Latest GHS Classification Results by the Japanese Government (edited by NITE)
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 100-63-0 |
| Chemical Name | Phenylhydrazine |
| Substance ID | m-nite-100-63-0_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) | To Workplace Safety Site (MHLW) |
| Sample SDS by MHLW (External link) | To Workplace Safety Site (MHLW) |
| OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
| 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 |
- |
- | - | There is a chemical group associated with explosive properties (neighboring nitrogen atoms) present in the molecule. However, because it is classified in Division 6.1 (UN2572) in UNRTDG, it does not correspond to hazards of the highest precedence, explosives. | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Vapour pressure is 148.2 mmHg (about 19.8 kPa) at 40 deg C and 158.7 mmHg (about 21.2 kPa) at 60 deg C (Lange (2005)) and below 300 kPa at 50 deg C. Besides, because information of colorless liquid was obtained (Incompatible Hazard Handbook of Chemicals (1997)), it is not completely gaseous, and a melting point of 19.5 deg C (Lange (2005)) is below 20 deg C, it is a liquid (GHS definition). | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 6 | Flammable liquids | Category 4 |
Warning |
H227 | P370+P378 P210 P280 P403 P501 |
A flash point is 88 deg C (closed cup) (HSDB (Accessed Jun. 2018)). | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 8 | Self-reactive substances and mixtures | Not classified |
- |
- | - | There is a chemical group associated with explosive properties (neighboring nitrogen atoms) present in the molecule. However, because it is classified in Division 6.1 (UN2572) in UNRTDG, it does not correspond to hazards of the highest precedence, self-reactive substances and mixtures. | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 173 deg C (HSDB (Accessed Jun. 2018)). | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 10 | Pyrophoric solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not available. | FY2018 | 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) |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine. | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 17 | Desensitized explosives | - |
- |
- | - | - | - | - |
| 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) | Category 3 |
 Danger |
H301 | P301+P310 P264 P270 P321 P330 P405 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 3. [Evidence Data] (1) LD50 value for rats: 188 mg/kg (ACGIH (7th, 2001), PATTY (6th, 2012), NICNAS IMAP (Accessed Jun. 2018), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)) |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Dermal) | Category 2 |
Danger |
H310 | P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) LD50 value for rabbits: 90 mg/kg (PATTY (6th, 2012), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)) |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | [Rationale for the Classification] Liquid (GHS definition) |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. Besides, in both (1) and (2), this substance is considered to be in the mist state since each LC50 value exceeds the saturated vapor pressure (98.7 ppm), but none of them can be used for classification because there is no description of exposure time in any case. [Reference Data, etc.] (1) LC50 value for rats: 2.745 mg/L (610 ppm) (CICAD 19 (2000)) (2) LC50 value for mice: 2.093 mg/L (465 ppm) (CICAD 19 (2000)) |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 2 | Skin corrosion/irritation | Category 2 |
 Warning |
H315 | P302+P352 P332+P313 P362+P364 P264 P280 P321 |
[Rationale for the Classification] According to (1)-(4), many findings show irritation, and it was classified in Category 2. [Evidence Data] (1) There is a report that superficial erythema and bullous-papular were observed at the contact area (arm) of workers accidentally exposed to phenylhydrazine hydrochloride powder (CICAD 19 (2000), NICNAS IMAP (Accessed Jun. 2018)). (2) There is a report that plural burns and small blisters were observed at the contact area (hands or feet through the gloves or shoes) of workers accidentally exposed to phenylhydrazine hydrochloride powder (CICAD 19 (2000), NICNAS IMAP (Accessed Jun. 2018)). (3) There is information that there are plural reports of irritation in humans (DFGOT vol.11 (1998)). (4) There are reports that in animal test data with rabbits and rats, skin irritation occurred at high frequency, and necrosis and sloughing were observed in some animals (Fundam Appl Toxicol. 1987, 8(4), 583-94). [Reference Data, etc.] (5) The Ministry of Health, Labour and Welfare concluded that this substance shows irritation/corrosion (Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)). (6) This substance was classified as "Skin Irrit. 2" by EU CLP. |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. Besides, since no information to enable subcategorization is obtained, the category was changed from the previous classification. [Evidence Data] (1) There is a report that in an eye irritation test with rabbits, in which this substance was applied, severe suppurative conjunctivitis was observed (CICAD 19 (2000)). (2) There is information that phenylhydrazine and in particular, its hydrochloride salt are irritating to the eyes (DFGOT vol.11 (1998)). [Reference Data, etc.] (3) The Ministry of Health, Labour and Welfare concluded that there is no serious eye damage/eye irritation from this substance (Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)). (4) This substance was classified as "Eye Irrit. 2" by EU CLP. |
FY2018 | 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. Besides, although there is also information suggesting respiratory sensitisation (1), it was not used to judge the classification because the details were unknown. [Reference Data, etc.] (1) There is a report that as soon as entering a room with this substance in use, recurrence of allergic symptoms due to respiratory provocation were observed (DFGOT vol. 11 (1998)). |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] Based on (1)-(5), it was classified in Category 1. [Evidence Data] (1) There is a report that skin sensitization from this substance has been demonstrated by clinical symptoms and disease coursing in chemical industry workers, laboratory technicians, students and chemists (DFGOT vol.11 (1998)). (2) There is a report that when a patch test with phenylhydrazine crystals was applied on the arms of one subject marked erythema and edema occurred at the application site after 18 hours, blisters formed after 30 hours, and crusts were formed after 54 hours (CICAD 19 (2000)). (3) There is a report that hypersensitivity reactions were observed after the application of solid or aqueous solutions of phenylhydrazine and its salts to the skin (CICAD 19 (2000)). (4) There is a report of a so-called cross-sensitization that the subjects who have already been sensitized to hydrazine which is a known skin sensitizer are also sensitized to hydrazine derivatives including this substance (CICAD 19 (2000)). (5) There is a report that in a skin sensitization test with guinea pigs, sensitization was induced in 7/8 animals, and reactions, moderate to strong in 2/7 animals and weak to moderate in 5/7 animals were observed (DFGOT vol. 11 (1998), Br J Ind Med. 1967, 24 (3), 189-202). [Reference Data, etc.] (6) The Ministry of Health, Labour and Welfare concluded that this substance shows skin sensitizing (Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)). (7) This substance was classified as "Skin Sens. 1" by EU CLP. |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Base on (1), (2), it was classified in Category 2. [Evidence Data] (1) As for in vivo, there are reports that it was positive in a chromosomal aberration test and a micronucleus test with mouse bone marrow, positive in a micronucleus test with mouse peripheral blood erythrocytes, positive in alkaline elution tests with mouse liver and lung, and positive in a DNA adduct test with rat liver (ACGIH (7th, 2001), PATTY (6th, 2012), DFGOT vol. 11 (1998), CICAD 19 (2000), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013), NICNAS IMAP (Accessed Jun. 2018)). (2) As for in vitro, there are reports of being positive among bacterial reverse mutation tests, chromosomal aberration tests, micronucleus tests, gene mutation tests with cultured mammalian cells, and unscheduled DNA synthesis tests with rodent primary hepatocytes (ACGIH (7th, 2001), PATTY (6th, 2012), DFGOT vol. 11 (1998), CICAD 19 (2000), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)) [Reference Data, etc.] (3) In results of mutagenicity tests by the Ministry of Health, Labour and Welfare (a bacterial reverse mutation test, a chromosome aberration test with cultured mammalian cells), this substance was recognized to show strong mutagenicity (Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law (Accessed Jun. 2018)), and specified as a target substance in "Guidelines for Preventing Health Impairment by Chemical Substances with Mutagenicity Recognized" (Workplace Safety Site (Ministry of Health, Labour and Welfare, Accessed Jun. 2018)). |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] As for carcinogenicity, there are no available reports on humans. Based on (1) and (2), evidence of carcinogenicity in this substance is limited to one species, but neoplastic lesions including malignant tumors were observed in plural studies, and effects were observed in males and females in one study. Also, based on the result. From EU classification, Category 1B was judged to be reasonable. Besides, the Ministry of Health, Labour and Welfare also concluded that this chemical is "Presumed to have carcinogenic potential for humans" (Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)). [Evidence Data] (1) Increases in the incidence of malignant tumors and total tumors in the lungs were observed after oral administration of 1 mg/animal/day (equivalent to 50 mg/kg/day) to mice for 42 weeks (CICAD 19 (2000), ACGIH (7th, 2001), DFGOT vol. 11 (1998), PATTY (6th, 2012), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)). (2) In a study in which the hydrochloride of this substance was administered by drinking water to mice at a concentration of 100 ppm throughout the life, an increased incidence of vascular tumors (hemangioma, hemangiosarcoma) was observed in both sexes (ACGIH (7th, 2001), DFGOT vol. 11 (1998), PATTY (6th, 2012), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)). (3) As for classification results by domestic and international organizations, it was classified in A3 by ACGIH (ACGIH (7th, 2001)) and Carc. 1B by EU CLP. [Reference Data, etc.] (4) In a test in which mice were dosed orally at 0.5 mg for the first 5 weeks and then 0.25 mg, for a total of 40 weeks (5 days/week), no significant neoplastic effects were observed. Since this test caused marked anemia, the test could not be conducted with administration of high doses (ACGIH (7th, 2001), PATTY (6th, 2012), DFGOT vol.11 (1998)). |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In a test with rats of gestational days, 17–19 by intraperitoneal administration at 7.5 mg/kg/day, the fetal mortality increased, but effects on the parental animals are unknown (NICNAS IMAP (Accessed Jun. 2018)). (2) In a test with rats of gestational day, 18-19 by intraperitoneal administration at 15 mg/kg/day, fetal mortality increased, but effects on the parental animals are unknown (NICNAS IMAP (Accessed Jun. 2018)). |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (blood system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (haemal system). According to (4), although by not single exposure, among the target organ toxicity assumed from acute effects in dogs, effects on the liver, kidney and spleen are considered to be secondary effects due to hemolytic anemia. In addition, the possibility is considered that effects on the testes were non-specific findings reflecting the deterioration of general conditions due to severe toxicity. Therefore, none of these were adopted as a target organ. [Evidence Data] (1) The main effect of this substance on acute intoxication in humans is methemoglobinemia (DFGOT vol. 11 (1998)). (2) There is a case report that systemic symptoms such as hemolytic jaundice due to erythrocyte destruction were observed despite skin washing after dermal exposure to liquefied phenylhydrazine in humans (Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)). [Reference Data, etc.] (3) There is a description that although the animal species and doses are not known, the acute effects of this substance are neurologic toxicity, cyanosis, hypothermia, hematuria, vomiting, convulsions, and degenerative changes of the liver and kidney (ACGIH (7th, 2001)). (4) There is a report that as a result of a 2-day subcutaneous administration of 20-40 mg/kg to dogs, hemolytic anemia, Heinz bodies in the erythrocytes, hematuria, methemoglobinemia, splenomegaly, hepatic and renal hypertrophy with hemoglobin-filled convoluted tubules, and reduced spermatogenesis were observed (ACGIH (7th, 2001), PATTY (6th, 2012), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2013)). |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (blood system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1 (haemal system). Besides, as for (4) and (5), it cannot be used for classification because the exposure time and duration are unknown. [Evidence Data] (1) There are multiple cases that haemolytic anaemia due to occupational exposure via the dermal and inhalation route was observed (ACGIH (7th, 2001), PATTY (6th, 2012)). (2) There is a report that after oral administration of the hydrochloride of this substance at a dose of 30 mg/day (0.4 mg/kg) to volunteers for 8 days, haemolysis of transfused erythrocytes occurred at a level of 0-10% (DFGOT vol. 11 (1998)). (3) There is a report that jaundice, anaemia and edema were observed as side effects during oral administration of this substance at a dose of 100 mg/day for the treatment of polycythemia (DFGOT vol. 11 (1998)). [Reference Data, etc.] (4) There is a report that slight changes in haematological parameters were observed after inhalation exposure at a concentration of 1.5 mg/m3 to rats for 3-4 months (DFGOT vol. 11 (1998)). (5) There are reports that haematotoxic effects were observed after inhalation exposure to 21 mg/m3 to rats for 6 months, and that in a short-term exposure (exposure period unknown) to 210 mg/m3, mortality increased, and degenerative changes to the liver, spleen and brain were observed in addition to haematotoxic effects (DFGOT vol. 11 (1998)). |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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) | Category 1 |
 Warning |
H400 | P273 P391 P501 |
It was classified in Category 1 from 48-hour EC50 (immobile) = 0.016 mg/L for crustacea (Daphnia magna), and 96-hour LC50 = 0.016 mg/L for fish (Oryzias latipes) (both Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2018)). | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Category 1 |
Warning |
H410 | P273 P391 P501 |
Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable, and it is classified in Category 1 in acute toxicity. | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. | FY2018 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
NOTE:
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