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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	98-82-8
Chemical Name	Cumene
Substance ID	23B5530
Classification year (FY)	FY2011
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It corresponds to Category 3 from a flash point of 31 deg C [closed-cup] (ICSC (2000)), which is >= 23 deg C and <= 60 deg C. Besides, it is classified in Class 3, PG III in UNRTDG (UN1918).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	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 420 deg C (ICSC (2000)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not applicable	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13	Oxidizing liquids	Not applicable	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	Among five LD50 values for rats (1,400 mg/kg, 4,000 mg/kg, 2,700 mg/kg, 3,980 mg/kg (the above, EU-RAR (2001)), 2,910 mg/kg (ACGIH (2001))), one corresponds to Category 4, and four correspond to "Not classified" in the Classification JIS. It was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification), to which most corresponded.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on two LD50 values for rabbits (10,600 mg/kg and > 3,150 mg/kg (the above, EU-RAR (2001))).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	It was classified in Category 3 based on an LC50 value of about 2,000 ppm by 4-hour exposure of mice (DFGMAK-Doc.13 (1999)). Besides, because the LC50 value was lower than 90% of the saturated vapour pressure concentration (5921 ppm), the reference value of gasses was applied as a vapour with little mist.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	It was classified as "Not classified" based on LC50 of 8000 ppm (39.3 mg/L) by 4-hour exposure of rats (ACGIH (2001)). Besides, because the LC50 value was above the saturated vapour pressure concentration (5920 ppm), it was regarded as a test on mist.
2	Skin corrosion/irritation	Not classified	- -	-	-	In a test in which 0.5 mL of undiluted this substance was applied to rabbits for 24 hours, only a slight defatting and flaking of the skin were observed, and it was assessed as slightly irritating (ACGIH (2001)). Therefore, it was classified as "Not classified" in the Classification JIS (Category 3 in UN GHS classification).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In a test in which two drops of this substance were applied to the rabbit eye, there was slight conjunctival irritation but no corneal injury, and it was assessed as slightly irritating (ACGIH (2001)), and in a test in which 0.1 mL of undiluted this substance was applied to the rabbit eye for 24 hours, moderate erythema and discharge were seen, but the improvement was complete within five days (ACGIH (2001)). Therefore, it was classified in Category 2B.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Not classified	- -	-	-	It was classified as "Not classified" because it is reported that there was no skin sensitization in a maximization test with guinea pigs (OECD TG 406) (CICAD 18 (1999)).
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" because negative results were obtained in a micronucleus test with bone marrow after oral administration to mice and a micronucleus test with peripheral blood or bone marrow after inhalation exposure of mice (in vivo somatic cell mutagenicity tests) (DFGMAK-Doc.13 (1999), NTP DB: (Access on Sep. 2011)). Besides, as for in vitro tests, it was reported to be negative in all of an Ames test, a chromosomal aberration test with Chinese hamster ovary cells, and an HGPRT test with Chinese hamster ovary cells (ACGIH (2001), CICAD 18 (1999)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 2 because IARC classified it in Group 2B for carcinogenicity (IARC news (vol.101, 2011)). Besides, in 2-year inhalation exposure carcinogenicity tests with rats and mice, increased incidences of respiratory epithelial adenoma in the nose and renal tubule adenoma or carcinoma in rats, and increased incidences of alveolar/bronchiolar neoplasms in mice were reported and regarded as evidence of carcinogenicity (NTP TR 542 (2009)).
7	Reproductive toxicity	Classification not possible	- -	-	-	In developmental toxicity tests by inhalation exposure of rats and rabbits during the organogenesis period, in rats, general toxicity such as significantly decreased food consumption and significantly reduced weight gain was observed in the high concentration group, but there were no effects on reproductive parameters such as the number of implantations, sex ratio, and fetal body weight, and no increases in incidences of malformations or variations were seen (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Also, in rabbits, general toxicity was found in the high concentration group, including death in maternal animals (2/15 animals), significantly decreased food consumption, and significantly reduced weight gain, and there were tendencies for increases in resorptions and dead implants and a decrease in viable fetuses, but there were no significant effects on gestational parameters and no increased incidence of malformations (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). From the above results, there were no adverse effects on the development of offspring, but it was impossible to judge effects on sexual function and fertility due to lack of data. Therefore, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, liver, kidney), 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	After oral administration to rats, motor disturbances, narcosis, reductions in the white blood cell count, and changes in the liver and kidney by necropsy were observed at 1350-2000 mg/kg (EU-RAR (2001), DFGMAK-Doc.13 (1999)), and as for inhalation exposure (vapour), gait abnormalities were seen after 6-hour exposure of rats to 2.45 mg/L (converted 4-hour equivalent value: 3.0 mg/L) or above (EU-RAR (2001)), and there were symptoms of central nervous system depression such as narcosis, ataxia, and loss of reflexes after 4-hour exposure of mice (LC50 = 9.89 mg/L), and the histopathological examination revealed fatty deposits in the liver and kidney and phagocytosed nuclear fragments in the reticular cells on the splenic corpuscles (DFGMAK-Doc.13 (1999)). Furthermore, in another test with mice, signs of central nervous system depression and pathological changes in the liver, kidney, and spleen were found after 7-hour exposure to 10 mg/L (converted 4-hour equivalent value: 13.23 mg/L) (EU-RAR (2001)). The above effects were observed within the guidance value range for Category 2 in oral administration but were seen within the guidance value range for Category 1 for inhalation exposure. Therefore, it was classified in Category 1 (central nervous system, liver, kidney). Furthermore, because narcosis was described as one of the symptoms of central nervous system depression for both oral and inhalation routes, it was classified in Category 3 (narcotic effects). On the other hand, it was classified in Category 3 (respiratory tract irritation) from the report that short-term inhalation exposure of mice led to a decrease in the respiration rate and irritation of the mucous membranes of the upper respiratory tract (DFGMAK-Doc.13 (1999)). Besides, reductions in the white blood cell count were seen in the above oral administration test with rats (1350-2000 mg/kg) (EU-RAR (2001)), but it was not used for classification because the changes had no consistency as blood effects.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	It corresponds to "Not classified" in the oral route because it is reported that in a 6-month repeated oral administration test with rats (0, 154, 462, 769 mg/kg bw/day), there were no effects except those on kidney weight seen in the high dose group, and NOAEL was 154 mg/kg bw/day (EU-RAR (2001)). On the other hand, in 14-week inhalation exposure (vapour) tests with rats and mice (doses for both animal species: 0, 62.5, 125, 250, 500, 1000 ppm [0, 0.30, 0.61, 1.23, 2.46, 4.9 mg/L]), effects observed within the guidance value range were limited to lesions of the kidney characteristic of alpha 2-micro globulin accumulation in male rats, and no other findings indicative of adverse effects were found (NTP TR 542 (2009)). Because the findings in the kidney were considered specific to male rats and not applicable to humans, it corresponds to "Not classified" also in the inhalation route. However, the effects of dermal exposure are unknown due to no data. Therefore, it was classified as "Classification not possible" for specific target organ toxicity (repeated exposure). Besides, as information in humans, it is reported that in workers who had used this substance as a solvent for 1-2 years, there we no occurrences of damage caused by everyday exposure (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)).
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	It was classified in Category 1 because it is a hydrocarbon, and the kinematic viscosity at 40 deg C was 0.73 mm2/s (EU-RAR (2001)), which was <= 20.5 mm2/s. Besides, it is described that if swallowed, the substance enters the lung and could result in chemical pneumonitis (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)), and the EU classified it in R65.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 1.2 mg/L for crustacea (Mysidopsis bahia) (CICADS 18, 1999).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (a 28-day degradation rate in a test on a degradation rate according to 84/449/EEC (using closed bottles): 13% (EU-RAR, 2001)), 72-hour NOEC = 0.22 mg/L for algae (Desmodesmus subspicatus) (EU-RAR, 2001), and 21-day NOEC = 0.35 mg/L for crustacea (Daphnia magna) (EU-RAR, 2001, etc.). 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 due to being not rapidly degradable (a 28-day degradation rate in a test on a degradation rate according to 84/449/EEC (using closed bottles): 13% (EU-RAR, 2001)), and 96-hour LC50 = 2.7 mg/L for fish (Oncorhynchus mykiss) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)). From the above results, it was classified in Category 2.
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.

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