GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 348635-87-0
Chemical Name 3-(3-Bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide; Amisulbrom
Substance ID R02-A-017-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 New
Classification result in other fiscal year  
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.
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is a chemical group associated with self-reactive properties, a sulfonyl group, present in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
10 Pyrophoric solids Not classified
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it decomposes at 200 deg C or above (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), EU CLP CLH (2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), EU CLP CLH (2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))
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) Classification not possible
-
-
- - [Rationale for the Classification]
It was classified as "Classification not possible" because the category could not be determined from (1).

[Evidence Data]
(1) LC50 for rats (nose exposure, 4 hours): > 2.85 mg/L (no dead animals) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), EU CLP CLH (2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) No irritation was observed in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" because the findings observed were transient and slight in (1). Besides, conjunctival redness, which transiently disappeared and recurred, did not disappear after 21 days after application, but because it was not a finding that was seen continuously, and its severity was slight, conjunctival redness that recurred was not used for judgment.

[Evidence Data]
(1) In an eye irritation test with rabbits (3 animals), slight irritation (conjunctival redness and discharge) was seen, and the mean score after 24/48/72 hours was less than 2. Besides, conjunctival redness that transiently disappeared recurred in 2/3 animals, and slight conjunctival redness (score 1) persisted for 22 days post-application (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
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).

[Evidence Data]
(1) No sensitization was observed in a skin sensitization test with guinea pigs (maximization test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, in micronucleus tests with the bone marrow cells of orally dosed mice or rats, an unscheduled DNA synthesis test of orally dosed rats, comet assays (hepatocytes, forestomach and glandular stomach cells) of orally dosed rats, and a comet assay (hepatocytes) of orally dosed mice, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(2) As for in vitro, in a bacterial reverse mutation test, an in vitro mammalian cell chromosome aberration test, and a gene mutation test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 2.

[Evidence Data]
(1) As for the classification results by domestic and international organizations, the EPA classified this substance in S (Suggestive Evidence Of Carcinogenic Potential) (EPA Annual Cancer Report 2019 (Access on October 2020): Classification in 2010) and EU CLP classified this substance in Carc.2 (Classification in EU CLP (Access on November 2020)).
(2) In a two-year combined chronic toxicity/carcinogenicity study with male and female rats dosed by feeding, a significant increase in the incidence of hepatocellular adenomas was observed in males and females. Furthermore, squamous cell papilloma and squamous cell carcinoma of the forestomach, which were considered to be caused by chronic inflammatory changes, were observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) In an 18-month carcinogenicity study with male and female mice dosed by feeding, a significant increase in the incidence of hepatocellular adenomas was observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
In (1), atrophy of the ovary and reduced fertility were observed in females, but the findings were observed in F1 females at 1,810 mg/kg/day, which was a very high dose (dose exceeding 1,000 mg/kg/day which was a normal limit dose in reproduction toxicity studies for chemicals), and were considered to be related to a reduced body weight gain from the birth, and therefore, those findings were not adopted as evidence of the classification. In developmental toxicity studies in (2) and (3), no effect was observed in fetuses. Therefore, it was classified as "Not classified."

[Evidence Data]
(1) In a two-generation reproductive study with rats dosed by feeding, toxicity in parent animals (reduced body weight gain and a decrease in food consumption in males and females, and atrophy of the ovary in F1 females (without significant difference) at or above 3,000 ppm; noticeable reduced body weight gain continued from the birth, noticeable atrophy of the reproductive organs, abnormality of the estrus cycle, and vacuolation in the pituitary with a form similar to that at castration in F1 females at 15,000 ppm (P1 females: 1,290 mg/kg/day; F1 females: 1,810 mg/kg/day)) was observed; a reduced number of pregnant animals (2 pregnant animals) and a reduced number of live pups in F2 were observed at 15,000 ppm; and in offspring at or above 3,000 ppm, reduced body weight gain and decreases in absolute and relative thymus weight in males and females, delayed sexual maturity in F1 females, and decreases in absolute and relative uterus weight, etc. in F2 females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). It was reported that various additional examinations were carried out on the effects on the ovary, etc. observed in this study, which confirmed that this substance did not directly affect the reproductive organs, sex hormone, and fetus follicles, and determined that the symptoms were expressed as a result of inhibition of normal development due to noticeable reduced body weight gain during the lactation period (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) Two developmental toxicity studies with female rats dosed by gavage on days 6-19 of gestation were carried out, and no effect was observed in maternal animals and fetuses at the highest dose of 1,000 mg/kg/day or 1,500 mg/kg/day (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) In a developmental toxicity study with female rabbits dosed by gavage on days 6-28 of gestation, no effect was observed in fetuses even at doses at which maternal toxicity (lower corrected body weight, and reduced food consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
There was no report on single exposure to this substance in humans. In test animals, based on (1), no findings by which target organs could be identified were obtained in a test in the inhalation route, and therefore, it was considered to be "Not classified." However, based on (2), as the possibility that the decrease in brain weight was due to the administration of this substance could not be ruled out, it was classified as "Classification not possible."

[Evidence Data]
(1) In a 4-hour inhalation exposure test (nasal exposure) with rats, at 2.85 mg/L (within the range for Category 2), there was no death, and hyperpnea, soiled fur due to excrement, moist fur, and brown soiling around the nose and jaw were observed in males and females, and reduced body weight gain was observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(2) In an acute neurotoxicity test with rats dosed by gavage (0, 20, 200, 2,000 mg/kg), no abnormalities were observed in the neurological examination items, but a slight reduction in absolute brain weight (7%) was observed in males at 2,000 mg/kg (upper limit of Category 2). Since the brain was an organ of which weight was less affected by body weight, etc., the Food Safety Commission of Japan determined that the possibility that this reduction was due to the administration could not be ruled out (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
There was no report on repeated exposure to this substance in humans. In a test in the oral route with test animals, based on (1) and (2), there were no toxicity findings by which target organs could be identified at doses within the range for Category 1 and Category 2, and therefore, it was considered to be "Not classified" in the oral route. However, since there was not sufficient or no information on toxicity in the other routes, it was determined that classification was not possible.

[Evidence Data]
(1) It was reported that in an 18-month test with mice dosed by feeding, at or above 800 ppm (males/females: 97.8/121 mg/kg/day; within the range for Category 2/exceeding Category 2), pigmentation in cecal mucosa cells, and pigmentation in cecal submucosa and submucosa venule wall cells were observed, and increases in absolute and relative liver weight were observed in males. It was reported that the pigments observed in the cecum were suspected to be hemosiderin, lipofuscin, bile pigment, etc., but could not be identified by special staining (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It was reported that in a one-year test with dogs dosed by capsules, at or above 100 mg/kg/day (within the range for Category 2), reduced body weight gain was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).

[Reference Data, etc.]
(3) It was reported that in a 21-day dermal exposure (closed patch) test with rats, at 1,000 mg/kg/day (converted guidance value: 233 mg/kg/day, exceeding Category 2), reduced body weight gain, and a decrease in feed efficiency were observed in males, but no findings of toxicity were observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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 96-hour LC50 = 0.0229 mg/L for fish (Cyprinus carpio) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2019), EU CLP CLH, 2016).
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 72-hour NOErC = 0.0139 mg/L for algae (Raphidocelis subcapitata) (EU CLP CLH, 2016).
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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