Latest GHS Classification Results by the Japanese Government (edited by NITE)

Japanese



GENERAL INFORMATION
Item Information
CAS RN 10024-97-2
Chemical Name Dinitrogen oxide; Nitrous oxide
Substance ID m-nite-10024-97-2_v1
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) To Guidance List
UN GHS document (External link) To UN GHS document
FAQ(GHS classification results by the Japanese Government) To FAQ
List of Information Sources (Excel file) List of Information Sources
List of Definitions/Abbreviations Definitions/Abbreviations
Sample Label by MHLW (External link) MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) To OECD/eChemPortal (External link)

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Explosives Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Flammable gases Not classified
-
-
- - It was classified as "Not classified" from information that it is a non-flammable gas (Hommel (1991)). FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Oxidizing gases Category 1


Danger
H270 P370+P376
P220
P244
P403
It was classified in Category 1 because it is classified in Division 2.2, Subsidiary Risk 5.1 in UNRTDG (UN 2201). FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Gases under pressure High pressure liquefied gas


Warning
H280 P410+P403 It was classified as high-pressure liquefied gases from a critical temperature of 36.65 deg C (Japanese Pharmacopoeia (2018)). FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Flammable liquids Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Flammable solids Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Self-reactive substances and mixtures Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Self-heating substances and mixtures Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15 Organic peroxides Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16 Corrosive to metals Classification not possible
-
-
- - Classification is not possible because test methods applicable to gas substances are not available. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17 Desensitized explosives Not classified (Not applicable)
-
-
- - Gas (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Acute toxicity (Oral) Not classified (Not applicable)
-
-
- - [Rationale for the Classification]
Gas (GHS definition). It was classified as "Not classified (Not applicable)."
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Dermal) Not classified (Not applicable)
-
-
- - [Rationale for the Classification]
Gas (GHS definition). It was classified as "Not classified (Not applicable)."
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Gases) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Vapours) Not classified (Not applicable)
-
-
- - [Rationale for the Classification]
Gas (GHS definition). It was classified as "Not classified (Not applicable)."
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Dusts and mists) Not classified (Not applicable)
-
-
- - [Rationale for the Classification]
Gas (GHS definition). It was classified as "Not classified (Not applicable)."
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Skin corrosion/irritation Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Serious eye damage/eye irritation Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Skin sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
There are no in vivo data on this substance alone. However, negative results were obtained in in vitro tests of multiple indicators. Therefore, based on expert judgments, it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, there are no data on studies conducted with this substance alone.
(2) As for in vitro, there are negative results in a bacterial reverse mutation test, an HPRT test and a micronucleus test with cultured mammalian cells (DFGOT vol.9 (1998), ACGIH (7th, 2001)).

[Reference Data, etc.]
(3) As for in vivo, in a test in which rats were concurrently exposed to this substance and halothane (CAS RN 151-67-7), chromosomal aberrations in the bone marrow cells and spermatogonia were reported. However, halothane alone also has clastogenic effects so it is not clear whether this substance alone has clastogenic effects (DFGOT vol.9 (1998)).
(4) In epidemiological and occupational exposure data where exposure to this substance was clear, neither increased SCE nor chromosomal aberrations were observed in lymphocytes in workers (DFGOT vol.9 (1998)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Based on classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified as A4 by ACGIH (ACGIH (7th, 2001)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Reproductive toxicity Category 1A


Danger
H360 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1)-(3), since increases in spontaneous abortions were observed in exposed humans, it was classified in Category 1A.

[Evidence Data]
(1) In female workers who were exposed to waste anesthetic gas, increases in spontaneous abortions were reported (ACGIH (7th, 2001), DFGOT vol.9 (1998), IPCS, PIM 381 (1991)).
(2) Also, in female dentists and their assistants exposed to anesthetic gas in dental clinics, increases in spontaneous abortions were reported (ACGIH (7th, 2001)).
(3) There is a report that increases in congenital abnormalities were observed in children of women who were exposed during pregnancy, but it was not proven (ACGIH (7th, 2001), DFGOT vol.9 (1998), IPCS, PIM 381 (1991)).

[Reference Data, etc.]
(4) In a developmental toxicity test with pregnant rats exposed by inhalation, after continuous exposure to high concentrations (50,000-75,000 ppm) for 24 hours, an increased resorption rate, visceral and skeletal anomalies were reported, however, for intermittent exposures less than 24 hours/day, effects were less pronounced or not detectable (DFGOT vol.9 (1998)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 3 (narcotic effects).

[Evidence Data]
(1) It was described that it showed analgesic effects at or above 300,000 ppm and anesthetic effects at or above 800,000 ppm in inhalation exposure (DFGOT vol.9 (1998)).
(2) In the medical field, this substance has been used for a long time as an inhalation anesthetic in Japan and internationally and is listed in the Japanese Pharmacopoeia (Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2004)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system, hematopoietic system)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1)-(3), this substance was considered to affect the nervous system and hematopoietic system in humans. Therefore, it was classified in Category 1 (nervous system, hematopoietic system). By reviewing the information sources, the classification result was changed from the previous classification.

[Evidence Data]
(1) Chronic exposure to high concentrations of this substance may cause megaloblastic bone marrow depression and neurological symptoms (IPCS, PIM 381 (1991), HSDB (Access on July 2019)).
(2) Reversible bone marrow depression with aplastic anemia was observed in tetanus patients exposed to 500,000 ppm of this substance as a sedative for 23 days (DFGOT vol.9 (1998)).
(3) In dentists heavily exposed to this substance (greater than 3000 hours within the prior 10 years), neurologic symptoms (numbness, tingling, and weakness) were observed (ACGIH (7th, 2001)).

[Reference Data, etc.]
(4) There is a report that hepatic and renal disease rates were higher for dentists and dental assistants exposed to this substance. On the other hand, there is also a report that tests for hepatic and hematological functions, performed on operating room personnel, ward nurses, and technicians and physicians on radiology services, showed no significant differences between the groups exposed to the anesthetic gases containing this substance and the control group (ACGIH (7th, 2001), Cohen et al., 1980, De Zotti et al., 1983).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Aspiration hazard Not classified (Not applicable)
-
-
- - [Rationale for the Classification]
Gas (GHS definition)
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
11 Hazardous to the aquatic environment Short term (Acute) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Hazardous to the aquatic environment Long term (Chronic) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Hazardous to the ozone layer Classification not possible
-
-
- - Classification not possible due to lack of data. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))


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.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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