value: 1.47 mg/L], within the range exceeding Category 2) (MAK (DFG) (2019)). (4) In a two-year inhalation exposure test with rats, atrophy of the olfactory epithelium was observed at or above 15 ppm (equivalent to 0.0528 mg/L, within the range for Category 1), and hyperplasia of basal cells of the nasal mucosa was observed at 45 ppm (equivalent to 0.158 mg/L, within the range for Category 1) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009), OEL Documentations (Japan Society For Occupational Health (JSOH), 2004)). (5) In a 104-week inhalation exposure test of this substance with rats, atrophy and regeneration of the olfactory epithelium, hyperplasia of basal cells and goblet cells of the respiratory epithelium, and metaplasia in the respiratory epithelium were observed at or above 40 ppm (equivalent to 0.141 mg/L, within the range for Category 1); and hyperplasia of the squamous epithelium and transitional epithelium, metaplasia in the squamous epithelium, inflammation of the transitional epithelium and olfactory epithelium, degeneration of the gland, inflammatory polyps, and adhesion and mineral deposits in the turbinate were observed in the nasal cavity at 160 ppm (equivalent to 0.563 mg/L, within the range for Category 2) (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2016)). [Reference Data, etc.] (6) In a case-crossover study for over 8 weeks at a chemical products manufacturing plant involving 10 production workers, 4 intermittently exposed workers, and one industrial hygienist with previous very low exposure, there were no changes in the results of a spirometry inspection, which was one of pulmonary function tests, and a methacholine inhalation test before, during, and after the work. According to a preliminary study, however, 50% of the target workers of the study and 60% of all workers involved in manufacturing complained of bronchial hypersensitivity at the start of the study (OEL Documentations (Japan Society For Occupational Health (JSOH), 2004), MAK (DFG) (2019)). (7) In a 13-week toxicity test of this substance with rats dosed by drinking water, renal damages such as renal tubular enlargement and formation of acidophilic casts were observed at 20 mg/kg (within the range for Category 2). However, these damages were spontaneous renal lesions which commonly occur in the strain of rats used in the test, and they were not considered to be related to the administration (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| 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 96-hour LC50 = 1.1 mg/L for fish (Cyprinodon variegatus) (SIAR, 2003). |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Category 2 |
 - |
H411 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 because it is not rapidly degradable (a 28-day degradation rate by BOD, OECD TG301D: 59.8% (SIAR, 2003)) and due to 21-day NOEC = 0.36 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999), Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2011), Initial Risk Assessment (NITE, CERI, NEDO, 2008)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because it is not rapidly degradable (a 28-day degradation rate by BOD, OECD TG301D: 59.8% (SIAR, 2003)) and due to 96-hour LC50 = 1.1 mg/L for fish (Cyprinodon variegatus) (SIAR, 2003). From the above results, it was classified in Category 2. The classification result was changed from the previous classification by reviewing the information used in judgment on rapid degradability. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
NOTE:
|