GHS Classification Result

Chemical Name:folpet (ISO); N-(trichloromethylthio)phthalimide
CAS:133-07-3

Result:
ID: 20A2195
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
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid
5 Gases under pressure Not applicable - - - - Solid
6 Flammable liquids Not applicable - - - - Solid
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
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
14 Oxidizing solids Not applicable - - - - It contains chlorine and oxygen (but not fluorine), which are chemically bonded only to carbon.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Its rat LD50 values are documented to be >= 5000 mg/kg (JMPR (No. 897, 1995)) and >= 10000 mg/kg (Patty (5th, 2001)). Thus, the substance was classified into the "Not classified" category.
1 Acute toxicity (Dermal) Not classified - - - - Based on its rabbit LD50 of 22600 mg/kg (Patty (5th, 2001)), the substance was classified into "Not classified".
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Category 2 Danger H330: Fatal if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P284: Wear respiratory protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P320: Specific treatment is urgent (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on its rat LC50 of 0.39 mg/L/4h (JMPR (No. 897, 1995)), the substance was classified into Category 2. A total of three LC50 values for rats were obtained from two separate studies: 0.39 mg/L/4h for male, 0.43 mg/L/4h for female (JMPR (No. 897, 1995)), and > 5.0 mg/L/2h (Patty (5th, 2001)). Its saturated vapour pressure concentration (conversion value) is 0.02 ppm. Given that its LC50 value is higher than its saturated vapour pressure, classification was carried out using the criteria for dusts, not vapour.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
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 ...
In guinea pig maximization tests (JMPR (No. 897, 1995)), more than 30% of animals (18 of 20 treated subjects) showed extensive erythema, and the substance was evaluated to be a strong sensitizer. Thus, the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - Since in vivo mutagenicity tests (micronucleus tests using rat bone marrow cells) yielded negative results (JMPR (No. 897, 1995), the substance was classified into the "Not classified" category. Regarding in vitro tests, Ames tests and chromosomal aberration tests using CHO cells gave positive results while hprt locus gene mutation tests using Chinese hamster lung fibroblasts yielded negative results (JMPR (No. 897, 1995)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer 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 studies using rats (strains: Charles River Crl:CD (SD) BR and Fischer) (JMPR (No. 897, 1995)), no carcinogenic effect was noted. In two separate tests using CD-1 mice (JMPR (No. 897, 1995)), duodenal adenomas, duodenal adenocarcinomas, and benign papillomas in the stomach were noted. Tumors seen in the duodenum are documented to be indirectly caused by congestion of folpet resulted from duodenal obstruction. However, tumorigenesis was detected mainly in the digestive system in a number of studies, and the substance is rated as B2 by the US EPA (IRIS (2002)). Thus, the substance was classified into Category 2.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging 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 teratogenicity tests using rats (JMRP (No. 897, 1995)), reproductive toxic effects (implantation loss, reduced body weight gain in maternal animals, decreased uterine weights, and dose-related reduction in ossification) were noted at doses that showed general toxicity to parental animals, and in teratogenicity tests using rabbits, hydrocephaly and malformations of bones, digestive system, and lung were found at doses that showed toxic effects on parental animals (JMPR (No. 897, 1995)). Thus, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In 13-week oral administration tests using rats (doses: 24-72 mg/L) (JMPR (No. 897, 1995)), decreased total serum proteins and albumin, irritation of the proximal gastrointestinal tract, hyperkeratosis of the non-granular gastric mucosa, and acanthosis of the stomach occurred. Thus, the substance was classified into Category 2 (stomach, intestine, and blood). In a 12-week mixed diet test using rats (doses: 0.01, 0.32, and 1 % (90-day correction: 5, 160, and 500 mg/kg bw/day, respectively), no abnormalities were revealed in the liver, kidneys, adrenals, intestines, lungs, and gonads (JMPR (No. 897, 1995)). In a 13-week mixed diet test using rats (doses: 0, 0.03, 0.1, 0.3, and 1.0%), the NOAEL was found to be 300 mg/kg bw/day, and no abnormalities were shown in the blood, hepatic enzymes, renal functions, or organ weights (JMPR (No. 897, 1995)). Results from these two studies indicate that the substance falls under the "Not classified" category for oral route administration, but since no test results focusing on other administration routes are available, classification is not possible. In other studies using rats or dogs, doses used did not fall under the range of guidance values, thus, these studies were not used as grounds for 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 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Since its 96-hour LC50 = 0.015 mg/L for fish (rainbow trout) (ECOTOX, 2008), the substance was classified into Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1 Warning H410: Very 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 1, and it is not rapidly degradable (SRC: BiioWin V4.10), the substance was classified into Category 1.


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)


To GHS Information