GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 2312-35-8
Chemical Name 2-(4-tert-butylphenoxy)cyclohexyl 2-propynyl sulfite; Propargite
Substance ID R02-B-068-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 Classification not possible
-
-
- - There is a chemical group associated with explosive properties, acetylenes, present in the molecule, but the classification is not possible due to no data.
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (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)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Category 4
-
Warning
H227 P370+P378
P210
P280
P403
P501
From a flash point of 71.5 deg C (test method: unknown) (GESTIS (Access on May 2020)), even if this was by the open-cup method, a flash point is estimated to be >=60 deg C and < 93 deg C in the prescribed closed-cup method. Therefore, it was classified in Category 4.
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is a chemical group associated with explosive properties, acetylenes, present in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Not classified
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable to heat at 170 deg C or below (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to liquid 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 Classification not possible
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to the element other than carbon or hydrogen (S). However, the classification is not possible due to no data.
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). 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
-
-
- - No data available.
17 Desensitized explosives Classification not possible
-
-
- - There is a chemical group associated with explosive properties, acetylenes, present in the molecule, but the classification is not possible due to no data.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
[Rationale for the Classification]
It was classified in Category 4 from (1) - (6).

[Evidence Data]
(1) LD50 for rats: 1,480 mg/kg (HSDB (Access on May 2020))
(2) LD50 for rats: females: 1,750 mg/kg, males: 1,860 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011))
(3) LD50 for rats: 2,200 mg/kg (HSDB (Access on May 2020))
(4) LD50 for rats: males: 2,639 mg/kg, females: 2,947 mg/kg (Amendment of EPA Pesticides RED (2008), HSDB (Access on May 2020))
(5) LD50 for rats: males: 2,640 mg/kg, females: 2,950 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(6) LD50 for rats: 2,800 mg/kg (Amendment of EPA Pesticides RED (2008), JMPR (1999), GESTIS (Access on May 2020), HSDB (Access on May 2020))
1 Acute toxicity (Dermal) Category 4


Warning
H312 P302+P352
P362+P364
P280
P312
P321
P501
[Rationale for the Classification]
It was classified in Category 4 from (1).

[Evidence Data]
(1) LD50 for rats: males: 1,400 mg/kg, females: 2,060 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011))

[Reference Data, etc.]
(2) LD50 for rats: males: 250 mg/kg, females: 680 mg/kg (HSDB (Access on May 2020))
(3) LD50 for rabbits: > 2,000 mg/kg (Amendment of EPA Pesticides RED (2008), HSDB (Access on May 2020))
(4) LD50 for rabbits: > 4,000 mg/kg (JMPR (1999), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(5) LD50 for rabbits: 10,300 mg/kg (GESTIS (Access on May 2020))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Liquid (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) - (4).
Besides, by the use of new information sources, the classification result was changed from the previous classification.
Because exposure concentrations were higher than the saturated vapor pressure concentration (5.7E-006 mg/L), a reference value in the unit of mg/L was applied as mist.

[Evidence Data]
(1) LC50 for rats (4 hours): 0.89 mg/L (Amendment of EPA Pesticides RED (2008), JMPR (1999))
(2) LC50 for rats (4 hours): 0.95 mg/L (Amendment of EPA Pesticides RED (2008), JMPR (1999), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(3) LC50 for rats (4 hours): > 0.94 mg/L (GESTIS (Access on May 2020))
(4) LC50 for rats (4 hours): > 2.5 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(5) Vapor pressure of this substance: 3E-007 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 5.7E-006 mg/L)
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
[Rationale for the Classification]
It was classified in Category 2 from (1), (2).

[Evidence Data]
(1) This substance was irritating to the rabbit skin (JMPR (1999), EU REACH CoRAP (2019), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
(2) Skin illness and eye irritation were reported in incident cases of workers who used this substance (HSDB (Access on May 2020)).

[Reference Data, etc.]
(3) In a skin irritation test with rabbits on Omite Technical (effective concentration of this substance 57%) according to EPA OPPTS 870.2500, it was judged as a corrosive substance (EPA Pesticides RED (2001)).
(4) It was classified in Skin Irrit. 2 (H315) in EU-CLP classification (EU CLP classification (Access on August 2020)).
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
[Rationale for the Classification]
It was classified in Category 2 from (1), (2). The classification result was changed based on new data (1), (2).

[Evidence Data]
(1) This substance was irritating to the rabbit eye (JMPR (1999), EU REACH CoRAP (2019), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
(2) Skin illness and eye irritation were reported in incident cases of workers who used this substance (HSDB (Access on May 2020)).

[Reference Data, etc.]
(3) In an eye irritation test with rabbits on Omite Technical (effective concentration of this substance 57%) according to EPA OPPTS 870.2400, it was judged as a corrosive substance (EPA Pesticides RED (2001)).
(4) It was classified in Eye Dam. 1 (H318) in EU-CLP classification (EU CLP classification (Access on August 2020)).
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) - (3). The classification result was changed based on new data (1) - (3).

[Evidence Data]
(1) This substance was reported to be negative in a skin sensitization test with guinea pigs (a Buehler test) (JMPR (1999), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(2) This substance was reported to be negative in a skin sensitization test with guinea pigs (EU REACH CoRAP (2019)).
(3) This substance was reported to be negative in a skin sensitization test by intradermal administration to guinea pigs (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).

[Reference Data, etc.]
(4) In a skin sensitization test with guinea pigs on Omite Technical (effective concentration of this substance 57%) according to EPA OPPTS 870.2600, it was judged as positive (EPA Pesticides RED (2001)).
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 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), JMPR (1999), HSDB (Access on May 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
(2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test, and as for test systems using cultured mammalian cells, it was reported to be negative in a chromosomal aberration test and negative in a gene mutation test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), JMPR (1999), HSDB (Access on May 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
As for classification results by other organizations in (1), EPA classified it in B2 (equivalent to Category 1B), but because no carcinogenicity was found in mice, and it was classified in Carc.2 in EU CLP classification, it was classified in Category 2. By the study using new information sources, the classification result was changed.

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified in B2 (likely human carcinogen) by EPA (Amendment of EPA Pesticides RED (2008)) and Carc.2 in EU CLP classification (EU CLP classification (Access on May 2020)).
(2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female rats, undifferentiated sarcoma in the jejunum significantly increased in males and females. And also in a chronic toxicity test by 2-year diet administration of this substance to male rats, undifferentiated sarcoma in the duodenum, jejunum, and abdominal soft tissue and mucous adenocarcinoma in the jejunum were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(3) In a carcinogenicity test by 18-month diet administration of this substance to male and female mice, no increase in the treatment-related tumor incidences was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), a comprehensive judgment was made and this substance was classified as "Not classified."
In (4), at a dose at which no maternal toxicity was observed, effects on the fetal skeleton were observed, but in a similar study in (2) at doses including the dose in (4), no effect in fetuses was observed and no reproducibility was observed. Therefore, they were adopted as reference data. In (5), serious maternal toxicity effects, including death, were observed, and it was adopted as reference data.

[Evidence Data]
(1) In a two-generation reproductive study with rats dosed by feeding, at doses at which parental toxicity effects (reduced body weight gain and a decrease in food consumption) was observed, low body weight was observed in offspring, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, no effect in fetuses was observed even at a dose (105 mg/kg/day) at which maternal toxicity (staining of the anogenital area and trunk, reduced body weight gain, and a decrease in adjusted body weight (body weight excluding gravid uterus)) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(3) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, at a dose at which maternal toxicity (reduced body weight gain, miscarriage (4 cases), and in individuals which had miscarriage, generalized alopecia, a decrease in feces, emaciation, etc.) was observed, an increase in fused sternebrae was observed in fetuses but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).

[Reference Data, etc.]
(4) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose (25 mg/kg/day) at which no maternal toxicity was observed, absence of sternebrae and absence of hyoid bone and smaller hyoid bone were observed in fetuses; and at a dose (105 mg/kg/day) at which maternal toxicity (an increase in mortality, hematoid secretion from the nose and vagina, urinary incontinence, alopecia) was observed, discontinuous costal cartilages and incomplete closure of the skull were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). In this study, a dose group was added in the middle of the study and effects could not be properly evaluated. Therefore, it was adopted as refence material.
(5) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, at a dose at which maternal toxicity (a tendency of increased mortality, a tendency of reduced body weight gain, a decrease in water intake, anorexia) was observed, a decrease in the number of viable fetuses, a decrease in the number of resorptions, and a delay in ossification of the skull in fetuses were observed In addition, at a dose at which depression, a significant increase in mortality, and reduced body weight gain were observed in dams, hydrocephalus (2 cases) was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation)


Warning
H335 P304+P340
P403+P233
P261
P271
P312
P405
P501
[Rationale for the Classification]
There was no report on single exposure to this substance in humans. This substance is highly irritating to the skin and eyes, and based on (1), it was classified in Category 3 (respiratory tract irritation). A new information source was used and the classification results were changed from the previous classification.

[Evidence Data]
(1) In an acute inhalation toxicity test with rats (4 hours), common symptoms observed after exposure at 0.95 mg/L (within the range for Category 1) were labored breathing and an increase in various secretory responses (JMPR (1999), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
9 Specific target organ toxicity - Repeated exposure Category 2 (blood system)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 2 (blood system).

[Evidence Data]
(1) In a 13-week feeding study with dogs, a decrease in body weight, a decrease in food consumption, a tendency of increased AST and decreased TP, pigmentation in the reticuloendothelial cells of the liver, and hemosiderosis in the spleen were observed in males and females at 2,000 ppm (weeks 1 to 3) or at 2,500 ppm (weeks 4 to 13) (males/females: 54.7/67.7 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), EU REACH CoRAP (2015)).
(2) In a one-year oral administration test with dogs, reduced body weight gain, a decrease in food consumption, decreases in red blood cell count, hemoglobin, hematocrit, MCV, MCH, and MCHC, and an increase in platelet count in males and females, and thymic atrophy in females were observed at or above 1,250 ppm (males/females: 38/40 mg/kg/day, within the range for Category 2); and sacrifice in extremis (one case each in males and females), a decrease in body weight, emaciation and dehydration in males and females, and scabs/erosion, alopecia, thymic atrophy, and erythroid/myeloid depletion/atrophy of the bone marrow in males were observed at 2,500/1,875 ppm (males/females: 44/42 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), EU REACH CoRAP (2015)).
(3) In a two-year feeding study with rats, increases in reticulocyte count and reticulocyte rate, a decrease in globulin, an increase in A/G ratio, and pulmonary leukocytosis were observed in males at 800 ppm (males/females: 38.9/49.4 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
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 = 0.013 mg/L for crustacea (Daphnia magna) (Document for registration standards for agricultural chemicals set by the Minister of Environment to prevent harm to animals and plants in areas of public waters, 2019).
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 = 0.009 mg/L for crustacea (Daphnia magna) (EPA RED, 2001).
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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