NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	96-45-7
Chemical Name	2-Imidazolidinethione; Ethylenethiourea
Substance ID	25B0059
Classification year (FY)	FY2013
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	FY2009 FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
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 solid	Classification not possible	- -	-	-	No data available. Besides, it is described in ICSC (1994) that it is combustible.
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	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	- -	-	-	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	It was classified in Category 4 based on reports on LD50 values for rats of 900 mg/kg, 940 mg/kg, and 1,832 mg/kg (DFGOT vol. 11 (1998), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NTP TR388 (1992), JMPR (1993)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, a 24-hour occlusive application test with guinea pigs is described in DFGOT vol. 11 (1998), but there are no descriptions of the intensity of irritation, etc. And it is described in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2008) that there is a report that this substance was irritating to the skin and eye in humans, but the details are unknown.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2008) that slight irritation was observed in a 24-hour primary eye irritation test with rabbits, and it was irritating to the skin and eye in humans, but the details are unknown.
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 effects in humans, it is reported in DFGOT vol. 11 (1998) that a female worker in a rubber factory who developed an itching rash on the hands and arms was patch tested positive, one was positive in a patch test in 200 dermatological patients, and positive results were obtained in two out of 30 dermatological patients. And it is reported that positive reactions were seen in seven out of 10 animals in a maximization test with guinea pigs (DFGOT vol. 11 (1998)). It was classified in Category 1 based on the above information.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for in vivo, it was negative in all of a dominant lethal test with mice, micronucleus tests with rat bone marrow cells, bone marrow cells and peripheral blood of mice, a chromosomal aberration test with rat bone marrow cells, a sister chromatid exchange test with mouse bone marrow cells, and a DNA damage test with mouse bone marrow cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), IARC 79 (2001)). As for in vitro, it was negative in a chromosomal aberration test with cultured mammalian cells, positive results were mixed with negative results in bacterial reverse mutation tests and mouse lymphoma tests, but the positive results all occurred at higher doses, and they were weakly positive (JECDB (Access on September 2013), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), IARC 79 (2001), NTP DB (Access on September 2013)).
6	Carcinogenicity	Classification not possible	- -	-	-	IARC described it as Group 3 (IARC 79 (2001)). However, reports are indicating that the substance is carcinogenic: in a carcinogenicity test with rats, follicular cell adenoma/carcinoma of the thyroid and tumors in the Zymbal's gland, and mononuclear cell leukemia significantly increased; in a carcinogenicity test with mice, liver carcinoma, lymphoma, follicular cell adenoma/carcinoma of the thyroid, hepatocellular adenoma/carcinoma, and adenoma/carcinoma of the anterior lobe of the pituitary significantly increased (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). And it was classified in Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2013)), and R by NTP (NTP ROC 12th (2011)). Therefore, it was classified as "Classification not possible" by prioritizing IARC 79 (2001).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	No reproductive toxicity was seen in an oral administration two-generation test with rats (DFGOT vol. 11 (1998)), but in an oral administration test with rats (single administration during the organogenesis period: day 8-19 of gestation), increased resorptions and hydrocephaly were observed at the doses that did not cause parental toxicity (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and in an oral administration test with rats (organogenesis period: day 6-15 of gestation), hydrocephaly and ectrodactyly were found, although there are no descriptions of parental toxicity (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). And in another oral administration test with rats (organogenesis period: day 7-21 of gestation), hydrocephaly was seen at the exposure dose that did not cause parental toxicity, and malformations in the central nervous system and skeletal system, cleft palate, etc. were observed at the exposure dose that produced parental toxicity (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), IARC 79 (2001)). Furthermore, in an oral administration test with rabbits (organogenesis period: day 7-21 of gestation), increased resorptions were found at the dose that did not cause effects in parents (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), IARC 79 (2001)), and in an oral administration test with hamsters (organogenesis period: day 6-13 of gestation), at the dose where there were no effects in parents, malformations in the skeletal system and lung were seen in addition to a dose-dependent increase in mortality and decreased body weights in the fetuses, and effects on the central nervous system were observed (DFGOT vol. 11 (1998)). It was classified in Category 1B based on the above information. Besides, it was classified in "Repr. Cat.2; R61" in EU DSD classification and "Repr. 1B, H360D" in EU CLP classification.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported that increased relative weights and fatty accumulation were observed in the liver after oral administration to rats, but the liver was not adopted as the target organ because the other toxicity findings and doses are unknown (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (pituitary, thyroid)	Danger	H372	P260 P264 P270 P314 P501	In 13-week, 1-year, or 2-year diet administration tests with rats, effects on the thyroid ( increased weights, follicular cell hyperplasia, fluctuation of thyroid hormone, decreased colloid in the follicular lumen) at the doses within the range for Category 1 (0.25-8.3 mg/kg/day) and vacuolization of the pituitary cells at the doses equivalent to Category 2 (12.5-25 mg/kg/day) were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). And in a 28-day gavage administration test with rats, enlargement, follicular cell hypertrophy, and a decrease in colloid in the thyroid and hypertrophy of basophilic cells in the anterior lobe of the pituitary were found at the doses (6-30 mg/kg/day (converted guidance value: 1.9-9.3 mg/kg/day)) corresponding to Category 1 (JECDB (Access on October 2013)). Therefore, the pituitary and thyroid system was estimated to be the target organ. Besides, effects on the pituitary and thyroid system were also seen after repeated oral exposure to mice, but at the doses equivalent to Category 2 or "Not classified." And centrilobular hepatocellular hypertrophy was observed in part of tests with rats and mice, but the liver was not included in the target organ by judging it to be adaptive responses to foreign bodies. From the above, it was classified in Category 1 (pituitary, thyroid). Besides, the category for the pituitary was changed from the previous classification because the report by the Ministry of Health, Labour and Welfare was newly added as the information source this time.
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 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 13.3 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	It was classified as "Not classified" due to 21-day NOEC = 2.50 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)) although it is not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1982)).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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