GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 623-91-6
Chemical Name Diethyl fumarate
Substance ID 25A0047
Classification year (FY) FY2013
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) GHS Classification Guidance by the Japanese Government (July, 2013)
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
-
-
- - Liquid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Liquid (GHS definition)
6 Flammable liquids Not classified
-
-
- - From a flash point of 104 deg C (closed cup) (HSDB (Access on October 2013)) above 93 deg C, it was classified as "Not classified."
7 Flammable solid Not applicable
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is a chemical group associated with self-reactive properties (unsaturated bond) in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Classification not possible
-
-
- - No data available.
10 Pyrophoric solids 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 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 applicable
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No data available.

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
It was classified in Category 4 based on reports on LD50 values for rats of 1,367 mg/kg (females), 1,540-2,000 mg/kg (males) (JECDB (Access on August 2013)), and 1,780 mg/kg (PATTY (6th, 2012)).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- - Classification not possible due to lack of data.
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, it is described in PATTY (6th, 2012) that there was slight irritation in the eye of rabbits, but it was not adopted for classification because the details are unknown.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. There are no in vivo data, and as for in vitro, it was negative in a bacterial reverse mutation test and positive in a chromosomal aberration test with cultured mammalian cells (JECDB (Access on September 2013)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, no reproductive and developmental toxicity was observed in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats in the oral route (gavage) (JECDB (Access on October 2013), PATTY (6th, 2012), HSDB (Access on October 2013)). Because it is the result of a screening test, and there are no sufficient reports on developmental toxicity, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Category 2 (kidney, liver, spleen, thymus)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
In a gavage administration test with rats (JECDB (Access on October 2013)), a decrease in spontaneous activity, salivation, prone position, subnormal temperature, bradypnea, and diarrhea were observed in the surviving animals at the doses (910-2,000 mg/kg) within the guidance value range. Histopathological examinations revealed ulcer, thickening of the mucosal layer, granulation growth in the submucosal tissue, etc. in the forestomach and regeneration of the tubular epithelium and fibrosis in the kidney. And atrophy and an increase in extramedullary hematopoiesis in the spleen were observed. The dead animals showed necrosis of the mucosal epithelium in the forestomach, focal necrosis and congestion of hepatocytes, necrosis and atrophy of the tubular epithelium in the kidney, necrosis in the spleen, congestion of the lung and edema in the alveoli, and atrophy of the thymus and thymic cyst. Among these, the findings in the forestomach were thought to be caused by irritation of the substance, and the findings in the lung were thought to be those at an agonal stage. Therefore, these were not taken as the target organs. Based on the findings except those of the forestomach and lung, it was classified in Category 2 (kidney, liver, spleen, thymus).
9 Specific target organ toxicity - Repeated exposure Category 2 (thymus)


Warning
H373 P260
P314
P501
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats by gavage exposure, thickening of the mucosa and hyperkeratosis in the forestomach at or above the low dose (converted guidance value: 5.5 mg/kg/day) corresponding to Category 1, edema in the submucosal tissue and ulcer in the forestomach and atrophy of the thymus at the middle dose (converted guidance value: 15 mg/kg/day; corresponding to Category 2), and increased absolute and relative weights of the liver and kidney at the high dose (50 mg/kg/day; corresponding to Category 2) were observed (JECDB (Access on October 2013), HSDB (Access on October 2013), PATTY (6th, 2012)), but among these, the findings in the forestomach were thought to be caused by irritation of the substance. Furthermore, increased weights of the liver and kidney were not accompanied by relevant blood chemical findings and pathological changes, and the organs except for the thymus were excluded because their findings were not thought to be of significance in toxicity. From the above, it was classified in Category 2 (thymus).
10 Aspiration hazard Classification not possible
-
-
- - 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 (Acute) Category 2
-
-
H401 P273
P501
From 72-hour EbC50 = 1.1 mg/L (SIDS, 2004) for algae (Pseudokirchneriella subcapitata), it was classified in Category 2.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - Chronic toxicity data for algae were obtained, but it is not possible to use it for classification because it is of low reliability although chronic toxicity is suspected by considering acute toxicity.
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 93% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1995; SIDS, 2004)), and a low bioaccumulation estimate (Log Pow = 2.12 (SIDS, 2004)) despite 72-hour EC50 = 2.4 mg/L for fish (Oryzias latipes) (SIDS, 2004).
From the above, although chronic toxicity data usable for classification were obtained for algae, chronic toxicity was suspected, therefore it was classified as "Classification not possible" by expert judgment.
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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