GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 431-03-8
Chemical Name Diacetyl
Substance ID H27-A-011/C-011A_P
Classification year (FY) FY2015
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 for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 present in the molecule associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Liquids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Liquids" according to GHS definition.
6 Flammable liquids Category 2


Danger
H225 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501 		Based on a flash point of 6 degrees C (closed cup) and a boiling point of 88 degrees C (ICSC (2009)), it was classified in Category 2.
Besides, it is classified in class 3, PGII (UN2346) in UNRTDG.
7 Flammable solids Not applicable
-
-
- - "Liquids" according to GHS definition.
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 classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an ignition point of 365 degrees C (ICSC (2009)).
10 Pyrophoric solids Not applicable
-
-
- - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible
-
-
- - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen.
14 Oxidizing solids Not applicable
-
-
- - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - Due to no data, the classification is not possible.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - There are 3 reported LD50 values of 1,580 mg/kg (PATTY (6th, 2012)), 3,400 mg/kg (males), and 3,000 mg/kg (females) (PATTY (6th, 2012), JECFA FAS 42 (1999)) for rats. Because one corresponds to Category 4 and 2 correspond to "Not classified" (Category 5 in UN GHS classification), it was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- - From a reported LD50 value of > 5,000 mg/kg for rabbits (PATTY (6th, 2012)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Liquids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - The classification is not possible due to lack of data.
It is reported that toxic effects were not observed after 6-hour exposure in rats at 99.3 ppm (converted to a 4-hour equivalent: 122 ppm) (PATTY (6th, 2012)). A reference value in the unit of ppm was applied because the test concentration is lower than the saturated vapour pressure concentration (68,421 ppm), but the category cannot be determined from this data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321 		Because it was described to be moderately irritating in a test in which this substance was applied to rabbit skin (PATTY (6th, 2012)), it was classified in Category 2.
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310 		From the information that in a test in which this substance was applied to rabbit eyes, irritation and no recovery within 21 days were observed (PATTY (6th, 2012)), it was classified in Category 1.
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501 		A mouse local lymph node assay (LLNA) using diacetyl of 1.25 to 24% concentrations was positive (PATTY (6th, 2012)) with an EC3 value (a concentration at which an irritation index that is a relative response factor against the vehicle control becomes 3) of 1.9% (Anderson et al., Toxicol. Sci., 97, 355, 2007) or 11.3% (Roberts et al., Contact Dermat., 41, 14, 1999).
Therefore, the substance was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, it is reported that a micronucleus test using rat and mouse bone marrow cells was negative (NTP DB (Access on June 2015)). As for in vitro, it is reported that a mouse lymphoma test, a sister chromatid exchange test, and an unscheduled DNA synthesis test using cultured mammalian cells were positive (PATTY (6th, 2012)). Moreover, there are multiple reports of both positives and negatives in bacterial reverse mutation tests (JECFA FAS42 (1999), NTP DB (Access on June 2015)).


6 Carcinogenicity Classification not possible
-
-
- - Due to no classification result by other organizations and lack of data, the classification is not possible.
Besides, increased incidence of lung tumor was not observed after 8-week (3 times/week) intraperitoneal administration (total amount administered: 1,700, 8,400 mg/kg) as a screening test using strain A mice (PATTY (6th, 2012)). NTP is conducting a long-term inhalation test using rats and mice (NTP testing status (Access on June 2015)).
7 Reproductive toxicity Classification not possible
-
-
- - A 90% solution of this substance was administered by gavage at doses up to 1,600 mg/kg/day to pregnant rats or mice on day 6 to 15 of gestation, or to pregnant hamsters on day 6 to 10 of gestation in a teratogenicity test. It is written that maternal toxicity was not observed in any species, and malformation effects on the external, skeletal, and soft tissues in fetuses were not found (PATTY (6th, 2012), JECFA FAS 42 (1999), HSDB (Access on June 2015)).
However, because there is no information to classify in the evaluation of effects on fertility, the classification is not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory organs)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501 		In inhalation exposure to this substance in rats, bronchial irritation and the following were reported: necro-suppurative rhinitis with neutrophilic inflammation of nasal cavity at 99 ppm (0.35 mg/L) to 198 ppm (0.70 mg/L);
and necrosis with neutrophilic inflammation of nasal epithelial cells and bronchial epithelial cells (including necro-suppurative bronchitis and rhinitis) at 295 ppm (1.04 mg/L). In inhalation exposure in mice (unknown concentration), the nasal epithelial damage was reported (PATTY (6th, 2012)). Besides, it is reported that this substance is irritating to the skin and eyes (PATTY (6th, 2012)), and there is information that it is irritating to the respiratory tract (HSDB (Access on June 2015)). There is no other information.
From the above, damage to the respiratory tract found above in experimental animals is the effect on the respiratory organs and observed within a range of Category 1 in Guidance values.
Therefore, the substance was classified in Category 1 (respiratory organs).

9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs)


Danger
H372 P260
P264
P270
P314
P501 		There is no information in humans.
As for experimental animals, in a 12-week inhalation toxicity test using mice, the following was observed (PATTY (6th, 2012)): peribronchial lymphocytic inflammation and atrophy/metaplasia of the nasal and olfactory epithelium at doses of 25 ppm (0.088 mg/L) corresponding to Category 1 or higher; and decreased body weight, decreases in respiratory rates and minute volume (at week 3 and 6), moderate suppurative rhinitis, chronic active inflammation and epithelial ulceration/necrosis of nasal and olfactory epithelium, atrophy/denudation of large bronchi, and degeneration that extended into the smaller airways and bronchioles, and peribronchial lymphocytic inflammation at 100 ppm (0.35 mg/L) corresponding to Category 2.
Therefore, the substance was classified in Category 1 (respiratory organs).
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

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) Classification not possible
-
-
- - No data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - No data.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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