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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	1569-02-4
Chemical Name	Propylene glycol monoethyl ether; 1-Ethoxy-2-propanol
Substance ID	R01-B-031
Classification year (FY)	FY2019
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	FY2008
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 based on flash point data of 40 deg C (closed cup) (ICSC (2004)).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 255 deg C (ICSC (2004)).
10	Pyrophoric solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to low-temperature-boiling liquids are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: >2,000 mg/kg, >4,400 mg/kg, >=5,000 mg/kg (ACGIH (7th, 2019)) (2) LD50 for rats: 4,500 mg/kg (ECETOC TR95 (2005)) (3) LD50 for rats: >5,000 mg/kg (PATTY (6th, 2012))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: 8,100 mg/kg (ACGIH (7th, 2019), PATTY (6th, 2012), ECETOC TR95 (2005))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Based on (1), since there were no deaths by exposure to this substance, the LC50 was considered to be higher than 2,213 ppm, but the category could not be determined. Therefore, it was classified as "Classification not possible." Besides, the exposure concentrations were lower than 90% of the saturated vapor pressure concentration (5,079.3 ppm), so the reference values in units of ppm were applied as vapour with little mist. [Evidence Data] (1) Inhalation in rats (4 hours): no mortality at 3,337 ppm (whole-body exposure), 2,213 ppm (nose-only exposure) (ACGIH (7th, 2019), PATTY (6th, 2012))
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Besides, since the exposure concentration was higher than 90% of the saturated vapor pressure concentration (5,079.3 ppm), a reference value in unit of mg/L was applied as a mist. [Evidence Data] (1) Inhalation in rats (4 hours): no mortality at 1,420 mg/L (ACGIH (7th, 2019))
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a skin irritation test with rabbits equivalent or similar to OECD TG 404, slight erythema was observed at 1 and 24 hours after exposure and disappeared after 48 hours. Flaking was also noted, but it disappeared within 7 days. The mean scores for erythema and edema at 24/48/72 hours were 0-1.33 and 0, respectively (REACH registration dossier (Access on August, 2019)). [Reference Data, etc.] (2) This substance was slightly irritating to the skin of rabbits, producing minimal transient reddening and edema with slight flaking of the skin after 72 hours (ACGIH (7th, 2019)). (3) Moderate irritation was observed in skin irritation tests by 24-hour occlusive or 4-hour semi-occlusive application to rabbits (ECETOC TR64 (1995)). (4) This substance is slightly irritating to the skin (PATTY (6th, 2012)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2B. [Evidence Data] (1) In an eye irritation test with rabbits, no severe irritation was shown and the effects were fully reversible within 7 days (ECETOC TR64 (1995), PATTY (6th, 2012)). (2) Results of eye irritation tests with rabbits ranged from non-irritating to moderately irritating (ACGIH (7th, 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) A skin sensitization test with guinea pigs (maximization method) on the acetate of this substance (CAS RN 54839-24-6) was negative, suggesting that the parent compound, this substance, would also be unlikely to possess skin sensitizing potential (ECETOC TR64 (1995), ACGIH (7th, 2019)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, there were reports of it being negative in a bacterial reverse mutation test and a chromosomal aberration test with human lymphocytes (ECETOC TR95 (2005)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1), as for developmental toxicity, no effects on embryos/fetuses were observed even at doses where maternal toxicity was observed. However, since there were no data on parental sexual function and fertility, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) In tests in which female rats and rabbits were exposed by inhalation to the vapor of this substance during gestation, reduced body weight gain and decreased food consumption were observed in maternal animals, but no effects on fetal development were observed (ECETOC TR95 (2005), PATTY (6th, 2012), ACGIH (7th, 2019)).
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	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 3 (narcotic effects, respiratory tract irritation). [Evidence Data] (1) In a 4-hour single inhalation exposure test with rats, at 10,000 ppm (42.5 mg/L, exceeding the range of Category 2), irritation of the eyes and nose and central nervous system depression were observed, but no mortality was reported (ACGIH (7th, 2019), PATTY (6th, 2012), ECETOC TR95 (2005)). (2) In another 4-hour single inhalation exposure test with rats, transient lachrymation, salivation, and central nervous system depression were observed at 2,213 ppm (9.59 mg/L, equivalent to Category 1), but no mortality was observed (ACGIH (7th, 2019), PATTY (6th, 2012), ECETOC TR95 (2005)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1), it is considered to correspond to "Not classified" in the inhalation route. The classification was not possible due to lack of data in the oral and dermal route. [Evidence Data] (1) In a 13-week inhalation exposure test with rats (6 hours/day, 5 days/week), increased urine volume was observed at or above 300 ppm (converted guidance value: 0.9 mg/L, within the range of Category 2), reversible eye and nose irritation, sedation and increased liver weights, and focal macrophage aggregation in the lungs were observed at 2,000 ppm (converted guidance value: 6.2 mg/L, exceeding Category 2) (ACGIH (7th, 2019), PATTY (6th, 2012), ECETOC TR95 (2005)). [Reference Data, etc.] (2) When rats were administered orally at 2 mL/kg 10 times, slightly reduced body weight gain and minor hematological changes in males, and increased liver weight in males and females were observed (ECETOC TR95 (2005)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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