NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	95-65-8
Chemical Name	3,4-xylenol; 3,4-Dimethylphenol
Substance ID	m-nite-95-65-8_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)

PHYSICAL HAZARDS

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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is a flammable solid, and a flash point is 80-95 deg C for a liquid after melting (Hommel (1991)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 500 deg C (GESTIS (Access on July 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2019	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). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."	FY2019	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. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	Not classified	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

HEALTH HAZARDS

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 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 727-1,600 mg/kg (NICNAS IMAP (Access on August 2019)) [Reference Data, etc.] (2) LD50 for mice: 400 mg/kg (HSDB (Access on June 2019)) (3) LD50 for rabbits: 800 mg/kg (HSDB (Access on June 2019))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	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] Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	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.	FY2019	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.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1. Besides, since new data was obtained, the category was changed. [Evidence Data] (1) A study in guinea pigs reported this substance at doses of 0.25-1 mg/kg, to be severely irritating to the skin, with moderate edema developing within 24 hours, in addition to necrosis and eschar formation (NICNAS IMAP (Access on August 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1. Besides, since new data were obtained, the category was changed. [Evidence Data] (1) In an eye irritation test in which several dry crystals of this substance were applied to one rabbit, slight to moderate erythema, edema and corneal opacity were found after 1 hour, and some remaining effects were observed after 14 days (ACGIH (7th, 2019)). (2) Eye irritation studies with rabbits report permanent damage following administration of this chemical (NICNAS IMAP (Access on August 2019)) (3) This substance was classified as Skin Corrosion (Category 1).	FY2019	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.	FY2019	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), it was classified in Category 1. Besides, since new data was obtained, the category was changed. [Evidence Data] (1) It is reported that a mouse local lymph node assay showed an SI value of 10, and this substance was positive for skin sensitization (ACGIH (7th, 2019)). [Reference Data, etc.] (2) For all dimethylphenol isomers, including this substance, and mixtures thereof, ACGIH classified them as skin sensitizers (DSEN) (ACGIH (7th, 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, it is reported to be negative in a bacterial reverse mutation test (ACGIH (7th, 2019), NICNAS IMAP (Access on August 2019), NTP DB (Access on June 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on classification results by other organizations in (1) and the report of (2), it was classified in Category 2. Since new data were obtained, the category was changed from the previous classification. [Evidence Data] (1) In the classification results by domestic and international organizations, it was classified in A3 by ACGIH (ACGIH (7th, 2019)). (2) In a test in which this substance was dermally applied to mice for 28 weeks, it is reported to be carcinogenic to the skin (ACGIH (7th, 2019)).	FY2019	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 combined oral repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats by oral gavage of a mixture of six dimethylphenol (xylenol) isomers, including this substance, although increases in relative weights of the kidney, liver and ovaries were observed as general toxicity, no apparent reproductive effects were observed (ACGIH (7th, 2019), NICNAS IMAP (Access on August 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) There is one case report of an individual who ingested 250 mL of a disinfectant product that was reported as a mixture of six isomeric dimethylphenols (xylenol) including this substance, in an alcoholic, anionic base. The individual exhibited gastrointestinal effects (active bowel sounds, nausea and vomiting) and central nervous system depression (barely rousable) that progressed to metabolic acidosis and heart and cardiovascular changes (hypotension with reduced cardiac output), and then death about 16 hours following the ingestion. The lethal dosage of dimethylphenol (xylenol) ingestion in this case report was not reported (ACGIH (7th, 2019)). (2) In experimental animals, it is reported that sublethal signs of toxicity for xylenol compounds, including this substance, included dyspnea, loss of motor coordination and spasms, but the details are not available (NICNAS IMAP (Access on August 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) As a result of oral administration of this substance for 8 months to rats, decreased body weight and effects on blood pressure, the liver, spleen, heart and lungs are reported at 14 mg/kg/day (within the range of Category 2), however, as these effects have not been replicated in more recent studies conducted at higher dosages, these findings are not considered reliable (ACGIH (7th, 2019)). (2) Regarding dimethylphenol (xylenol), ACGIH considers that the 6 isomers and the mixed isomer substance are similar in toxicity, and sets a common TLV after conversion to an inhalation exposure based on the toxicity information of 2,4-dimethylphenol (2,4-xylenol) (CAS RN 105-67-9) (NOAEL based on changes in hematological parameters observed in a 90-day oral dose study with mice at 250 mg/kg/day (exceeding the range of Category 2) = 50 mg/kg/day) (ACGIH (7th, 2019)).	FY2019	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.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

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 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 14 mg/L for fish (Pimephales promelas) (AQUIRE, 2008, Mattson, 1976).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 3 because it is not rapidly degradable (a degradation rate by BOD: 44%, a degradation rate by TOC: 49% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and it was classified in Category 3 in acute toxicity.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

To GHS Information