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

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 111-44-4
Chemical Name Bis(2-chloroethyl) ether
Substance ID m-nite-111-44-4_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 molecule. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Flammable liquids Category 3


Warning
H226 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
A flash point is 55 deg C (closed cup) (GESTIS (Access on September 2017)). Besides, it is classified in Division 6.1, Subsidiary risk 3, PGII in UNRTDG (UN 1916). FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 365 deg C (GESTIS (Access on September 2017)). FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid substances are not available. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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). FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16 Corrosive to metals Classification not possible
-
-
- - No data available. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
Based on reports of LD50 values for rats of 75 mg/kg (ATSDR (1989), PATTY (6th, 2012)), 105 mg/kg, and 150 mg/kg (PATTY (6th, 2012)), it was classified in Category 3. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
Based on the report of an LD50 value for rabbits of 870 mg/kg (ATSDR (1989)), it was classified in Category 3. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Vapours) Category 1


Danger
H330 P304+P340
P403+P233
P260
P271
P284
P310
P320
P405
P501
There are reports of 20 ppm (CaPSAR (1993)) and 330 mg/m3 (56.4 ppm) (ChemID (Access on January 2018)) as LC50 values in 4-hour inhalation exposure tests with rats, both of which correspond to Category 1. In addition, although it is not an LC50 value, there is a report that in a 4-hour inhalation exposure test with rats, the lethal LOAEL is 250 ppm corresponding to Category 2, and about half the animals died (ATSDR (1989)). By adopting the category with the largest number of cases and the higher hazard from these pieces of information, it was classified in Category 1. Besides, since the exposure concentrations are lower than 90% of the saturated vapor pressure concentration (2,046 ppm), a reference value in the unit of ppm was applied as vapour with little mist. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
There are multiple descriptions that skin irritation was seen after an application of this substance in skin irritation tests with rabbits (ATSDR (1989), BUA 21 (1987)), therefore, it was classified in Category 2. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
Based on descriptions that in an eye irritation test with rabbits, moderate pain, conjunctival irritation and corneal injury, which resolved within 24 hours occurred (ACGIH (7th, 2001)), and that in another test with rabbits, moderate eye irritation was shown (ATSDR (1989), PATTY (6th, 2012)), and that moderate to strong eye irritation was shown although the test animal is unknown (BUA 21 (1987)), it was classified in Category 2B. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, it was negative in a DNA binding test with rat liver (IARC 71 (1999), ATSDR (1989)). As for in vitro, it was positive in a bacterial reverse mutation test (ATSDR (1989), EHC 201 (1998), NTP DB (Access on September 2017)). From the above, it was classified as "Classification not possible" according to the GHS classification guidance for the Japanese government. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
Among two epidemiological studies on workers exposed to 1,2-dichloroethane and ethylene chlorohydrin together with this substance, in one study, an excess of pancreatic cancers, and lymphatic and hematopoietic tumors were suggested, while in the other one, no excess of tumors was shown (IARC 71 (1999)). As for experimental animals, in tests in which two strains of mice were given by gavage 100 mg/kg/day of this substance from postnatal day 7 and were given by feeding 300 ppm after 4 weeks of age for 18 months, both strains showed increases in the incidence of liver tumors (hepatomas) (IARC 71 (1999), IRIS (1987), ACGIH (7th, 2001)). In addition, there is a report that in a test with female mice dosed subcutaneously, a development of sarcomas at the injection site was observed although in a low incidence (IARC 71 (1999), IRIS (1987), ACGIH (7th, 2001)). On the other hand, in a test in which rats were dosed by gavage at up to 50 mg/kg/day for 78 weeks and necropsied after two years, no increase in the tumor incidence was observed (IARC 71 (1999), IRIS (1987), ACGIH (7th, 2001)). IARC classified it in Group 3 because there was limited evidence for carcinogenicity in experimental animals (IARC 71 (1999)). ACGIH also classified it in A4 (ACGIH (7th, 2001): proposed in 1995). On the other hand, EPA classified it in B2 (IRIS (1987)) based on positive results in two strains of mice and evidence of mutagenicity in bacteria, and EU in Carc. 2 (ECHA CL Inventory (Access on August 2017)).
As described above, it can be classified in Category 2, Category 1B or as "Classification not possible" from the results of carcinogenicity classification by other organizations. However, since there was an increase in the incidence of tumors (unknown whether benign or malignant) only in one species from animal test results, it is assumed that there is limited evidence of carcinogenicity in animal experiments, therefore, it was judged as appropriate to classify it in Category 2 for this hazard class. Besides, classification result was revised from the previous classification (FY 2006: "Not classified").
FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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

As for humans, there is a report that in a test in which volunteers were exposed by inhalation to the vapor of this substance for brief periods, intolerable irritation of the eyes and nose, coughing, retching, and nausea occurred at or above 550 ppm (ATSDR (1989), CaPSAR (1993), ACGIH (7th, 2001), PATTY (6th, 2012), OEL Documentations (Japan Society For Occupational Health (JSOH), 1967)). In addition, although the details are not included, there is a description that narcotic effects are manifested at high concentration but these narcotic effects are concealed because of a strong stimulatory effect (OEL Documentations (Japan Society For Occupational Health (JSOH), 1967)). As for experimental animals, for single inhalation exposure tests with guinea pigs, there are reports that irritation of the nose at 35 ppm (0.2 mg/L), and congestion, edema and hemorrhage in the lung at or above 100 ppm (0.59 mg/L) were observed (ATSDR (1989)), and that death occurred due to inhalation exposure at 500 ppm (2.93 mg/L) for 90 minutes (converted to 4-hour equivalent value: 1.79 mg/L), and the main cause of death was lung damage (ACGIH (7th, 2001)). The doses where lung effects were observed in experimental animals correspond to Category 1. In addition, there is a report that in a single inhalation exposure test with guinea pigs exposed by inhalation, at or above 100 ppm, lethargy and decreased coordination began within several hours, and there was a case of lost consciousness after that, resulting in death (ATSDR (1989)). From the above, it was classified in Category 1 (respiratory organs), Category 3 (narcotic effects).
FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - No information on humans is available.
As for experimental animals, there is a report that in a 130-day inhalation toxicity study (93 exposures, 7 hours/day, 5 days/week) with rats or guinea pigs exposed to the vapour, only decreased body weight gain was observed in both animal species at 69 ppm (converted guidance value: 0.47 mg/L) within the guidance value range for Category 2, and it is described that there was no serious injury, and this was an abnormality which reflected slight physical responses to stress (PATTY (6th, 2012), ACGIH (7th, 2001), ATSDR (1989)). This study is a test of one concentration of 69 ppm (converted guidance value: 0.47 mg/L), which is within the guidance value range for Category 2 (0.2 mg/L < C <= 1.0 mg/L), however, since the concentration is lower than the upper limit, the effect near the upper limit is unknown. Therefore, it was classified as "Classification not possible" due to lack of data.
FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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
-
-
- - From 72-hour EC50 (rate method) = 340 mg/L for algae (Pseudokirchneriella subcapitata), 96-hour LC50 >100 mg/L for fish (Oryzias latipes) (both Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), and 48-hour EC50 = 240 mg/L for crustacea (Daphnia magna) (WHO EHC: 1998), it was classified as "Not classified." FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Hazardous to the aquatic environment Long term (Chronic) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 8.3% (J-CHECK, 1977)), 21-day NOEC (reproduction inhibition) = 3.1 mg/L for crustacea (Daphnia magna), and 72-hour NOEC (rate method) = 56 mg/L for algae (Pseudokirchneriella subcapitata) (both Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 8.3% (J-CHECK, 1977)), and 96-hour LC50 >100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)).
From the above results, it was classified as "Not classified."
FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available. FY2017 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))


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.

To GHS Information