GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 106-50-3
Chemical Name p-Phenylenediamine
Substance ID 23B5580
Classification year (FY) FY2011
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) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 solids 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 (ICSC (1997)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - No data 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
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure.
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) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
It was classified in Category 3 from LD50 values of 80 mg/kg and 98 mg/kg for rats (both, DFGMAK-Doc.6 (1994)).
1 Acute toxicity (Dermal) Not classified
-
-
- - Because an LD50 value was judged to be above 5,000 mg/kg from an LDLo value of 5,000 mg/kg for rabbits (IUCLID (2000)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Category 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
It was classified in Category 3 from an LC50 value of 0.92 mg/L/4 hours for rats (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)). Besides, because the LC50 value was above the saturated vapour pressure concentration (0.0291 mg/L), the reference value for dust was applied.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
In a Draize test in which 2.5 or 25% in vaseline, 10% in oil, or a 50% aqueous solution of this substance was applied to rabbits, it was slightly irritant at 2.5% and moderately irritant at 10-50%, reversibility was seen, and the skin irritation index was 1.4-3.4 (BUA 97 (1995)). Therefore, it was classified in Category 2. Besides, in humans, it is reported that the application of 50% ointment of this substance to six volunteers resulted in only slight irritation (DFGMAK-Doc.6 (1994)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
In a Draize test in which this substance was applied to rabbits without dilution, the irritation score (equivalent to AOI) was 17 (maximum 110), and it was assessed as slightly irritant (BUA 97 (1995)), and in another test in which 30 mg was applied to rabbits, redness and edema of the conjunctiva and corneal opacity were observed but disappeared within 7 days, and it was assessed as irritant (BUA 97 (1995)). It was classified in Category 2B based on the above. Besides, it is described that when the hair dyes containing this substance entered the eye in humans, severe reactions occur in the eyeball, lid, and conjunctiva, and in some cases, the corneal epithelium was eroded and accompanied by iritis and iridocyclitis, a vision has been occasionally lost or permanently damaged by severe cornea ulceration (ACGIH (2001)). However, because the components of the hair dyes were not specified, it is unknown how much the relationship to this substance is.
4 Respiratory sensitization Category 1


Danger
H334 P304+P340
P342+P311
P261
P284
P501
There is a report on workers who developed allergic asthma from occupational exposure and showed inflammation of the pharynx by direct irritation, and it is described that very small quantities could cause asthma after 3 months to 10 years of exposure (ACGIH (2001)), and it is described that this substance is a sensitizer of the skin and respiratory tract and may cause asthma (PATTY (5th, 2001)). Based on the above, it was classified in Category 1.
4 Skin sensitization Category 1A


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
It was classified in Category 1A because the Japan Society for Occupational Health (JSOH) classified it in occupational skin sensitizers Group 1 (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2011)). There are multiple test reports that it was sensitizing in both humans and animals, including a report that all animals showed positive reactions in a patch test with 20 guinea pigs (DFGMAK-Doc.6 (1994)) and a report that there was a 100% positive response in a maximization test in humans (ECETOC TR 77 (1999)). Furthermore, this substance was listed as standard allergens by the Japanese Society for Contact Dermatitis this substance (Japanese Standard Allergens (2008), corresponding to List 1) and as contact allergens in Contact Dermatitis (Frosch) (4th, 2006) (Contact Dermatitis (Frosch) (4th, 2006), corresponding to List 1).
5 Germ cell mutagenicity Not classified
-
-
- - It was classified as "Not classified" from a negative result in a dominant lethal test by intraperitoneal administration to rats (in vivo heritable germ cell mutagenicity test) (NTP TR 174 (1979)) and negative results in micronucleus tests with bone marrow cells after oral administration to rats or intraperitoneal administration to mice (in vivo somatic cell mutagenicity tests) (IARC 16 (1978), DFGMAK-Doc.6 (1994)). Besides, as for in vitro tests, an Ames test was positive (IARC 16 (1978)), and a positive result was obtained in a mouse lymphoma test (ACGIH (2001)).
6 Carcinogenicity Classification not possible
-
-
- - It was classified as "Classification not possible" because it was classified in Group 3 by IARC (IARC suppl.7 (1987)) and A4 by ACGIH (ACGIH (2001)). Besides, no tumors were found in an 8-month oral administration test with rats and a 2-year dermal administration (twice a week) test with mice (IARC 16 (1978), DFGMAK-Doc.6 (1994)), and in carcinogenicity tests by 2-year diet administration of the dihydrochloride of this substance to rats or mice, only slightly reduced weight gain was observed in male and female rats and female mice, there were no treatment-related effects on mortality in either animal species of either sex, and none of the statistical tests for any site indicated a significant positive association between administration of the test substance and tumor incidence. As a result, it was concluded that there was no convincing evidence that dietary administration of this substance was carcinogenic in rats or mice (NTP TR 174 (1979)).
7 Reproductive toxicity Classification not possible
-
-
- - It is reported that in a test by oral administration to rats on gestational days 6-15, no increases in malformations or variations were observed in offspring at the dose where reduced weight gain and death were found in parent animals (ACGIH (2001)). However, because there was no information about effects on sexual function and fertility, the classification is not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 1 (heart, muscle, kidney)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
In humans, there are multiple case reports in which after ingesting this substance, dyspnea and edema of the face, neck, tongue or throat occurred, in some cases, increased blood CPK, oliguria, and renal tubular degeneration were seen, and some had rhabdomyolysis, leading to acute renal failure, including fatal cases (DFGMAK-Doc.6 (1994)). On the other hand, after administration of 70 mg/kg bw, corresponding to the guidance values for Category 1, to mice via nasogastric tube, significantly increased blood CPK was seen within 24 hours, and acute rhabdomyolysis and necrosis of microfibers in the skeletal muscles were observed after 24 hours (DFGMAK-Doc.6 (1994)). From the above, based on knowledge in humans and animals, it was classified in Category 1 (heart, muscle, kidney).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, nervous system, kidney), Category 2 (heart, muscle)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
It was classified in Category 1 (liver, nervous system) from a case report, in humans, of a woman who had regularly used commercially available hair dyes containing this substance, showed hepatomegaly and spleen enlargement, and developed progressive neurological symptoms prior to her death 11 weeks after hospital admission (ACGIH (2001)), a case report of a person who died of jaundice and subacute atrophy of the liver after occupational exposure to hair dyes containing this substance over 5 years (ACGIH (2001)), a case report of a person who had used hair dyes containing this substance and showed digestive and neurological symptoms, and a case report in which pathological changes in the central nervous system were observed in a person who had used hair dyes containing this substance for one and a half years (DFGMAK-Doc.6 (1994)). Also, it was classified in Category 1 (kidney) from a case report of a person who had used hair dyes containing this substance and died with chronic kidney failure, uremia, extremely small kidneys, and hyalinized glomeruli (DFGMAK-Doc.6 (1994)), and a case report of a person who used hair dyes containing this substance and developed renal failure, uremia, oliguria, vasculitis, myalgia, enlarged kidneys, and glomerulonephritis and died 3 weeks later (DFGMAK-Doc.6 (1994)). On the other hand, as for animal tests, in a 90-day oral administration test with rabbits, alterations of the myocardial parenchyma (edema, swelling of muscular fibers, cytoplasmic homogenization, disappearance of cross-striation) were found at 10 mg/kg (ACGIH (2001)), and because the dose was within the guidance value range for Category 2, it was classified in Category 2 (heart, muscle). From the above, it was classified in Category 1 (liver, nervous system, kidney), Category 2 (heart, muscle).
10 Aspiration hazard Classification not possible
-
-
- - No data available.

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 1


Warning
H400 P273
P391
P501
It was classified in Category 1 from 96-hour LC50 = 0.066 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001)).
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 (a 4-week degradation rate by BOD: 5% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 21-day NOEC = 0.043 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (a 4-week degradation rate by BOD: 5% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 96-hour LC50 = 0.066 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001)).
From the above results, it was classified in Category 1.
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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