GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 135-20-6
Chemical Name Ammonium N-nitrosophenylhydroxylamine (synonym: Cupferron)
Substance ID R03-C-008-MHLW
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2016   FY2010  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 -
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2 Flammable gases -
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3 Aerosols -
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4 Oxidizing gases -
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5 Gases under pressure -
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6 Flammable liquids -
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7 Flammable solids -
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8 Self-reactive substances and mixtures -
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9 Pyrophoric liquids -
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10 Pyrophoric solids -
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11 Self-heating substances and mixtures -
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12 Substances and mixtures which, in contact with water, emit flammable gases -
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13 Oxidizing liquids -
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14 Oxidizing solids -
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15 Organic peroxides -
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16 Corrosive to metals -
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17 Desensitized explosives -
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HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
1 Acute toxicity (Oral) -
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1 Acute toxicity (Dermal) -
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1 Acute toxicity (Inhalation: Gases) -
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1 Acute toxicity (Inhalation: Vapours) -
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1 Acute toxicity (Inhalation: Dusts and mists) -
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2 Skin corrosion/irritation -
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3 Serious eye damage/eye irritation -
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4 Respiratory sensitization -
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4 Skin sensitization -
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5 Germ cell mutagenicity -
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6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501 		[Rationale for the Classification]
Based on (1) and (2), since there was sufficient evidence of carcinogenicity in two or more animal species, it was classified in Category 1B.

[Evidence Data]
(1) In a carcinogenicity study with rats dosed by feeding for 78 weeks (observation for an additional period of 19 to 28 weeks), an increase in the respective incidences of hemangiosarcoma of the circulatory system (mostly originating in the spleen), hepatocellular carcinoma, and squamous cell carcinoma of the forestomach in males and females, and an increase in the incidence of carcinoma of the Zymbal gland in females were observed (IARC 127 (2021), NTP RoC (14th, 2016), NTP TR100 (1978), HSDB (Accessed Sep. 2021)).
(2) In a carcinogenicity study with mice dosed by feeding for 78 weeks (observation for an additional period of 17 or 18 weeks), an increase in the incidences of hemangiosarcoma of the circulatory system (mostly originating in the spleen) in males and females and hepatocellular carcinoma in females was observed. A trend towards increased incidence of carcinoma of the Zymbal gland (auditory sebaceous gland) was also observed in female mice (IARC 127 (2021), NTP RoC (14th, 2016), NTP TR100 (1978), HSDB (Accessed Sep. 2021)).
(3) As for the classification results by domestic and international organizations, the IARC classified this substance in Group 2B (IARC 127 (2021)) and the NTP classified it in R (NTP RoC (14th, 2016)).

[Reference Data, etc.]
(4) There was strong evidence that this substance exhibited key characteristics of carcinogens in experimental systems (IARC 127 (2021)).
7 Reproductive toxicity -
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8 Specific target organ toxicity - Single exposure -
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9 Specific target organ toxicity - Repeated exposure -
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10 Aspiration hazard -
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ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) -
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11 Hazardous to the aquatic environment Long term (Chronic) -
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12 Hazardous to the ozone layer -
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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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