NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	75-87-6
Chemical Name	Trichloroacetaldehyde (Chloral)
Substance ID	m-nite-75-87-6_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)	- -	-	-	Containing no chemical groups with explosive properties	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Containing no chemical groups with explosive or self-reactive properties	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available. Those containing stabilizers are classified into Division 6.1 (UN#2075) (UN Recommendations on the Transport of Dangerous Goods).	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2006	GHS Classification Manual （10 Feb, 2006）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing oxygen and chlorine (but not fluorine), with the oxygen and chlorine bound to carbon and hydrogen respectively (but not to other elements)	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no "-O-O-" structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available. Those containing stabilizers are classified into Division 6.1 (UN#2075) (UN Recommendations on the Transport of Dangerous Goods).	FY2006	GHS Classification Manual （10 Feb, 2006）
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 the rat LD50 (oral route) value of 480mg/kg (CICAD 25 (2000)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Based on the guinea pig LD50 (dermal route) value of 1,510mg/kg representing the lower of the two testing data, 1,510mg/kg and 15,000mg/kg (CERI Hazard Data 2000-52 (2001)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Due to the fact that the substance is "liquid" according to the GHS definition.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Category 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on the rat LC50 value of 0.44mg/L (equivalent to 73ppm), representing the lower of the two testing data of rat LC50 (inhalation of vapour) of 2.12mg/L (4 hours) (CERI Hazard Data 2000-52 (2001)) and 0.44mg/L (MOE Risk Assessment vol. 3 (2004)), was lower than 90% of the saturated vapour concentration (47,000ppm) under a saturated vapour pressure of 4.7kPa (20degC) (CERI Hazard Data 2000-52 (2001)), the substance was considered as "vapour containing substantially no mist" and was classified based on standard values expressed in ppm.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Category 3	- Warning	-	-	Based on the description of the human health effects (CERI-NITE Hazard Assessment No.97 (2004)): "Chloral hydrate has a potential for skin and mucosal irritation, and at clinical doses, abdominal pain, nausea and vomiting may occur." The substance is thus considered a skin irritant, but classified into Category 3 in the absence of data on the degree of irritation. According to NITE Initial Risk Assessment No.97 (2005), "trichloroacetaldehyde rapidly reacts in vivo with water to form chloral hydrate." However, only those studies specifying "trichloroacetaldehyde" as the test material were used as a basis for classification.	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on the description of the human health effects (CERI-NITE Hazard Assessment No.97 (2004)): "Chloral hydrate has a potential for skin and mucosal irritation, and at clinical doses, abdominal pain, nausea and vomiting may occur." The substance is thus considered a skin irritant, but classified into Category 2B in the absence of data on the degree of irritation. According to NITE Initial Risk Assessment No.97 (2005), "trichloroacetaldehyde rapidly reacts in vivo with water to form chloral hydrate." However, only those studies specifying "trichloroacetaldehyde" as the test material were used as a basis for classification.	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Skin sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	Based on the absence of data on multi-generation mutagenicity tests and positive data on germ cell mutagenicity tests in vivo (micronucleus tests), described in NITE Initial Risk Assessment No.97 (2005), NTP DB (Access on April 2006) and IARC 63 (1995).	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Information on carcinogenicity in humans is limited to (7). Because this substance (chloral) is rapidly converted to chloral hydrate in an aqueous solution, information on chloral hydrate was used for evaluation. Based on the IARC's classification result (1) and test results of (2)-(6), it was classified in Category 1B. The category was revised as the result of reviewing the previous classification due to the revision of the classification in 2014 by IARC. Besides, NTP regarded the results of (3), (4) as equivocal evidence and some evidence of carcinogenicity respectively and did not classify for carcinogenicity. However, the IARC's evaluation was adopted according to the GHS classification guidance for the Japanese government. [Evidence Data] (1) IARC classified this substance and chloral hydrate in Group 2A by stating that there is sufficient evidence in experimental animals for the substances (IARC 106 (2014)). There are no classification results by domestic and international organizations other than IARC. (2) In two tests in which male mice were given chloral hydrate (CAS: 302-17-0) by drinking water for 104 weeks, increased hepatocellular adenoma and carcinoma were observed (IARC 106 (2014)). (3) In a test in which female mice were dosed by gavage with chloral hydrate for two years, increased incidences of malignant lymphoma and adenoma of the pituitary gland were observed. However, NTP, the organization that conducted the test, did not use malignant lymphoma in evaluation because its incidence was within the historical control range (NTP TR502 (2002), IARC 106 (2014)). (4) In a test in which male mice were given chloral hydrate by gavage for two years, increased hepatocellular carcinoma was observed (NTP TR503 (2002), IARC 106 (2014)). (5) In a test in which rats were dosed with chloral hydrate by drinking water for 104 weeks, the incidence of hepatocellular carcinoma in the male low-dose group was higher than that for the historical control (IARC 106 (2014)). (6) As for patters of the absorption, distribution, metabolism and excretion of chloral hydrate in the body, there are major similarities between humans and experimental animals. Besides, strong evidence suggesting that chloral hydrate is genotoxic was obtained (IARC 106 (2014)). [Reference Data, etc.] (7) As for carcinogenicity in humans, in a study in the USA, significant associations were not observed between the number of prescriptions for chloral hydrate and morbidity for cancers (IARC 106 (2014)).	FY2018	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	Based on the evidence of learning deficits in the offspring, described in MOE Risk Assessment vol. 2 (2003), CICAD 25 (2000) and IARC 63 (1995), though no data are available regarding the general conditions of parental animals.	FY2006	GHS Classification Manual （10 Feb, 2006）
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	Based on the evidence from animal studies including "strong narcotic effects, vacuolization of Clara cells, alveolar necrosis, epithelial exfoliation and alveolar edema" (NITE Initial Risk Assessment No.97 (2005)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 1. According to NITE Initial Risk Assessment No.97 (2005), "trichloroacetaldehyde rapidly reacts in vivo with water to form chloral hydrate." However, only those studies specifying "trichloroacetaldehyde" as the test material were used as a basis for classification.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Classification not possible due to the insufficiency of data. According to NITE Initial Risk Assessment No.97 (2005), "trichloroacetaldehyde rapidly reacts in vivo with water to form chloral hydrate." However, only those studies specifying "trichloroacetaldehyde" as the test material were used as a basis for classification.	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

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	- -	-	-	It was classified into Not classified from 48 hours EC50=112mg/L of the crustacea (Daphnia magna) (CERI/NITE Hazard Assessment Report (2005) and others.).	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Since it was not water-insolubility (the water-solubility =30000mg/L (PHYSPROP Database, 2005)), and acute toxicity was low, it was classified into Not classified.	FY2006	GHS Classification Manual （10 Feb, 2006）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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