GHS Classification Results by the Japanese Government
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 100-41-4 |
| Chemical Name | Ethylbenzene |
| Substance ID | R03-B-006-MHLW |
| Classification year (FY) | FY2021 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2015 FY2014 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 (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. |
| 2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 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 18 deg C (closed cup) and a boiling point of 136 deg C (ICSC (2018)). Besides, it is classified in Class 3, PG II in UNRTDG (UN1175). |
| 7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 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. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 432 deg C (ICSC (2018)). |
| 10 | Pyrophoric solids | Not classified (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 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). |
| 13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine. |
| 14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. |
| 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. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1), it was classified as "Not classified" (Category 5 in UN GHS classification). [Evidence Data] (1) LD50 for rats: between 3,500 to 4,700 mg/kg (SIAR (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (2011), OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), AICIS IMAP (2020), EHC 186 (1996)) |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: 15,400 mg/kg (SIAR (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (2011)) (2) LD50 for rabbits: 17,800 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), AICIS IMAP (2020)) (3) LD50 for rabbits: 77,400 mg/kg (EHC 186 (1996)) |
| 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] Based on (1) and (2), it was classified in Category 4. Also, since the exposure concentration was lower than 90% (7,994 ppm) of the saturated vapor pressure concentration, it was judged to be in a vapor state and classified based on the reference value in units of ppmV. [Evidence Data] (1) LC50 (4 hours) for rats: 4,000 ppm (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2011, AICIS IMAP (2020), EHC 186 (1996), SIAR (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), REACH registration dossier (Accessed Oct. 2021)) (2) LC50 (2 hours) for rats: 13,367 ppm (converted 4-hour equivalent value: 9,451.9 ppm) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2011, AICIS IMAP (2020)) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1), it was classified as "Not classified." Besides, the exposure concentration was higher than the saturated vapor pressure concentration (38.55 mg/L) and it was judged as mist. Based on the new findings, the classification result was changed. [Evidence Data] (1) LC50 (2 hours) for rats: 55 mg/L (converted 4-hour equivalent value: 27.5 mg/L) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015)) |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. Besides, since the application time was long in (1) and the number of applications was large in (2), the findings of (1) and (2) were not used for classification. [Reference Data, etc.] (1) It was reported that, in a skin irritation test with rabbits (24-hour occlusive application of 0.01 mL of undiluted solution), slight skin irritation was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EHC 186 (1996), REACH registration dossier (Accessed Nov. 2021)). (2) It was reported that, in a skin irritation test with rabbits (application of undiluted test substance 20 times in total during a 4-week period), clear erythema and edema and superficial necrosis were observed and this substance caused moderate cumulative skin irritation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2011), ACGIH (7th, 2011), EHC 186 (1996), REACH registration dossier (Accessed Nov. 2021)). |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
[Rationale for the Classification] Based on (1) to (5), it was classified in Category 2B. [Evidence Data] (1) It was reported that, in 9 volunteers exposed to 25 ppm of this substance for 7.5 hours, reversible conjunctival and respiratory tract irritation were observed, and in 3 subjects, mucosal irritation was observed (AICIS IMAP (2020)). (2) Volunteers were exposed to this substance at 23 to 85 ppm for 8 hours. As a result, no adverse effects were observed after the exposure, but after exposure at over 100 ppm, central nervous system symptoms, such as malaise, drowsiness, and headache, and irritative symptoms in the eyes and the respiratory mucous membranes were observed (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020)). (3) It was reported that. in an eye irritation test with rabbits (application of two drops of undiluted test substance), this substance caused slight conjunctival irritation but no effects on the cornea were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EHC 186 (1996), ACGIH (7th, 2011), REACH registration dossier (Accessed Nov. 2021)). (4) It was reported that, in an eye irritation test with rabbits (application of 0.5mL undiluted test substance), this substance caused slight irritant reaction (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EHC 186 (1996), REACH registration dossier (Accessed Nov. 2021)). (5) There was a report that it was slightly irritating to the eyes and caused no damage to the cornea in rabbits, while there was also a report that it caused minor irreversible damages (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2011)). [Reference Data, etc.] (6) It was reported that six subjects exposed at 1,000 ppm for up to five minutes experienced eye irritation with profuse lacrimation, but tolerance developed rapidly. At 2,000 ppm, eye irritation and lacrimation were immediate and severe and were accompanied by moderate nasal irritation, constriction in the chest, and vertigo. 5,000 ppm produced intolerable irritation to the eyes and nose (ACGIH (7th, 2011)). |
| 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] Based on (1), it was classified as "Not classified." Besides, since there was no skin sensitization in human findings, the classification result was changed in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In a human repeat insult patch test (HRIPT) with 25 volunteers, no skin sensitization reaction was observed after application of a mixture containing 10% of this substance in petrolatum (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), AICIS IMAP (2015), ACGIH (7th, 2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIAR (2002)). |
| 5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Also, the classification result was changed in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for in vivo, in two micronucleus assays: one in the bone marrow of mice (intraperitoneal application, twice with an interval of 24 hour, 650 mg/kg/time) and the other in the peripheral blood erythrocytes of mice (inhalation exposure, 13 weeks, up to 1,000 ppm), and an unscheduled DNA synthesis test with the hepatocytes of mice, this substance was all negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), AICS IMAP (2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), ACGIH (7th, 2011), ATSDR (2010), REACH registration dossier (Accessed Oct. 2021)). (2) As for in vitro, in a bacterial reverse mutation test and a chromosomal aberration test with the cultured mammalian cells (rat liver cell lines (RL1, RL4) and Chinese hamster ovary cells), the results were all negative, but in a gene mutation test using the mouse lymphoma cells (L5878Y) and a micronucleus test using the syrian hamster embryo cells, positive (-S9) results were obtained (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), AICS IMAP (2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), ACGIH (7th, 2011), ATSDR (2010), REACH registration dossier (Accessed Oct. 2021)). [Reference Data, etc.] (3) In a micronucleus test using the bone marrow of mice for 1-phenylethanol (CAS RN 98-85-1), which is a metabolite of this substance, used as a test substance (single oral dose, up to 750 mg/kg), negative results were also obtained (AICS IMAP (2020), REACH registration dossier (Accessed Oct. 2021)). |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] From (1), as for the classification results by international evaluation organizations, the IARC classified it in Group 2B, and in addition, among the increase in tumors observed in (2) to (4), only the increased incidences of renal tubule adenomas and renal tubule adenomas and carcinomas combined in male rats in (2) gave a clear evidence, which provided only limited evidence for carcinogenicity. Accordingly, it was judged that there was inadequate evidence to classify it in Category 1B, and this substance was classified in Category 2. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) As for the classification results by domestic and international organizations, the IARC classified this substance in Group 2B (IARC 77 (2000)), the Japan Society For Occupational Health (JSOH) classified it in Group 2B (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020: proposed in 2001)), the ACGIH classified it in A3 (ACGIH (7th, 2011)), the DFG classified it in Category 4 (DFG MAK (2011)). On the other hand, the EPA has not changed the classification in Group D (not classifiable as to human carcinogenicity) (IRIS (1991)). (2) In a two-year carcinogenicity study by inhalation exposure with rats, at the highest dose of 750 ppm, there was clear evidence in males based on increased incidences of renal tubule adenomas and renal tubule adenomas and carcinomas combined and there was some evidence in females based on increased incidences of renal tubule adenomas (IARC 77 (2000), OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), AICIS IMAP (2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), ACGIH (7th, 2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), NTP TR466 (1999)). (3) In a two-year carcinogenicity study by inhalation exposure with mice, at the highest dose of 750 ppm, there was some evidence in males based on increased incidences of alveolar/bronchiolar adenomas and in females based on increased incidences of hepatocellular adenomas and hepatocellular adenomas + carcinomas (IARC 77 (2000), OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), AICIS IMAP (2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), ACGIH (7th, 2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), NTP TR466 (1999)). (4) Rats were dosed by gavage with this substance at 800 mg/kg/day for two years. As a result, olfactory neuroepitheliomas in the nasal cavity developed in 3 of 50 males and 1 of 50 females. Since the neoplasms occur very rarely in the same strain of rats, it was regarded as an evidence for carcinogenicity of this substance. However, the lack of details on the number of animals with tumors, survival rate, control data, statistical analysis, etc. was noted (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), IARC 77 (2000)). (5) Based on the classification in Group 2B by the IARC, this substance is a target substance in the public announcement on guidelines (carcinogenicity 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 (guidelines in order to prevent the impairment of workers' health, announcement No. 26 on March 31, 2016). |
| 7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on the classification result of the Japan Society For Occupational Health and the fact that it is subject to the Rules on Labour Standards for Women in (1) to (5), it was classified in Category 1B. [Evidence Data] (1) This substance was classified in Group 2 of reproductive toxicants by the Japan Society For Occupational Health (JSOH) (proposed in FY2014) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2021)). (2) Based on its reproductive toxicity, this substance was designated as a target substance under the Rules on Labour Standards for Women (Order of Ministry of Labour No. 3 of 1986, designated in the amendment in 2012)). (3) In a developmental toxicity study with female rats by inhalation exposure on days 6 to 20 of gestation, lower fetal weight and an increase in the number of fetuses with skeletal variations were observed at or above 1,000 ppm at which a decrease in maternal body weight was observed, and furthermore, an increase in the number of dead fetuses and the increasing number of resorbed embryos were observed at 2,000 ppm (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), ACGIH (7th, 2011), DFG MAK (2018)). (4) In a developmental toxicity study with female rabbits by inhalation exposure on days 1 to 24 of gestation (days 0 to 23), increased liver weight in maternal animals and a decreased number of viable fetuses were observed at a high dose of 1,000 ppm (AICIS IMAP (2020), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), ACGIH (7th, 2011)). (5) In a developmental toxicity study with female rabbits by inhalation exposure on days 7 to 20 of gestation, at a high dose of 230 ppm, no adverse effects were observed in maternal animals but a decrease in the number of fetuses was observed (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), ACGIH (7th, 2011)). [Reference Data, etc.] (6) In a two-generation reproduction toxicity study with rats (dosed by gavage on lactation days 1 to 4) by inhalation exposure (25 to 500 ppm, 6 hours/day), at the highest dose of 500 ppm, transient decreases in bodyweight gain and increased liver weight (adaptive change) were observed in F0 and F1 parental animals, but no developmental effects were observed in F1 and F2 pups up to 500 ppm. In addition, F2 pups were subjected to an FOB observation after the lactational period of F1 maternal animals until postnatal day 60, a motor activity test, an acoustic startle reaction test, a learning and memory test in the Biel water maze, and histological investigations of the brain and the nervous system (postnatal days 21 and 72), but no effect suggesting developmental neurotoxicity were detected up to 500 ppm (AICIS IMAP (2020), OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), ACGIH (7th, 2011), DFG MAK (2018)). (7) Sperms of 48 men exposed to organic solvent of ethylbenzene (50.7 to 53.8 ppm), benzene (10.0 to 14.9 ppm), toluene (50.6 to 56.7 ppm), and xylene (10.8 to 13.0 ppm) for two years at a Mexican rubber factory and 42 male office clerks who were unexposed were collected once a week for 3 weeks and qualitative differences in the sperms were examined. The result showed that the normal motile sperms were 17% in the exposed group and 76% in the unexposed group and the OR=16.0, 95% CI: 5.11 to 51.99. An increase in nonspecific aggregation, a decrease in sperm count, and reduced motility were observed in the exposed group compared to the unexposed group, but no associations with the solvent were described (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015)). |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (respiratory tract irritation, narcotic effects) |
Warning |
H335 H336 |
P304+P340 P403+P233 P261 P271 P312 P405 P501 |
[Rationale for the Classification] Based on (1) and (2), there were respiratory tract irritation and narcotic effects in the human findings. Based on (3) to (5), there were effects on the respiratory organs within the range for Category 1 in the findings in animals. Besides, based on (4), the effects on the respiratory organs observed in guinea pigs were judged as reversible effects. Based on the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects). [Evidence Data] (1) It was reported that, in 9 volunteers exposed to 25 ppm of this substance for 7.5 hours, reversible conjunctival and respiratory tract irritation were observed and mucosal irritation was observed in 3 subjects (AICIS IMAP (2020)). (2) It was reported that, in volunteers exposed to this substance, no adverse effects were observed at 100 ppm but when exposures exceeded 200 ppm, respiratory tract irritation, conjunctivitis, and drowsiness were commonly observed (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), ACGIH (2011)). (3) It was reported that, in an acute inhalation exposure test with guinea pigs (100 minutes), moderate pulmonary congestion was observed at 44.6 mg/L (converted 4-hour equivalent value: 28.8 mg/L, in the range corresponding to "Not classified"). Besides, since it resolved following 4 to 8 day recovery period, it was reported that it was considered to be a reversible change (AICIS IMAP (2020)). (4) It was reported that, in an acute inhalation exposure test with guinea pigs (8 hours), ataxia was observed at 8.92 mg/L (converted 4-hour equivalent value: 12.6 mg/L, within the range for Category 2) and intense irritation of the conjunctiva and nasal mucous membranes, followed by unsteadiness, staggering gait, apparent unconsciousness, intermittent tremors and twitching of the extremities, and changes in respiration were observed at 22.3 to 44.6 mg/L (converted 4-hour equivalent value: 31.5 to 63.1 mg/L, in the range corresponding to "Not classified") (ACGIH (2011)). (5) It was reported that, in an acute inhalation exposure test with mice, lacrimation, reduced respiration rate, effects on the central nervous system, sedation, closed eyes, and numbness were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (auditory organ, nervous system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1) to (3), there were auditory organs and nervous system effects in the human findings, and based on (4), it was auditory organ effects in the findings in animals. Based on the above, it was classified in Category 1 (auditory organs, nervous system). Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that many reports on auditory toxicity were obtained. It was reported that, in an epidemiological study, the blood ethylbenzene level was significantly higher in people who complained of hearing loss than those with no complaint and the odds ratio for hearing loss in the high-frequency range after adjusting for sex, age, etc. was significantly related to the blood ethylbenzene level (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020)). (2) It was reported that, in workers exposed simultaneously to approx. 30 ppm of ethylbenzene and noise at 85 dB, hearing loss was observed more markedly compared to the workers exposed only to noise, and it suggested that exposure to a relatively low level of ethylbenzene was associated with hearing loss (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015)). (3) It was reported that, as a result of a neurobehavioral function test with the workers in (2), the workers at both factories were significantly inferior in simple reaction time, number counting, manual dexterity, visual memory retention, and eye tracking ability to office workers, and in terms of length of service, the workers with 3 years or more were significantly inferior. For this reason, neurotransmitters of the workers at both factories and the office workers were examined, and it was found that acetylcholinesterase activity was significantly lower in the workers at both factories. Accordingly, it was reported that reduced neurological function and neurotransmitter disorder were suggested (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), OEL Documentations (Japan Society For Occupational Health (JSOH), 2020)). (4) It was reported that, in a 13-week repeated inhalation exposure test with rats (vapor, 6 hours/day, 6 days/week), 30% loss in the three rows of outer hair cells (OHCs) in the organ of Corti was observed at 0.893 mg/L (0.765 mg/L, within the range for Category 2), and an increase in audiometric threshold due to brainstem auditory evoked potential (23 to 27 db) was observed at 1.79 mg/L (1.53 mg/L, in the range corresponding to "Not classified") (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015), AICIS IMAP (2020)). [Reference Data, etc.] (5) It was reported that, in a 103-week repeated inhalation exposure test with mice (vapor, 6 hours/day, 5 days/week), syncytial change (multinucleation) of hepatocytes (males) and hyperplasia of the anterior pituitary (females) were observed at 1.12 mg/L (0.8 mg/L, within the range for Category 2), and hyperplasia of thyroid follicular cells, centrilobular hepatocyte hypertrophy (males), hepatocellular necrosis (males), metaplasia of the alveolar epithelium (males), and an increased incidence of eosinophilic foci of hepatocytes (females) were observed at 3.35 mg/L (2.39 mg/L, in the range corresponding to "Not classified") (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015)). (6) It was reported that, in a 104-week repeated inhalation exposure test with rats (vapor, 6 hours/day, 5 days/week), inflammation of the prostate (males) and lower body weight (females) were observed at 0.33 mg/L (0.236 mg/L, within the range for Category 2) and lower body weight (males) was observed at 1.12 mg/L (0.8 mg/L, within the range for Category 2) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2015)). |
| 10 | Aspiration hazard | Category 1 |
Danger |
H304 | P301+P310 P331 P405 P501 |
[Rationale for the Classification] Based on (1) - (3), it was classified in Category 1. [Evidence Data] (1) This substance is a hydrocarbon compound. (2) This substance has a kinematic viscosity of 0.63 mm2/s as determined at 40 deg C (CLH Report (2010), ECHA RAC Opinion (2012)). (3) This substance or mixtures containing this substance could have the potential to cause chemical pneumonitis if aspirated (AICIS IMAP (2020), Environmental Risk Assessment for Chemical Substance (Ministry of Environment, 2015)). |
| 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) | - |
- |
- | - | - |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | - |
- |
- | - | - |
| 12 | Hazardous to the ozone layer | - |
- |
- | - | - |
NOTE:
|