GHS Classification Result (Revision of the past classification result)

Chemical Name:2-Imidazolidinethione
CAS:96-45-7

Result:
ID: 21B3083
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 - - - - No data available.
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
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 ...
LD50 values of 545, 900, 940 and 1832 mg/kg for rats (DFGOT vol. 11 (1998)) correspond to Category 4.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
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 - - - - Although a 24-hour occluded application test in guinea pigs was conducted with this substance (DFGOT vol. 11 (1998)), the results of irritancy is unknown. Classification was not possible due to lack of sufficient data.
3 Serious eye damage/eye irritation Category 2 Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
Based on a result of "mild irritation" in a rabbit test (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)), the substance was classified into Category 2.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
An itching rash developed on the hands and arms of a woman worker exposed to the substance in a factory producing rubber goods. A patch test carried out with the substance produced positive results (DFGOT vol. 11 (1998)). In a dermatological hospital 200 patients were tested in a patch test. One person produced a positive test result. In another dermatological hospital, 2/30 patients produced positive results (DFGOT vol. 11 (1998)). In a guinea pig maximization test, an allergic reaction was observed in 7 of 10 animals (DFGOT vol. 11 (1998)). Based on these data, the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - Based on a negative result in a mouse dominant lethal test (oral administration, intraperitoneal administration) (in vivo heritable germ cell mutagenicity test) (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)), the substance was classified as "Not classified". There are reports of negative mouse and rat micronucleus tests (in vivo somatic cell mutagenicity tests) (IARC 79 (2001)). As relevant information, from in vitro mutagenicity tests, there are reports of negative Ames tests ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2004)) and positive Ames tests (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), "Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2004)), a negative mouse lymphoma cell gene mutation test (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)), a negative CHO cell chromosomal aberration test (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)), a negative female Chinese hamster lung cell (CHL/IU) chromosomal aberration test ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2004)), and a negative CHO cell sister chromatid exchange test (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)).
6 Carcinogenicity Not classified - - - - Based on the classification of "Group 3" in IARC (IARC vol. 79 (2001)), the substance was classified as "Not classified". In a rat carcinogenicity test, the incidences of follicular cell adenoma/carcinoma in the thyroid, Zymbal's gland tumor and mononuclear cell leukemia were significantly increased (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). In mice carcinogenicity tests, the incidences of liver cancer and lymphoma (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)), and the incidences of follicular cell adenoma/carcinoma in the thyroid, hepatocellular adenoma/carcinoma, and adenoma/carcinoma in the pituitary gland (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)) were significantly increased. The substance is classified into "2B" in Japan Society For Occupational Health (JSOH) and as "R" in NTP.
7 Reproductive toxicity Category 1B Danger H360: May damage 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 ...
In a 2-generation test in rats, there was no reproductive toxicity (DFGOT vol. 11 (1998)). In a rat oral test (single dose during organogenesis: day 8 - 19 of gestation), increased resorptions and hydrocephalus were observed at doses at which no toxicity in the parents were observed (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). In a second rat oral test (during organogenesis: day 6 - 15 of gestation), hydrocephalus and oligodactyly were observed (parental toxicity not stated) (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). In a third rat oral test (during organogenesis: day 7 - 21 of gestation), hydrocephalus was observed at doses at which no toxicity in the parents were observed. Central nervous system and skeletal anomalies and cleft palate were observed at doses at which toxicity in the parents was observed (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). In a rabbit oral test (during organogenesis: day 7 - 21 of gestation), an increase in resorptions was seen at doses at which no toxicity in the parents were observed (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). In a hamster oral test (during organogenesis: day 6 - 13 of gestation), dose-dependent increased fetal mortality and decreased fetal weight, malformations of the skeleton and lungs, and effects on the central nervous system were observed at doses at which no toxicity in the parents were observed (DFGOT vol. 11 (1998)). Based on the reported information, the substance was classified into Category 1B. As relevant information, the substance is classified into Repr. Category 2; R61 in EU classification.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Category 1 (thyroid), Category 2 (pituitary) Danger
Warning
H372: Cause damage to organs through prolonged or repeated exposure (thyroid)
H373: May cause damage to organs through prolonged or repeated exposure (pituitary)
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 ...
For the substance it is reported that the thyroid is a target organ in mice, rats and dogs (DFGOT vol. 11 (1998)). In a 13-week oral (feeding: 0, 60, 125, 250, 500 and 750 ppm) test in rats, focal and diffuse hyperplasia of follicular cell in the thyroid were observed in males and females exposed to the substance at 60 ppm (3 mg/kg/day) and higher dose level groups (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). Similar findings are also noted in a 13-week oral test in mice (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). Since the findings in rats were observed at dose levels within the guidance value range for Category 1, the substance was classified into Category 1 (thyroid gland). In the 13-week oral test in rats reported above, cellular vacuolization in the pituitary gland was observed in the 250 ppm (12.5 mg/kg/day) and higher dose level groups (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). Based on this data, the substance was classified into Category 2 (pituitary gland). In a 28-day drinking water test in rats, effects on the kidneys (vacuolization and edema in the tubular epithelial cell) were observed in the 18 mg/kg (90-day equivalence: 6 mg/kg/day) and higher dose level groups (DFGOT vol. 11 (1998)). Since this test was conducted using males only, the data was not used as the basis of classification.
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) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 3 from its 48h-LC50 = 13.3 mg/L for Crustacea (Daphnia magna) (Initial Risk Assessment Report (NITE, CERI, NEDO), 2008).
11 Hazardous to the aquatic environment (Long-term) Category 3 - - H412: Harmful to aquatic life with long lasting effects P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (Non-biodegradable, BOD degradation rate: 0% (Biodegradation and Bioconcentration 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 Annexes to the Montreal Protocol.


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)


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