GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 111-44-4
Chemical Name Bis(2-chloroethyl) ether
Substance ID H29-B-115
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 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).
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 365 deg C (GESTIS (Access on September 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 chlorine and oxygen (but not fluorine) which are 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) 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.
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.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
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.
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
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.
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.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
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.
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").
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data.
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).
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.
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 (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."
11 Hazardous to the aquatic environment (Long-term) 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."
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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