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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	22781-23-3
Chemical Name	2,2-dimethyl-1,3-benzodioxol-4-yl N-methylcarbamate; Bendiocarb
Substance ID	R02-B-041-MHLW, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (GESTIS (Access on May 2020)).
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1) - (7). [Evidence Data] (1) LD50 for rats: males: 25 mg/kg, females: 27.3 mg/kg (CLH Report (2014)) (2) LD50 for rats: males: 25-156 mg/kg, females: 27-40 mg/kg (EU CLP CLH (2015)) (3) LD50 for rats: females: 34-40 mg/kg, males: 40-64 mg/kg (CLH Report (2014), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)) (4) LD50 for rats: 40-45 mg/kg (ACGIH (7th, 2018)) (5) LD50 for rats: males: 45-48 mg/kg (CLH Report (2014)) (6) LD50 for rats: males: 71.9-155.9 mg/kg (CLH Report (2014)) (7) LD50 for rats: 108-156 mg/kg (ACGIH (7th, 2018), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1) - (3). Besides, because the classification result in the previous classification was wrong, it was changed. [Evidence Data] (1) LD50 for rats: 566 mg/kg (CLH Report (2014), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), GESTIS (Access on May 2020)) (2) LD50 for rats: males: 566-800 mg/kg (ACGIH (7th, 2018), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)) (3) LD50 for rats: females: 800 mg/kg (CLH Report (2014))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1) - (3). Besides, the classification result was changed from the previous classification due to the use of new information sources. Because exposure concentrations were higher than the saturated vapor pressure concentration (0.0004 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (4 hours): 0.47 mg/L (CLH Report (2014), EU CLP CLH (2015)) (2) LC50 for rats (4 hours): 0.55 mg/L (EU CLP CLH (2015)) (3) LC50 for rats (4 hours): males: 0.61 mg/L (CLH Report (2014), EU CLP CLH (2015)) (4) Vapor pressure of this substance: 3.45E-005 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 0.0004 mg/L) [Reference Data, etc.] (5) LC50 for rats (6 hours): 250 mg/L (converted 4-hour equivalent value: 375 mg/L) (ACGIH (7th, 2018), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) It was reported to be a mild irritant in a skin irritation test with rabbits (JMPR (1982), ACGIH (7th, 2018)). (2) It is reported that slight irritation to the skin was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). The classification result was changed due to new data obtained. [Evidence Data] (1) It was reported to be minimally irritating to the eye in an eye irritation test with rabbits (JMPR (1982), ACGIH (7th, 2018)). (2) It is reported that minimal irritation to the eye was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). The classification result was changed because new data were obtained. [Evidence Data] (1) It was reported to be negative in a skin sensitization test with guinea pigs (ACGIH (7th, 2018)). (2) It was reported to be negative in a skin sensitization test with guinea pigs (maximization test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). [Reference Data, etc.] (3) From the available information, it cannot be excluded that some of the carbamates will have a slight to moderate sensitization potential (EHC 64 (1986)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a dominant lethal test with rats, a chromosomal aberration test with rat bone marrow cells, and micronucleus tests using bone marrow cells of mice or rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), CLH Report ANNEX_3 (2006), JMPR (1982), ACGIH (7th, 2018)). (2) As for in vitro, it is reported that it was negative in a bacterial reverse mutation test, negative in a gene mutation test with mouse lymphoma cells, and positive (S9+) in a chromosomal aberration test with human lymphocytes (same as the above). (3) It is described in the Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009) that it was considered that it did not have genotoxicity that could pose a problem in vivo (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). [Reference Data, etc.] (4) 2,2-Dimethyl-1,3-benzoxodiol-4-ol, the metabolite, was negative in a bacterial reverse mutation test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There were no available reports in humans. It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in A4 by ACGIH (ACGIH (7th, 2018)) and Group E (Evidence of Non-Carcinogenicity for Humans) by EPA (EPA Annual Cancer Report 2019 (Access on September 2020): classification in 1997). (2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female rats, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) In a carcinogenicity test by 2-year diet administration of this substance to male and female mice, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (4), at a dose at which parental toxicity was observed, effects in fetuses and pups were observed, and therefore, it was classified in Category 2. New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) In a three-generation reproduction study with rats dosed by feeding, at doses at which toxicity in parental animals ((slight) growth depression during the gestation period, an increase in the incidence and severity of geriatric nephropathy in males, irregular estrous cycle in females) was observed, a decrease in survival rate was observed in pups (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), JMPR (1982)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose at which maternal toxicity (vellication, lip smacking, salivation, tremors and slight reduced body weight gain) was observed, increases in the incidence of total embryo resorption and post-implantation embryo death per dam were observed in fetuses, and in association with them, a decrease in the number of viable fetuses per dam was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose at which maternal toxicity (signs of toxicity characteristic of inhibition of cholinesterase (ChE) activity) was observed, late fetal death was observed in the uterus in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), JMPR (1982)). (4) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 28 of gestation, at doses at which maternal toxicity (inhibition of whole blood ChE activity (20% or more)) was observed, eye anomalies, etc. were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), JMPR (1982)).
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1 (nervous system). New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) A male volunteer was given five oral doses at a 48 hour interval starting with a dose of 0.004 mg/kg and increasing doses up to 0.25 mg/kg. No clinical symptoms or no inhibition of erythrocyte AChE occurred at dosages up to 0.125 mg/kg. However, at the two higher-dose groups of 0.187 mg/kg and higher, symptoms including vertigo, nausea, and vomiting along with a 30 to 40% inhibition of AChE were observed. In a confirmatory study, no effect was observed, but a single oral dose was low, which was 0.12 mg/kg at maximum (ACGIH (7th, 2018)). (2) In acute oral toxicity tests with rats, mice, guinea pigs, and rabbits, an acute dermal toxicity test with rats, and an inhalation exposure test with rats (for 6 hours), AChE poisoning (salivation, miosis, tremors) was observed within several minutes of exposure (ACGIH (7th, 2018), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) Symptoms of poisoning included excessive sweating, headache, chest tightness, giddiness, nausea, vomiting, stomach pains, salivation, blurred vision, slurred speech, and muscle twitching (HSDB (Access on May 2020)). [Reference Data, etc.] (4) Three male volunteers were given a single dose of 0.12 mg/kg, and a transient depression was observed in one of the three subjects 30 minutes after treatment (HSDB (Access on May 2020)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, eye)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) to (3), effects on the nervous system within the range for Category 1, and based on (2), effects on the eye within the range for Category 1 were observed. Therefore, it was classified in Category 1 (nervous system, eye). Since the new information was obtained, the classification results were changed from the previous classification. [Evidence Data] (1) In a 90-day oral toxicity test with rats dosed by feeding, inhibition of whole blood cholinesterase (ChE) activity (20% or more) was observed at 50 ppm (2.5 mg/kg/day, within the range for Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (2) In a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, lens opacity was observed in males at or above 20 ppm (1 mg/kg/day, within the range for Category 1); inhibition of brain ChE activity (20% or more) was observed in males and females at 200 ppm (10 mg/kg/day, within the range for Category 1); and hyperreactivity to external stimulus, hyperplasia, hyperkeratosis or acanthosis of the forestomach, etc. were observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (3) In a 16-week oral toxicity test with dogs dosed by feeding, inhibition of whole blood ChE activity (20% or more) was observed at 100 ppm (2.5 mg/kg/day, within the range for Category 1), and inhibition of brain ChE activity (20% or more) and focal C-cell hyperplasia and focal atrophy of the thyroid (one male and one female) were observed at 500/1,000 ppm (12.5/25 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). [Reference Data, etc.] (4) In a 90-day inhalation exposure test with rats (no description about administration frequency), inhibition of whole blood ChE activity (20% or more) was observed at or above 0.00197 mg/L, and an increase in alveolar macrophages and inhibition of brain ChE activity (20% or more) were observed at 0.0193 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (5) In a 21-day dermal toxicity test with rats, inhibition of whole blood ChE activity (20% or more) was observed at or above 50 mg/kg/day (converted guidance value: 12 mg/kg/day, within the range for Category 1), and signs of toxicity characteristic to ChE inhibitor poisoning (details unknown) were observed at 200 mg/kg/day (converted guidance value: 47 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)). (6) In a two-year carcinogenicity study with mice dosed by feeding, increases in absolute and relative kidney weight were observed in females at or above 50 ppm (7.5 mg/kg/day, within the range for Category 1), and cataract and increases in absolute and relative testicular weight in males, and an increase in mortality in females were observed at 1,250 ppm (187.5 mg/kg/day, exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.038 mg/L for crustacea (Daphnia magna) (EU CLP CLH, 2015).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 21-day NOEC = 0.000882 mg/L for crustacea (Daphnia magna) (EU CLP CLH, 2015).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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