GHS Classification Result

Chemical Name:carbendazim (ISO); methyl benzimidazol-2-ylcarbamate
CAS:10605-21-7

Result:
ID: 20A2069
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 - - - - 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 - - - - Among documented rat LD50 values of > 15000 mg/kg (EHC 149 (1993)), > 17000 mg/kg, > 11000 mg/kg, and > 10000 mg/kg (JMPR 892 (1995)), all values are equivalent to the guidance values of "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Among documented rat LD50 value of > 2000 mg/kg (EHC 149 (1993)) and rabbit LD50 value of > 10000 mg/kg (EHC 149 (1993)), all values are equivalent to the guidance values of "Not classified".
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 - - - - Its rat LC50 > 1.47 mg/L (four-hour conversion, mists) (EHC 149 (1993)). However, classification is not possible depending on this datum only.
2 Skin corrosion/irritation Classification not possible - - - - Classification not possible due to lack of data. As relevant information, it is reported that, in a rabbit Draize test using the wettable powder (which hydrolyzes into the substance), no dermal irritation was seen (EHC 149 (1993)). However, the document was not used for classification.
3 Serious eye damage/eye irritation Not classified - - - - Since in a test using rabbits, no irritation was seen (JMPR 892 (1995)), the substance was classified into "Not classified". As relevant information, in a test using a wettable powder formulation, transient eye irritation was found. However, the irritation response was probably related to the inert ingredients in the wettable powder formulation (JMPR 892 (1995)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on the result of not sensitizing from a test using guinea pigs (EHC 149 (1993)), the substance was classified into "Not classified".
5 Germ cell mutagenicity Category 1B Danger H340: May cause genetic defects 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 ...
Dominant lethal tests by oral administration or i. p. administration to mice have yielded negative results (PATTY (5th, 2001); EHC 149 (1993)). However, based on positive findings of a bone marrow micronucleus and a chromosomal aberration test of germ cells using mice or rats and findings from exposure germ cells to the substance (Mutation Res., 512, 1 - 35, 2002), it was classified into Category 1B. As relevant information, it has been reported that a mutagenicity test using Chinese hamster cells (in vitro mutagenicity test, HGPRT) yielded negative results, an Ames test gave positive results (NTP DB (accessed July 2008)), a mouse lymphoma assay provided positive results, while a chromosomal aberration test using human lymphocytes did not cause chromosomal abnormalities but formed micronuclei (EHC 149 (1993)) (expert advice).
6 Carcinogenicity Not classified - - - - In an oral administration test to CD-1 mice for two years, there was a dose-dependent increase in hepatocelluar adenoma in males (EHC 149 (1993)). Also, in a test of SPF Swiss mice, increase of incidences of hepatocelluar adenoma and hepatocelluar carcinoma in males and increase of incidence of hepatocelluar adenoma in females were indicated (EHC 149 (1993)). While, in a test of NMRKf mice, no dose-dependent incidence of hepatocelluar adenoma was observed (EHC 149 (1993)). Since it is described that carbendazim is estimated to have increased hepatic tumors in CD-1 and SPF Swiss mice with higher natural incidences of hepatic tumors, and in repeated exposure/carcinogenicity combined tests on rats, all tumors were examined, and there was no difference between the treated and control groups (EHC 149 (1993)), the substance was classified into "Not classified".
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 three-generation reproduction study of rats, at up to the moderate dose of carbendazim (500 mg/kg diet), no harmful effects were observed (EHC 149 (1993)). While, in a study in which rats were administered 50, 100, 200, or 400 mg/kg/day bw of carbendazim by gavage, administration of 200, 400 mg/kg/day markedly altered sperm morphology, testicular and epididymal weights, sperm counts, and testicular histology in males, and in females, postimplantation losses at high doses and a few malformed rat pups at 100, 200 mg/kg/day bw were found (EHC 149 (1993)). After administration of 400 mg/kg/day bw to male rats for 10 days, atrophy of the seminiferous tubule were found and rats with unrecovered fertilizing ability were seen (PATTY 5th (2001)). In a test in which 0, 5, 10, 20, or 90 mg/kg/day bw of carbendazim was administered to female rats on 7 - 16 days of gestation, administration of 90 mg/kg/day bw showed a decreased pregnancy rate and increase in the incidence of early resorptions, administration of 20 and 90 mg/kg/day bw showed reductions in fetal weight, administration of 90 mg/kg/day bw indicated an increase in the incidence of fetal malformations (such as hydrocephaly, microophthalmia, anophthalmia, and malformed scapulae) (EHC 149 (1993)). In addition, in rabbits, administration of 20, 125 mg/kg/day bw on 7 - 19 days of gestation showed a slightly decreased implantation rate, administration of 125 mg/kg/day bw indicated an increased incidence of resorption (EHC 149 (1993)). Based on the above test results, the substance was classified into Category 1B.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Classification not possible due to lack of data. As relevant information, in an oral administration test to rats, at the dose of 1000 mg/kg bw or more, changes in the testis and epididymis were observed, and degeneration of the seminiferous tubule was found in more than 70% of rats (JMPR 892 (1995)). However, the relations among the results and the exposure levels are not clear.
9 Specific target organ toxicity - Repeated exposure Category 2 (liver) Warning H373: May cause damage to organs through prolonged or repeated exposure (liver) 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 ...
Multiple tests on repeated oral exposure for 13 weeks (90 days) or two years (104 weeks) using rats, mice, and dogs have been conducted (EHC 149 (1993), JMPR (1995)). After administration to rats for 90 days at 32 or 64 mg/kg/day, in addition to increase in GPT, alkaline phosphatase activity, and serum bilirubin concentrations, dose-related changes from infiltration by inflammation to degeneration have been reported (JMPR 892 (1995)). In a test in which dogs were exposed for two years, at doses of 500 ppm (approximately 25 mg/kg/day) or more, elevated serum GPT, swollen, vacuolated hepatic cells, and marginal proliferation of the portal triads with cellular infiltration were observed, and as findings of final examination, hepatic cirrhosis and hepatitis were described (JMPR 892 (1995)). Also, it was documented that as results of exposure of mice for two years, in males at 1500 - 7500 ppm (approximately 75 - 375 mg/kg/day), hepatotoxicity from centrilobular hypertrophy and necrosis was seen (JMPR 892 (1995)). Since adverse effects on the liver range extend to the dose equivalent to guidance values of Category 2 in multiple animal species as described above, the substance was classified into Category 2 (liver). As relevant information, such as tubular dilation and hydropic degeneration, bronchitis, and lymphocyte depletion at the thymus glands are described as other findings (EHC 149 (1993), JMPR (1995)). However, since these results lack consistency in multiple tests using multiple animal species or with solitary occurrence, and their reliability as evidence is doubted, they were not used as evidence.
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 96h-LC50 = 0.01 mg/L for fish (American catfish) (EHC, 1993), 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 preexisting classification for acute toxicity is Category 1 and it is not rapidly degradable (non-biodegradable: BOD degradability, 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1985)), 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)


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