GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 87-66-1
Chemical Name Pyrogallol
Substance ID H29-B-026
Classification year (FY) FY2017
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 FY2007  
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)  
Model SDS by MHLW (External link)  
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
-
-
- - It is described that it is combustible (ICSC (J) (1999)), but the classification is not possible due to no data.
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 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 Not applicable
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
Based on reports of LD50 values for rats of 800 mg/kg (female) (PATTY (6th, 2012)) and 1,270 mg/kg (male) (PATTY (6th, 2012)), it was classified in Category 4.
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on a report of an LD50 value of > 2,100 mg/kg (PATTY (6th, 2012)) for rats, it was classified as "Not classified." Besides, since the information in HSDB (2003) used in the previous classification is not described in the current HSDB (Access on June 2017) and cannot be confirmed, it was not adopted. The category was changed from the previous classification according to 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 Not classified
-
-
- - Based on multiple reports that it is slightly irritating to the skin in humans (HSDB (Access on June 2017)) and on reports that the primary irritation index was 0.5 in a skin irritation test with rabbits, and that it was slightly irritating in a skin irritation test with guinea pigs (HSDB (Access on June 2017), J. Am. Coll. Toxicol., 10 (1), 67-85 (1991)), it was classified as "Not classified" (Category 3 in UN GHS classification).
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
There are reports that it is irritating to the human eyes (HSDB (Access on June 2017)), and that in an eye irritation test with rabbits, irritation was observed when the powder of this substance was applied (PATTY (6th, 2012), J. Am. Coll. Toxicol., 10 (1), 67-85 (1991)). Based on these, it was classified in Category 2.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - There are multiple descriptions that this substance shows sensitization in humans (HSDB (Access on June 2017), J. Am. Coll. Toxicol., 10 (1), 67-85 (1991)). On the other hand, there is a report that it was not sensitizing (J. Am. Coll. Toxicol., 10 (1), 67-85 (1991)), and there is a report that results differed depending on the tests (PATTY (6th, 2012)). Therefore, it was classified as "Classification not possible."
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, micronucleus tests with bone marrow cells and peripheral blood of mice were negative (NTP DB (Access on June 2017), NTP TR574 (2013)) and positive (Review of Toxicological Literature (1998)) results, however, neither dose dependency nor reproducibility was observed in the positive results. As for in vitro, bacterial reverse mutation tests were positive (NTP DB (Access on June 2017), NTP TR574 (2013)). From the above, it was classified as "Classification not possible" according to the GHS classification guidance for the Japanese government.
Besides, descriptions of positive results (HSDB (2003)) in micronucleus tests with mouse bone marrow cells, which were used for Category 2 in the previous classification, could not be confirmed in the current HSDB (Access on June 2017).
6 Carcinogenicity Classification not possible
-
-
- - In carcinogenicity studies in which it was dermally applied (vehicle: 95% ethanol) to rats and mice for 2 years, in rats, only hyperplasia was observed on the skin at the site of application in both sexes, a neoplastic change was not observed, and it was concluded that there is no evidence of carcinogenicity in both sexes (NTP TR574 (2013)). On the other hand, in mice, it was concluded that there is equivocal evidence of carcinogenicity on the basis that squamous cell papilloma of the skin at the site of application was observed in 2/50 in the high dose group (75 mg/kg/day) in males, and that there is some evidence of carcinogenicity on the basis that the squamous cell carcinoma of the skin at the site of application was observed in the high dose group (75 mg/kg/day) in females (NTP TR574 (2013)). Other than these, it is described that in tests where it was dermally applied to mice or rabbits for a lifetime, no skin tumors were observed in either animal species (PATTY (6th, 2012)). From the above, from the conclusion in NTP that there are many results that the carcinogenicity of this substance is negative in animal experiments, but that there is some evidence of carcinogenicity in dermal application to female mice, it was classified as "Classification not possible" not "Not classified."
7 Reproductive toxicity Classification not possible
-
-
- - In a developmental toxicity test with pregnant rats dosed by gavage (vehicle: propylene glycol) during organogenesis period (gestational day 6-15), only slight effects on fetuses (a low value in body weight and a slight increase in the number of fetal resorptions) were observed at the high dose (300 mg/kg/day) where reduced body weight gain was observed in maternal animals (PATTY (6th, 2012), (confirmed in original literature) Picciano, J.C. et al. (1983): J. Am. Col. Toxicol., 2 (4), 325-333), therefore, it is not a sufficient finding based on which a category is assigned. In addition, there is no information on this substance on fertility and sexual function, therefore, classification was not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system), Category 3 (respiratory tract irritation)



Danger
Warning
H370
H335
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
Two cases of poisoning by ingestion of 8 g or 15 g of this substance are reported in humans. It was reported that the former recovered but the latter died, and the intoxication symptoms were vomiting, hypothermia, tremors, muscular incoordination, loss of reflexes, coma, and asphyxia (PATTY (6th, 2012)). In addition, there is a report that this substance is irritating to the nose and throat and causes cough and dyspnea (HSDB (Access on June 2017)). As for experimental animals, there is a report that in a single oral dose test with rats, cyanosis, reduced activity, reduced muscle tone, tremors, ataxia, lacrimation, salivation, piloerection, decreased body surface temperature, hunched posture, pale extremities, in addition, as necropsy findings, darkening and hypertrophy of the spleen, darkening of the kidneys, and browning or paleness of the liver and lungs were observed (PATTY (6th, 2012)). Although there is no detailed description of the doses where these symptoms were observed, they are considered to be around an LD50 value of 800-1,270 mg/kg within the range for Category 2. By summarizing the above information, it is considered that the target organ of this substance is a central nervous system, and it is irritating to the respiratory tract. Therefore, it was classified in Category 1 (central nervous system), Category 3 (respiratory tract irritation).
Besides, based on the description in HSDB (2003) that this substance may cause irritation to the digestive system, damage of the kidney and liver, hemolysis, convulsions and circulatory collapse in humans, the gastrointestinal system, circulatory organ system, kidney, liver, and haemal system were also adopted as target organs in addition to the central nervous system in the previous classification. However, the effects on the circulatory organ system may be secondary effects associated with those on the central nervous system, and the effects on the gastrointestinal system are thought to be due to irritation from this substance. Moreover, as for the effects on the kidney, liver, and haemal system, since the information described in HSDB (Access on June 2017) is unknown in detail and insufficient as evidence, and there is no other information available for the evidence, these organs were also excluded from the target organ. Therefore, the classification result was changed from the previous one.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
Besides, as for experimental animals, 14-week and 2-year repeated toxicity tests with rats and mice dermally dosed were conducted. In all tests, findings due to irritation (hyperplasia, hyperkeratosis, inflammation etc. of the skin of the application site) were observed on the skin of the application site from within the guidance value range for Category 2 in the 14-week tests, and from within the guidance value range for Category 1 in the 2-year tests. However, other findings related to the target organs were not observed (NTP TR574 (2013)).
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) Classification not possible
-
-
- - No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - No data available.
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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