Chemical Name：5-Ethyl-5-phenyl-2,4,6(1H,3H,5H)-pyrimidinetrione; Phenobarbital
CAS：50-06-6

Hazard class		Classification	Symbol	Signal word	Hazard statement	Precautionary statement	Rationale for the classification
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