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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	107-98-2
Chemical Name	Propylene glycol monomethyl ether
Substance ID	25B0008
Classification year (FY)	FY2013
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 by the Japanese Government (July, 2013)
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	From a flash point of 32 deg C (closed cup) (HSDB (Access on July 2013)), it was classified in Category 3. Besides, it is classified in Class 3, PG III (UN3092) in UNRTDG.
7	Flammable solid	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 270 deg C (HSDB (Access on July 2013)).
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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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	- -	-	-	It was classified as "Not classified" from LD50 values for rats: 6,100, 5,200, > 5,000, 5,900 mg/kg (SIDS (2003)), 7,350 mg/kg (ACGIH (7th, 2001)), and 7,510 mg/kg (DFGOT vol. 5 (1993)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 values of 13,000 and 14,100 mg/kg for rabbits (SIDS (2003)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	The category cannot be determined from LC50 values for rats: > 6 mg/L/4 hours (> 1,626 ppm) and > 24 mg/L/1 hour (> 3,252 ppm/4 hours) (SIDS (2003)). However, it was classified in Category 4 based on an LC50 value for male mice: 6,038-7,559 ppm/6 hours = 7,395-9,258 ppm/4 hours (GLP-compliant, (SIDS (2003))). Besides, because the test concentrations were lower than 90% of the saturated vapour pressure concentration of 16,435 ppm (60.6 mg/L), a reference value in the unit of ppmV was applied as a vapour without mist.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (corresponding to Category 3 in UN GHS classification) because no clear irritation was observed in a Draize test by 24-hour application to rabbit skin, there was extremely slight irritation, and the primary skin irritation index was 2 (SIDS (2003)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It was classified in Category 2B with rabbits because it was slightly irritating in all of the multiple tests (SIDS (2003)).
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. The result of no skin sensitization was obtained in a test with guinea pigs (modified Maguire test) (SIDS (2003)), but the test method is not approved by OECD, and the details such as positive rate are unknown. Therefore, it was classified as "Classification not possible."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was reported to be negative in a micronucleus test with mouse bone marrow erythrocytes (SIDS (2003), ACGIH (7th, 2013)). And as for in vitro, it was negative in all of an Ames test, a gene mutation test, a chromosomal aberration test, and a micronucleus test with cell lines of Chinese hamsters (CHO, V79) (SIDS (2003), ACGIH (7th, 2013)).
6	Carcinogenicity	Classification not possible	- -	-	-	Because it is classified in A4 by ACGIH (7th, 2013), it was classified as "Classification not possible" according to the revised GHS classification guidance for the Japanese government.
7	Reproductive toxicity	Not classified	- -	-	-	In two-generation reproductive tests in mice by oral exposure (SIDS (2003)) and rats by inhalation exposure (ACGIH (7th, 2013), SIDS (2003)), prolonged estrous cycles, reduced fertility, reduced survival and litter size of offspring, etc. were observed only in the high dose group (3,000 ppm) in rats, but it is described that the findings were the effects caused by marked toxicity that occurred as a sedation symptom and 21% body weight reduction from the control group in parent animals at the dose. Therefore, the above was not used for classification. Therefore, the above was not used for classification. No adverse effects on sexual function or fertility were found in rats at the other doses and in the two-generation test with mice. On the other hand, in tests in rats or rabbits by inhalation exposure during organogenesis period (SIDS (2003)) and tests in which rats, mice, or rabbits were orally exposed during a gestation period (SIDS (2003)), only delayed ossification was observed in a part of the tests, and no adverse effects on fetal development including teratogenicity were seen. From the above results, no adverse effects on reproduction and development were observed in tests in multiple animal species in the multiple exposure routes, therefore it was classified as "Not classified."
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	As symptoms related to narcotic effects in acute toxicity tests, somnolence, uncoordinated gait, and ataxia in rats by oral administration (ECETOC TR95 (2005)), lateral position, unresponsiveness, and central nervous system depression in rats by inhalation exposure (SIDS (2003)), and narcosis varying in intensity from slight weakness and drowsiness to deep anesthesia in rabbits by dermal administration (ECETOC TR95 (2005)) were described, respectively. It was classified in Category 3 (narcotic effects) based on these results.
9	Specific target organ toxicity - Repeated exposure	Not classified	- -	-	-	Transient central nervous system depression, slight histological changes in the liver, etc. were observed in rats, mice, and rabbits by inhalation exposure at the higher concentrations (SIDS (2003)), but NOEL or NOAEL in tests by 13-week inhalation exposure (6 hours /day) was 300 ppm (1.11 mg/L) and 1,000 ppm (3.68 mg/L) for rats, 1,000 ppm (3.68 mg/L) for mice, and 1,000 ppm (3.68 mg/L) for rabbits (SIDS (2003)). Because NOEL was above the guidance value range in all cases, it corresponds to "Not classified" in the inhalation route. Also in the cases of oral and dermal administration, NOEL of 919 mg/kg/day (converted guidance value: 357 mg/kg/day) in a 35-day oral administration test with rats (SIDS (2003)) and NOEL of 2 mL/kg/day (1,840 mg/kg/day) in a 90-day dermal administration test with rabbits (SIDS (2003)) were above the guidance value range in both, and it corresponds to "Not classified." From the above, it was classified as "Not classified" because it corresponds to "Not classified" in the oral, dermal, and inhalation routes.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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)	Not classified	- -	-	-	From 96-hour EC50 > 1000 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour EC50 > 1000 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 1000 ppm for fish (Oncorhynchus mykiss) (all EU-RAR, 2003), acute toxicity is not reported at 100 mg/L for algae, crustacea, and fish. Therefore, it was classified as "Not classified."
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not water-insoluble (solubility: very good, ICSC, 1997), and it was classified as "Not classified" in acute toxicity.
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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