GHS Classification Result

Chemical Name:fenhexamid; N-(2,3-dichlor-4-hydroxyphenyl)-1-methylcyclohexancarboxamid
CAS:126833-17-8

Result:
ID: 20A2323
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 - - - - Organic compounds containing chlorine and oxygen (but not fluorine), which are bonded only to carbon or hydrogen.
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 Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Its rat LD50 of > 5000 mg/kg bw (JMPR (2005)) corresponds to the "Not classified" category.
1 Acute toxicity (Dermal) Not classified - - - - Its rat LD50 of > 5000 mg/kg bw (JMPR (2005)) corresponds to the "Not classified" category.
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 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 ...
Its rat LC50 of > 0.32 mg/L (aerosol) (JMPR (2005)) corresponds to Category 2. Although another rat LC50 value of > 5.05 mg/L (dust) has been documented (JMPR (2005)), we chose the former value that represents a higher hazard for the classification purpose. Based on its saturated vapour pressure concentration of 4.8E-008 mg/L, the experiment was presumably conducted in a dust (mist) state.
2 Skin corrosion/irritation Not classified - - - - In Draize tests using rabbits, signs of skin irritation were not observed, drawing a conclusion that the substance is not a skin irritant (JMPR (2005)). Thus, it was classified into the "Not classified" category.
3 Serious eye damage/eye irritation Not classified - - - - In Draize tests using three rabbits, no signs of irritation were observed, except for eye mucus detected in one rabbit 1 hour after application, drawing a conclusion that the substance is not an eye irritant (JMPR (2005)). Thus, it was classified into "Not classified".
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - Four skin sensitization tests using guinea pigs have been documented (JMPR (2005)), in which one Buehler test gave a negative result, three maximization tests gave two negative results and one positive result, and an LLNA method using mice gave a negative result (JMPR (2005). Since these reports alone do not provide sufficient information to justify classification of the substance into the "Not classified" category, it was classified into "Classification not possible".
5 Germ cell mutagenicity Not classified - - - - Based on negative results acquired in micronucleus tests using bone marrow cells of mice that underwent intraperitoneal administration (in vivo mutagenicity tests using somatic cells) (JMPR (2005)), the substance was classified into the "Not classified" category. As for in vitro mutagenicity tests, all of the following tests gave negative results: chromosomal aberration tests using cultured ovarian cells of Chinese hamsters, gene mutation tests using cultured pneumocytes of Chinese hamsters, and Ames tests (JMPR (2005)).
6 Carcinogenicity Not classified - - - - In 2-year oral administration (mixed diet) toxicity tests using rats, no signs of carcinogenicity were found (JMPR (2005)). Similarly, in 2-year administration (mixed diet) toxicity tests using mice, no carcinogenic effects were observed in mice (JMPR (2005)). Based on these reports, the substance was classified into the "Not classified" category.
7 Reproductive toxicity Not classified - - - - In two-generation reproduction tests using rats that underwent oral administration (mixed diet), no signs of toxicity toward fertility were detected at 20000 ppm, the highest dose tested (JMPR (2005)), although body weight of offspring decreased at 5000 ppm at the doses that caused suppression of body weight gain in parental animals. In addition, in developmental toxicity tests using rats that underwent forced oral administration, no embryo or fetal toxicity, or no signs of teratogenicity were observed at the doses that had no toxic effects on maternal animals (JMPR (2005)). Similarly, in developmental toxicity tests using rabbits that underwent forced oral administration, no embryo or fetal toxicity, or no signs of teratogenicity were observed at the doses that caused suppression of body weight gain in maternal animals (JMPR (2005)). Based on these results, the substance was classified into the "Not classified" category.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In 90-day oral administration (mixed diet) toxicity tests using rats, kidney damage was observed at 50000 ppm (5585 mg/kg bw /day for male and 8100 mg/kg bw /day for female), which is above Category 2 guidance doses (JMPR (2005)). In addition, in 90-day oral administration toxicity (mixed diet) tests using mice, a decreased kidney weight was noted at 10000 ppm (3283 mg/kg bw /day for male and 5151 mg/kg bw /day for female), which is above Category 2 guidance doses (JMPR (2005)). In different 90-day oral administration toxicity (mixed diet) tests, a decreased kidney weight and kidney degeneration identified by the naked eye or under the microscope were found at 20000 ppm (3416 mg/kg bw /day for male and 6145 mg/kg bw /day for female), which is above Category 2 guidance doses (JMPR (2005)). Based on these three reports, the effects of the substance on the kidney are suspected. All effects were observed at "Not classified" category guidance doses, and its effects at Category 2 guidance doses are unknown. As such, the substance was classified into "Classification not possible". Also, in 28-day repeated inhalation toxicity tests using rats, an increased lung weight, grey discolouration of the lungs, and bronchoalveolar proliferations were noted at 486.7 mg/m3 (= 0.487 mg/L) (90-day correction: 0.151 mg/L), which falls under Category 2 guidance doses; however, these changes were documented to be small from a toxicological standpoint (JMPR (2005)).
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 96-hour LC50 = 1.24 mg/L for fish (rainbow trout) (Aquire 2009), 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 there are no data on its rapid degradability, 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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