Chemical Name:5-Ethyl-5-phenyl-2,4,6(1H,3H,5H)-pyrimidinetrione; Phenobarbital
CAS:50-06-6
ID: | 519 |
Classifier: | Inter-ministerial Committee on GHS |
Year Classified: | FY2006 |
Reference Manual: | GHS Classification Manual (10 Feb, 2006) |
Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
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1 | Explosives | Not applicable | - | - | - | - | Containing no chemical groups with explosive properties |
2 | Flammable gases (including chemically unstable gases) | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
3 | Aerosols | Not applicable | - | - | - | - | Not aerosol products |
4 | Oxidizing gases | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
5 | Gases under pressure | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
6 | Flammable liquids | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
7 | Flammable solids | Classification not possible | - | - | - | - | No data available |
8 | Self-reactive substances and mixtures | Not applicable | - | - | - | - | Containing no chemical groups with explosive or self-reactive properties |
9 | Pyrophoric liquids | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
10 | Pyrophoric solids | Classification not possible | - | - | - | - | No data available |
11 | Self-heating substances and mixtures | Classification not possible | - | - | - | - | No data available |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - | - | Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) |
13 | Oxidizing liquids | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
14 | Oxidizing solids | Not applicable | - | - | - | - | Organic compounds containing oxygen (but not fluorine and chlorine), with the oxygen bound to carbon and hydrogen (but not to other elements) |
15 | Organic peroxides | Not applicable | - | - | - | - | Organic compounds containing no "-O-O-" structure |
16 | Corrosive to metals | Classification not possible | - | - | - | - | Test methods applicable to solid substances are not available |
Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
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1 | Acute toxicity (Oral) | Category 3 | Danger | H301: Toxic if swallowed |
P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P321: Specific treatment (see ... on this label). P330: Rinse mouth. P405: Store locked up. P501: Dispose of contents/container to ... |
Based on the rat LD50 (oral route) value of 162mg/kg (IARC 79 (2001)). | |
1 | Acute toxicity (Dermal) | Classification not possible | - | - | - | - | No data available |
1 | Acute toxicity (Inhalation: Gases) | Not applicable | - | - | - | - | Due to the fact that the substance is "solid" according to the GHS definition and inhalation of its gas is not expected. |
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 | Classification not possible | - | - | - | - | No data available |
3 | Serious eye damage/eye irritation | Classification not possible | - | - | - | - | No data available |
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 ... |
Based on the absence of data on multi-generation mutagenicity tests and positive data on germ cell mutagenicity tests in vivo (chromosome aberration tests), described in IARC 79 (2001) and NTP DB (Access on May 2006). | |
6 | Carcinogenicity | Category 2 | Warning | H351: Suspected of causing cancer |
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 ... |
Due to the fact that the substance is classified as Group 2B by IARC (2001). | |
7 | Reproductive toxicity | Category 2 | Warning | H361: Suspected of damaging fertility or the unborn child |
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 ... |
Based on the evidence of cleft palate and abnormal behaviour of the offspring observed in teratogenicity studies with mice and rats, described in IARC 79 (2001) (though no data are available regarding parental toxicity). | |
8 | Specific target organ toxicity - Single exposure | Category 3 (Narcotic effects) | Warning | H336: May cause drowsiness or dizziness (narcotic effects) |
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. P405: Store locked up. P501: Dispose of contents/container to ... |
Based on the evidence from animal studies including "somnolence" (RTECS (2006)). | |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, thyroid), Category 2 (liver, kidney) |
Danger Warning |
H372: Cause damage to organs through prolonged or repeated exposure (nervous system, thyroid) H373: May cause damage to organs through prolonged or repeated exposure (liver, kidney) |
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 ... |
Based on the human evidence: "Sedation is the most common side effect of exposure to phenobarbital in humans. Overdosage of phenobarbital leads to nystagmus and ataxia," "In the patient, T4 level was decreased whereas T3 and TSH responses to thyrotropin-releasing hormone were within the normal range" (IARC 79 (2003)), "A 2-yr-old child developed massive hepatic necrosis caused by an unusual hypersensitivity response to phenobarbital that was prescribed for presumed febrile seizures," "phenobarbital induced a hypersensitivity state consisting of tubulointerstitial nephritis, exfoliative dermatitis and hepatitis" (HSDB (2002)). Also based on the evidence from animal studies: "the liver of the test animal showed an occurrence of moderate to severe hypertrophy of centrolobular hepatocytes," "serum T4 and T3 levels were decreased, whereas TSH production was increased," "mild to moderate follicular hypertrophy of the thyroid gland and moderate hepatocellular hypertrophy occurred" (IARC 79 (2003)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 2. Since the priority rating of the study reporting the effects on the liver and kidneys in humans is 2, these effects are classified into Category 2. | |
10 | Aspiration hazard | Classification not possible | - | - | - | - | No data available |
Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment (Acute) | Not classified | - | - | - | - | It was classified into Not classified from 96 hours LC50=484mg/L of the fish (Fathead Minnows) (HSDB, 2004). |
11 | Hazardous to the aquatic environment (Long-term) | Not classified | - | - | - | - | Since it was not water-insolubility (the water-solubility =1110mg/L (PHYSPROP Database, 2005)), and acute toxicity was low, it was classified into Not classified. |
* 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 Manual |
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Definitions / Abbreviations |
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Model Label by MHLW |
MHLW Website (in Japanese Only) |
Model SDS by MHLW |
MHLW Website (in Japanese Only) |