NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	124-48-1
Chemical Name	Dibromochloromethane
Substance ID	m-nite-124-48-1_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	Not classified	- -	-	-	It is not combustible (GESTIS (Access on September 2017)).	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 not combustible (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	Not classified	- -	-	-	It is not combustible (GESTIS (Access on September 2017)).	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 (but not fluorine or oxygen) which is 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 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on reports of LD50 values for rats of 370 mg/kg (male), 760 mg/kg (female) (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)), 1,186 mg/kg (male), and 848 mg/kg (female) (ATSDR (2005), Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)), it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	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))
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)	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))
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	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))
3	Serious eye damage/eye irritation	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	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, a micronucleus test with mouse bone marrow cells was negative, chromosomal aberration tests with bone marrow cells of rats and mice were positive, sister chromatid exchange tests with mouse bone marrow cells were positive and negative results, DNA damage tests with liver, kidney etc. of rats and an unscheduled DNA synthesis test were negative (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2009), ATSDR (2005), IARC 71 (1999), Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), IRIS (1990), NTP DB (Access on August 2017)). As for in vitro, a bacterial reverse mutation test was weakly positive, and a mouse lymphoma test, a chromosomal aberration test, and a sister chromatid exchange test with cultured mammalian cells were positive (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2009), ATSDR (2005), IARC 71 (1999), IRIS (1990), Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), NTP DB (Access on August 2017)). The positive result of the in vivo rat bone marrow chromosome aberration test was a finding of intraperitoneal administration at 20.8 mg/kg, and the test of 5-day oral administration to rats at 20.8 mg/kg/day by the same author was negative. In addition, micronucleus tests by intraperitoneal administration at up to 500 mg/kg were negative for both rats and mice. This substance is one kind of trihalomethane, the genotoxicity of trihalomethane depends on the reactivity with glutathione (GSH) (GSTT1-1 activity), and the activity of the GST pathway is markedly high in mice, very low in rats and hamsters, and even lower in humans (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2009)). Based on the above findings, it was judged that the weight of positive results in rats was extremely low, and clear genotoxicity was not shown. 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	Classification not possible	- -	-	-	Among epidemiological studies which investigated the relationship between this substance in tap water and specific cancers, a significant correlation was found in a part of them, but many of them showed a result of no significant correlation between the two (Environmental Risk Assessment for Chemical Substances Vol. 14 (Ministry of the Environment, 2016)). As for experimental animals, in 2-year carcinogenicity studies with rats or mice dosed by gavage, in rats, no increase in the incidence of tumors was observed. However, in the mouse study, an increase in the incidence of hepatocellular carcinoma and a marginal increase in the combined incidences of hepatocellular adenomas and carcinomas in males of the high dose group, and an increase in the incidence of hepatocellular adenomas and an increase in the combined incidences of hepatocellular adenomas and carcinomas in females were observed (NTP TR282 (1985), IARC 52 (1991)). It was concluded in NTP that there was no evidence of carcinogenicity in either sex of rats, but that in mice, there was equivocal evidence of carcinogenicity in males and some evidence in females (NTP TR282 (1985)). Other than these, in a 2-year study with mice dosed by drinking water, an increase in the incidence of tumors was not observed in either sex (IARC 52 (1991)). As for classifications by other organizations, although the evidence of carcinogenicity is limited in experimental animals, because of its structural similarity to trihalomethane, which is a known carcinogen in experimental animals, EPA classified this substance as Category C (possible human carcinogen) (IRIS (1990)). On the other hand, IARC classified it in Group 3 based on the limited evidence for the carcinogenicity (IARC 52 (1991)) and did not change the classification result even in the re-evaluation in 1999 (IARC 71 (1999)). In addition, Ministry of the Environment gives the opinion that it is not possible to obtain sufficient findings on the carcinogenicity of this substance, and that it is not possible to judge the presence or absence of carcinogenicity in humans (Environmental Risk Assessment for Chemical Substances Vol. 14 (Ministry of the Environment, 2016)). From the above, based on the classification result by IARC, the evaluation year of which is new and the opinion on carcinogenicity in humans of Ministry of the Environment, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	It was reported that in multiple epidemiological studies that examined the relationship of exposure to trihalomethane from drinking water with spontaneous abortion, semen quality, and congenital malformations in California, there was no relationship between them. However, there is a report that in a prospective study which examined the association between exposure to trihalomethane from tap water and the menstrual cycle in 18-39 year old married women living in northern California, the lengths of menstrual cycle and follicular phase were significantly shortened by the exposures to three kinds of trihalomethane including this substance and the total for bromides, but their degree were the largest by the exposure to this substance or the total for bromides (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), ATSDR (2005)). As for experimental animals, in a multigeneration study in which male and female mice were dosed by drinking water at up to 4 g/L, a decrease in litter size (F1c), a decrease in the lactation rate (F1b, F2b), and a decrease in the viability index on day 4 (F1b) were observed at or above 1 g/L (corresponding to 171-200 mg/kg/day) where decreased body weight gain (females only) was observed in F0 and F1b parental animals, furthermore, decreased conception rate (F2b), lower delivery index (F1a, F1b, F1c), a decrease in litter size (F1a, F1b, F2a, F2b), and a decrease in the viability index on day 4 (F1a, F1c, F2a) were observed at 4 g/L (corresponding to 685-800 mg/kg/day) where decreased body weight gain (males) and swelling of the liver were observed in F0 and F1b parental animals (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2009), ATSDR (2005)). On the other hand, in a developmental toxicity study with pregnant rats dosed by gavage during the organogenesis period (gestational day 6-15), decreased body weight gain was observed at high dose in maternal animals. However, no developmental effect was observed in fetuses (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)). From the above, for one report in which effects on the menstrual cycle in humans were observed, the effects were due to the exposure to trihalomethane, and cannot be identified as to be due to exposure to this substance. However, based on the reproductive and developmental effects observed at the general toxic dose of the parental animals in the study with mice, it was judged to be reasonable to classify it in Category 2 for this hazard class. Besides, the classification result was changed due to the use of a new information source after the previous classification.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	There is no single-exposure information on this substance in humans. As for experimental animals, there is a report that lethargy was observed at or above 310 mg/kg in a single oral dose test with rats (NTP TR282 (1985)), and that in a single oral dose test with mice, at 500 mg/kg, sedation and paralysis appeared within 30 minutes and persisted for about 4 hours (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)). In addition, there is a description that as acute oral toxicity of this substance in rats, piloerection, sedation, muscle relaxation, ataxia, and weakness were observed (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)), Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2009). Moreover, there is a description in ATSDR (2005) that this substance causes central nervous system depression such as lethargy, ataxia, and sedation in experimental animals. From the above, it was classified in Category 3 (narcotic effects).	-	-
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	No information on humans is available. As for experimental animals, in a 90-day repeated oral dose toxicity test with rats, increased relative liver weight, centrilobular fatty change in the liver, and renal tubule degeneration at or above 50 mg/kg/day within the guidance value range for Category 2, and increased ALT, increased creatinine, increased relative kidney weight, and degeneration with tubular cell swelling at 100 mg/kg/day were observed (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)). In a 13-week repeated oral dose toxicity test with rats, vacuolar degeneration and necrosis of liver cells, and degeneration of renal tubule cells were observed at or above 60 mg/kg/day (converted guidance value: 43 mg/kg/day) within the guidance value range for Category 2. In a 2-year repeated oral dose toxicity test with rats, fatty degeneration and ground-glass cytoplasmic change in the liver, and an increase in the incidence of nephropathy were observed at or above 40 mg/kg/day within the guidance value range for Category 2 (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), NTP TR282(1985)). From the above, it was classified in Category 2 (liver, kidney).	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)	Category 2	- -	H401	P273 P501	From 72-hour EC50 (rate method) = 9.6 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Due to being not rapidly degradable (BioWin), and 21-day NOEC (reproduction inhibition) = 0.063 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, 2017)), it was classified in Category 1.	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.

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