NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	108-65-6
Chemical Name	Propylene glycol monomethyl ether acetate
Substance ID	m-nite-108-65-6_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Its flash point is 42degC (NFPA (13th, 2006)), which is >= 23degC and <= 60degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified	- -	-	-	Its autoignition point is 354degC (NFPA (13th, 2006)), which is >= 70degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on the rat LD50 values documented (> 10000mg/kg (males), > 8532mg/kg (females), and > 13700mg/kg b.w. (males)) (SIDS (accessed June 2008)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rabbit LD50 (> 5000mg/kg) (SIDS, accessed June 2008), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Its acute toxicity values for rats (4-hour exposure values) are: LC0 > 31.01mg/L (5737 ppm) (SIDS (accessed in June 2008)), LC0 > 9.342mg/L (1728 ppm) (DFGOT vol. 5 (1993)), LD50 > 19.82mg/L (3667 ppm) (SIDS (accessed in June 2008)). Because these values are lower than 90% of the saturated vapour pressure concentration, criterion values for gases were adopted. Since no categories were appropriate, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	No detailed information is available other than descriptions that the substance was not irritating based on the primary skin irritation index of 0.0 obtained from rabbit tests (SIDS (accessed June 2008)), and that the substance caused slight irritation or cutaneous irritation (DFGOT vol. 5 (1993), PATTY (5th, 2001)). Based on JIS classification criteria, the substance was classified into "Not classified" (Category 3 in the United Nations GHS classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In a test involving 9 rabbits, conjunctival redness, chemosis, iritis and corneal opacity were observed following application of the substance. Mean scores were 0.8, 0.5, 0.1 and 0.2, respectively. All signs of irritation disappeared after 4 days. The effects were judged to be "slightly irritating" (SIDS (2000)). The substance was conclusively estimated to be slightly to moderately irritating (SIDS (2003)). Based on these data, the substance was classified into Category 2B.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Not classified	- -	-	-	Several tests using guinea pigs (Magnusson-Kligman maximization tests and the method of Maguire) concluded that the substance did not produce sensitization (SIDS (accessed June 2008), DFGOT vol. 5 (1993)). Based on these results, the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Although in vitro mutagenicity tests (Ames tests and chromosomal aberration tests) yielded negative results (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed June 2008)), there were no in vivo test data available. Thus, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Not classified	- -	-	-	In combined repeated oral dose toxicity study with the reproduction/developmental toxicity tests using rats, body weight gain was significantly suppressed in parents of both sexes, but no significant differences from control were observed in indices that measure reproductive functions of parents, fertility, and development of the offspring (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed in June 2008)). In addition, in oral administration tests using pregnant rats during the organogenetic period, no effects were observed on development of the offspring including teratogenicity (SIDS (accessed in June 2008)). As results suggested no adverse effects on reproductive functions, fertility, and development of the offspring including teratogenicity, the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	In an oral test in rats, observations included lethargy at all doses (500 - 10000 mg/kg) (SIDS (access on June 2008)). In a dermal test in rabbits, narcotic effects were also found as the main symptoms (DFGOT vol. 5 (1993)). In a 2-week inhalation test with mice, an acute change, degeneration of olfactory epithelium in the nasal cavities, occurred at dose levels of 16.2 mg/L and higher concentrations and the effect was more severe and more extensive in a dose-related manner. An inflammatory exudate was found in the lumen of the nasal cavities in some animals (SIDS (access on June 2008)). Based on these data, the substance was classified into Category 3 (narcotic effects, respiratory tract irritation).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In combined repeated oral dose toxicity study with the reproduction/developmental toxicity tests using rats, decreased body weight gain and reduced food consumption were observed at 1000mg/kg/day, however, at 300mg/kg/day or below, no effects of exposure were observed. Its NOAEL was 300mg/kg/day (90-day conversion: approx. 150mg/kg/day) for both sexes and serious toxic effects were not detected (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed in June 2008)). On the other hand, in 2-week inhalation exposure tests, a slight increase in the eosinophilic granularity of the proximal convoluted tubules of the kidneys were detected mostly in male rats at 5.39mg/L (90-day conversion: 0.83mg/L) or above. In addition, degeneration of olfactory epithelium in nasal cavities in rats was detected at 16.18mg/L, and in mice, degradation occurred rapidly at concentrations of 1.62mg/L (90-day conversion: 0.25mg/L) or above, and it became more severe and extensive with increased exposure concentrations. In some of the treated animals, inflammatory exudate was observed in their lumens (SIDS (accessed in June 2008)), but its toxicological significance is unclear since the symptoms may be recoverable (the substance is a respiratory tract irritant by single exposure). From these results, symptoms observed in male rat kidney are mild, and histological changes in nasal cavities of rats and mice, especially of mice, were detected at concentrations within the range of Category 2 guidance values. However, since details of these tests were not provided, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	Based on its 72h-ErC50 > 1000mg/L for algae (Pseudokirchn eriella subcapitata), 48h-EC50 of 370mg/L for crustaceans (Daphnia magna), and 96h-LC50 > 100mg/L for fish (medaka) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 1997), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Since it is water soluble (water solubility > 100g/L (EU-RAR, 2006)) and its classification for acute toxicity is "Not classified", the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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