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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	98-00-0
Chemical Name	Furfuryl alcohol
Substance ID	R02-B-030-MHLW, MOE
Classification year (FY)	FY2020
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 FY2018
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	It was classified in Category 4 based on a flash point of 65 deg C (closed cup) (ACGIH (7th, 2017)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified."
9	Pyrophoric liquids	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 390 deg C (ICSC (2019)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.
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."
13	Oxidizing liquids	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."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

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] It was classified in Category 3 from (1) - (5). [Evidence Data] (1) LD50 for rats: 110-132 mg/kg (MAK (DFG) vol.7 (1996)) (2) LD50 for rats: 132 mg/kg (Patty (6th, 2012)) (3) LD50 for rats: 177 mg/kg (ACGIH (7th, 2017)) (4) LD50 for rats: 275 mg/kg (Patty (6th, 2012)) (5) LD50 for rats: 275-451 mg/kg (MAK (DFG) vol.7 (1996))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1), (2). [Evidence Data] (1) LD50 for rabbits: 400 mg/kg (ACGIH (7th, 2017), HSDB (Access on April 2020)) (2) LD50 for rabbits: 657 mg/kg (MAK (DFG) vol.7 (1996), ACGIH (7th, 2017), Patty (6th, 2012))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1) - (3). Besides, because exposure concentrations were lower than 90% of the saturated vapor pressure concentration (801 ppm), the reference value in the unit of ppm was applied as a vapor with little mist. [Evidence Data] (1) LC50 for rats (4 hours): 233 ppm (MAK (DFG) vol.7 (1996), ACGIH (7th, 2017), Patty (6th, 2012)) (2) LC50 for rats (6 hours): 85 ppm (converted 4-hour equivalent value: 104 ppm) (MAK (DFG) vol.7 (1996)) (3) LC50 for rats (1 hour): 592 ppm (converted 4-hour equivalent value: 296 ppm) (ACGIH (7th, 2017)) (4) Vapor pressure of this substance: 0.609 mmHg (25 deg C) (HSDB (Access on April 2020)) (converted value for the saturated vapor pressure concentration: 801 ppm)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) This substance was irritating to the skin and eyes in rabbits (MAK (DFG) (2016), EU REACH CoRAP (2018)). (2) This substance irritated the skin in an animal test (AICIS IMAP (2016)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) In an eye irritation test in a rabbit (one) according to OECD TG 405, corneal opacity, iritis, conjunctival redness, and chemosis were observed but disappeared within 14 days. MMAS (Modified maximum average score) was 44 (ECETOC TR48 (2) (1998)). (2) This substance was irritating to the skin and eyes in rabbits (MAK (DFG) (2016), EU REACH CoRAP (2018)). [Reference Data, etc.] (3) Application of this substance (56 mg) to rabbits in an eye irritation test caused inflammation, mucous secretion, and clouding of the cornea which reversed within 40 to 64 days. However, by application of a lower dose (23 mg), ocular effects were less severe, and recovery was observed within two weeks (AICIS IMAP (2016)). (4) This substance is markedly irritating and injurious to the eyes (HSDB (Access on April 2020)). (5) It was classified in Eye Irrit. 2 (H319) in EU-CLP classification (EU CLP classification (Access on July 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1B from (1). The classification result was changed due to new data obtained. [Evidence Data] (1) It was positive in two mouse local lymph node assays (LLNA) according to TG 429, and the EC3 value was 4.63% and 25.6%, respectively (EU REACH CoRAP (2018), AICIS IMAP (2016), REACH registration dossier (Access on June 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] From (1), (2), it was classified as "Not classified" based on expert judgment. [Evidence Data] (1) As for in vivo, it is reported that it was negative in a micronucleus test, a chromosomal aberration test, and a sister chromatid exchange test in mouse bone marrow (IARC 119 (2019), NTP TR482 (1999), SCOEL (2011), MAK (DFG) (2016)), negative in a comet assay with mice (OECD TG 489) (EU REACH CoRAP (2018)), and positive in DNA adduct formation tests by 28-day repeated exposure (oral) or single administration (oral or intraperitoneal) to mice (IARC 119 (2019)). (2) As for in vitro, it is reported that it was negative in reverse mutation tests using standard test strains, negative in a sister chromatid exchange test in human lymphocytes, positive in a sister chromatid exchange test in cultured mammalian cells, and equivocal in a chromosomal aberration test (IARC 119 (2019), NTP TR482 (1999), MAK (DFG) vol.7 (1996)). It was reported to be positive in reverse mutation tests using genetically modified Salmonella typhimurium strains (derived from TA100) and a DNA adduct formation test (IARC 119 (2019), EU REACH CoRAP (2018)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 119 (2019)), Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), proposed in 2019)), A3 by ACGIH (ACGIH (7th, 2017)), Carc.2 in EU-CLP (EU CLP classification (Access on April 2020)), and 3B in MAK (DFG) (MAK (DFG) (2016)). (2) In carcinogenicity tests by 105-week inhalation exposure to this substance of male and female rats and mice, a significant increase in the combined incidence of nasal neoplasms (adenoma, carcinoma, or squamous cell carcinoma of the respiratory epithelium) was observed in male rats. In female rats, the incidences of neoplasms in the nasal cavity and renal tubules slightly increased. A significant increase in the incidence of renal tubule adenoma or carcinoma (combined) was seen in male mice. There was no significant increase in the incidence of any neoplasm in female mice (NTP TR482 (1999), IARC 119 (2019), ACGIH (7th, 2017)). From the above, it was concluded that there was some evidence of the carcinogenicity of this substance in male rats, there was equivocal evidence in female rats, there was some evidence in male mice, and there was no evidence of carcinogenicity in female mice (NTP TR482 (1999)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 3 (narcotic effects, respiratory tract irritation). [Evidence Data] (1) The effects of short-time exposure of humans to inhalation of high concentrations of this substance were irritation of the eyes and nose (SCOEL (2011)). (2) It was reported that in an inhalation exposure test with rats, excitement followed by eye irritation and lethargy was observed (OEL Documentations (Japan Society For Occupational Health (JSOH), 1978).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs), Category 2 (liver, kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1), effects on the respiratory organs were observed in humans, and based on (2) to (6), effects on the respiratory organs within the range for Category 1 and the liver and kidney within the range for Category 2 were observed in experimental animals. Therefore, it was classified in Category 1 (respiratory organs) and Category 2 (liver, kidney). As for (7), which was considered to be the basis for effects on the central nervous system in the previous classification, it was not used as the rationale for the classification because it was not a standard test and no effects on the central nervous system were observed in other tests. Accordingly, the classification result was changed from the previous classification. [Evidence Data] (1) It was reported that in a study for foundry workers, 28 workers had respiratory tract symptoms (cough, nose, throat) and eye irritation. The time-weighted exposure level was 7 mg/m3, with a peak value exceeding 40 mg/m3 (SCOEL (2011), MAK (DFG) (2016)). (2) In a 14-week test (6 hours/day, 5 days/week) by inhalation exposure of rats to 2, 4, 8, 16 and 32 ppm (converted guidance value: 0.0062, 0.0125, 0.0250, 0.0499, and 0.0999 mg/L; within the range for Category 1 in all cases) of this substance, effects on the nasal cavity (squamous metaplasia of the transitional epithelium at or above 2 ppm, degeneration of the olfactory epithelium at or above 4 ppm, squamous metaplasia and goblet cell hyperplasia of the respiratory epithelium at or above 8 ppm, hypertrophy of the respiratory epithelium lining the nasopharyngeal duct, hyperplasia of the olfactory epithelium, cell infiltration of the lamina propria mucosa at or above 16 ppm, metaplasia of the olfactory epithelium at 32 ppm, etc.) were observed (NTP TR482 (1999), MAK (DFG) (2016)). (3) In a 14-week test (6 hours/day, 5 days/week) by inhalation exposure of mice to 2, 4, 8, 16 and 32 ppm (converted guidance value: 0.0062, 0.0125, 0.0250, 0.0499, and 0.0999 mg/L; within the range for Category 1 in all cases) of this substance, effects on the nasal cavity as in the case of rats were observed within the range for Category 1 (2 ppm or above) (NTP TR482 (1999), MAK (DFG) (2016)). (4) In a 13-week repeated dose toxicity study with rats dosed by gavage, at 75 mg/kg/day (within the range for Category 2), increases in absolute liver and kidney weight, and liver and kidney lesions (liver: degeneration of hepatocytes, cytoplasmic vacuolation; kidney: lesions of the tubular epithelium in the cortex) were observed (NTP TR482 (1999), AICIS IMAP (2016)). (5) In two-year inhalation exposure tests with rats and mice, effects on the nasal cavity as well as increased severity of nephropathy, as non-neoplastic changes, were observed at a dose within the range for Category 1 (NTP TR482 (1999), AICIS IMAP (2016)). [Reference Data, etc.] (6) In a 4, 9, and 16-week inhalation exposure test (6 hours/day, 5 days/week) with rats in which effects on the nervous system were examined, an increase in creatine kinase activity was observed after 4 weeks at or above 50 ppm (converted guidance value: 0.045 mg/m3, within the range for Category 1) (the authors presented this result as an indication of the proliferation of astroglial cells, a consequence of nonspecific nervous tissue damage), and a decrease in brain protein synthesis in the glial cell fraction was observed after 16 weeks at 100 ppm (converted guidance value: 0.36 mg/m3, within the range for Category 2) (ACGIH (7th, 2017)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, from (1), kinematic viscosity was calculated as 4.1 mm2/sec at 25 deg C, and kinematic viscosity was not more than 14 mm2/s at 40 deg C, but no other information could be obtained. [Reference Data, etc.] (1) Kinematic viscosity was 4.1 mm2/s at 25 deg C (calculated from viscosity at 25 deg C: 4.62 mPa*s (HSDB (Access on April 2020)) and density of 1.13 g/cm3 (HSDB (Access on April 2020))).

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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.
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.

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