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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	129-67-9
Chemical Name	Endothal disodium salt
Substance ID	24A6031
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	The substance contains a metal (Na), but from data on water solubility: 19300 mg/L (SRC Phys Prop (Access on June 2012)), it is estimated that it does not react vigorously with water.
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Classification not possible	- -	-	-	No data available.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

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	An LD50 value was reported to be 51 mg/kg for rats (RTECS (2006)), corresponding to Category 3, although it is List 3 data. On the other hand, it was classified in T; R25 in EU classification, corresponding to Category 2 or Category 3. Therefore, it was classified in Category 3, which was common for both. As for the health hazards, also refer to (1R, 2S, 3R, 4S)-7-oxabicyclo[2.2.1]heptane-2,3-dicarboxylic acid (CAS RN: 145-73-3), the related substance (free acid).
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	There is a report on an LD50 value for rats of 750 mg/kg and an LD50 value for rabbits of 100 mg/kg (both RTECS (2006)), corresponding to Category 3 and Category 2, respectively, although it is List 3 data. On the other hand, it was classified in Xn: R21 in EU classification (EC-JRC (ESIS) (Access on June 2012)), corresponding to Category 3 or Category 4. It was classified in Category 3, which was common.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available. Besides, it was classified in Xi; R36/37/38 in EU classification (EC-JRC (ESIS) (Access on June 2012)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available. Besides, it was classified in Xi; R36/37/38 in EU classification (EC-JRC (ESIS) (Access on June 2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	No data available. Besides, as for in vitro tests for endothal, the free acid, negative results were obtained in both an Ames test and a chromosomal aberration test with human peripheral blood lymphocytes (HSDB (2010)).
6	Carcinogenicity	Classification not possible	- -	-	-	In a 104-week diet administration test rats, an increase in endometrial stromal tumors was observed in females in the groups at or above 900 ppm, and lesions in the glandular and non-glandular stomach occurred in many animals (HSDB (2010)). On the other hand, in a 78-week diet administration test with mice, the target organ was the gastrointestinal tract, mucosal hyperplasia and glandular dilatation in the glandular stomach were found in the groups of 750 ppm or above, and there is a report on mucosal hyperplasia in the duodenum, an increased incidence of tumors in the duodenum and jejunum, and decreased survival in the 1,500 ppm group (HSDB (2010)). Because both are List 2 data, and the details are unknown, it was classified as "Classification not possible."
7	Reproductive toxicity	Classification not possible	- -	-	-	In a reproductive test by diet administration to two generations of rats, reduced weight gain was observed in parents and offspring of both generations after the administration of the high dose, but there is no description of reproductive effects (HSDB (2010)), and it is reported that administration to pregnant rats during the organogenesis period caused decreased body weights in maternal animals, but no abnormality was found in offspring or reproduction (Teratogenic (12th, 2007), List 2). However, because both are List 2 data, and the details are unknown, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In a report on a case of a man who ingested about two mouthfuls of the herbicide containing this substance, the autopsy revealed widespread hemorrhages and edema in the lung and gross hemorrhage in the gastrointestinal tract (HSDB (2010)). However, because it is List 2 data with only one case, it was classified as "Classification not possible" due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	In a 52-week diet administration test with dogs, mild or very mild stomach epithelial hyperplasia was observed at the low dose of 150 ppm (3.25 mg/kg bw/day), effects on liver parenchymal and bile ductule cells were found at or above 450 ppm (11.25 mg/kg bw/day), and the dose of 1,000 ppm (25 mg/kg bw/day) was not tolerated: five out of eight animals were killed in extremis (HSDB (2010)). Because the doses that affected the liver (11.25 mg/kg bw/day or above) corresponded to the guidance values for Category 2, it was classified in Category 2 (liver). Besides, findings in the stomach also seen at the low dose were not used for the rationale for classification because these were thought to be local effects after repeated oral exposure to an irritating substance, and this substance was classified in Xi; R36/37/38 in EU classification.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from the geometric mean of 96-hour LC50 values = 0.82 mg/L from for fish (Oncorhynchus mykiss) (AQUIRE, 2012).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because appropriate data on rapid degradability were not obtained, and it corresponds to Category 1 in acute toxicity for fish (AQUIRE, 2012).
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.

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