GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 62-56-6
Chemical Name Thiourea
Substance ID H29-B-056
Classification year (FY) FY2017
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link)  
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - Solid (GHS definition).
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- - Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- - Solid (GHS definition).
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.
8 Self-reactive substances and mixtures Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- - Solid (GHS definition).
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)).
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
-
-
- - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition).
14 Oxidizing solids Not applicable
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
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.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
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."
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.
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.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
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)).
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)).
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.
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)).
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).
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.
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (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.
11 Hazardous to the aquatic environment (Long-term) 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.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* 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.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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