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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	75-34-3
Chemical Name	1,1-Dichloroethane
Substance ID	H26-B-045, R-019
Classification year (FY)	FY2014
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)
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	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 2 based on a flash point of -6 deg C (closed cup) and a boiling point of 57 deg C (ICSC (1993)). Besides, it is classified in Class 3, PG II (UN2362) in UNRTDG.
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 458 deg C (ICSC (1993)).
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 (but not fluorine or oxygen) 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. Besides, it is described that it attacks aluminum and iron (ICSC (1993)).

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 3 reports of LD50 values of 725 mg/kg (ATSDR (2013), PATTY (6th, 2012)), 8,200 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)) and 14,100 mg/kg (ATSDR (2013), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)) for rats. It was classified as "Not classified" to which the larger number of data corresponded according to the GHS Classification Guidance for the Japanese Government.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on a report of an LC50 value (4 hours) of 13,000 ppm for rats (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), ACGIH (7th, 2001)), it was classified in Category 4. Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (236,920 ppm), the reference value in units of ppm was applied as a vapour without a mist. A new information source (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)) was added, and the classification was revised by giving priority to 4-hour data in accordance with the GHS Classification Guidance for the Japanese Government.
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 that the vapor of this substance was irritating to the skin in humans (PATTY (6th, 2012)), it was classified in Category 2. Besides, slight edema and slight necrosis were observed in repeated exposure in rabbits, and it was reported to be moderately irritating (IUCLID (2000)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is a description that in an eye irritation test with rabbits, irritation to the cornea and local swelling were observed but disappeared in 1 week (IUCLID (2000)). In addition, there is a description that the vapor of this substance was irritating to the eyes in humans (PATTY (6th, 2012), HSDB (Access on June 2014)). From the above results, it was classified in Category 2. Besides, this substance was classified as "Xi; R36" in the EU DSD classification, and as "H319 Eye Irrit. 2" in the EU CLP classification.
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	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, it was all positive in a micronucleus test and a chromosomal aberration test with mouse bone marrow cells, and adduct formation tests with DNA, RNA and protein in the liver, kidney, stomach and lung of rats and mice, and it was negative in a DNA damage test with mouse liver (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), ATSDR (2013), ACGIH (7th, 2001), IUCLID (2000)). As for in vitro, it was all positive in bacterial reverse mutation tests, sister chromatid exchange tests with cultured mammalian cells and unscheduled DNA synthesis tests with primary hepatocytes of rat and mouse, and it was negative only in a chromosomal aberration test with cultured mammalian cells (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), ATSDR (2013), IUCLID (2000), ACGIH (7th, 2001), NTP DB (Access on July 2014)). From the above, since it was positive in vivo, and positive results were observed in in-vitro tests such as reverse mutation tests, this substance was judged to be mutagenic in vivo, and it was classified in Category 2 according to the GHS Classification Guidance for the Japanese Government.
6	Carcinogenicity	Classification not possible	- -	-	-	Since it was classified in A4 by ACGIH (2008) and as C by EPA (2000), the newer ACGIH information was given priority, therefore, it was classified as "Classification not possible."
7	Reproductive toxicity	Classification not possible	- -	-	-	In a teratogenicity test with rats by the inhalation route, only slight effects (delayed ossification) were observed in the fetuses at doses where decreased food consumption and decreased body weight gain were observed in maternal animals (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), ACGIH (7th, 2001), ATSDR (2012)). However, since there are no data on the effects on fertility, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects)	Danger Warning	H370 H335 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	In humans, there is a report that inhalation exposure caused respiratory tract irritation, salivation, dizziness, lethargy, hypesthesia, nausea, vomiting, unconsciousness, lacrimation, cyanosis and circulatory system failure, and at high concentrations, unconsciousness, etc. were observed, and that although it has a central nervous system depression effect, since it might cause arrhythmia when used as an anesthetic, it is no longer used. On oral ingestion, a burning sensation was observed. In a report in which the nervous systems of 14 patients who died due to acute intoxication by oral ingestion were examined morphologically, it is described that vascular impairment and diffuse changes were observed in the brain, morphological changes in the brain and spinal cord were acute swelling, atrophy and ischemic changes, and there were changes in the spinal cord and peripheral nerves shown as moderate myelin degeneration (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), ACGIH (7th, 2001), ATSDR (2013), PATTY (6th, 2012)). As for experimental animals, there are reports of central nervous system depression by an oral administration of 4,000 mg/kg to rats and of narcotic effects by an inhalation exposure with rats (PATTY (6th, 2012)). From the above, although effects in experimental animals were observed at doses exceeding the range of Category 2, it was classified in Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects) since the effects in humans were clearly observed. Besides, although it was classified in Category 1 (liver, kidney) in the previous classification, these organs were not adopted since enough not findings on them were observed. In addition, although the central nervous system was not adopted in the previous classification, the central nervous system was adopted in this classification.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In humans, factory workers who were exposed to a combination of this substance and vinyl chloride, although there were suspicious findings in some parameters in the liver function tests and hematological tests, in a case diagnosed as "vinyl chloride disease," the effect was considered to be that of a combined exposure (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)), and the relevance to exposure to this substance was unknown. Other than this information, there is no description of the effects of exposure to this substance in humans in ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010) and ATSDR (2013). As for experimental animals, in tests in which rats and mice were administered by gavage for 6 weeks and 78 weeks, there were no toxic effects within and lower than the dose range of Category 2, and in the 78-week administration tests, although decreased survival rate was observed at high doses of 382 mg/kg/day in rats and of 2,885 mg/kg/day in mice, toxicity to specific organs was not shown (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), ATSDR (2013)). On the other hand, as for the inhalation route, in tests in which rats, guinea pigs, rabbits and cats were exposed by inhalation at 500 ppm for 13 weeks, followed by additional exposure at an increased concentration of 1,000 ppm for 13 weeks, at concentrations up to 1,000 ppm, although no toxic effects were observed in rats, guinea pigs and rabbits, decreased body weight gain, increases in blood urea nitrogen and creatinine, and crystalline precipitates, obstruction of lumina and dilation in the renal tubules were observed in cats (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), ATSDR (2013)). The status of this substance in this inhalation exposure test was presumed to be a vapour, and the effects on the kidney were observed only in cats at 1,000 ppm (4,050 mg/m3) corresponding to "Not classified." From the above, from the toxicity information in experimental animals, although it was considered to be corresponding to "Not classified" by the oral and inhalation routes, there was a lack of findings about the dermal route and effects on humans, therefore, it was classified as "Classification not possible" due to lack of data. Besides, in the previous classification, although it was classified based on the findings in humans from information sources listed in List 3 or outside the list, according to the investigation from the information sources in List 1, in this classification, it was revealed that there were no reliable data available for classification in humans as described above.
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	It was classified in Category 3 from 48-hour EC50 = 34.3 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2008), Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010)).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (Halogenated aliphatic hydrocarbons are generally thought to be non-biodegradable. A degradation rate by BOD for 1,2-dichloroethane that is the isomer: 0% (Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010))), and 21-day NOEC = 0.525 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2008), Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010)). 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 96-hour LC50 > 112 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, 2008), Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010)), and being not water-insoluble (water solubility = 5040 mg/L, PHYSPROP Database, 2009). By drawing a comparison between the above results, it was classified in Category 2.
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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