NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	120-80-9
Chemical Name	Catechol; Pyrocatechol
Substance ID	24B6516
Classification year (FY)	FY2012
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 and 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	- -	-	-	There is the information that it is combustible (ICSC (J) (1997)), but the classification is not possible due to no data in the prescribed test method.
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 510 deg C (HSDB (2009)).
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.
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 based on LD50 values for rats of 260 mg/kg (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)) and 300 mg/kg (SIDS (Access on Apr. 2012)).
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	Both an LD50 value of 600 mg/kg for rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) and an LD50 value of 800 mg/kg for rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) correspond to Category 3.
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)	Classification not possible	- -	-	-	There were no deaths after 8-hour exposure of rats to a concentration of 1.5 mg/L (converted 4-hour equivalent value: 3.0 mg/L) (ACGIH (2001)), which means LC0 > 3.0 mg/L/4 hours. However, because the category cannot be determined, the classification is not possible. Besides, because the test concentration (1.5 mg/L) was higher than the saturated vapour pressure concentration (0.13 mg/L), it was regarded as a test on dust.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In a primary skin irritation test (US Federal Register (1961)) by 24-hour occlusive application of 0.5 g of this substance to (six) rabbits, moderate erythema and slight edema were seen in all animals after 24 hours, but the signs were diminished after 72 hours and disappeared after 14 days, and it was assessed as moderate irritation (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). Therefore, it was classified in Category 2.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In a primary eye irritation test (US Federal Register (1961)) in which 0.1 g of this substance was applied to six rabbits, moderate erythema and edema in the conjunctiva, secretion of exudate, and corneal opacity were observed immediately after the application, and conjunctival congestion, lid closure, marked secretion of exudate, iritis, and severe corneal opacity were seen after 24 hours. There was no recovery after 48, 72 hours, corneal pannus formation and keratoconus were found in all animals after 14 days, and it was judged as a severe irritant (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). Based on the judgment and the fact that corneal pannus formation and keratoconus after 14 days were irreversible signs, it was classified in Category 1.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	It is reported that an 18-year-old woman who used a permanent hair dye cream developed acute contact dermatitis around the eyes, and after its disappearance, she was patch tested with cream components, using ICDRG (International Contact Dermatitis Research Group) criteria and showed a positive reaction to this substance, which was proven to be a causal substance for allergic contact dermatitis (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). Furthermore, it is reported that a 33-year-old woman who had worked as a technician of radiography and photographic development for 10 years developed dermatitis in her hands two years after the start of the work, keratinization of the squamous epithelium with itchiness was observed, and a moderate positive reaction to this substance, which was a component of a developer, was seen in a patch test, using ICDRG criteria (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). From the above, because case reports indicating that this substance caused allergic contact dermatitis came from two different facilities, it was classified in Category 1. Besides, in animal tests, positive results were reported in both two kinds of skin sensitization tests with guinea pigs (Freund's Complete Adjuvant Test and Split Adjuvant Test), although they were not the test methods approved by OECD (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)).
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 2 based on positive results in micronucleus tests with bone marrow cells after oral or intraperitoneal administration to mice (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). There are reports on negative results in other micronucleus tests by oral or intraperitoneal administration to mice (NTP DB (1994), Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)) and both negative and positive results in genotoxicity tests by oral administration to rats (DNA synthesis, cleavage, and repair tests) (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). On the other hand, as for in vitro tests, it is reported that Ames tests were mostly negative, and a gene mutation test, a chromosomal aberration test, and a micronucleus test with cultured mammalian cells gave positive results (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	As assessment for carcinogenicity, it was classified in Group 2B by IARC (IARC 71 (1999)), A3 by ACGIH (ACGIH (2001)), and Group 2B by Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2011)). Therefore, it was classified in Category 2. Besides, it is reported that in carcinogenicity tests by about 2-year diet administration to mice and rats, no increase in the incidence of malignant tumors was observed in mice, but this substance induced adenocarcinoma in the glandular stomach in several strains in rats (IARC 71 (1999)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a test by oral administration to rats on a gestational day 11, maternal animals showed reduced weight gain and a dose-dependent increase in deaths, the number of pups decreased by postnatal day 6, and a ratio of live births having paralyzed hindlimbs, short or kinked tails increased dose-dependently (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). Therefore, it was classified in Category 2.
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	As information in humans, it is described that short-term exposure to this substance affects the central nervous system, causing depression, convulsions, and respiratory failure (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)). And it is described that effects on the central nervous system (convulsions, etc.) by dermal absorption are severer than those by phenol (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). Based on the above knowledge, it was classified in Category 1 (central nervous system). And it is described that short-term exposure to this substance is irritating to the respiratory tract (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), and inhalation leads to burning sensation to the throat and lung, followed by marked tachypnea (PATTY (5th, 2001)). Therefore, it was classified in Category 3 (respiratory tract irritation). Besides, in animal tests, it is reported that continuous shiver was observed after inhalation exposure of rats to 2.0 mg/L or above (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)), and in a dermal application test with rats, marked shiver occurred five minutes after the application at or above 875 mg/kg (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Effects observed after 104-week diet administration to rats were hyperplasia of the gastric pyloric gland and cystic enlargement or dilatation of lymph nodes around the stomach at or above 0.1% (33 mg/kg/day), thickening of the gastric pylorus at or above 0.2%, and hyperplasia of the squamous epithelium in the forestomach at or above 0.4% (Initial Risk Assessment Report Ver.1.0 No.145 (NITE, CERI, NEDO, 2008)). And in a test by 13-week oral administration of 150-300 mg/kg/day to rats and mice, hyperplasia and squamous papillomas in the forestomach were seen (ACGIH (2001)), but there are no reports on adverse effects on organs other than the stomach. Due to its irritating/corrosive property, this substance produced local effects in the digestive system after oral administration, and was carcinogenic to the stomach in rats, and made preneoplastic lesions. Therefore, it was classified as "Classification not possible" for this hazard class by not using the above results. Besides, as information in humans, it is described that 30 workers exposed to this substance and phenol complained of sore throat, cough, and eye irritation, especially many skin disorders, and examination revealed no decreased function in the hematopoietic system, liver, and kidney, and no anomalies in urine test (IUCLID (2000)). And kidney effects were suggested from the description of degenerative lesions in the renal tubules (PATTY (4th, 1999)), but the details are unknown.
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 2	- -	H401	P273 P501	It was classified in Category 2 from 24-hour EC50 = 1.66 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. Despite 24-hour EC50 = 1.66 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)), due to being rapidly degradable (readily biodegradable (a 2-week degradation rate by BOD: 83%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1979)), and a low bioaccumulation estimate (log Kow = 0.88 (PHYSPROP Database, 2009)), it is classified as "Not classified." From the above results, it was classified as "Not classified."
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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