NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	79-11-8
Chemical Name	Chloroacetic acid [monochloroacetic acid]
Substance ID	m-nite-79-11-8_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 present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	It is flammable (ICSC (2003)), but the classification is not possible due to no data.	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an ignition point of 470 degrees C (GESTIS (Access on June 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for solid substances with a melting point of 140 degrees C or lower.	FY2015	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)	- -	-	-	Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It is an organic compound which does not contain fluorine but contains oxygen and chlorine and the oxygen and the chlorine are not chemically bonded to the elements other than carbon or hydrogen.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an organic compound that does not contain bivalent -O-O- structure in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	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	Eleven LD50 values within a range of 55-580 mg/kg (55-165 mg/kg (IPCS, PIM 352), 55-200 mg/kg (ECETOC TR081 (2001)), 55-580 mg/kg (ACGIH (7th, 2006)), 90.4 - 450 mg/kg (Initial Risk Assessment, NITE (2008)), 55 mg/kg (EU-RAR (2005); Result of the initial environmental risk assessment of chemicals, Vol. 3, Ministry of the Environment in Japan: Tentative hazard assessment sheet (2004)), 76.2 mg/kg (ACGIH (7th, 2006), ECETOC JACC 038 (1999), NTP TR396 (1992)), 90.4 mg/kg (EU-RAR (2005), SIDS (2004), ECETOC JACC 038 (1999)), 100-300 mg/kg (SIDS (2004)), 102 mg/kg (ECETOC JACC 038 (1999)), 108 mg/kg (NTP TR396 (1992)), 277.5 mg/kg (EU-RAR (2005), SIDS (2004))) were reported for rats. It was classified in Category 3 to which most of the data (7) correspond. Besides, classification was conducted without including 4 data which are a summarized value from multiple data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 2	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	Two LD50 values of 145 mg/kg (Initial Risk Assessment, NITE (2008); ACGIH (7th, 2006)) and 305 mg/kg (EU-RAR (2005), SIDS (2004), ECETOC JACC 038 (1999)) were reported for rats. As for rats, because one each corresponds to Category 2 and 3, it is classified in Category 2 to which the minimum LD50 value corresponds. Three LD50 values of 178 mg/kg (SIDS (2004)), 230 mg/kg (IPCS, PIM 352) and 250 mg/kg (EU-RAR (2005), SIDS (2004), ECETOC JACC 038 (1999)) were reported for rabbits. As for rabbits, because one corresponds to Category 2 and two correspond to Category 3, it is classified in Category 3 to which most of the data correspond. By drawing a comparison between the Category for rats and rabbits, the substance was classified in Category 2 by adopting the classification of the higher hazard for rats.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	It is "Solids" according to GHS definition. Besides, an LC50 value (1 hour) of > 66 ppm (converted to a 4-hour equivalent: > 33 ppm) was reported for rats (Initial Risk Assessment, NITE (2008); EU-RAR (2005); SIDS (2004)), but the category cannot be determined. A reference value in the unit of ppm was applied as vapour without mist because the LC50 value is lower than the saturated vapour pressure concentration (137 ppm) at 20 degrees C (EU-RAR (2005)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	From a reported LC50 value (4 hours) of 0.18 mg/L for rats (Initial Risk Assessment, NITE (2008); ACGIH (7th, 2006); EU-RAR (2005); SIDS (2004)), it was classified in Category 2. Besides, although lower than the saturated vapour pressure concentration (0.53 mg/L) at 20 degrees C (EU-RAR (2005)), a reference value of mists was applied from the information that the test was conducted on aerosol (ACGIH (7th, 2006)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 1A	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	This substance is strongly acidic (pH <1 at 800g/L, 20 degrees C, GESTIS (Access on July 2015)). It is reported that in a skin irritation test using rabbits that 2 animals died after 24-hour occlusive application with 500 mg, and severe erythema and edema were observed, and a primary dermal irritation index was 7.66 (maximum 8) (ECETOC JACC 38 (1999)), and it is reported that after 0.5 mL of a 75% solution of this substance was applied, necrosis was observed after 30 seconds (SIDS (2009)). Besides these, corrosion is reported in an application of this substance in a test using rats or mice (EU-RAR (2005); Initial Risk Assessment, NITE (2008)). Moreover, in multiple accidental contacts in humans, it is reported that chemical burns occurred (EU-RAR (2005); Initial Risk Assessment, NITE (2008)). From the above, because necrosis was observed 30 seconds after application in rabbits, the substance was classified in Category 1A. Besides, it is classified in "Skin. Corr. 1B H314" in EU CLP classification (ECHA CL inventory (Access on September 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is reported in an eye irritation test using rabbits that corrosion was observed after 100 mg this substance was dissolved in 0.01 mL of a 0.9% sodium chloride solution and applied, and corrosion was found after a high concentration solution of this substance was applied. (EU-RAR (2005); Initial Risk Assessment, NITE (2008); ECETOC JACC 38 (1999)) Besides, this substance was classified in Category 1A in Skin Corrosion/irritation. From the above, it was classified in Category 1.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, it is reported that in a skin sensitization test using rabbits (Open epicutaneous test), it is not sensitizing (EU-RAR (2005); Initial Risk Assessment, NITE (2008); ECETOC JACC 38 (1999)), which was not used for the classification in accordance with the GHS classification guidance for the Japanese government.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	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, it was classified as "Classification not possible." As for in vivo, there were positive and negative results in a chromosomal aberration test in mouse bone marrow cells (Initial Risk Assessment, NITE (2008); ECETOC JACC 038 (1999)), and a DNA damage test in mouse liver, spleen, duodenum, and stomach and a DNA damage test in rat liver were negative (Initial Risk Assessment, NITE (2008); EU-RAR (2005); ECETOC JACC 038 (1999)). As for in vitro, there is a positive result in a mouse lymphoma test in cultured mammalian cells, but other data, namely, a bacterial reverse mutation test, a chromosomal aberration test, a sister chromatid exchange test, a gene mutation test (HGPRT), and a DNA damage test in cultured mammalian cells had resulted in negative (Initial Risk Assessment, NITE (2008); SIDS (2004); EU-RAR (2005); ACGIH (7th, 2006); ECETOC JACC 038 (1999); NTP TR396 (1992)). Besides, it is written that the positive in vivo chromosomal aberration test result in mouse bone marrow cells cannot be considered relevant in the assessment (ECETOC JACC 038 (1999)). Moreover, in all of SIDS (2004), EU-RAR (2005), and ECETOC JACC 038 (1999), it is concluded that this substance is not mutagenic.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no carcinogenicity information in humans. As for experimental animals, it is written that in a carcinogenicity test in rats or mice in 2-year gavage administration, even after administered up to the doses (rats: 30 mg/kg/day, mice: 100 mg/kg/day) where a decreased survival rate compared with a control group was observed in both males and females of rats and mice, increased tumor incidence was not found (ACGIH (7th, 2006); EU-RAR (2005); Initial Risk Assessment, NITE (2008)), and it is written that also in a test in which mice were administered by gavage with this substance at 46.4 mg/kg/day for 21 days, followed by 17-month diet administration (149 ppm: corresponding to 24.8 mg/kg/day), tumor formation was not observed (ACGIH (7th, 2006); Initial Risk Assessment, NITE (2008)). Moreover, it is written that in a dermal route, after 2 mg this substance/animal was dermally applied in female mice 3 times/week for 63 weeks, skin tumor including papilloma was not observed (EU-RAR (2005); ACGIH (7th, 2006); Initial Risk Assessment, NITE (2008)), and it is written that after 63-week subcutaneous injection in female mice at 0.5 mg/animal once/week, local sarcoma was observed in 3/50 animals in a dosed group (a control group: 1/50 animals), which was not a statistically significant increase (EU-RAR (2005); ACGIH (7th, 2006); Initial Risk Assessment, NITE (2008)). In experimental animals, there is no evidence showing carcinogenicity in oral and dermal routes, but there is no carcinogenicity information in an inhalation route. ACGIH classified this substance in A4 in carcinogenicity (ACGIH (7th, 2006)), but there is no classification result by other organizations. As above, it was judged that data to classify as "Not classified" are lacking including the fact that there is no available information in humans, and the substance was classified as "Classification not possible" in this hazard class in accordance with the GHS classification guidance for the Japanese government.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	There is no reproductive effect information in humans. As for experimental animals, it is reported that after gavage administration in pregnant rats (a number of animals: unknown) during an organogenetic period (day 6-15 of gestation), weight gain reduction in maternal animals, malformations in cardiovascular system (predominantly　"levocardia") in fetuses were observed at the highest dose of 140 mg/kg/day (ACGIH (7th, 2006); EU RAR (2005); Initial Risk Assessment, NITE (2008)). However, after confirmation of the original literature, it was judged to be inappropriate test result to be used for the classification because this report has a brief description as a summary of a lecture for an academic meeting. Besides these, it is written that in a developmental toxicity test in pregnant rats (10 animals/group) in drinking water administration through a gestation period, abnormality was not observed in either maternal animals or fetuses (ACGIH (7th, 2006); EU RAR (2005); Initial Risk Assessment, NITE (2008)), and it is written that in an in vitro fetus culturing experiment, an increased incidence of malformations such as neural tube defects and heart malformations was observed (EU RAR (2005), ACGIH (7th, 2006)). As above, the substance was classified as "Classification not possible" due to lack of data in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, respiratory organs, cardiovascular system, blood system, liver, kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance is corrosive and causes severe local irritation signs in eyes, skin, and the respiratory tract. Multiple poisoning cases by exposure to this substance (including oral, inhalation, and dermal) were reported. Respiratory tract irritation and pulmonary edema in inhalation exposure, moderate to severe acute systemic toxicity in oral exposure, and severe acute systemic toxicity in dermal exposure were shown (above ACGIH (7th, 2006)). Many of poisoning cases were by dermal exposure, 8 of which died, and 15 survived, and all were similar in clinical symptoms and (blood) biochemical characteristics. Namely, as acute signs, starting from burns and skin damage due to skin corrosion, systemic toxicity appears. Vomiting and diarrhea are shown soon after the onset of systemic toxicity, followed by central nervous system disorder such as agitation, disorientation, convulsions, and coma, severe metabolic acidosis, hypokalemia, hypocalcemia, myoglobinemia, leukocytosis, (blood) coagulation disorder, hyperglycemia, blood pressure drop, arrhythmia, heart damage with tachycardia, myocardial disorder, cardiovascular shock, renal failure resulting from it (mentioned as within 12 hours), and renal tubular necrosis and so on (ECETOC TR081 (2001); ECETOC JACC 038 (1999); ACGIH (7th, 2006); Initial Risk Assessment, NITE (2008); ACGIH (7th, 2006); EU-RAR (2005); Result of the initial environmental risk assessment of chemicals, Vol. 3, Ministry of the Environment in Japan: Tentative hazard assessment sheet (2004)). As for experimental animals, decreased respiratory rate, clonic and tonic convulsion after oral administration in rats at 55-580 mg/kg, neurotoxicity effects such as neurobehavioral effects and forelimb paralysis in oral administration or dermal application in rats, mice, and rabbits were reported. It is reported that severe toxicity was found after dermal application in rats, mice, and rabbits, and dermal application with 0.5 mL of a 40% solution caused degeneration of collagen bundles in the epidermal and endothelial tissue and acute systemic effects such as hepatocellular damage in the liver, renal failure, and glyconeogenesis disorder and ammonia metabolism (EU-RAR 52 (2005); Initial Risk Assessment, NITE (2008); ACGIH (7th, 2006); EU-RAR (2005); SIDS (2004)). From the above, because this substance affects central nervous system and peripheral nervous system, respiratory organs, cardiovascular system, blood system, liver, and kidney, the substance was classified in Category 1 (nervous system, respiratory system, cardiovascular system, blood system, liver, kidney). Besides, central nervous system and peripheral nervous system are combined to "nervous system." Moreover, although effects on the liver and kidney could be thought to result from metabolism, blood system and so on, they were taken as targets for the classification because they are the organ disorder that occurred acutely by administration of this substance. By adding new information, the previous classification was revised.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (heart, liver, kidney)	Warning	H373	P260 P314 P501	There is no human information. As for experimental animals, in a 13-week gavage administration toxicity test using rats, cardiomyopathy, death from cardiomyopathy, increased serum BUN/ALT/AST, and increased relative weight of the liver and kidney were observed at 60 mg/kg/day (converted to a 90-day equivalent: 43 mg/kg/day) or higher (NTP TR396 (1992); Initial Risk Assessment, NITE (2008); ECETOC JACC 038 (1999); EU-RAR (2005)). Moreover, in a 90-day gavage administration toxicity test using rats (drinking water administration), decreased absolute liver weight, bile duct proliferation in hepatic portal region, edema, and increased inflammatory cells in the liver were reported at 19 mg/kg/day (Initial Risk Assessment, NITE (2008), ECETOC JACC 038 (1999), EU-RAR (2005)). Furthermore, renal tubular necrosis and so on were observed after single administration. As above, effects on the heart, liver, and kidney were found within a range of Category 2. Therefore, the substance was classified in Category 2 (heart, liver, kidney).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	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 1	Warning	H400	P273 P391 P501	From 72-hour EC50 = 0.033 mg/L for algae (Desmodesmus subspicatus) (EU-RAR, 2005; Initial Risk Assessment, NITE, 2008), it was classified in Category 1.	FY2015	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 rapid degradability (standard test methods of a 3-week test period had BOD: 65.0%, TOC: 98.8%, GC: 100% (Official Bulletin of Ministry of International Trade and Industry, 1976), and degradation rates of 60-70% within a time-window of 10-14 days shown in four tests (EU-RAR, 2005)), and 72-hour NOEC < 0.005 mg/L for algae (Pseudokirchneriella subcapitata) (Initial Risk Assessment, NITE, 2008), it was classified in Category 1.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	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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