GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 39300-45-3
Chemical Name Dinitromethylhepthylphenylcrotonate
Substance ID R03-C-070-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 -
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2 Flammable gases -
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3 Aerosols -
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4 Oxidizing gases -
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5 Gases under pressure -
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6 Flammable liquids -
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7 Flammable solids -
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8 Self-reactive substances and mixtures -
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9 Pyrophoric liquids -
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10 Pyrophoric solids -
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11 Self-heating substances and mixtures -
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12 Substances and mixtures which, in contact with water, emit flammable gases -
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13 Oxidizing liquids -
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14 Oxidizing solids -
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15 Organic peroxides -
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16 Corrosive to metals -
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17 Desensitized explosives -
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HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) -
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1 Acute toxicity (Dermal) -
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1 Acute toxicity (Inhalation: Gases) -
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1 Acute toxicity (Inhalation: Vapours) -
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1 Acute toxicity (Inhalation: Dusts and mists) -
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2 Skin corrosion/irritation -
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3 Serious eye damage/eye irritation -
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4 Respiratory sensitization -
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4 Skin sensitization -
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5 Germ cell mutagenicity -
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6 Carcinogenicity -
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7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) to (6), since one isomer composing this substance, which is an isomer mixture, was regarded as a teratogen, and teratogenic effects were reported at the dose at which no marked maternal toxicity was observed, it was classified in Category 1B. Based on the new information source, the category was changed.

[Evidence Data]
(1) It was reported that, in a developmental toxicity study with pregnant mice dosed by gavage, in the intermediate-dose (10 mg/kg/day) group and the high-dose (25 mg/kg/day) group showing maternal toxicity, an increase in the incidence of malformations (cleft palate, open eyelids) was observed in fetuses (JMPR (1998)).
(2) It was reported that, in a developmental toxicity study by dermal application to pregnant mice, in the highest dose (25 mg/kg/day) group showing no maternal toxicity, teratogenic effects including impaired otolith formation were observed in fetuses (JMPR (1998)).
(3) It was reported that impaired otolith development, which was one of teratogenic effects in mice, was also seen in hamsters at doses that cause maternal toxicity, while in an oral administration test with rats, no teratogenicity was observed (JMPR (1998)).
(4) It has been established that this substance (dinocap) is an isomer mixture and one isomer, 4-PP (2,6-dinitro-4-[(4RS)-octan-4-yl]phenyl (2E/Z)-but-2-enoate) is responsible for the teratogenic effects observed in mice and the other dinocap isomers, including DE-126 (meptyldinocap, CAS RN 131-72-6), do not share the teratogenic effects (EFSA (2014)).
(5) In a developmental toxicity study with female mice dosed by gavage (4 to 25 mg/kg/day, days 6 to 15 of gestation) (about half of the mice in each group were killed on day 18 of gestation and the fetuses were examined. The remaining dams were allowed to naturally deliver and their liveborn pups were observed after birth), a decreasing trend of body weight gain (not significant) was only observed in dams at the high dose (25 mg/kg/day). However, in fetuses, at the intermediate dose (10 mg/kg/day) that causes no maternal toxicity, open eyelids (1/12 litters, one fetus) and cleft palate (3/12 litters, 4 fetuses) were observed, and at the high dose, open eyelids (2/9 litters, 3 fetuses) and an increase of cleft palate (7/9 litters, 65 fetuses) were observed. In naturally-delivered pups, there were an increased incidence of stillborn pups, decreased body weight gain and an increased incidence of litters with pups with head tilt or cleft palate (7 of 9 pups with cleft palate were from the same litter), and in a swimming test on day 43, abnormal swimming postures or ability were observed (JMPR (1998): Part II (Toxicological Evaluation)).
(6) It was reported that, in a developmental toxicity study by dermal administration (1 to 25 mg/kg/day, days 6 to 15 of gestation, 4 hours/day) with female mice, local irritation at or above 10 mg/kg/day and one death at the highest dose of 25 mg/kg/day (the relation to the treatment is not clear) were observed in dams. As for developmental effects, it was reported that impaired otolith formation in addition to cleft palate (1/6 litters, 3 fetuses) and open eyelids (1/6 litters, 2 fetuses) was observed in fetuses in the highest dose group (JMPR (1998): Part II (Toxicological Evaluation)).

[Reference Data, etc.]
(7) In the EU, it was classified in Repr. 1B (EU CLP Classification Results (Accessed Dec. 2021)).
8 Specific target organ toxicity - Single exposure -
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9 Specific target organ toxicity - Repeated exposure -
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10 Aspiration hazard -
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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) -
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11 Hazardous to the aquatic environment Long term (Chronic) -
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12 Hazardous to the ozone layer -
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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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