GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 68-12-2
Chemical Name N,N-Dimethylformamide
Substance ID H30-C-044-MHLW
Classification year (FY) FY2018
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2008   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 (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 -
-
-
- - -
2 Flammable gases (including chemically unstable gases) -
-
-
- - -
3 Aerosols -
-
-
- - -
4 Oxidizing gases -
-
-
- - -
5 Gases under pressure -
-
-
- - -
6 Flammable liquids -
-
-
- - -
7 Flammable solids -
-
-
- - -
8 Self-reactive substances and mixtures -
-
-
- - -
9 Pyrophoric liquids -
-
-
- - -
10 Pyrophoric solids -
-
-
- - -
11 Self-heating substances and mixtures -
-
-
- - -
12 Substances and mixtures which, in contact with water, emit flammable gases -
-
-
- - -
13 Oxidizing liquids -
-
-
- - -
14 Oxidizing solids -
-
-
- - -
15 Organic peroxides -
-
-
- - -
16 Corrosive to metals -
-
-
- - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) -
-
-
- - -
1 Acute toxicity (Dermal) -
-
-
- - -
1 Acute toxicity (Inhalation: Gases) -
-
-
- - -
1 Acute toxicity (Inhalation: Vapours) -
-
-
- - -
1 Acute toxicity (Inhalation: Dusts and mists) -
-
-
- - -
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
[Rationale for the Classification]
Because there are multiple pieces of evidence that this substance is irritating from (1)-(6), it was classified in Category 2. Besides, the previous category was revised by using new information sources.

[Evidence Data]
(1) There are multiple pieces of information that exposure to this substance causes symptoms of skin irritation and eruption in humans, and it is reported that it is slightly to moderately irritating to the skin (ACGIH (2018), CICAD (2001)).
(2) A 52-year-old man who accidentally contacted this substance (about 20% of the body surface) washed himself, dressed, and drove home, and skin inflammation and hyperemia are reported as symptoms after 45 minutes (PATTY (6th, 2012), Ministry of Health, Labour and Welfare Hazard Assessment Report (CERI, NITE, 2017)).
(3) It is reported that 21-year-old and 28-year-old men who exposed to this substance at work developed erythematous rash in their hands and forearms (Ministry of Health, Labour and Welfare Hazard Assessment Report (CERI, NITE, 2017)).
(4) It is reported that after this substance was applied to the skin of mice at 500 mg/kg body weight, transient irritation was observed after 2-3 hours, and slight irritation was found at 2,500 and 5,000 mg/kg body weight (EHC (1991), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Ministry of Health, Labour and Welfare Hazard Assessment Report (CERI, NITE, 2017)).
(5) It is reported that when this substance was applied to the skin of rats at 94, 472, 944 mg/kg body weight, skin irritation was shown at 944 mg/kg body weight (PATTY (6th, 2012)).
(6) It is reported that when this substance was applied to the skin of rabbits at 100, 200, 400 mg/kg body weight, it was irritating to the skin at 400 mg/kg body weight (PATTY (6th, 2012)).
(7) In the notice regarding guidelines to prevent health problems, this substance was designated as a substance strongly irritating the skin, eye, and mucous membrane (the notice No. 0614001 issued by Director of Labour Standards Bureau, the Ministry of Health, Labour and Welfare, demolished by the notice No. 0331-26, March 31, 2016).

[Reference Data, etc.]
(8) In the announcement No. 33 of the Ministry of Labour (1996) (revised by the announcement No. 316 of the Ministry of Health, Labour and Welfare, 2013), this substance is designated as "dimethylformamide" in Simple chemical substances or compounds designated by the Minister of Health, Labour and Welfare based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act, and a disease principally having specific symptoms and disorders (subjective symptoms such as headaches, dizziness, and vomiting, and skin disorders, anterior eye disorders, respiratory tract disorders, liver disorders, or gastrointestinal disorders) due to work involving exposure to this substance was designated as an occupational disease by the Minister of Health, Labour and Welfare.
(9) In the notice No. 0811001 issued by Director of Labour Standards Bureau, the Ministry of Labour (2003), this substance is designated as "dimethylformamide" among hazardous substances for which installation of protective equipment to prevent eye disorders such as protective glasses is mandated in Article 593 in the Industrial Safety and Health Regulations.
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
[Rationale for the Classification]
This substance is thought to be irritating to from (1)-(5). By giving weight to evidence in a GLP-compliant test (1), it was classified in Category 2B. Besides, the category was revised from the previous classification by using information sources.

[Evidence Data]
(1) It is reported that in an eye irritation test with rabbits (GLP-compliant, n = 6), after application of undiluted this substance, large blisters were observed on the inside of the upper and lower eyelids after 1 and 4 hours, but they decreased in size after 24 hours and resolved 48 hours (REACH registration dossier (Accessed Dec. 2018)).
(2) It is reported that in an eye irritation test with rabbits (n = 3), after application of undiluted, 10%, 50% solution (0.9% NaCl) of this substance, chemosis and erythema were found after one hour but resolved after six days (REACH registration dossier (Accessed Dec. 2018)).
(3) It is reported that in an eye irritation test in rabbits, effects were not observed after 0.1 mL of aqueous solution (25%) of this substance was applied to conjunctival sac, but slight irritation by a 50% aqueous solution and severe irritation by 75% aqueous solution and undiluted this substance were seen (EHC (1991), Ministry of Health, Labour and Welfare Hazard Assessment Report (CERI, NITE, 2017)).
(4) It is reported that in an eye irritation test in rabbits, after 0.1 mL of this substance was applied, moderate corneal damage and conjunctival redness were found and pronounced after 2-3 days, and after 14 days, mild conjunctival redness and moderate corneal damage with severe injury, slight surface distortion, and subsurface vascularization were observed (EHC (1991), Ministry of Health, Labour and Welfare Hazard Assessment Report (CERI, NITE, 2017)).
(5) In the notice regarding guidelines to prevent health problems, this substance was designated as a substance strongly irritating the skin, eye, and mucous membrane (the notice No. 0614001 issued by Director of Labour Standards Bureau, the Ministry of Health, Labour and Welfare, demolished by the notice No. 0331-26, March 31, 2016).
4 Respiratory sensitization -
-
-
- - -
4 Skin sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Although there are multiple pieces of evidence indicating that it is not sensitizing from (1)-(3), sufficient information to judge whether it is sensitizing was not obtained, therefore, it was classified as "Classification not possible."

[Reference Data, etc.]
(1) It is reported that in an LLNA test with mice (OECD TG406, n = 6), when a solution of this substance (acetone/olive oil (4:1 v/v)) was applied, clear signs of sensitization were not seen (SIAR (2001), ACGIH (2018), REACH registration dossier (Accessed Dec. 2018)).
(2) It is reported that in an LLNA test with mice, after this substance was applied, no difference was observed between the control group and the treated group (CICAD (2001), ACGIH (2018)).
(3) It is reported that in a maximization test with guinea pigs, when this substance was applied, it was not sensitizing (EHC (1991), SIAR (2001), REACH registration dossier (Accessed Dec. 2018)).
5 Germ cell mutagenicity -
-
-
- - -
6 Carcinogenicity -
-
-
- - -
7 Reproductive toxicity -
-
-
- - -
8 Specific target organ toxicity - Single exposure -
-
-
- - -
9 Specific target organ toxicity - Repeated exposure -
-
-
- - -
10 Aspiration hazard -
-
-
- - -

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) -
-
-
- - -
11 Hazardous to the aquatic environment (Long-term) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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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