GHS Classification Result

Chemical Name:thiophanate-methyl (ISO); 1,2-di-(3-methoxycarbonyl-2-thioureido)benzene
CAS:23564-05-8

Result:
ID: 20A2263
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

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 solid 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 - - - - The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - 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 Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Based on its rat LD50 values of > 5000 mg/kg (JMPR (1977)) and 6640-7500 mg/kg (EHC No. 64 (1986)), the substance was classified into "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Based on its rat LD50 values of > 2000 mg/kg (JMPR (1977)) and > 10000 mg/kg (EHC No. 64 (1986)), the substance was classified into "Not classified" (Category 5 or "Not classified" category in the United Nations classification).
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) Category 4 Warning H332: Harmful if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
Based on its rat LC50 value of 1.8 mg/L (JMPR (1998)). With its saturated vapour pressure concentration being 1.28E-05 mg/L, it is speculated that this study was carried out under the condition in which its vapour concentration was higher than its saturated vapour pressure concentration.
2 Skin corrosion/irritation Not classified - - - - No signs of irritation were observed during 72 hours of observation in the tests using rabbits that were treated with a dose of 0.5 g for 4 hours (JMPR (1977). Based on this report, the substance was classified into "Not classified". In addition, slight reversible erythema was observed in the tests using rabbits that were treated with 1g of the substance for 21 days (JMPR (1993)).
3 Serious eye damage/eye irritation Not classified - - - - In the tests using rabbits in which conjunctival redness was observed in 4 of 6 treated animals whose eyes were unwashed after the application and 3 treated animals whose eyes were washed after the application. All rabbits with this symptom recovered 24 hours after the application, except for one rabbit who recovered in 48 hours (JMPR (1977)). Based on these reports, the substance was classified into "Not classified".
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 ...
The substance was documented to be sensitizing in maximization tests (JMPR (1977)), and it is rated as R43 in the EU's classification. Based on these reports, the substance was classified into Category 1. Additionally, the substance is reported to be not sensitizing in Buehler tests (JMPR (1977)).
5 Germ cell mutagenicity Not classified - - - - Negative results were found in the following tests documented: in vivo heritable mutagenicity tests using germ cells (dominant lethal tests using mice that underwent intraperitoneal administration), in vivo mutagenicity tests using germ cells (chromosomal aberration tests using spermatocytes of mice that underwent intraperitoneal administration), and in vivo mutagenicity tests using somatic cells (chromosomal aberration tests using bone marrow of mice that underwent intraperitoneal administration) (JMPR (1977)). Based on these reports, the substance was classified into "Not classified". Regarding in vitro mutagenicity tests, both negative and positive reactions were seen in Ames tests, negative reactions were observed in chromosomal aberration tests using CHO cells, and negative reactions resulted from gene mutation tests using V79 cells (JMPR (1977)).
6 Carcinogenicity Not classified - - - - Two-year mixed diet administration tests using ICR mice found that the substance has no carcinogenic effects (EHC No. 64 (1986)). In addition, in 18-month mixed diet administration tests using CD1 mice, an increase in tumors was not observed in treated mice compared with historical data on control groups (JMPR (1977)). Furthermore, in the tests using SD rats that were administered for 2 years, no signs of substance's effects were found other than suppressed growth (EHC No. 64 (1986)). In contrast, in 2-year mixed diet administration tests using Fischer rats, incidences of thyroid follicular-cell adenoma (developed in 12 of 60 treated rats) increased at the highest dose tested (6000 ppm). Thyroid follicular-cell adenocarcinomas were detected in 1 of 2 males in the highest dose group who survived to the end of the experiment, and 2 of 53 treated males that died or were killed during the experiment (JMPR (1977)). Overall, because thyroid follicular cell adenocarcinoma were detected in the tests involving Fischer rats only, the adenocarcinoma incidences occurred at a low rate, and adenocarcinoma was associated with males only, the substance was classified into "Not classified".
7 Reproductive toxicity Not classified - - - - In 2-generation tests using rats, neither dose-dependent abnormalities nor reproductive toxicity were found in F1a, F2a or F2b in the functional examinations, although abnormalities were detected in the thyroid gland or liver in F0 and F1 animal groups that were treated with the highest dose. In 3-generation tests using rats, dose-dependent effects on mating, gestation period or pregnancy rate were not detected in dissected F0, F1b and F2b, and no dose-dependent effects on the external appearance, weight of the organs, pathology low index or a skeleton in offspring of F3b. In the tests using pregnant rats or mice that underwent oral administration during the organogenetic period, no dose-dependent effects were detected on the number of implantation, post-implantation loss, weight of fetuses, sex ratio, number of surviving fetuses, fetal malformation or abnormal development (JMPR (1977)). In the tests using pregnant rabbits that underwent oral administration during the organogenetic period, no effects of administration were detected except for numerical abnormality of ribs and skeletal deformity such as incomplete and asymmetrical ossification of the pelvis or vertebra (JMPR (1977)). Since no signs of reproductive toxicity were detected in the heritable tests using rats, and no signs of developmental toxicity were found in rats, mice or rabbits, the substance was classified into "Not classified".
8 Specific target organ toxicity - Single exposure Classification not possible - - - - In inhalation tests using mice that were exposed to wet powder aerosol, lacrimation and salivation were reported (HSDB (2002)); however, classification is not possible due to insufficient data available.
9 Specific target organ toxicity - Repeated exposure Category 2 (thyroid) Warning H373: May cause damage to organs through prolonged or repeated exposure (thyroid) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In dogs that underwent oral administration (capsules) for 24 months, no abnormalities were observed in pathological examinations other than an increased weight of the thyroid gland was observed at doses of 50 and 250 mg/kg (EHC No. 64 (1986)). In 6-month mixed diet administration tests using mice, abnormalities were detected in the liver in animal groups that received a dose (240 mg/kg/day) much higher than Category 2 guidance doses. In 6-month mixed diet administration tests using rats, abnormalities were detected in the thyroid gland at the dose (400 mg/kg/day) that exceeded Category 2 guidance doses. In 3-month oral administration (capsules) tests using dogs, follicular-cell hypertrophy in the thyroid was observed in animal groups for all doses including 50 mg/kg/day. It is also documented that 1-year oral administration (capsules) tests using dogs, follicular-cell hypertrophy in the thyroid was observed at 40 mg/kg/day in pathological examinations (JMPR (1977)). Since follicular-cell hypertrophy in the thyroid was observed in 3-month and 1-year dog tests at the doses that fall under Category 2 guidance values, the substance was classified into Category 2 (thyroid gland).
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 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Since its 48h EC50 = 5.4 mg/L for crustaceans (Daphnia magna) (Aquire 2008), the substance was classified into Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Since its classification for acute toxicity is Category 2 and it is not rapidly degradable (estimated value: SRC: BioWin V4.10), the substance was classified into Category 2.


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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