GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 122-99-6
Chemical Name 2-Phenoxyethanol
Substance ID 25B0012
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 FY2008  
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 Not classified
-
-
- - A flash point is 127 deg C (closed cup) (HSDB (Access on July 2013)) above 93 deg C.
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 500 deg C (ICSC (2003)).
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
-
-
- - There are three reports on LD50 for rats of 2,937 mg/kg (males), 4,013 mg/kg (females) (GLP-compliant) (SIDS (2005)), and 1,300-4,000 mg/kg (PATTY (6th, 2012)), and it was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification) based on two GLP-compliant reports.
1 Acute toxicity (Dermal) Not classified
-
-
- - There are reports on four LD50 values for rabbits of 2,000 mg/kg (PATTY (6th, 2012)), 2,251 mg/kg (SIDS (2005)), < 3,815 mg/kg (SIDS (2005)), 13 mL/kg (PATTY (6th, 2012)) and one LD50 value for rats of < 14,300 mg/kg (SIDS (2005)). Among these, one corresponds to Category 4, and four correspond to "Not classified" including "Not classified" in the Classification JIS (Category 5 in UN GHS classification). Therefore, it was classified as "Not classified" according to the GHS classification guidance for the Japanese government. The classification was conducted using the information described in PATTY (6th, 2012) obtained in this investigation.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not classified
-
-
- - There are two reports that there was no effect in a test with rats by 7-hour inhalation of the saturated vapour at room temperature (SIDS (2005), PATTY (6th, 2012)). From the converted 4-hour equivalent value (176.5 mg/L) of the saturated vapour concentration, a reference value for vapour (mg/L) was applied, and it was classified as "Not classified." The classification was conducted based on data in SIDS (2005) and PATTY (6th, 2012) obtained in this investigation.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - In a skin irritation test with rabbits, transient erythema was observed in 2/6 animals for a 10% solution of this substance and 1/6 animals for a 2% solution, respectively (SIDS (2005)). And in another skin irritation test with rabbits, no irritation was found after the 24-hour occlusive application of undiluted this substance (SIDS (2005)). Furthermore, as for effects in humans, no irritation was seen in a patch test in 51 volunteers with a 10% solution of this substance, and no irritation was also observed in a patch test in 2,736 persons with a 1% solution of this substance. It was classified as "Not classified" based on the above information.
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
In an eye irritation test with rabbits (six animals), Draize scores at 24, 48, 72 hours after application of this substance were 0 for cornea at all time points (except for two animals with score 20 after 72 hours), 5 for iris at all time points (except for two animals with score 0 after 48 hours), and 10-14, 8-14, 8-14 for conjunctiva, respectively, and no information on recovery was obtained (SIDS (2005)). This substance is classified in "Xi; R36" in EU DSD classification and "Eye Irrit. 2 H319" in EU CLP classification. It was classified in Category 2 based on the above information.
EU DSD classification and EU CLP classification were obtained in this investigation and were added, and the category was changed to Category 2 because the information on sub-categorization could not be obtained (the information that irritation in a Draize test with rabbits or human findings is mild and disappear within seven days).
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - It is reported in PATTY (6th, 2012) that two maximization tests with guinea pigs did not indicate any potential of skin sensitization. And as for effects in humans, it is reported in SIDS (2005) that there was no sensitization in a patch test in 501 patients, and there was no sensitization in a patch test in 2,736 patients. It was classified as "Not classified" based on the above information.
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, negative results in a chromosomal aberration test with rat bone marrow cells and a micronucleus test with mouse bone marrow cells are reported (SIDS (2005)). As for in vitro, it was negative in a bacterial reverse mutation test, a chromosomal aberration test and a gene mutation test (hgprt gene) with cultured mammalian cells (SIDS (2005), NTP DB (Access on June 2013)).
6 Carcinogenicity Not classified
-
-
- - There is no classification of carcinogenicity by the international organizations. It is reported that in 104-week drinking water administration carcinogenicity tests with rats and mice, no increased incidence of tumors or tumor-related findings was observed in either species or either sex (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on June 2013)). Furthermore, FDA cancer models predict a negative result in male and female rats and male and female mice (SIDS (2005)). It was classified as "Not classified" from the above information.
7 Reproductive toxicity Classification not possible
-
-
- - It is described that in a two-generation breeding test with mice by oral administration, lower birth weights were observed in offspring at the dose where parent animals showed general toxicity (reduced weight gain, increased relative liver weights), and decreases in litter size and the proportion of pups born alive were found in offspring at the dose where parent animals died (males 25/32 animals, females 21/24 animals) (SIDS (2005), NTP DB (Access on June 2013)), but it was impossible to judge whether there were reproductive toxicity effects because general toxicity effects in parent animals were severe. Furthermore, it is described that in a test in which pregnant rabbits were dermally applied, no effects on fetuses were noted at the doses that produced maternal toxicity (SIDS (2005)). From the above, it was classified as "Classification not possible" due to lack of data.
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501
It is described that in an oral administration test with rats, signs of central nervous system depression such as reduction of activity, decreased reflex, labored respiration, and coma were observed (SIDS (2005)), and this substance is used as an anesthetic for fish (PATTY (6th, 2012)). Therefore, it was classified in Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - In a 13-week repeated oral administration test with rats, NOAEL = 80 mg/kg/day, LOAEL = 400 mg/kg/day, and inflammation in the kidney was observed at or above 400 mg/kg/day above the guidance value for Category 2 (SIDS (2005)), but NOAEL was within the guidance value range for Category 2, and toxicity effects are unclear at the upper limit of the guidance value range for Category 2. Furthermore, in a 13-week repeated dermal administration test with rabbits, there were no findings except for erythema found at the application site of the skin at 500 mg/kg/day, and there is a description of NOAEL = 500 mg/kg/day (SIDS (2005)). From the above, it corresponds to "Not classified" in the dermal route, but effects are unclear in the other routes. Therefore, it was classified as "Classification not possible" due to lack of data.
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 72-hour EC50 > 500 mg/L for algae (Desmodesmus subspicatus), 48-hour EC50 = 488 mg/L for crustacea (Daphnia magna), and 96-hour LC50 = 344 mg/L for fish (Pimephales promelas) (all SIDS, 2005), 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 (water solubility = 2.67 g/100 mL, Merck 14th, 2006), 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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