Chemical Name:2,3-Dihydro-6-propyl-2-thioxo-4(1H)-pyrimidinone; Propylthiouracil
CAS:51-52-5
ID: | 533 |
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 | |
---|---|---|---|---|---|---|---|
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 | |
---|---|---|---|---|---|---|---|
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 (oral route) value of 1,250mg/kg (RTECS (2006)). | |
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 | Classification not possible | - | - | - | - | Classification is not possible due to the insufficiency of data. No data are available on multi-generation mutagenicity tests and germ cell mutagenicity tests in vivo, whereas a somatic cell mutagenicity study in vivo (chromosome aberration test) showed negative results (NTP DB (Access on June 2006) and IARC 79 (2001)). However, the latter test was exceptional in that it was conducted ex vivo using the thyroid gland and therefore cannot serve as an adequate basis for the classification. |
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 Category R by NTP (2005) and 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 reduced cerebral neocortex volume and abnormal behaviour in the pups observed in rat teratogenicity studies, described in IARC 79 (2001) (though no data are available regarding parental toxicity). | |
8 | Specific target organ toxicity - Single exposure | Classification not possible | - | - | - | - | No data available |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (thyroid, blood system, liver, cardiovascular system, skin) | Danger | H372: Cause damage to organs through prolonged or repeated exposure (thyroid, blood system, liver, cardiovascular system, skin) |
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 (patients given doses of propylthiouracil): "Agranulocytosis is the most common side effect; rare but severe side effects include hepatitis, angitis and drug induced lupus syndrome," "Propylthiouracil has been widely used in the treatment of hyperthyroidism; patients tend to develop hypothyroidism due to inappropriate management of dosage regimens" (IARC 79 (2001)). Also based on the evidence from animal studies: "Both serum T3 and T4 levels are decreased; hyperplasia of the follicular epithelial cells has been reported" (IARC 79 (2001)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for 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) | Classification not possible | - | - | - | - | Classification not possible due to lack of data |
11 | Hazardous to the aquatic environment (Long-term) | Classification not possible | - | - | - | - | Classification not possible due to lack of data |
* 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) |