GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 96-31-1
Chemical Name N,N'-Dimethylurea
Substance ID 25A0046
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
-
-
- - 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 solid 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 Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 400 deg C (IUCLID (2000)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - 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 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
-
-
- - Solid (GHS definition)
14 Oxidizing solids Not applicable
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
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) Not classified
-
-
- - It was classified as "Not classified" (Category 5 in UN GHS classification) based on a report on an LD50 value of about 4,000 mg/kg for rats (SIDS (2005)).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - Because it is reported that in test in which an 80% aqueous solution was applied to rabbits, there was slight irritation, and the score was 1.25 (SIDS (2005)), it was classified as "Not classified" (Category 3 in UN GHS classification).
3 Serious eye damage/eye irritation Not classified
-
-
- - In SIDS (2005), there are reports on the results of two tests, both of which resulted in slight irritation and recoveries within eight days. Therefore, it was classified as "Not classified."
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 a mouse lymphoma test with cultured mammalian cells (SIDS (2005), NTP DB (Access on September 2013)). Besides, it is described in SIDS (2005) that because mutagenic nitrosoureas may be produced from this substance with nitrite, a mutagenic potential cannot be totally excluded.
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, nitrosation of this substance may occur with nitrite with the formation of nitrosoureas. Nitrosoureas have been shown to be carcinogenic (SIDS (2005)).
7 Reproductive toxicity Classification not possible
-
-
- - No reproductive toxicity was observed in a reproduction/developmental toxicity screening test (OECD TG 421) with rats in the oral route (gavage). Furthermore, in a developmental toxicity test with rats in the oral route (gavage), maternal toxicity (reduced weight gain and food consumption) was found at or above 100 mg/kg bw/day, where developmental toxicity (reduced placental and fetal body weights, a soft tissue variation, delayed ossifications) was observed, but no malformations were seen (SIDS (2005)). The above was not adopted as evidence of the classification because no fertility effects were observed, but it is a screening test, and because developmental effects were slight ones found at the doses where maternal toxicity was seen. Therefore, it was classified as "Classification not possible" due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, it is reported that in rats in the oral route, no toxic signs were observed at the dose (3,160 mg/kg) above the guidance value range (SIDS (2005)), and it is thought to correspond to "Not classified" in the oral route. However, because no toxicity information was obtained for the other routes, it was classified as "Classification not possible" due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney)


Warning
H373 P260
P314
P501
It is described that in a 28-day gavage exposure test with rats, alterations in the kidney (tubular necroses, desquamation of the tubular epithelial cells, protein casts in the tubuli) were observed at the dose (converted guidance value: 50 mg/kg/day) corresponding to Category 2 (SIDS (2005), IUCLID (2000)). Therefore, it was classified in Category 2 (kidney).
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) Not classified
-
-
- - From 72-hour ErC50 > 500 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2005), 24-hour ErC50 > 500 mg/L for crustacea (Daphnia magna) (SIDS, 2005), and 96-hour LC50 of about 10,000 mg/L for fish (Leucicus idus) (SIDS, 2005), it was classified as "Not classified."
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" due to 72-hour ErC10 = 318 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2005) despite being not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2003)).
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" because it corresponds to "Not classified" in acute toxicity for both crustacea and fish, and it is not water-insoluble (very soluble in water, HSDB, 2013).
From the above results, it was classified as "Not classified."
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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