GHS Classification Result

Chemical Name:carbendazim(ISO)
CAS:10605-21-7

Result:
ID: 15
Classifier: Ministry of Economy, Trade and Industry (METI)
Year Classified: FY2007
Reference Manual: GHS Classification Manual (10 Feb, 2006)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives - - - - - -
2 Flammable gases (including chemically unstable gases) - - - - - -
3 Aerosols - - - - - -
4 Oxidizing gases - - - - - -
5 Gases under pressure - - - - - -
6 Flammable liquids - - - - - -
7 Flammable solids - - - - - -
8 Self-reactive substances and mixtures - - - - - -
9 Pyrophoric liquids - - - - - -
10 Pyrophoric solids - - - - - -
11 Self-heating substances and mixtures - - - - - -
12 Substances and mixtures which, in contact with water, emit flammable gases - - - - - -
13 Oxidizing liquids - - - - - -
14 Oxidizing solids - - - - - -
15 Organic peroxides - - - - - -
16 Corrosive to metals - - - - - -

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Based on rat LD50 value (>15,000, >5,000, and >5,000 mg/kg) in EHC149 (1993), it is classified into "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - EHC149 (1993) describes >10,000 mg/kg (an aqueous paste (1974)), >2,000 mg/kg (75% wettable powder (1982)), and >2,000 mg/kg (50% wettable powder (1987)) as rabbit LD50 value, and it is classified into "Not classified" based on the LD50 value of >10,000 mg/kg.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Since it was a solid by the definition of GHS, it was classified into "Not applicable".
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - Classification not possible due to lack of data
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - Due to insufficient data, classification is not possible. It is written in EHC149 (1993) that rat LC50 value is >5 mg/L in the test employing the dust, and it is unknown whether or not there is mortality. Therefore, although it was not classified into Category 4, suitability of Category 5 cannot be judged.
2 Skin corrosion/irritation Not classified - - - - Since EHC149 (1993) states, "There is no skin irritation, because no irritation was observed in all of the 4 hour applications of 2.5g to rabbits in 4, 24, 48 and 72 hours," it was classified into "Not classified".
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.
Since EHC149 (1993) describes as "There is moderate or mild conjunctiva irritation to the eyes of a rabbit from the negative result employing a rabbit and the result of moderate to mild irritation", it is classified into Category 2.
4 Respiratory sensitization Classification not possible - - - - Classification is not possible since there is no data.
4 Skin sensitization Not classified - - - - It can be classified into "Not classified" since it has been described in EHC149 (1993) that "no skin sensitizing potential was shown from the two negative results in guinea pig (1. negative to both of intracutaneous injection and repeated application to skin of industrial products and 75% wettable powder in 10, 2. negative to application of 80% Ethanol solution for all of the substance, test solvent, and eliciting negative control in 10, and positive reaction for all of positive controls (1-Chloro-2,4-dinitrobenzene).
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing 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 ...
According to the statement of EHC149 (1993), although there are two negative results (mouse dominant lethal tests) but there is no positive result in in vivo heritable mutagenicity test employing a germ cell. Since there are two positive results (murine chromosome aberration test, the mouse micronucleus test) in in vivo mutagenicity test employing a somatic and there is no positive result in in vivo genotoxicity testgenotoxicity test employing a germ cell, it is classified into Category 2. In addition, it is indicated in EHC149 (1993) that, "although this substance is not a generation to generation mutagen and neither the effect on DNA nor the mutation of reproductive cells occurs in in vivo and in vitro studies using somatic cells and reproductive cells, chromosomal abnormalities of dysploidy or polyploidy occur in in vivo and in vitro studies. Moreover, EU Annex I is Cat.2; R46 and is equivalent to the GHS Category 1B.
6 Carcinogenicity Classification not possible - - - - There is no existing classification of IARC others. EHC149 (1993) describes that "although carcinogenicityity was negative in rats and NMRKf mice (both sexes, maximum dose 5,000 ppm mixed with foods, 96 weeks), increasing hepatocellular tumors were observed in CD-1 mice (both sexes, maximum dose 3,750 ppm mixed with foods, 2 years) and Swiss mice (both sexes, maximum dose 5,000 ppm mixed with foods, 80 weeks). The same study examples of EHC 149 (1993) are quoted in WHO Documents (WHO Pesticides residues in food (1995), WHO/FAO Data sheets on pesticides No.89 (1996)), where the presence of the carcinogenicityity is not clearly described. Moreover, EPA/OPP describes their views as follows; "Data is insufficient for defining the carcinogenicity mechanism of action in mouse liver tumors caused by this substance and for analyzing the existing study examples. Therefore, a relation between heteroploidy induced by this substance and the carcinogenicityity of the mouse liver cancer cannot be determined at present" (Mutation Res., 512, 1-35, 2002). Therefore, it was classified into "Classification not possible".
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 ...
There is a report as follows in EHC 149 (1993) "No adverse effect has been observed in the 3 generation reproduction study via oral administration using rats." There are ,however, reports in the developmental toxicity study, that hydrocephalus, microphthalmia and skeletal variants (spinal segments, rib and strenebrae amalgamation, cerebral hernia) increased at the dose level where body weight reduction was observed in mother animals, that resorption increased and the number of live pups decreased at the dose level where general toxicity cannot be observed in mother animals and that the reproductive capacity decreased according to the decrease in the number of sperms. Therefore, it was classified in Category 1B. Incidentally, EU Annex 1 is Cat.2; R60-61, corresponding to GHS Category 1B.
8 Specific target organ toxicity - Single exposure Not classified - - - - Although the acute toxicity test result of the various medication courses employing different animal species is indicated by EHC149 (1993), there is no publication of toxic influence except for testis. Since testis toxicity was already indicated in sections of reproductive toxicity, it was excluded from terms of single exposure, and classified into "Not classified".
9 Specific target organ toxicity - Repeated exposure Not classified - - - - In EHC 149 (1993), in a 6-month maximum dose feeding study in rats with 2,500 ppm (initially 360 mg/kg/day of body weight, finally 123-152 mg/kg/day of body weight), no abnormalities were observed apart from a slight increase in the relative weight of livers in females at the maximum dose (NOAEL 500 ppm feeding, 25 mg/kg/day). Furthermore, according to the WHO document (WHO Pesticides residues in food (1995)), the enlargement of liver was observed in rats of both sexes 6 weeks after the commencement of 13-week study with a dose of 1,350 ppm (equivalent to 135 mg/kg/day) mixed with foods. However, this lesion was not accompanied by histopathological changes and was reversible (NOAEL450 ppm, 35 mg/kg/day). Since these doses exceeded the guidance value of Category 2, it was defined "Not classified".
10 Aspiration hazard Classification not possible - - - - Classification not possible due to lack of data

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) - - - - - -
11 Hazardous to the aquatic environment (Long-term) - - - - - -


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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