GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 122-60-1
Chemical Name 2,3-Epoxypropyl phenyl ether [Phenyl glycidyl ether]
Substance ID H29-B-043
Classification year (FY) FY2017
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 FY2006  
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) 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 114 deg C (closed cup) (ICSC (J) (2005)).
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is a chemical group associated with self-reactive properties (strained ring in chemical structure) in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 430 deg C (GESTIS (Access on June 2017)).
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
-
-
- - Based on reports of LD50 values of 2,600 mg/kg, 3,850 mg/kg (male), and 4,260 mg/kg (male) for rats (all in DFGOT Vol. 4 (1992)), it was classified as "Not classified" (Category 5 in UN GHS classification). The category was changed from the previous classification according to the current GHS classification guidance for the Japanese government.
1 Acute toxicity (Dermal) Category 4


Warning
H312 P302+P352
P362+P364
P280
P312
P321
P501
There are two reports of LD50 values of 1.5 mL/kg (1,655 mg/kg) (male) and 2,990 mg/kg for rabbits (both in DFGOT Vol.4 (1992)), one case corresponds to Category 4, and the other one corresponds to "Not classified" (Category 5 in UN GHS classification). It was classified in Category 4 by adopting the category with higher hazard.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
Based on a description of skin irritation in humans (Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and a report that slight irritation was shown in a skin irritation test with rabbits (ACGIH (7th, 2014)), it was classified in Category 2. Besides, this substance was classified as "Skin Irrit. 2" in the EU CLP classification (ECHA CL Inventory (Access on June 2017)).
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
Based on a description that this substance is irritating to the eyes (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2014)), and a report that it was moderately irritating in an eye irritation test with rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), it was classified in Category 2.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
On the basis of multiple case reports showing skin sensitization of this substance in humans (Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and that positive results were shown in multiple skin sensitization tests with guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), it was classified in Category 1. Besides, this substance is classified as "Skin Sens. 1" in the EU CLP classification (ECHA CL Inventory (Access on June 2017)).
5 Germ cell mutagenicity Classification not possible
-
-
- - The substance 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, a dominant lethal test with rats was negative, a micronucleus test with mouse bone marrow cells, and a chromosomal aberration test with rat bone marrow cells was negative, and a DNA synthesis test with mouse testes was negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2014), PATTY (6th, 2012), IARC 47 (1989)). As for in vitro, a bacterial reverse mutation test was positive, a gene mutation test and a chromosomal aberration test with mammalian cultured cells were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2014), PATTY (6th, 2012)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
In a carcinogenicity test in which rats were exposed by inhalation to this substance for 2 years, a significant increase in the incidence of epidermoid carcinomas was observed in the anterior parts of the nasal cavity in a high dose group (12 ppm) in both female and male (IARC 47 (1989), ACGIH (7th, 2014)). Based on this result, IARC classified it in Group 2B as there was sufficient evidence of carcinogenicity in experimental animals (IARC 47 (1989), IARC 71 (1999)). Other than this, ACGIH classified it in A3 (ACGIH (7th, 2014)), EU in Carc. 1B (ECHA CL Inventory (Access on June 2017)), and Japan Society For Occupational Health (JSOH) in Group 2B (Recommendation of Occupational Exposure Limits (2016); proposal in 1991), respectively. The evidence for EU classification result was unknown, and based on the classification results by other multiple organizations, it was classified in Category 2 for this hazard class.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a test in which after male rats were exposed by inhalation to this substance for 19 days, they were mated with untreated females, and the male fertility was evaluated, seminiferous tubule degeneration was observed in 1/8 animals from each of the exposure groups at 1, 5, and 12 ppm, and a decreased male fertility index was observed in the high dose group (12 ppm) (ACGIH (7th, 2014), IARC 47 (1989), Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004)). On the other hand, in a developmental toxicity test in which pregnant rats were exposed by inhalation to this substance (gestational day 4-15), no effect was observed in either maternal animals or fetuses at doses up to 12 ppm (ACGIH (7th, 2014), IARC 47 (1989), Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004)).
From the above, based on the decreased male fertility index in male rats, it was classified in Category 2.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory organs), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
There are reports that in single oral dose tests with rats and mice, dyspnea and central nervous system depression occurred, and deaths were due to paralysis of the respiratory muscles (DFGOT Vol. 4 (1992), ACGIH (7th, 2014)). Although there is no detailed description of the doses at which these symptoms were observed, it is reported that the LD50 value for rats was 3,850 mg/kg exceeding the guidance value range for Category 2, and the LD50 value for mice was 1,400 mg/kg within the guidance value range for Category 2. Also, it is considered highly probable that the effects were observed at doses within or above the range for Category 2. In addition, there is a report that in single inhalation tests with rats and mice, after 4-hour inhalation at 100 ppm within the guidance value range for Category 1, there was no death, however, dyspnea, lacrimation, nasal discharge, salivation, and aerophagia were observed; and on autopsy, irritation findings were seen in the lung diagnosed as interstitial pneumonitis (DFGOT Vol. 4 (1992), ACGIH (7th, 2014)). From the above, it was classified in Category 1 (respiratory organs), Category 3 (narcotic effects). As for the information used in the previous classification, the Chemical Substance Hazard Data (CERI) is the information in List 3 in the current GHS classification guidance for the Japanese government, moreover, the information on effects on humans in the Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004) is from the original source ICSC which is in List 3, and the details are unknown, therefore, they were not adopted. The classification result was changed from the previous classification by using the new information sources.
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs)


Danger
H372 P260
P264
P270
P314
P501
No information on humans is available.
As for experimental animals, in a 24-month inhalation toxicity test with rats exposed to vapour, inflammation of the respiratory mucosal epithelium and squamous metaplasia in the anterior parts of the nasal cavity were observed at 12 ppm (0.075 mg/L) within the guidance value range (vapour) for Category 1 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004), DFGOT Vol. 4 (1992), ACGIH (7th, 2014)).
From the above, it was classified in Category 1 (respiratory organs).
Besides, as for a report of hepatocellular necrosis which was adopted as evidence of effects on the liver in the previous classification, it was a result from a 10-week inhalation toxicity test with rats. However, there is no description of exposure time per day, and the test data could not be confirmed in the confirmation of the original literature (Hine et al., 1956). In addition, there is a description in Initial Risk Assessment Report (NITE, CERI, NEDO, 2008) that "Terrill and Lee (1977) reported that in the test by Hine et al. (1956), although the vapour pressure of 0.01 mmHg (25 deg C) should be used as a basis for calculation of concentration, the concentration was calculated based on a vapor pressure of 0.1 mmHg (25 deg C), therefore, the value was uncertain." Since it was uncertain, it was not adopted as evidence of classification. Therefore, the classification result was different from the previous classification.
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) Category 3
-
-
H402 P273
P501
From 96-hour LC50 = 43 mg/L for fish (Carassius auratus) (ECETOC TR91: 2003, Initial Risk Assessment (NITE, CERI, NEDO, 2008)), it was classified in Category 3.
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - Chronic toxicity data were not obtained. Due to being rapidly degradable (readily biodegradable, average degradation rate by BOD: 51%, average degradation rate by LC: 98% (J-CHECK, 1982)), no bioaccumulation (LogKow: 1.61 (PHYSPROP Database: 2017)), it was classified as "Not classified."
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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