NITE - Chemical Management Field

GHS Classification Result

Chemical Name：2,3-Dihydro-6-propyl-2-thioxo-4(1H)-pyrimidinone; Propylthiouracil
CAS：51-52-5

Result：


ID:	533
Classifier:	Inter-ministerial Committee on GHS
Year Classified:	FY2006
Reference Manual:	GHS Classification Manual （10 Feb, 2006）

PHYSICAL HAZARDS

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

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 (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

ENVIRONMENTAL HAZARDS

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

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）