GHS Classification Result

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 98-83-9
Chemical Name alpha-Methylstyrene
Substance ID H27-B-036/C-072B_P
Classification year (FY) FY2015
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 FY2009   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 (FY2013 revised edition (Ver. 1.1))
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
Based on a flash point of 46 deg C (closed cup) (GESTIS (Access on July 2015)), it was classified in Category 3. Besides, it is classified in Class 3, PG III (UN 2303) in UNRTDG.
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Type G
-
-
- - There is a chemical group associated with self-reactive properties (olefins) present in the molecule, but because it is classified in Class 3, PG III (UN 2303) in UNRTDG, it does not correspond to hazard class of the highest precedence, self-reactive substances and mixtures.
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 574 deg C (HSDB (Access on July 2015)).
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 in the molecule
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
-
-
- - There are a total of three reports of LD50 values for rats of 4,900 mg/kg in 2 cases (PATTY (6th, 2012), NTP TR 543 (2007), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), SIDS (2002), DFGOT Vol. 15 (2001)) and 4,900-5,900 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and all data correspond to "Not classified." Besides, since the 2 cases correspond to Category 5 in UN GHS classification, it was classified as "Not classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on a report of an LD50 value of 14,560 mg/kg for rabbits (SIDS (2002)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - Based on a report of an LCLo value (6 hours) of 3,000 ppm (converted 4-hour equivalent value: 4,500 ppm (21.78 mg/L)) for rats (SIDS (2002)), it was classified as "Not classified." Besides, the reference value of mist was applied because the LCLo value is higher than the saturated vapor pressure concentration (2,962 ppm).
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
There is a report that moderate irritation was observed in a skin irritation test (standard Draize test) with rabbits (SIDS (2002)). From the above, based on the descriptions of the moderate irritation, it was classified in Category 2. Besides, after a 24-hour application of 0.5 mL of undiluted solution of this substance, severe erythema, edema, blistering, and skin corrosivity occurred after 24 hours, and the Draize score was 8.0 (maximum value 8.0) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), but this was not used for the classification because it was a 24-hour application test. This substance was classified as "Skin. Irrit. 2 H315" in EU CLP classification (ECHA CL Inventory (Access on September 2015)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
There is a report that in an eye irritation test with rabbits, after a 24-hour application of 0.1 mL of an undiluted solution of this substance, slight to moderate irritation was observed, but this resolved after 48 hours, and the Draize score was 8 (maximum value 110) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). For other eye irritation tests with rabbits, there is a report that moderate irritation was observed by an application of 86 mg of this substance (SIDS (2002)), and there is information that slight conjunctivitis was observed, but there was no corneal damage (NTP TR 543 (2007)). In addition, there are multiple descriptions that it was irritating to the eyes in humans (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), DFGOT Vol. 15 (2001)). From the above, it was classified in Category 2B based on the recovery after 48 hours in the animal test. Besides, this substance was classified as "Eye. Irrit. 2 H319" in EU CLP classification (ECHA CL Inventory (Access on September 2015)).
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there are reports of contact dermatitis and eczema in occupational exposure to this substance (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). However, since details on the exposure situation etc. were unknown, it was judged as insufficient information for the use in the classification.
5 Germ cell mutagenicity Classification not possible
-
-
- - Since a positive in-vivo micronucleus test was not a definitive finding, and all in-vitro tests were negative, classification was not possible according to the GHS classification guidance for the Japanese government. As for in vivo, in a micronucleus test with peripheral blood of female and male mice exposed by inhalation for 13 weeks, positive results in the females and negative results in the males were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NTP TR 543 (2007)). However, among these, the positive findings in females were observed at a dose where 2 out of 10 animals died, 1.8-time higher induction than the control group (0.510% vs 0.913%) was shown in NCE, it was negative in PCE. In males, it was negative in both NCE and PCE. No difference in metabolism between the female and male mice was reported. Therefore, it is difficult to say that these findings were definitive evidence for micronucleus induction. There are no other in vivo test data. As for in vitro, one positive result was observed in a sister chromatid exchange test with mammalian cultured cells, but other tests, i.e. bacterial reverse mutation tests, mammalian cell chromosome aberration tests, sister chromatid exchange tests with human lymphocytes, etc. were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JECDB (Access on July 2015), SIDS (2002), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), DFGOT Vol. 15 (2001), NTP TR 543 (2007)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
There is no information on carcinogenicity in humans. As for experimental animals, in 2-year carcinogenicity studies with rats or mice by the inhalation route, in rats, dose-related increases in the incidence of renal tubule adenoma and carcinoma (combined) were observed in males, and in mice, increases in the incidence of hepatocellular adenoma or carcinoma (combined) were observed in both sexes (IARC 101 (2012), NTP TR 543 (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and IARC classified it in Group 2B (IARC 101 (2012)). Other than this, there are no other classification results by other organizations. Therefore, it was classified in Category 2 for this hazard class.
7 Reproductive toxicity Classification not possible
-
-
- - In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by oral administration, at the high dose (1,000 mg/kg/day) where general toxic effects (decreased body weight gain, increased liver and kidney weight, thymus atrophy, etc.) were manifested significantly in parental animals, two maternal animals (2/10) failed to produce enough lactation due to the deterioration of the general conditions, resulting in the deaths of all the newborns within two days after delivery. Other than this, no effects on the sexual function and fertility of parental animals, the development of pups, and the index on growth up to 4 days after birth were observed, and the NOAEL for reproductive and developmental toxicity under this test condition is reported as 1,000 mg/kg/day (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2002), JECDB (Access on July 2015)). However, it is impossible to classify it as "Not classified" with only this result since this test is a screening test, and there is no data available for classification other than this. Therefore, it was classified as "Classification not possible" for this hazard class.
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
This substance is irritating to the respiratory tract in humans (Environmental Risk Assessment for Chemical Substances Vol.2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), ACGIH (7th, 2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), DFGOT Vol. 15 (2001), HSDB (Access on August 2015)). As for experimental animals, a decrease in motor activity and staggering gait in oral administration (at doses exceeding Category 2) in rats, eyelid closure, coordination ataxia, and sensation loss in inhalation exposure (at the doses corresponding to Category 2) in rats, and decreased motor activity and convulsions in dermal application in rabbits (at doses exceeding Category 2) were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
From the above, this substance is irritating to the respiratory tract and has narcotic effects, and it was classified in Category 3 (respiratory tract irritation, narcotic effects).
New information was added, and the previous classification was reviewed.
9 Specific target organ toxicity - Repeated exposure Category 1 (liver), Category 2 (respiratory organs, kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
As for humans, there is a report on liver dysfunction, vitamin B12 deficiency, and immunological change (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG422) with rats, at 200 mg/kg/day (converted guidance value: male 95.6 mg/kg/day, female 91.1-100 mg/kg/day) within the range of Category 2, increased ALT, increases in absolute and relative weight of the liver and kidney, acidophilic change in hepatocytes, and vacuolation of the renal tubular epithelium (female) were observed (JECDB (Access on July 2015)).
Atrophy and metaplasia of the olfactory epithelia in the nasal cavity, and atrophy or hyperplasia of the Bowman's glands were found at or above 75 ppm (converted guidance value: 0.27 mg/L) within the range for Category 2, and hyaline degeneration of the olfactory epithelia in the nasal cavity was seen at 150 ppm (converted guidance value: 0.53 mg/L) in a 14-week inhalation toxicity test with mice. Hyperplasia of basal cells of the olfactory epithelia was observed at 100 ppm (0.48 mg/L) within the range for Category 2 in a 2-year carcinogenicity test with rats by the inhalation route, and olfactory epithelial metaplasia and hyperplasia of the glands were observed at 100 ppm (0.48 mg/L) within the range for Category 2 in a 2-year carcinogenicity test with mice by the inhalation route (NTP TR 543 (2007)).
From the above, effects on the liver were observed in humans, and as for experimental animals, effects on the nasal cavity, liver, and kidney were observed within the range for Category 2.
Therefore, it was classified in Category 1 (liver), Category 2 (respiratory organs, kidney).
Besides, in the previous classification, the effect on the kidney in rats was denied as a finding specific to male rats, but the kidney was adopted as the target organ this time since the effect on the kidney was also observed in female rats. In addition, effects on the liver observed in rats were denied as an adaptive response. However, in the same test, the effects on lipid metabolism such as disappearance of lipid droplets in hepatocytes, decreased triglycerides, fatty changes of the renal tubular epithelium in the kidney, and an increase in lipid droplets of adrenal zona fasciculata were suggested, and there are reports of findings in humans, therefore, the liver was adopted as the target organ.
10 Aspiration hazard Category 1


Danger
H304 P301+P310
P331
P405
P501
Since it is a hydrocarbon, and the kinematic viscosity is calculated to be 1.03 mm2/sec (20 deg C) from the numerical data (viscosity: 0.940 mPa*s (20 deg C), density (specific gravity): 0.9106) listed on HSDB (Access on August 2015), it was classified in Category 1.

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
From 48-hour EC50 = 2.62 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005), Initial Risk Assessment (NITE, CERI, NEDO, 2008)), it was classified in Category 2.
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 (non-biodegradable, a degradation rate by 14-day BOD = 0% (Official Bulletin of Ministry of International Trade and Industry, 1979)), and 72-hour NOEC = 0.3 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)).
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 and 96-hour LC50 = 7.28 mg/L for fish (Oryzias latipes) (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005), Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
From the above results, it was classified in Category 2.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

To GHS Information