GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 510-15-6
Chemical Name 4,4'-dichlorobenzilic acid ethyl ester; Chlorobenzilate
Substance ID R02-B-082-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 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. Besides, there is information that it is combustible (ICSC (2003)).
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 Classification not possible
-
-
- - No data available.
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 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
-
-
- - It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
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 4


Warning
H302 P301+P312
P264
P270
P330
P501
[Rationale for the Classification]
It was classified in Category 4 from (1) - (3).

[Evidence Data]
(1) LD50 for rats: 700 mg/kg (IARC 30 (1983), GESTIS (Access on May 2020), HSDB (Access on May 2020))
(2) LD50 for rats: males: 1,040 mg/kg, females: 1,220 mg/kg (HSDB (Access on May 2020))
(3) LD50 for rats: 2,784-3,880 mg/kg (HSDB (Access on May 2020))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
It was classified as "Classification not possible" because the category could not be determined from (1).
Besides, the classification result was changed from the previous classification by using a new information source.

[Evidence Data]
(1) LD50 for rabbits: > 1,000 mg/kg (GESTIS (Access on May 2020))
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]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- - [Rationale for the Classification]
There was a description of (1), but the classification was not possible due to lack of data. Because rationale data for the previous classification could not be confirmed, and data sufficient for classification were not obtained, the classification result was changed.

[Reference Data, etc.]
(1) This substance was a mild skin irritant, and chronic skin exposure caused inflamed skin or rashes (HSDB (Access on May 2020)).
3 Serious eye damage/eye irritation Classification not possible
-
-
- - [Rationale for the Classification]
There was a description of (1), but the classification was not possible due to lack of data. Because rationale data for the previous classification could not be confirmed, and data sufficient for classification were not obtained, the classification result was changed.

[Reference Data, etc.]
(1) This substance was a mild eye irritant, and chronic eye exposure caused conjunctivitis (HSDB (Access on May 2020)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Evidence Data]
(1) There were no in vivo data.
(2) As for in vitro, it was negative in a bacterial reverse mutation test (IARC 30 (1983), HSDB (Access on May 2020), CEBS (Access on May 2020)), and it was reported in test systems using cultured mammalian cells that it was negative in a chromosomal aberration test, negative in a sister chromatid exchange test, and positive and negative in mouse lymphoma tests (CEBS (Access on May 2020)).

[Reference Data, etc.]
(3) As for in vivo, it is reported that no evidence of mutagenic effects was noted in chromosomal and morphological examinations of spermatocytes using mice (JMPR (1980)), but the details of the test were unknown.
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) As for classification results by domestic and international organizations, IARC classified it in Group 3 (IARC Sup7 (1987)).
(2) In carcinogenicity tests by diet administration of this substance to three strains of mice and two strains of rats, hepatocellular carcinoma was observed in males and females of one strain of mice and males of the other two strains of mice. Data in rats were insufficient for an evaluation (IARC 30 (1983)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1), effects on embryos and fetuses were observed at a dose of maternal toxicity, and it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. Since the new data were obtained, the classification result was changed from the previous classification.

[Evidence Data]
(1) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, embryo resorption and an increase in post implantation embryo loss in embryos and fetuses were observed at a dose at which maternal toxicity (salivation and lethargy) was observed (IRIS (1989), HSDB (Access on May 2020)).

[Reference Data, etc.]
(2) In a two-generation reproduction toxicity study with rats dosed by feeding, no reproductive toxicity effects were observed (IRIS (1989), HSDB (Access on May 2020)).
(3) In a three-generation reproduction toxicity study with rats dosed by feeding, no reproductive toxicity effects or teratogenicity were observed (IARC 30 (1983)).
(4) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, an increase in fused sternebrae was observed in fetuses at a dose at which maternal toxicity (hyperirritability, a decrease in stools, a decrease in food consumption, reduced body weight gain) was observed (IRIS (1989), HSDB (Access on May 2020)).
8 Specific target organ toxicity - Single exposure Category 1 (nervous system), 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]
Based on (1) and (2), effects on the nervous system were observed in humans. Therefore, it was classified in Category 1 (nervous system) and Category 3 (narcotic effects).

[Evidence Data]
(1) In a case of systemic poisoning in a worker involved in mixing and spraying this substance on trees, muscle pains, ataxia, mild delirium, and fever were reported (IARC 30 (1983)).
(2) Symptoms of acute poisoning in humans due to ingestion of this substance included incoordination, nausea, vomiting, fever, apprehension, confusion, muscle weakness or pain, disturbed sense of balance, dizziness, weight loss, wheezing, and coma. And death might result from discontinued breathing or irregular heartbeats (HSDB (Access on May 2020)).

[Reference Data, etc.]
(3) It was reported that signs of poisoning with this substance included depression with salivation, lacrimation, diarrhea, and deep rapid respiration, and autopsy revealed intestinal irritation and hemorrhage in the lungs (HSDB (Access on May 2020)).
(4) It was reported that, in animal studies of this substance with rats and mice, depressed motor activity, lacrimation, and wheezing were observed, and death was preceded by coma (IARC 30 (1983)).
9 Specific target organ toxicity - Repeated exposure Category 2 (central nervous system, blood system)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1) and (2), the information source in List 2 indicated that effects on the central nervous system were observed in humans, and based on (3), there was information that effects on the blood system were observed in test animals at a dose of Category 2, and therefore, it was classified in Category 2 (central nervous system, blood system) according to the GHS Classification Guidance for the Japanese Government. As a result of reviewing the information, the classification result was changed from the previous classification.

[Evidence Data]
(1) In humans, there was a report of a case of toxic encephalopathy following spraying this substance in a field for 14 days at 10 hours per day without wearing protectors. The patient developed muscle pain, weakness, fever, mental status changes, and tonic-clonic seizure, but recovered without sequelae within 6 days (HSDB (Access on May 2020)).
(2) After continuous exposure to this substance, 16 out of 73 workmen had abnormal electroencephalograms. The most severe brain activity changes were observed in a group exposed to the herbicide for one to two years (HSDB (Access on May 2020)).
(3) It was reported that, in a two-year test with dogs dosed by feeding, an increase in ALP, reduced serum protein levels, and anemia (extramedullary hematopoiesis of the liver and spleen, erythroid hyperplasia of the bone marrow) were observed at 5,000/3,000 ppm (125/75 mg/kg/day, within the range for Category 2 to the range exceeding Category 2) (IRIS (1989)).
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 = 0.88 mg/L for fish (Cyprinodon variegatus) (ECOTOX, 2020, EPA OPP Pesticide Ecotoxicity Database, 2020).
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (BIOWIN), and it was classified in Category 1 in acute toxicity.
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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