NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	62-56-6
Chemical Name	Thiourea
Substance ID	m-nite-62-56-6_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	There is the information that it is combustible (GESTIS (Access on June 2017)), but the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 440 deg C (GESTIS (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on a reported LD50 value of 1,750 mg/kg (BUA 179 (1995)) for rats, it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the information on an LD50 value of > 2,800 mg/kg (CICAD 49 (2003)) for rabbits, it was classified as "Not Classified." The classification result was changed from the previous one.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	There is a report that in a 4-hour inhalation exposure test with rats, the LC50 value of the dust of this substance was > 0.17 mg/L (BUA 179 (1995)), but the category could not be specified only by this value. Therefore, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on a report that in a skin irritation test with rabbits, this substance was not irritating (CICAD 49 (2003), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), it was classified as "Not classified." Besides, there is a report that in 24-hour application, mild to severe erythema and slight edema were caused (CICAD 49 (2003), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), but it was not adopted because of the result of long-term application.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on a report in an eye irritation test with rabbits, slight redness and edema were observed (CICAD 49 (2003), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), it was classified in Category 2B.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	As for humans, there are multiple case reports showing sensitization such as a case of skin reaction caused by administration of a thyroid inhibitor, a main ingredient of which is this substance, or a case of work of polishing silver products using this substance, blisters with itching on the finger tips and under the nails were repeatedly produced, and later eczema spread to the face, forehead, nose, and mouth (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol. 13 (Ministry of the Environment, 2015), CICAD 49 (2003)). Therefore, it was classified in Category 1. Besides, there is a report of a negative in a skin sensitization test with guinea pigs (CICAD 49 (2003), DFGOT Vol. 14 (2000)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, a micronucleus test with rat bone marrow cells was negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), CICAD 49 (2003)). As for in vitro, bacterial reverse mutation tests were negative, gene mutation tests with mammalian cultured cells were negative, mouse lymphoma tests were positive and negative results, micronucleus tests were positive, and a sister chromatid exchange test was negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), IARC 79 (2001), CICAD 49 (2003)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	There is a report that in a study with rats dosed by drinking water for a maximum of 23.5 months, thyroid follicular-cell adenoma and carcinoma were observed. Meanwhile, there are reports that in a 2-year test with rats dosed by feeding and a test with mice dosed for up to 81 weeks, only thyroid hyperplasia was observed, but tumors were not observed (IARC 79 (2001)). On the other hand, there are reports that in a test with rats dosed by drinking water for a maximum of 26 months, epidermoid carcinomas of the external auditory canal or meibomian glands were observed, and that in a 14-23 month test with rats dosed by drinking water, squamous-cell carcinomas of the Zymbal gland and meibomian gland were observed. All the tests used a small number of animals, and it was judged that they were not tests that meet current protocol standards (IARC 79 (2001)). Accordingly, IARC classified it in Group 3 because there is limited evidence in experimental animals for the carcinogenicity (IARC 79 (2001)). In contrast, NTP classified it as R since there is sufficient evidence of carcinogenicity in experimental animals (NTP RoC (14th, 2016)). Other than these, EU classified it in Carc. 2 (ECHA CL Inventory (Access on June 2017)), and Japan Society for Occupational Health (JSOH) classified it in Group 2B (Recommendation of Occupational Exposure Limits, 2016: proposed in 1995). From the above, by considering comprehensively the test results and the classification results by other organizations, it was judged that it was reasonable to classify in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	It is reported that in a single administration test in which pregnant rats or mice were dosed by gavage (day 12 or 13 of gestation) at 1,000 mg/kg with maternal toxicity, an increase in fetus resorption rate was observed in both rats and mice, that in a test with pregnant rats dosed by drinking water at 2,000 ppm (from day 1 to day 14 of gestation), growth retardation, effects on the central and peripheral nervous system, effects on the skeletal system, and effects on the eye were observed in fetuses, and that in an oral administration test with pregnant rats dosed by gavage at 100 and 250 mg/day (approximately 350 and 900 mg/kg/day) from day 18 of gestation to day 10 of postpartum, decreased weight gain at or above 100 mg/day, decreased thyroid function, and developmental delay of auditory startle reflex at or above 250 mg/day were observed in offspring (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol. 13 (Ministry of the Environment, 2015)). From the above, at doses where maternal toxicity occurred or was unknown, fetotoxicity and developmental effects on fetuses or newborns were observed, therefore, it was judged that Category 2 was adequate. Besides, EU also classified this substance in Repr. 2 (ECHA CL Inventory (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	There is a report that in a single-oral administration test with rats, at near 1,750 mg/kg which is within a range for Category 2, bradykinesia, hunched position, discoloration of the eyes were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 179 (1995)). In addition, there is a report that in a 4-hour single inhalation exposure test with rats exposed to the dust of this substance, at 0.17 mg/L which is within the range for Category 1, bradykinesia following restlessness and irritation of the respiratory tract were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 179 (1995)). Since respiratory tract irritation was observed, it was classified in Category 3 (respiratory tract irritation).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (thyroid), Category 2 (liver)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	As for humans, as a case of occupational exposure, there is a report that the symptoms observed in workers who were exposed to this substance during working processes such as maintenance of machinery and packaging at a Russian plant, were face edema which is typical thyroid hypofunction, hypotension, bradycardia, electrocardiographic change with a drop of the basal metabolic rate, constipation, abdominal distension, polyuria, granulocytopenia with an increase in lymphocytes and monocytes (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). There is a report that in male workers in a textile factory which had used this substance and resorcinol at the finishing section, thyroid hypofunction was observed, and relevance to exposure was suggested (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). In addition, there is a report that as a report of toxic effects in cases where this substance was used as thyroid depressant, there were fever in 24 persons, gastrointestinal dysfunction in 17 persons, eruption in 9 persons, leukopenia in 4 persons, arthralgia and myalgia in 4 persons, granulocytopenia in one person, urticaria in one, lymph node swelling in one, edema in one and other symptoms in 20 persons. In another report, symptoms indicating sensitization are reported, including urticaria, nausea, vomiting, and fever (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). As for experimental animals, there is a report that in a 2-year repeated oral dose toxicity test with rats dosed by feeding, at or above 0.05% (converted guidance value: 25 mg/kg/day) within the guidance value range for Category 2, hyperplasia of the thyroid follicles was observed, and at 0.1% (converted guidance value: 50 mg/kg/day) or above, increased thyroid weight, hyperplasia and disordering of the structure of liver cells, bile duct proliferation, vacuolation and hyaline degeneration of liver cells were observed (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). From the above, in humans, thyroid hypofunction was primarily observed, and in experimental animals, effects on the thyroid and liver were observed within the guidance value range for Category 2. Therefore, it was classified in Category 1 (thyroid), Category 2 (liver). By reviewing the contents of the existing information source, the classification result differed from the previous classification.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 2	- -	H401	P273 P501	From 96-hour EC50 = 1.8 mg/L for crustacea (Daphnia magna) (WHO/IPCS CICAD: 2003), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 2.6% (J-CHECK, 1979)), and 21-day NOEC (reproduction inhibition) = 0.75 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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