GHS Classification Result

Chemical Name：Chloral hydrate
CAS：302-17-0

Result：
ID: 22A4071
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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 - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solids Not classified - - - - Not combustible (ICSC(J) (1999))
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 applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Not combustible (ICSC(J) (1999))
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) 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 - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance is an organic compound containing chlorine and oxygen which are chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		Based on the rat LD50 value of 480 mg/kg (CICAD 25 (2000)), the substance was classified into Category 4.
1 Acute toxicity （Dermal） Not classified - - - - Based on the rat LD50 value of 3030 mg/kg (HSDB (2010)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification).
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 1 Danger H314: Causes severe skin burns and eye damage P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN （or hair）: Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ... 		The substance was classified as Category 1 since it was described that the substance was corrosive to skin and mucous membrane in human (NTP TR 503 (2002), HSDB (2010)).
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		The substance was classified as Category 1 since it was reported that chloral hydrate is corrosive to the skin and mucous membrane in human (NTP TR 503 (2002), HSDB (2010)), and its preexisting classification concluded as a corrosive substance to skin.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Category 1B Danger H340: May cause genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		The classification was concluded as "Category 1B" based on 3 positive results out of 5 micronucleus tests using spermatid obtained after intraperitoneal administration to mice (in vivo mutagenicity test in germ cells) (IARC 84 (2004)). In other mice micronucleus test using bone marrow cells obtained after intraperitoneal administration (in vivo mutagenicity test in somatic cells), 4 positive results out of 6 tests were found (IARC 84 (2004)), and equivocal results of positive and negative data were obtained in the single-strand DNA break test (IARC 84 (2004)). As relevant information, as for in vitro studies, negative or positive results in the Ames test, negative result using Chinese hamster Cl-1 cells and positive result using V79 cells in the micronucleus test, and negative result using Chinese hamster CHED cells and positive result using ovarian cells in the chromosome aberration test (IARC 84 (2004)), were reported.
6 Carcinogenicity Classification not possible - - - - The classification was concluded as "Classification not possible" based on the criterion of "Group 3" by the IARC carcinogenicity assessment. As relevant information, in the 2-year oral administration study in mice, increased incidence of hepatocellular adenoma or carcinoma in males was considered to be certain evidence for carcinogenicity. For females, increased incidence of adenoma of the distal part of hypophysis increased was considered to be the evidence of possible carcinogenicity (NTP TR 503 (2002)). On the other hand, in the 2-year oral administration study in rats, treatment-related occurrence of tumors were not observed (IARC84 (2004)).
7 Reproductive toxicity Not classified - - - - In the study of mice administered via drinking water, males and females were exposed for 3 weeks prior to mating, and females were consequently continued during the gestation period and until weaning after 21 days of birth, no significant effect on drinking water consumption or weight gain in the dams, as well as on gross external malformations in pups, gestational period and number of pups delivered was observed. Thus, there were no effects except for on several parameters indicating neurobehavioral influence of pups, therefore, it was reported that the NOAEL for reproductive and developmental effects was 204.8 mg/kg/day (the highest dose tested) (IRIS (2000)). In the study, which pregnant rats were administered during the gestation period via drinking water, there was no evidence of maternal toxicity, no change in the number of implantation or resorption sites or no change in the developmental indices such as the number of live or dead fetuses (IRIS (2000)). Based on these results, there were no adverse effects on reproductive functions and fertility of parental animals, and development of offspring. Thus, the substance was classified as the "Not classified". In addition, this substance is known to pass the human placenta at some stage of pregnancy. However, it was reported that its use during pregnancy did not cause detectable increase in abnormal outcomes, even though there were few information. (IARC 84 (2004)).
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, heart), Category 3 (narcotic effects) Danger
Warning 		H370: Causes damage to organs (central nervous system, heart)
H336: May cause drowsiness or dizziness (narcotic effects) 		P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ...
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell. 		It was described that the primary effect on human at ingestion of this substance was depression of central nervous system, the basis of use in therapeutics, and it induced sedation and hypnosis (EHC 216 (2000)). It was reported that acute gavage exposure to mice at doses of 900 mg/kg or lower showed sedation, lethargy and loss of righting reflex, and deaths occurred by respiratory inhibition at 1200 mg/kg or higher (IRIS Toxicological Review (2000)). Based on the information in humans, the substance was classified as Category 1(central nervous system). In addition, the substance is used as a hypnotic drug, and it was reported that in mice study the substance induced clinical signs such as sedation, hypnosis, ataxia (IRIS (2000)). Thus, Category 3 (narcotic effects) was added. Furthermore, it was also described that the most important toxic effect is abnormal cardiac rhythm. It was reported that the induction of arrhythmias in the infant was noted and sinus arrhythmias associated with the substance in two of 12 subjects were also noted (EHC 216 (2000)). Thus, Category 1 (heart) was also added.
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system), Category 2 (liver) Danger
Warning 		H372: Cause damage to organs through prolonged or repeated exposure (central nervous system)
H373: May cause damage to organs through prolonged or repeated exposure (liver) 		P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		As the result of the investigation of medical records for 1618 patients who had received the substance, effects on central nervous system in 20 patients was the most common as the adverse reactions of the substance (IRIS (2000)). In another report reviewed medical records of 5435 hospital patients, adverse reactions were noted in 119 cases and effects on central nervous system in 58 patients was the most common, three of them showed so-called flapping tremor as life-threatening reactions (IRIS (2000)). Based on these, the substance was classified as Category 1 (central nervous system). As for the animal experiments, in the 90-day study via drinking water in rats, focal hepatocellular necrosis was observed in the liver of males at 96 mg/kg/day or more, and necrotic lesion was minimal at 96 mg/kg/day but more severe at 196 mg/kg/day (IRIS (2000)). In addition, the 90-day study via drinking water in mice revealed the findings of hepatomegaly and microsome proliferation in males at 16 mg/kg/day or more. Based on these results, Category 2 (liver) was added since the doses appeared were both within the Category 2 or above category.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Not classified - - - - Classified as "Not classified" from its 48h-EC50 = 500 mg/L for crustacea (Daphnia magna) (HSDB, 2010).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility = 793000 mg/L (PHYSPROP Database, 2011)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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