GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 96489-71-3
Chemical Name 2-tert-Butyl-5-(4-tert-butylbenzylthio)-4-chloro-3(2H)-pyridazinone; Pyridaben
Substance ID R02-B-123-MHLW
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
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 Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (RAC Background Document (2013)).
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 Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (RAC Background Document (2013)).
11 Self-heating substances and mixtures Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (RAC Background Document (2013)).
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 chlorine and oxygen (but not fluorine) which are 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 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
[Rationale for the Classification]
It was classified in Category 3 from (1) - (5).
Besides, the classification result was changed from the previous classification by using new information sources.

[Evidence Data]
(1) LD50 for rats: 161 mg/kg (EU EFSA (2010))
(2) LD50 for rats: males: 161 mg/kg, females: 181 mg/kg (EU CLP CLH (2013), Canada Pesticides (2016))
(3) LD50 for rats: 570 mg/kg (EU EFSA (2010))
(4) LD50 for rats: females: 570 mg/kg, males: 1,100 mg/kg (EU CLP CLH (2013), Canada Pesticides (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
(5) LD50 for rats: females: 820 mg/kg, males: 1,350 mg/kg (EU CLP CLH (2013), Canada Pesticides (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) LD50 for rats: > 2,000 mg/kg (Canada Pesticides (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
(2) LD50 for rabbits: > 2,000 mg/kg (Canada Pesticides (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
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 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
[Rationale for the Classification]
It was classified in Category 3 from (1).

[Evidence Data]
(1) LC50 for rats (4 hours): females: 0.62 mg/L, males: 0.66 mg/L (EU CLP CLH (2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) In a skin irritation test with rabbits, no irritation was observed (Canada Pesticides (2016)).
(2) In a skin irritation test with rabbits, the primary irritation index (PII) was 0, and no irritation was found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) In an eye irritation test with rabbits, very slight conjunctival redness and discharge were observed but disappeared within 72 hours after application (Canada Pesticides (2016)).
(2) In an eye irritation test with rabbits, conjunctival redness, chemosis, and discharge of scores 1-2 were seen but disappeared within 72 hours after application, and it was judged as slightly irritating. Besides, 2/6 animals showed conjunctival redness of score 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
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).

[Evidence Data]
(1) In a skin sensitization test with guinea pigs (maximization test), this substance was not sensitizing (Canada Pesticides (2016)).
(2) In skin sensitization tests with guinea pigs (a maximization test and a modified Buehler test), no skin sensitization was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
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 micronucleus test with bone marrow cells after oral administration to mice (Canada Pesticides (2016), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011)).
(2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test, a chromosomal aberration test and a gene mutation test using cultured mammalian cells (same as the above).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (4).

[Evidence Data]
(1) As for classification results by domestic and international organizations, EPA classified it in E (Evidence Of Non-Carcinogenicity For Human) (EPA Annual Cancer Report 2019 (Access on November 2020): classified in 1994).
(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, 2011)).
(3) In a carcinogenicity test by 78-week diet administration of this substance to male and female mice, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011)).
(4) Both EU EFSA and Canada assessed that this substance was not carcinogenic (EU EFSA (2010), Canada Pesticides (2016)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified."

[Evidence Data]
(1) In a two-generation reproductive study with rats dosed by feeding, in parent animals, reduced body weight gain, etc. in males/females were observed at 80 ppm, and low body weight were observed at 80 ppm in offspring. No effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011)).
(2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, in fetuses, at a dose (30 mg/kg/day) at which maternal toxicity (reduced body weight gain, a decrease in food consumption, and a decrease in placenta weight) was observed, low body weight and clear void between the internal organs and the body wall were observed, and although delayed ossification of the supraoccipital bone and delayed ossification of the thoracic vertebral body were observed, no skeletal abnormalities were observed. No teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011)).
(3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 19 of gestation, no effect in fetuses was observed at doses up to the maximum dose at which maternal toxicity (reduced body weight gain, abortion, a decrease in feces output) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011)).
(4) In a developmental neurotoxicity test with female rats dosed by gavage from day 3 of gestation to day 20 of lactation, no developmental neurotoxicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011)).
8 Specific target organ toxicity - Single exposure Category 1 (nervous system, respiratory organs), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
[Rationale for the Classification]
There was no report on acute exposure effects of this substance in humans. In experimental animals, based on (1) to (4), it was classified in Category 1 (nervous system, respiratory organs) and Category 3 (narcotic effects). New information sources were used and the classification results were changed from the previous classification.

[Evidence Data]
(1) In an acute oral toxicity test with rats (the minimum dose at which effects were observed was not described, and it was assumed that effects were observed at around the dose at which death began to be observed: 200 mg/kg (within the range for Category 1)), a decrease in locomotor activity, lying on belly or side, diarrhea including mucous feces, loose stool, and pasty stool, stain around the anus, eyelid closure, ataxic gait and bradypnea were observed within 1 hour after the administration, and stooping posture, piloerection, a decrease in feces output, soiled fur of the face, forelimbs, or abdomen, and reduced body weight gain were observed after 2 days or more from dosing (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012).
(2) In an acute oral toxicity test with rats, symptoms appeared in males at or above 528 mg/kg and in females at or above 310 mg/kg (within the range for Category 2 in both sexes). Symptoms observed in the animals that died were inactivity, ataxia, stooping posture, a decrease in grooming behavior, prone position, coma, wasting, diarrhea, loss of consciousness, muscular spasms, abdominal bloating, pigmented orbital and nasal discharges, piloerection, and reddening of the visible multi-vascular tissue. Deaths were observed in males at or above 900 mg/kg and in females at or above 310 mg/kg. In the animals that survived, similar symptoms as in the deceased animals were observed at or above 528 mg/kg, except that irregular respiration, prone position, loss of consciousness, muscular spasms, pigmented orbital and nasal discharges, and reddening of the visible multi-vascular tissue were not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
(3) In a 4-hour inhalation exposure test with rats (the minimum dose at which effects were observed was not described, and it was assumed that effects were observed at around the dose at which death began to be observed: 0.66 mg/L in males and 0.41 mg/L in females (within the range for Category 1 in both sexes)), eyelid closure, and slow and deep breathing were observed immediately after the start of exposure, and soiled fur around the anus in males, and lacrimation in females were observed. In a gross pathological examination, intratracheal white dust, white foamy liquid, pleural effusion, dark red discoloration of the liver, and smudge around the snout were observed, and in females, ocular cloudiness was also observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
(4) In a general pharmacological test with mice (oral dose), diarrhea, a decrease in locomotor activity, and deep breathing were observed in males at or above 30 mg/kg (within the range for Category 1); abnormal posture, decreased response to external stimuli, and muscle weakness were observed in males at or above 100 mg/kg (within the range for Category 1); and abnormal gait, a decrease in abdominal muscle tension, and loss of righting reflex were observed in males at 300 mg/kg (upper limit of Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011)).
(5) In an acute neurotoxicity test with rats (dosed by gavage), at 100 mg/kg (within the range for Category 1), reduced body weight gain in females, and a tendency of reduced body weight gain without significant difference in males were observed. At 200 mg/kg (within the range for Category 1), hypoactivity, a decrease in righting reflex, and subnormal temperature were observed in males in FOB. It was reported that the Food Safety Commission of Japan concluded that no neurotoxicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) to (6), the reported effects by an oral administration to test animals within the range for Category 2 were mainly body weight loss, and based on (7) and (8), no apparent target organ toxicity was observed either in the inhalation or the dermal route, but effects at a dose around the upper limit of Category 2 were unknown, and therefore, classification was not possible.

[Evidence Data]
(1) As a result of a 90-day test with rats dosed by feeding, reduced body weight gain in females at or above 65 ppm (males/females: 4.94/5.53 mg/kg/day, within the range for Category 1), a decrease in food and water intake in males and females, and reduced body weight gain in males at or above 155 ppm (males/females: 11.55/12.84 mg/kg/day, within the range for Category 2); and increases in gamma-GT and BUN in males and females, and an increase in ALP and a decrease in albumin in females at 350 ppm (males/females: 25.71/27.68 mg/kg/day, within the range for Category 2) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), Canada Pesticides (2016)).
(2) As a result of a 90-day test with mice dosed by feeding, reduced body weight gain and a decrease in food efficiency in males at or above 90 ppm (males/females: 13.02/14.65 mg/kg/day, within the range for Category 2); an increase in BUN and a decrease in water intake in males and females, a decrease in hematocrit in males, and reduced body weight gain and decreases in food intake and food efficiency in females at or above 270 ppm (males/females: 40.09/43.14 mg/kg/day, within the range for Category 2); and decrease in hemoglobin and a decrease in MCV in males and females, a decrease in food intake, and increases in ALP and AST in males, and decreases in hematocrit and platelet count in females at 810 ppm (males/females: 119.2/124.6 mg/kg/day, exceeding Category 2) were observed (Same as above).
(3) As a result of a 90-day oral toxicity test with dogs, at or above 4.0 mg/kg/day (within the range for Category 1), food-like emesis and salivation (the sex was unknown) were observed, and in males of the same groups, reduced body weight gain was observed (Same as above).
(4) As a result of a one-year chronic toxicity study by an oral administration to dogs, salivation, emesis, soft stool and diarrhea, and a tendency of reduced body weight gain through 52-week administration without significant difference were observed in males and females at or above 1.0 mg/kg/day (within the range for Category 1); and wasting, inactivity, dried nose, discoloration of the gum, and tangible subnormal temperature were observed in males and females at 32.0 mg/kg/day (within the range for Category 2) (Same as above).
(5) As a result of a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, reduced body weight gain, decreasing trend in food intake, and a decrease in food efficiency in males, and a tendency of reduced body weight gain in females were observed at or above 80 ppm (males/females: 3.18/4.23 mg/kg/day, within the range for Category 1) (Same as above).
(6) As a result of a 78-week carcinogenicity study with mice dosed by feeding, reduced body weight gain in males were observed at or above 25 ppm (2.78/2.78 mg/kg/day, within the range for Category 1), and an increase in mortality in males was observed at 80 ppm (8.88/9.74 mg/kg/day, within the range for Category 1) (Same as above).
(7) As a result of a 4-week inhalation exposure test with rats, dried red rhinorrhea in males and females, and a decrease in albumin in females were observed at or above 3 mg/m3 (converted guidance value: 0.0007 mg/L, within the range for Category 1); and a decrease in food intake in males and females, and reduced body weight gain and an increase in cholesterol in females were observed at 10 mg/m3 (converted guidance value: 0.002 mg/L, within the range for Category 1) (Same as above).
(8) As a result of a 21-day dermal toxicity test with rats, hyperplasia and desquamation of the stratified squamous epithelium of the epidermis in males and females at or above 100 mg/kg/day (converted guidance value: 23 mg/kg/day, within the range for Category 2); reduced body weight gain in females at or above 300 mg/kg/day (converted guidance value: 70 mg/kg/day, within the range for Category 2); and a decrease in food intake in males and females, and reduced body weight gain in males at 1,000 mg/kg/day (converted guidance value: 233 mg/kg/day, exceeding Category 2) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2011), Canada Pesticides (2016)).

[Reference Data, etc.]
(9) It was known that, as an action mechanism, this substance disturbed the respiratory system by inhibiting the mitochondrial electron transport system Complex I. Given that brain tissues from humans with Parkinson’s Disease (PD) exhibited reduced Complex I activity, this substance had been the subject of research in the scientific literature investigating risk factors for the development of PD or other parkinsonian disorders. Despite the uncertainty regarding the role of this substance within the context of neurodegenerative disease, given that rotenone, which had the same action mechanism, had demonstrated an effect on nigrostriatal dopaminergic neurons, an additional uncertainty factor was applied in the risk assessment in the Canada Pesticides (2016) to account for the lack of data addressing the potential for neuronal damage (Canada Pesticides (2016)).
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) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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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