GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 131-72-6
Chemical Name 2,4-Dinitro-6-(octan-2-yl)phenyl (E)-2-butenoate (synonym: Meptyldinocap)
Substance ID R03-B-018-MHLW
Classification year (FY) FY2021
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
-
-
- - There is a chemical group associated with explosive properties (N-O) present in the molecule, but it was classified as "Not classified" from information that it is not explosive (EFSA (2014)). Besides, the calculated oxygen balance is -185, higher than the criteria: -200.
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
6 Flammable liquids Category 3


Warning
H226 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
It is estimated that it is classified in Category 3 in the specified test method from the information that a flash point is 30 deg C (test method: unknown) (EFSA (2014)).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is chemical groups associated with explosive properties (N-O, ethylene group) present in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 294 deg C (EFSA(2014)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - 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).
13 Oxidizing liquids Not classified
-
-
- - 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 (N), but it was classified as "Not classified" from information that it is non-oxidising (EFSA (2014)).
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
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 (N-O) present in the molecule, but it was classified as "Not classified" from information that it is not explosive (EFSA (2014)).

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]
Based on (1), it was classified as "Not classified." Based on the new findings, the classification result was changed.

[Evidence Data]
(1) LD50 for rats: > 2,000 mg/kg (JMPR (2010), EFSA (2014))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (JMPR (2010), EFSA (2014))
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) Category 1


Danger
H330 P304+P340
P403+P233
P260
P271
P284
P310
P320
P405
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 1. Also, since the exposure concentration was lower than 90% (47,343 ppm) of the saturated vapor pressure concentration, it was judged to be a vapor and classified based on the reference value in units of ppmV.

[Evidence Data]
(1) LC50 (4 hours) for rats: 80.5 ppm (JMPR (2010))
(2) LC50 (4 hours) for rats (males): 83.2 ppm (EFSA (2014))
(3) LC50 (4 hours) for rats (females): 109 ppm (EFSA (2014))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified" (Category 3 in UN GHS classification). Also, based on the new assessment documents, the classification result was changed.

[Evidence Data]
(1) In a skin irritation test with rabbits, a slight irritation was observed (EPA Pesticides (2009)).
(2) This substance was a slight skin irritant (JMPR (2010)).
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
[Rationale for the Classification]
Based on (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. Also, based on the new assessment documents, the classification result was changed.

[Evidence Data]
(1) In an eye irritation test with rabbits, a moderate irritation was observed (JMPR (2010)).

[Reference Data, etc.]
(2) In an eye irritation test with rabbits, a minimal irritation was observed (EPA Pesticides (2009)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 1.

[Evidence Data]
(1) In a Local Lymph Node Assay (LLNA) with mice, positive results were obtained (JMPR (2010), EPA Pesticides (2009)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, it was reported that, in a micronucleus test (comply with EPAOPPTS 870.5395, up to 1,858 mg/kg, single dose by gavage) using the erythrocytes of mice, negative results were obtained (EPA Pesticides (2009)).
(2) As for in vitro, negative results were obtained in all of a bacterial reverse mutation test, and gene mutation tests and chromosomal aberration tests with the cultured mammalian cells (EPA Pesticides (2009)).
(3) The potential genotoxicity of this substance was investigated in an adequate range of tests in vitro and in vivo and no evidence of mutagenicity or clastogenicity was noted. The JMPR concluded that this substance was unlikely to be genotoxic (JMPR (2009)).
(4) This substance (DE-126) was neither genotoxic nor carcinogenic (EFSA (2014)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified." Also, based on the new information source, the classification result was changed.

[Evidence Data]
(1) As for the classification results by domestic and international organizations, the EPA classified this substance in Group E (EPA OPP Annual Cancer Report (2020): Classification in 2009). Before that, dinocap (CAS RN 39300-45-3) which is an analog of this substance was also classified in Group E (EPA OPP Annual Cancer Report (2020): Classification in 1994).
(2) This substance (meptyldinocap, DE-126) is one of 6 isomers contained in dinocap (CAS RN 39300-45-3), accounting for approximately 22% of dinocap (EFSA (2014), JMPR (2010), EPA Pesticides (2009)).
(3) In long-term studies of toxicity and carcinogenicity with dinocap, no evidence of carcinogenicity was seen at any dose up to the highest doses tested: 2,000 ppm (equal to 71 mg/kg/day) in rats and 150 ppm (equal to 23 mg/kg/day) in mice. Besides, note that 2,000 ppm in rats and 150 ppm in mice are doses at which general toxicity occurs (JMPR (2010)).
(4) Based on structural similarities and the demonstrated lower toxicity of this substance as compared to dinocap, the cancer classification of Group E in humans for dinocap was extended to this substance (EPA Pesticides (2009)).
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) to (4), no developmental effects were observed but there was no information on effects on fertility, and therefore, classification was not possible due to lack of data. Besides, in the previous classification, data on dinocap (CAS RN 39300-45-3), which is a mixture of 6 isomers including this substance, were used for classification. Based on the new information source, classification results were reviewed.

[Evidence Data]
(1) In a developmental toxicity study using pregnant mice, neither maternal toxicity nor fetal developmental effects were observed at any dose up to the highest dose of 500 mg/kg/day (EPA Pesticides (2009)).
(2) In a developmental toxicity study using pregnant rats, the test in a group treated at 500 mg/kg/day was discontinued due to significant maternal toxicity development, and conducted up to 150 mg/kg/day. At 150 mg/kg/day, maternal toxicity (decreased body weight/reduced body weight gain, decreased food consumption) was observed but no developmental effects in fetuses were observed (EPA Pesticides (2009)).
(3) In a developmental toxicity study using pregnant rabbits, no developmental effects were observed in fetuses at any dose up to the highest dose (48 mg/kg/day) at which maternal toxicity (reduced body weight gain, decreased food consumption) was observed (EPA Pesticides (2009)).
(4) The JMPR concluded that this substance did not induce developmental toxicity and that it was not teratogenic (JMPR (2010)).

[Reference Data, etc.]
(5) This substance (meptyldinocap, DE-126) is one of 6 isomers contained in dinocap (CAS RN 39300-45-3), accounting for approximately 22% of dinocap (EFSA (2014), JMPR (2010), EPA Pesticides (2009)).
(6) It was reported that, in a two-generation reproduction toxicity study with rats for dinocap used as a test substance, no effects on fertility, reproductive parameters, sperm, or reproductive tissues were seen at any dose up to the highest dose of 400 ppm (27 mg/kg/day) in the F0 and F1 generations. The reduced survival in F1 pups at 1,000 ppm (approx. 65 mg/kg/day) led to a reduction in the highest dose level to 400 ppm in F1 parental animals and F2 pups. The NOAEL in pups and parental animals was reported to be 200 ppm (approx. 13 mg/kg/day) (JMPR (2010)).
(7) In a developmental toxicity study in pregnant mice using dinocap as the test substance, at the dose of 25 mg/kg/day, cleft palate and effects on otoconia formation were observed in nearly all fetuses (JMPR (2010)).
(8) Dinocap was classified in Repr. 1B under the CLP Classification (EU CLP Classification Results (Accessed December 2021)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified" in the oral route. However, classification was not possible since there was no information available for classification in the other routes. Data on isomer mixture were not used, and based on the findings of the substance, the classification result was changed

[Evidence Data]
(1) It was reported that, in a repeated dose 28-day oral toxicity study with mice dosed by feeding, increased liver weight was observed at 126 mg/kg/day (converted guidance value: 39.2 mg/kg/day, within the range for Category 2) (JMPR (2010), EPA Pesticide (2009), EFSA (2014)).
(2) It was reported that, in a repeated dose 90-day oral toxicity study with rats dosed by feeding, increase in serum total protein, albumin, and cholesterol, mononuclear cell infiltration of the lacrimal glands, and effects on the liver (increased weight, very slight hepatocellular hypertrophy) were observed at 122 mg/kg/day (in the range corresponding to "Not classified") (JMPR (2010), EPA Pesticide (2009), EFSA (2014)).
(3) It was reported that, in a repeated dose 90-day oral toxicity study with dogs dosed by feeding, decreased body weight gain, and increases in AST and ALT were observed at 3.9 mg/kg/day (within the range for Category 1) (JMPR (2010), EPA Pesticide (2009), EFSA (2014)).
(4) It was reported that. in a one-year chronic toxicity study with dogs dosed by feeding, no effects on the eyes, heart, or nerve (tibial) were observed at 3.5 mg/kg/day (within the range for Category 1) (JMPR (2010), EPA Pesticide (2009), EFSA (2014)).
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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