GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 57-55-6
Chemical Name Propane-1,2-diol (Propylene glycol)
Substance ID H30-A-003-METI, MOE
Classification year (FY) FY2018
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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)  
Model SDS by MHLW (External link)  
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 Not classified
-
-
- - A flash point is 101 deg C (closed cup) (ICSC (J) (2014)).
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 (J) (2014)).
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
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Not classified."
[Evidence Data]
(1) LD50 for rats: 22,000 mg/kg (SIDS (2004))
(2) LD50 for rats: 8,000-46,000 mg/kg (EPA Pesticide (2006))
(3) LD50 for rats: 21,000-33,700 mg/kg (PATTY (6th, 2012))

[Reference Data, etc.]
(4) LD50 for mice: 24,900 mg/kg (SIDS (2004))
(5) LD50 for mice: 23,000-24,900 mg/kg (EPA Pesticide (2006))
(6) LD50 for mice: 23,900-31,800 mg/kg (PATTY (6th, 2012))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rabbits: 20,800 mg/kg (SIDS (2004))
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - [Rationale for the Classification]
Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1)-(5), it was classified as "Not classified."

[Evidence Data]
(1) There is a report that no irritation was observed when the undiluted liquid of this substance was applied to human skin for 48 hours (SIDS (2004)).
(2) There is a report that no irritation was observed when the undiluted liquid of this substance was applied to the skin of six people for 2 hours (SIDS (2004)).
(3) There is a report that no irritation was observed in a skin irritation test (OECD TG404) with rabbits (SIDS (2004)).
(4) There is a report that no irritation was observed in a skin irritation test (the modified Draize method) with rabbits (SIDS (2004)).
(5) There is a report that this substance is non irritant in a skin irritation test (EPA OPPTS 870.2400) with rabbits (EPA Pesticide RED (2006)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified." Besides, since (3) is a description of IPCS and as for (4) and (5), the details of the data are unknown, it was judged that they cannot be used for classification judgment.

[Evidence Data]
(1) There are reports that in 2 eye irritation tests (OECD TG 405) with rabbits, no irritation was observed by application of undiluted liquid of this substance (SIDS (2004)).
(2) There is a report that this substance is non irritant in an eye irritation test (EPA OPPTS 870.2400) with rabbits (EPA Pesticide RED (2006)).

[Reference Data, etc.]
(3) It is irritating to human eyes, causing redness and pain if entering the eyes (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).
(4) There is a report of eye irritation in humans (IPCS PIM 443 (Accessed Oct. 2018)).
(5) There is no report of eye damage by occupational exposure to this substance, but there is a report that it may cause transitory stinging, blepharospasm, and lacrimation (PATTY (6th, 2012)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
Based on (1)-(4), it was classified as "Not classified."

[Evidence Data]
(1) There are reports that in a human skin patch test (n=104, GLP), after induction by semi-occlusive/occlusive application of a 50% solution of this substance followed by the challenge of semi-occlusive/occlusive application of a 50% solution. As a result, no positive response was shown in either case (semi-occlusive or occlusive) (SIDS (2004)).
(2) There is a report that in a human skin patch test (the modified Draize method, n=204), after induction by occlusive application of a 12% solution of this substance followed by the challenge of occlusive application of a 12% solution. As a result, no positive response was shown (SIDS (2004)).
(3) There are reports of seven maximization tests (GPMT) with guinea pigs, only one test showed a weakly positive result, but all other six tests showed negative results (J. Am. Coll. Toxicol., 13 (1994)).
(4) There is a report that in a skin sensitization test (OECD TG 429, LLNA method, n = 4) with mice, a Stimulation Index was 1.2 for a 50% solution of this substance and 1.6 for an undiluted solution of this substance (REACH registration dossier (Accessed Oct. 2018)).
5 Germ cell mutagenicity Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) It was negative in a dominant lethal test (single or 5-day oral administration) with rats (SIDS (2004)).
(2) It was negative in an in vivo chromosomal aberration test (single or 5-day oral administration) with rat bone marrow (SIDS (2004)).
(3) It was negative in an in vivo micronucleus test (single intraperitoneal administration) with mouse bone marrow (SIDS (2004)).

[Reference Data, etc.]
(4) Two bacterial reverse mutation tests were negative (SIDS (2004)).
(5) It was negative in an in vitro chromosomal aberration test with human lymphocytes (SIDS (2004)).
(6) A positive result (S9-) was obtained in an in vitro chromosomal aberration test with cultured mammalian cells (CHO), but it was a result at high concentrations where cytotoxicity developed (SIDS (2004)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
As for carcinogenicity, there is no available report on humans.
The available animal test results are limited to one species in (1). Therefore, classification was not possible due to lack of data.

[Evidence Data]
(1) No increase in the incidence of tumors was observed in a carcinogenicity study (male 200-1,790 mg/kg/day, female: 300-2,100 mg/kg/day) with rats (30 animals/sex/group) dosed by feeding for 2 years (SIDS (2004)).
(2) There are no classification results by domestic or international organizations.

[Reference Data, etc.]
(3) No change in the incidence of tumors was observed in a chronic toxicity study with dogs (5 animals/sex/group) dosed by feeding (2,000, 5,000 mg/kg/day) for 2 years (SIDS (2004)).
(4) No increase in the incidence of skin tumors was observed in a test with female mice (number of animals unknown) dermally dosed (2-21 mg/body/day) for a lifetime (SIDS (2004)).
(5) No increase in the incidence of skin tumors was observed as a result of application of this substance (unknown dose) to the pinna of rats for 10-14 months (SIDS (2004)).
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
The fertility study by oral administration in (1) and the developmental toxicity tests with pregnant animals in (2) and (3) showed no reproductive and developmental toxicity. Therefore, it was classified as "Classification not possible."

[Evidence Data]
(1) In a continuous breeding study with mice dosed by drinking water, in which 10,100 mg/kg/day was administered for up to 98 days, no treatment-related reproductive effects were observed in F0 and F1 parental animals, and no treatment-related effects on viability and growth were observed in F1 and F2 pups (SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).
(2) In a developmental toxicity test with pregnant rats administered by gavage during the organogenesis period (gestational Day 6-15), no adverse effect was observed at up to 1,600 mg/kg/day in either maternal animals or fetuses (SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).
(3) In a developmental toxicity test with pregnant rabbits administered by gavage during the organogenesis period (gestational Day 6-18), deaths (no dose-related) were observed in the groups of 12-267 mg/kg/day for maternal animals, but no developmental effect was observed at up to the highest dose of 1,230 mg/kg/day in the fetuses (SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).

[Reference Data, etc.]
(4) In a developmental toxicity test with pregnant mice dosed by gavage during the organogenesis period (gestational Day 6-15), no adverse effects in maternal animals or fetuses were observed at doses up to 1,600 mg/kg/day (SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).
(5) In a developmental toxicity test with pregnant rats exposed by inhalation during the organogenesis period (gestational Day 6-15), no adverse effects were observed at doses up to 300 ppm in either maternal animals or fetuses (ATSDR Addendum (2008)).
(6) In a developmental toxicity test with pregnant rabbits exposed by inhalation during the organogenesis period (gestational Day 7-19), no adverse effects were observed at doses up to 300 ppm in either the maternal animals or fetuses (ATSDR Addendum (2008)).
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, haemal system), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
[Rationale for the Classification]
Based on the findings on humans in (1)-(3), the central nervous system and haemal system are considered to be target organs. Also, from the data on experimental animals in (3) and (4), the central nervous system and haemal system are also considered to be target organs. In addition, in (3), narcotic effects are observed. From the above, it was classified as Category 1 (central nervous system, haemal system), and Category 3 (narcotic effects).

[Evidence Data]
(1) A 2-year-old boy developed central nervous system depression and metabolic acidosis following accidentally ingesting about 3 ounces of hair gel containing about 1.75-2.25% of this substance. The boy vomited repeatedly, became lethargic, and only responded to strong pain (ATSDR Addendum (2008), SIDS (2004)).
(2) Symptoms of acute intoxication caused by ingestion range from drowsiness to anesthesia, loss of consciousness, and coma. Other signs include serum hyperosmolality, lactic acidosis, and hypoglycemia (IPCS PIM 433 (Accessed Oct. 2018)).
(3) Acute toxic symptoms by ingestion of high doses are central nervous system depression and narcotic effects. In the case of rats and mice, they are ataxia, ptosis, decreased locomotor activity, decreased body/limb tone, and decreased respiration (ATSDR Addendum (2008)).
(4) In a single oral dose study with rats, decreased erythrocyte counts, haemoglobin, and haematocrit values, and increased reticulocytes, plasma haemoglobin, and osmolality were observed at or above 730 mg/kg within the range of Category 2. In addition, rough cell surface and membrane destruction were also observed by electron microscopic observation of erythrocytes (SIDS (2004), ATSDR Addendum (2008)).
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system, respiratory organs)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on the human data in (1) and (2), the central nervous system is considered to be the target of this substance, and Category 1 (central nervous system) was adopted. In addition, according to the data on experimental animals in (3), as for effects in the inhalation route, effects on the respiratory organs were observed at the doses within the range of Category 1, therefore, it was classified in Category 1 (respiratory organs). Besides, since the test concentration of 160 mg/m3 (51.4 ppm) in the data of (3) is lower than 90% of the saturated vapor concentration (108.9 ppm), and it is considered to be a vapor without mist, a reference value was applied as a vapor.

[Evidence Data]
(1) As a result of ingesting large amounts of this substance repeatedly as a solvent for oral treatment, a 15-month-old youngster developed adverse symptoms due to hypoglycemia and central nervous system depression. The symptoms improved rapidly after discontinuation of treatment (PATTY (6th, 2012)).
(2) An 11-year-old boy suffered grand mal seizures after having taken a medication containing this substance for more than one year. In addition, there is a report of symptoms of central nervous system depression in patients taking phenytoin dissolved in this substance (IPCS PIM 443 (Accessed Oct. 2018)).
(3) In a study in which rats were exposed by inhalation (160-2,200 mg/m3, 6 hours/day, 5 days/week) to this substance for 13 weeks, at or above 160 mg/m3 (converted guidance value: 0.12 mg/L) within the range of Category 1, bleeding of the nasal cavity, an increase in secretion of the eye, and at or above 1,000 mg/m3, thickening of the respiratory epithelium with increases in goblet cell number and mucin in the nasal cavity were observed (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).

[Reference Data, etc.]
(4) No adverse effects were observed at 50,000 ppm (about 2,500 mg/kg/day) in a study with rats dosed by feeding for 15 weeks (SIDS (2004)).
(5) In a study with rats dosed by drinking water for 140 days, all the animals died from starvation and dehydration due to decreased water consumption at concentrations of 25% or more. NOAEL is reported as 10% (13,200 mg/kg/day) (SIDS (2004)).
(6) In a study with rats dosed by feeding for 104 weeks, no adverse effects were observed at 50,000 ppm (male: 1,700 mg/kg/day, female: 2,100 mg/kg/day) (SIDS (2004)).
(7) In a study with dogs dosed by feeding for 104 weeks, no adverse effects were observed at 2,000 mg/kg/day, but effects on the haemal system (decreases in erythrocyte counts and hemoglobin, etc.) were observed at 5,000 mg/kg/day (SIDS (2004)).
(8) In a study with cats dosed by feeding for 2-3 months, effects on the haemal system (increase in Heinz bodies, hemosiderin pigmentation of the liver (secondary changes)) were observed at or above 443 mg/kg/day (SIDS (2004)).
10 Aspiration hazard Classification not possible
-
-
- - [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 (Acute) Not classified
-
-
- - It was classified as "Not classified" from 72-hour EC50 (growth rate) > 1000 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour EC50 (immobile) > 1000 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (all Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment. 2018)).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - It was classified as "Not classified" due to rapid degradability (readily biodegradable, an average degradation rate by BOD: 90% (J-CHECK, 1991)), 72-hour NOEC (growth rate) = 1000 mg/L for algae (Pseudokirchneriella subcapitata), and 21-day NOEC (reproduction inhibition) = 1000 mg/L for crustacea (Daphnia magna) (both Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2018)).
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


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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