GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 624-18-0 |
| Chemical name | p-Phenylenediamine dihydrochloride |
| Substance ID | 23A5115 |
| Fiscal year of classification conducted | FY2011 |
| Classifier(s) (Ministries) | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| New/Revised | New |
| Download in Excel format | Excel file |
| Item | Information |
|---|---|
| Guidance used for classification (External link) |
Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government （July, 2010）
Environmental Hazards: UN GHS Document （4th revised edition） |
| 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 |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
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 | - | - | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Classification not possible | - | - | - | No data. |
| 8 | Self-reactive substances and mixtures | Not applicable | - | - | - | Containing neither chemical groups related to explosibility nor those related to self-reactivity. |
| 9 | Pyrophoric liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Classification not possible | - | - | - | No data. |
| 11 | Self-heating substances and mixtures | Classification not possible | - | - | - | No data. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - | Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Not applicable | - | - | - | It is conceivable that an organic compound containing chlorine which is ionically bonded to amine does not contribute to oxidizing other substances. |
| 15 | Organic peroxides | Not applicable | - | - | - | An organic compound that does not contain -O-O- structure. |
| 16 | Corrosive to metals | Classification not possible | - | - | - | No established test method suitable for solid substances. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 3 |  |
H301 |
P301+P310 P264 P270 P321 P330 P405 P501 |
On the basis of an LD50 value of 147 mg/kg for rats (BUA 97 (1992)), it was classified in Category 3. Besides, it is classified in T; R25 in EU classification (EC-JRC (ESIS) (Access on July. 2011)). Refer to health hazards of p-phenylenediamine (CAS: 106-50-3) that is a free body of this substance. |
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - |
No data. Besides, it is classified in T; R24 in EU classification (EC-JRC (ESIS) (Access on July. 2011)). |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - |
No data. Besides, it is classified in T; R23 in EU classification (EC-JRC (ESIS) (Access on July. 2011)). |
| 2 | Skin corrosion/irritation | Classification not possible | - | - | - | No data. |
| 3 | Serious eye damage/eye irritation | Classification not possible | - | - | - |
No data. Besides, it is classified in Xi; R36 in EU classification (EC-JRC (ESIS) (Access on July. 2011)). |
| 4 | Respiratory sensitization | Category 1 |  |
H334 |
P304+P341 P342+P311 P261 P285 P501 |
From the information about p-phenylenediamine which is a free body of this substance, it was classified in Category 1. The information is as follows: p-Phenylenediamine-exposed workmen who suffered from an "allergic asthma" and frequently show inflammatory reactions of the larynx and pharynx, evidently caused by direct irritation. It was further observed that very small quantities of p-phenylenediamine could cause asthma in persons after 3 months to 10 yeas exposure. (ACGIH (2001)) p-PDA is a potent sensitizer of the skin and respiratory tract and may cause asthma. (PATTY (5th, 2001)) |
| 4 | Skin sensitization | Category 1A |  |
H317 |
P302+P352 P333+P313 P261 P272 P280 P321 P363 P501 |
Taking the information about p-phenylenediamine hydrochloride into consideration, it was classified in Category 1A. The information that is taken into consideration is as follows: All animals showed positive reactions in a guinea pig Buehler test. (Chemical Substance Hazard Data, 2001-31 (2002), CERI,; List 3), This substance is classified in R43 in EU classification. (EC-JRC (ESIS) (Access on July. 2011)), p-Phenylenediamine that is a free body of this substance is classified as a sensitizing substance "skin; Group 1" in Japan Society for Occupational Health (The Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2010)), and it is classified as "skin sens" in ACGIH. (ACGIH-TLV (2011)) |
| 5 | Germ cell mutagenicity | Not classified | - | - | - |
This substance has no in vivo test data. But p-Phenylenediamine, a free body, shows that a dominant lethal study in rats following intraperitoneal administration (in vivo heritable germ cell mutagenicity test) was negative (NTP TR 174 (1979)) and micronucleus test using bone marrow cells after oral administration to rats and intraperitoneal administration to mice (in vivo somatic cell mutagenicity test) were negatives (IARC 16 (1978), therefore, it was classified as "Not classified." Besides, in vitro tests of this substance report that all of an Ames test, chromosome aberration test using Chinese hamster ovary cells, and a mouse lymphoma test are positives (NTP DB (Access on July. 2011)). |
| 6 | Carcinogenicity | Classification not possible | - | - | - |
p-Phenylenediamine, a free body of this substance, is classified in Group 3 in IARC (IARC suppl.7 (1987)) and in A4 in ACGIH (ACGIH (2001)), therefore, it was classified as "Classification not possible." Besides, a 2-year carcinogenicity test by diet administration of this substance in rats and mice reports only slight decreased weight gains in male and female rats and female mice, no dose-related effects on mortality in both species of either sex, and no statistically significant associations between dosing of test substance and tumor incidence in any organs, and consequently concluded that diet administration of this substance found no convincing carcinogenic evidence in rats and mice (NTP TR 174 (1979)). On the other hand, ACGIH reports that some epidemiologic studies for humans with occupational exposures and users of hair dyes indicated relevance to carcinogenicity, but it is difficult to evaluate the weight of evidence for p-phenylenediamine because ingredients were not distinguished (ACGIH (2001)). |
| 7 | Reproductive toxicity | Classification not possible | - | - | - |
No data. Besides, ACGIH reports that p-phenylenediamine, a free body of this substance, did not increase malformation or developmental variations in fetuses at a dose where parent animals showed general toxicity by oral administration to pregnant rats during an organogenetic period (ACGIH (2001)). |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (heart, muscle, kidney) | |
H370 |
P307+P311 P260 P264 P270 P321 P405 P501 |
Multiple cases including fatal cases in humans reported that ingesting p-phenylenediamine, a free body of this substance, causes dyspnea followed by edema on face, neck, tongue or pharynx, and in some cases increased blood CPK, oliguria, and degeneration of renal tubule, and developed rhabdomyolysis, and finally acute renal failure (DFGMAK-Doc.6 (1994)). Mice which were given a p-phenylenediamine dose of 70 mg/kg bw by nasogastric tube showed a significant increase in blood CPK within 24 hours and acute rhabdomyolysis and necrosis of microfibers in skeletal muscles after 24 hours (DFGMAK-Doc.6 (1994)). From the above knowledge in humans and animals, it is classified in Category 1 (heart, muscle, kidney). |
| 9 | Specific target organ toxicity - Repeated exposure |
Category 1 (liver, nervous system, kidney), Category 2 (heart, muscle) |
|
H372 H373 |
P260 P264 P270 P314 P501 |
From the reports of cases in human who used hair dyes containing p-phenylenediamine which is a free body of this substance, it was classified in Category 1 (liver, nervous system, kidney). The cases are as follows: A patient who showed hepatomegaly and spleen enlargement, and progressive neuropathy. (ACGIH (2001)) A patient who died of jaundice and subacute atrophy of the liver after 5-year occupational exposure. (ACGIH (2001)) A patient who showed symptoms in digestive organs and nervous, and a patient who showed pathological changes in the central nervous system. (DFGMAK-Doc.6 (1994)) A dead case with chronic renal failure, uremia, extremely small kidneys, and hyalinized glomeruli. (DFGMAK-Doc.6 (1994)) A dead case with oliguria, vasculitis, myalgia, enlarged kidneys, and glomerulonephritis. (DFGMAK-Doc.6 (1994)) Furthermore, an animal test, in which rabbits were orally administrated p-phenylenediamine for 90 days, showed alterations of myocardial parenchyma (edema, swelling of muscular fibers, cytoplasmic homogenization, and disappearance of cross striation) at a dose of 10 mg/kg (ACGIH (2001)) which corresponds to Category 2 in guidance values even assuming that it is dihydrochloride, therefore, it was classified in Category 2 (heart, muscle). From the above, it is classified in Category 1 (liver, nervous system, kidney) and Category 2 (heart, muscle). |
| 10 | Aspiration hazard | Classification not possible | - | - | - | No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Classification not possible | - | - | - | No data. |
| 11 | Hazardous to the aquatic environment （Long-term） | Classification not possible | - | - | - | No data. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - | This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* 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. |
Updated date:
|
2016/8/17 Addition of Rationale for the classification |