GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 302-17-0
Chemical Name Chloral hydrate
Substance ID H30-C-016-MHLW
Classification year (FY) FY2018
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2010  
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) 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 -
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2 Flammable gases (including chemically unstable gases) -
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3 Aerosols -
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4 Oxidizing gases -
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5 Gases under pressure -
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6 Flammable liquids -
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7 Flammable solids -
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8 Self-reactive substances and mixtures -
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9 Pyrophoric liquids -
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10 Pyrophoric solids -
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11 Self-heating substances and mixtures -
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12 Substances and mixtures which, in contact with water, emit flammable gases -
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13 Oxidizing liquids -
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14 Oxidizing solids -
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15 Organic peroxides -
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16 Corrosive to metals -
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HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) -
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1 Acute toxicity (Dermal) -
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1 Acute toxicity (Inhalation: Gases) -
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1 Acute toxicity (Inhalation: Vapours) -
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1 Acute toxicity (Inhalation: Dusts and mists) -
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2 Skin corrosion/irritation -
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3 Serious eye damage/eye irritation -
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4 Respiratory sensitization -
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4 Skin sensitization -
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5 Germ cell mutagenicity -
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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).
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)). As for classification results by domestic and international organizations other than this, EPA classified it as CBD (cannot be determined) (IRIS (2010)).
(2) In two tests in which male mice were dosed 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 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 dosed 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 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)).
7 Reproductive toxicity -
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8 Specific target organ toxicity - Single exposure -
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9 Specific target organ toxicity - Repeated exposure -
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10 Aspiration hazard -
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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) -
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11 Hazardous to the aquatic environment (Long-term) -
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12 Hazardous to the ozone layer -
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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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