GHS Classification Results by the Japanese Government
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 91-22-5 |
| Chemical Name | Quinoline |
| Substance ID | R02-B-024-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 FY2015 |
| 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 | Not classified |
- |
- | - | It was classified as "Not classified" from a flash point of 99 deg C (closed cup) (HSDB (Access on April 2020)). |
| 7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition). It was classified as "Not classified." |
| 8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified." |
| 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 480 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) |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine. 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 |
- |
- | - | No data 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." |
| 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) - (4). The category was changed from the previous classification due to the use of new information sources in (1), (4). [Evidence Data] (1) LD50 for rats (described to be a test equivalent to OECD TG 401): 262 mg/kg (AICIS IMAP (2015), REACH registration dossier (Access on April 2020)) (2) LD50 for rats: 331 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013), AICIS IMAP (2015), HSDB (Access on April 2020)) (3) LD50 for rats: 331-460 mg/kg (Patty (6th, 2012)) (4) LD50 for rats: 460 mg/kg (AICIS IMAP (2015), HSDB (Access on April 2020), REACH registration dossier (Access on June 2020)) |
| 1 | Acute toxicity (Dermal) | Category 3 |
Danger |
H311 | P302+P352 P361+P364 P280 P312 P321 P405 P501 |
[Rationale for the Classification] It was classified in Category 3 from (1), (2). [Evidence Data] (1) LD50 for rabbits: 0.54 mL/kg (described as 590 mg/kg or 593 mg/kg) (AICIS IMAP (2015), REACH registration dossier (Access on June 2020), Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013), Patty (6th, 2012)) (2) LD50 for rats: 1,377 mg/kg (AICIS IMAP (2015), REACH registration dossier (Access on April 2020)) |
| 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) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. There are data in (1), but because the category cannot be determined with the data alone, it was classified as "Classification not possible." Besides, because an exposure concentration was lower than 90% of the saturated vapor pressure concentration (79 ppm), a reference value in the unit of ppm was applied as a vapor with little mist. [Reference Data, etc.] (1) There were no dead animals in a test by 8-hour inhalation exposure of rats to the saturated vapor (about 17 ppm) (converted 4-hour equivalent value: 24 ppm, within the range for Category 1) (AICIS IMAP (2015), Patty (6th, 2012)). (2) Vapor pressure of this substance: 0.06 mmHg (25 deg C) (HSDB (Access on April 2020)) (converted value for the saturated vapor pressure concentration: 79 ppm) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. There are data in (1), but because the category cannot be determined with the data alone, it was classified as "Classification not possible." Besides, because an exposure concentration was higher than the saturated vapor pressure concentration (79 ppm), it was judged as a test on mist. [Reference Data, etc.] (1) In a test by 5.5-hour inhalation exposure of rats to super-saturated vapor (about 4,000 ppm, 21.1 mg/L), all the animals died (converted 4-hour equivalent value: 29 mg/L) (AICIS IMAP (2015), Patty (6th, 2012)). (2) Vapor pressure of this substance: 0.06 mmHg (25 deg C) (converted value for the saturated vapor pressure concentration: 79 ppm) (HSDB (Access on April 2020)) |
| 2 | Skin corrosion/irritation | Category 2 |
 Warning |
H315 | P302+P352 P332+P313 P362+P364 P264 P280 P321 |
[Rationale for the Classification] It was classified in Category 2 from (1) - (6). [Evidence Data] (1) The substance is irritating to the eye and skin and causes redness after skin contact and redness and pain after entry into the eye (Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013)). (2) In a skin irritation test (Draize test) in which this substance (100 mg) was applied to rabbits for 24 hours, moderate irritation was seen (AICIS IMAP (2015)). (3) In humans, the substance is irritating to the skin and severely irritating to the eyes, with the potential to cause permanent corneal damage and retinitis (AICIS IMAP (2015)). (4) Skin and eye exposure caused moderate to severe irritation in rabbits (Patty (6th, 2012)). (5) In a skin irritation test with rabbits, slight reddening became noticeable after 24 hours, and the skin irritation was mild (GESTIS (Access on April 2020)). (6) In a skin irritation test with rabbits according to CFR Title 16, section 1500.41, the mean score after 24/72 hours for erythema and edema was 0.9 and 1.5, respectively (REACH registration dossier (Access on June 2020)). [Reference Data, etc.] (7) It was classified in Skin Irrit. 2 (H315) in EU CLP classification (EU CLP classification (Access on July 2020)). |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
[Rationale for the Classification] It was classified in Category 2A from (1) - (4). [Evidence Data] (1) The substance is irritating to the eye and skin and causes redness after skin contact and redness and pain after entry into the eye (Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013)). (2) In an eye irritation test with rabbits according to US CFR Title 16, section 1500.42, the scores at 24/72 hours were 0.8/1 for corneal opacity, 0.5/1 for iris, 2/3 for conjunctival redness, and 2.2/3 for chemosis, effects were not reversible after 7 days, and it was judged as severely irritating to the eye (AICIS IMAP (2015), REACH registration dossier (Access on June 2020)). (3) In humans, the substance is irritating to the skin and severely irritating to the eyes, with the potential to cause permanent corneal damage and retinitis (AICIS IMAP (2015), GESTIS (Access on April 2020)). (4) Skin and eye exposure caused moderate to severe irritation in rabbits (Patty (6th, 2012)). [Reference Data, etc.] (5) It was classified in Eye Irrit. 2 (H319) in EU CLP classification (EU CLP classification (Access on July 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, SI values did not exceed 3, and it was judged as negative (AICIS IMAP (2015), REACH registration dossier (Access on June 2020)). |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) As for in vivo, in a gene mutation test in lac Z transgenic mice, it was positive only in the liver and negative in the bone marrow, testis, lung, kidney, and spleen. There are reports on positive and negative results in micronucleus tests in rat bone marrow cells, positive and negative results in micronucleus tests in rat liver, a positive result in a micronucleus test in mouse bone marrow cells, positive and negative results in micronucleus tests in mouse liver, positive results in a chromosomal aberration test and a sister chromatid exchange test in rat liver, negative results in a chromosomal aberration test and a sister chromatid exchange test in mouse bone marrow, and an equivocal result in an unscheduled DNA synthesis test in rat liver (IRIS Summary (2001), Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013), IARC 121 (2019)). (2) As for in vitro, there are reports on positive and negative results in bacterial reverse mutation tests, and positive results in all of a gene mutation test, a micronucleus test, a chromosomal aberration test, a sister chromatid exchange test, and an unscheduled DNA synthesis test in cultured mammalian cells (IRIS (2001), Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013), IARC 121 (2019)). [Reference Data, etc.] (3) It was classified in Muta. 2 in EU CLP classification (EU CLP classification (Access on June 2020)). |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Despite classification results done by other organizations as described in (1), because clear evidence of carcinogenicity, including malignant tumors, was observed in two animal species in carcinogenicity studies by the Ministry of Health, Labour and Welfare, conducted according to appropriate test guidelines and GLP in (3) and (4), by emphasizing the fact that the Ministry of Health, Labour and Welfare issued the guidelines from concerns in humans via discussion in its small committee of hazard evaluation, 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 121 (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)), L (likely to be carcinogenic to humans) by EPA (IRIS (2001)), and 1B in EU CLP (EU CLP classification (Access on May 2020)). (2) This substance is a target substance in the revised 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 (Public announcement on guidelines, Feb 7, 2020 No. 27). (3) In a carcinogenicity test by drinking water administration of this substance to male and female rats for 96 weeks for males or 104 weeks for females, significant increases in the incidences of hepatocellular adenoma, hepatocellular carcinoma, and hemangiosarcoma in the liver were observed in both males and females in the dosed groups, and in the nasal cavity, a significant increase in the incidence of neuroepithelioma was seen in males, and sarcoma occurred in males and females. These were tumors that rarely occur spontaneously. And although in a few cases, hemangioma and hemangiosarcoma also occurred in organs other than the liver (the adipose, mesentery, peritoneum, lung, nasal cavity for males, the adipose, peritoneum, retroperitoneum, lung, and ovary for females) (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003), Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013), IARC 121 (2019)). (4) In a carcinogenicity test by 104-week drinking water administration of this substance to male and female mice, the occurrence of hemangioma or hemangiosarcoma was found in many animals in both males and females in all the dosed groups. Significant increases in the incidence of hemangiosarcoma were seen in the retroperitoneum, mesentery, and liver for males, and in females, significant increases in the incidence were found in hemangioma and hemangiosarcoma in the subcutis and hemangiosarcoma in the retroperitoneum, mesentery, and peritoneum. Metastasis of these tumors to other organs was observed in many. Other than the above, increased incidences were also seen in histiocytic sarcoma and hepatocellular carcinoma in the liver, and renal cell carcinoma in the kidney in males, and histiocytic sarcoma in the liver in females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003), Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013), IARC 121 (2019)). (5) In tests by diet administration of this substance (1 dose only) to male rats (Wistar or WKY) for a maximum of 20 weeks or 32 weeks, significant increases in the incidence of hemangiosarcoma in the liver were observed (IRIS Tox. Review (2011), IARC 121 (2019)). [Reference Data, etc.] (6) In a test by intraperitoneal administration of this substance to newborn mice (postnatal day 1, 8, 15), liver tumors (adenoma and hepatocellular carcinoma) were observed (IRIS Tox. Review (2011), IARC 121 (2019)). |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification was not possible due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system), Category 3 (narcotic effects, respiratory tract irritation) |
Danger Warning |
H370 H336 H335 |
P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
[Rationale for the Classification] Based on (1) to (5), it was classified in Category 1 (nervous system) and Category 3 (narcotic effects, respiratory tract irritation). After a review of the information, the classification result was changed from the previous classification. [Evidence Data] (1) This substance paralyzed the respiratory muscles (HSDB (Access on April 2020), GESTIS (Access on April 2020)) (2) This substance could cause nausea, abdominal pain, vomiting, fever, dizziness, tachycardia, and fainting (AICIS IMAP (2015), HSDB (Access on April 2020)). (3) This substance caused lethargy, respiratory distress, and prostration leading to coma (HSDB (Access on April 2020)). (4) Oral ingestion and inhalation of this substance caused coughing, nausea, emesis, difficulty in breathing, shortness of breath, wheezing, and a sense of exhaustion (Environmental Risk Assessment for Chemical Substances Vol. 6: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)). (5) Inhalation of this substance caused coughing and sore throat, and oral ingestion caused sore throat (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). [Reference Data, etc.] (6) This substance was reported to be toxic to the retina or optic nerve in humans (HSDB (Access on April 2020)), but the original source was Patty (3rd, 1981-1982), and the corresponding description was not found in Patty (6th, 2012). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (nasal cavity, liver) |
Warning |
H373 | P260 P314 P501 |
[Rationale for the Classification] There was no report on repeated exposure to this substance in humans. Effects on the nasal cavity in (1) and effects on the liver in (2) to (4) were observed at the doses of Category 2 after oral administration to test animals, therefore, it was classified in Category 2 (nasal cavity, liver). With the addition of new information (1), the classification result was changed from the previous classification. [Evidence Data] (1) In a 13-week test with rats dosed by drinking water, at or above 158 ppm (males/females: 10.3/11.5 mg/kg/day equivalent, within the range for Category 2), increases in liver and kidney weight were observed; at or above 237 ppm (males/females: 14.3/15.5 mg/kg/day equivalent, within the range for Category 2), a decrease in hemoglobin was observed in males; at or above 355 ppm (males/females: 19.1/24.4 mg/kg/day equivalent, within the range for Category 2), manifestation of the duct of the olfactory gland of the olfactory epithelium in males and females, and a decrease in erythrocyte counts and hematocrit values and single cell vacuolar degeneration of the hepatocytes in males were observed; at or above 533 ppm (males/females: 27.9/30.8 mg/kg/day equivalent, within the range for Category 2), multinuclear-like changes of the supporting cells of the nasal cavity and atrophy of the olfactory epithelium were observed; and at 800 ppm (males/females: 39.9/42.6 mg/kg/day, within the range for Category 2), a decrease in MCV and an increase in reticulocyte percentage were observed in males (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 1999)). (2) In a 16 to 40-week test with male rats dosed by feeding, at or above 0.05％ (25 mg/kg/day equivalent, within the range for Category 2), an increase in liver weight, fatty change, bile duct proliferation, and oval cell infiltration in the liver were observed; and at 0.1％ (50 mg/kg/day equivalent, within the range for Category 2), nodular hyperplasia in the liver was observed (Environmental Risk Assessment for Chemical Substances Vol. 6: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)). (3) In a 30-week test with rats, mice, hamsters, and guinea pigs dosed by feeding, an increase in relative liver weight was observed in all species at 0.20%. In the liver, formation of the oval cells in rats, mice, and hamsters, and bile duct proliferation in rats and mice were observed, and nodular hyperplasia and fatty change in rats were also observed. Also in the results of a 30-week test with male rats dosed by feeding at 0.075% (37.5 mg/kg/day equivalent, within the range for Category 2), an increase in liver weight, formation of the oval cells, slight bile duct proliferation, fatty change, appearance of cytomegalic cells, and nodular hyperplasia in the liver were observed (Environmental Risk Assessment for Chemical Substances Vol. 6: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), IRIS (2001), IRIS Tox. Review (2001)). (4) In a 40-week oral toxicity test with male rats, at or above 0.05％ (25 mg/kg/day equivalent, within the range for Category 2), an increase in relative liver weight, oval cell infiltration, bile duct proliferation, fatty change, and nodular hyperplasia were observed (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013), IRIS (2001), IRIS Tox. Review (2001)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. Besides, kinematic viscosity was calculated as 2.8 mm2/sec at 30 deg C in (1), and kinematic viscosity was not more than 14 mm2/s at 40 deg C, but no other information could be obtained. [Reference Data, etc.] (1) Kinematic viscosity was 2.8 mm2/s at 30 deg C (calculated from viscosity at 30 deg C: 2.997 mPa*s (HSDB (Access on April 2020)) and density (specific gravity) of 1.09 g/cm3 (HSDB (Access on April 2020))). |
| 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 1 |
 Warning |
H400 | P273 P391 P501 |
It was classified in Category 1 from 96-hour LC50 = 0.44 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Category 1 |
Warning |
H410 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 21-day NOEC = 0.8 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 96-hour LC50 = 0.44 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). By drawing a comparison between the above results, it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
NOTE:
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