GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 86-30-6
Chemical Name N-Nitrosodiphenylamine
Substance ID H28-B-064, C-143B
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year 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 Classification not possible
-
-
- -  There is a chemical group associated with explosive properties (N-O) present in the molecule, and calculated oxygen balance is lower than -200 (-218). However, because the exothermic decomposition energy at 300-500 deg C is above 500 J/g (650 J/g, Bretherick(J) (5th, 1998)), the classification is not possible due to lack of data.
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 solids Classification not possible
-
-
- -  It is combustible (ICSC (2003)), but the classification is not possible due to no data.
8 Self-reactive substances and mixtures Classification not possible
-
-
- -  It is a nitroso compound containing a chemical group associated with explosive properties (N-O), but the classification is not possible due to no data.
9 Pyrophoric liquids Not applicable
-
-
- -  Solid (GHS definition).
10 Pyrophoric solids Classification not possible
-
-
- -  No data available.
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 Classification not possible
-
-
- -  The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (N), but the classification is not possible due to no data.
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
-
-
- -  Based on the LD50 value of 3,000 mg/kg for rats (PATTY (6th, 2012), IARC 27 (1982), ATSDR (1993), NTP TR164 (1979)), this substance was classified as "Not classified" (Category 5 in UN GHS classification).
 Besides, Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence for classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.
1 Acute toxicity (Dermal) Not classified
-
-
- -  Based on the LD50 value of > 7,940 mg/kg for rabbits (Environmental Risk Assessment for Chemical Substances vol.4 (Ministry of the Environment, 2005)), this substance was classified as "Not classified" (Category 5 in UN GHS classification).
 Besides, the Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence of classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.
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 Classification not possible
-
-
- -  Classification not possible due to lack of data.
 Besides, it is described that in a skin irritation test using rabbits, no irritation was observed, but the details are unknown (Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). In addition, the information in ATSDR adopted in the previous classification was not adopted in this classification because it is described as an insufficient test in ATSDR.
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
 Based on the report that in an eye irritation test using rabbits, slight irritation of the eyes was observed, this substance was classified in Category 2B.
 Besides, Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence of classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.
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
-
-
- -  The substance was classified as "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.
 As for in vivo, micronucleus tests using mouse bone marrow cells and DNA damage tests using rat livers were negative (ATSDR (1993), Environmental Risk Assessment for Chemical Substances vol.4 (Ministry of the Environment, 2005)).
 As for in vitro, bacterial reverse mutation tests were negative or positive, the mammalian cell gene mutation tests were negative, mouse lymphoma assays were negative or positive, the chromosomal aberration tests and sister chromatid exchange tests were negative or positive (NTP DB (Access on October 2016), ATSDR (1993), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), IARC 27 (1982)).
 Besides, Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence of classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
 In 2-year carcinogenicity studies using rats or mice administered by feeding, no evidence of carcinogenicity was observed in mice, but in rats, an increase in the incidence of transitional-cell carcinomas of the bladder was observed in both males and females in the high dose group (IARC 27 (1982), IRIS (1987)).
 Although there is limited evidence for carcinogenicity in experimental animals, there is insufficient data on humans, so IARC classified this substance in Category 3 (IARC Suppl. 7 (1987)).
 On the other hand, the EPA classified this substance in B2 (equivalent to Category 1B) based on the increased incidence of reticulum cell sarcomas in a single dose study administered subcutaneously using male mice and structural relationship to nitrosamines, carcinogens in addition to carcinomas of the bladder in rats (IRIS (1987)).
 As described above, the classification results by both organizations are different and this substance is an N-nitroso compound, so this substance could be classified in Category 1B. Classification in Category 2 was judged to be appropriate based on the carcinogenicity result of only one experimental animal species.
7 Reproductive toxicity Classification not possible
-
-
- -  Classification not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 2 (systemic toxicity)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
 There is no single exposure data on this substance in humans.
 As for experimental animals, it is described that in a single oral dose study using rats, animals died after showing decrease in food consumption, decrease in locomotor activity, exhaustion, tremors, and prostration at 1,825 mg/kg, which is equivalent to Category 2 (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)).
 This substance was classified in Category 2 (systemic toxicity) because it is not possible to specify target organs from these symptoms.
 Besides, Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence of classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.
9 Specific target organ toxicity - Repeated exposure Category 2 (urinary bladder)


Warning
H373 P260
P314
P501
 As for humans, there was no information that could identify adverse effects of this substance.
 As for experimental animals, carcinogenicity studies were conducted using rats and mice administered by feeding.
 In rats, hyperplasia of transitional epithelium cells in the urinary bladder was observed at 50 mg/kg/day, which is equivalent to Category 2, and in mice, epithelial hyperplasia in the urinary bladder and chronic inflammation of submucosal tissues were observed at 1,300 mg/kg/day or more in males, which is above Category 2, and at 301 mg/kg/day or more in females (NTP TR164 (1979), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)).
 Therefore, this substance was classified in Category 2 (urinary bladder).
 Besides, the evidence data for the classification in Category 2 (respiratory organs, liver, kidneys) in the previous classification is a study using rabbits, and there is a description that details on this study are unknown in Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), so it was not adopted.
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) Category 2
-
-
H401 P273
P501
 From 48-hour LC50 = 7.8 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)), it was classified in Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 1


Warning
H410 P273
P391
P501
 If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1980)), and 21-day NOEC (reproduction) = 0.075 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)).
 If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1980)), and 96-hour LC50 = 10.2 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)).
 It was classified in Category 1 from the above results.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


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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