GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 100-63-0
Chemical Name Phenylhydrazine
Substance ID H30-B-004-MHLW, MOE
Classification year (FY) FY2018
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 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.
2 Flammable gases (including chemically unstable gases) 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).
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Liquid (GHS definition)
6 Flammable liquids Category 4
-
Warning
H227 P370+P378
P403+P235
P210
P280
P501
A flash point is 88 deg C (closed cup) (HSDB (Accessed Jun. 2018)).
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
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.
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)).
10 Pyrophoric solids Not applicable
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid 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
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine.
14 Oxidizing solids Not applicable
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No data 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
[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))
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))
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - [Rationale for the Classification]
Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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))
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.
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.
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)).
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.
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)).
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)).
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)).
8 Specific target organ toxicity - Single exposure Category 1 (haemal 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)).
9 Specific target organ toxicity - Repeated exposure Category 1 (haemal 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)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
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 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)).
11 Hazardous to the aquatic environment (Long-term) 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.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


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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