NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	100-51-6
Chemical Name	Benzyl alcohol
Substance ID	m-nite-100-51-6_v2
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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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)	- -	-	-	Liquid (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)	- -	-	-	Liquid (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)	- -	-	-	Liquid (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	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	It was classified in Category 4 based on a flash point of 93 deg C (closed cup) (NFPA (2010)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	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	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 436 deg C (ICSC (2000)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	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 liquid 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)	- -	-	-	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))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). 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	- -	-	-	No data 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)-(7), it was classified in Category 4 which was applicable to many evidence data. [Evidence Data] (1) LD50 for rats: 1,200 mg/kg (JECFA FAS48 (2001)) (2) LD50 for rats: 1,230 mg/kg (SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012)) (3) LD50 for rats: 1,600 mg/kg (JECFA FAS48 (2001)) (4) LD50 for rats: 1,610 mg/kg (SIDS (2004), PATTY (6th, 2012)) (5) LD50 for rats: 1,660 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)) (6) LD50 for rats: 2,080-2,100 mg/kg (SIDS (2004), PATTY (6th, 2012), JECFA FAS48 (2001)) (7) LD50 for rats: 3,100 mg/kg (JECFA FS48 (2001), PATTY (6th, 2012))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rabbits: 2,000 mg/kg (SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013))	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] Liquid (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. Besides, since the data used in the previous classification were described to be obtained in a test with aerosol, the reference value for the mist was applied, and the classification was changed from the previous classification.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] Since there was no death case at 4.178 mg/L in GLP-compliant data in (1), it was classified as "Not classified." Since the data in (1) were described to be obtained in a test with aerosol, the reference value for the mist was applied, and the classification was changed from the previous classification. [Evidence Data] (1) LC50 for rats (4 hours): >4.178 mg/L (SIDS (2004)), (OECD TG 403, GLP-compliant) [Reference Data, etc.] (2) LC50 for rats (8 hours): >1,000 ppm (converted 4-hour equivalent value: 8.1 mg/L) (PATTY (6th, 2012)) (3) LC50 for rats (4 hours): 8.9 mg/L (SIDS (2004))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) It is reported not to be irritating in a skin irritation test according to OECD TG 404 with rabbits (SIDS (2004)). (2) In two reports of skin irritation tests with rabbits, primary irritation indices (PII) were reported to be 1.56 and 1.83, respectively (ECETOC TR66 (1995)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) In an eye irritation test according to OECD TG 405 with rabbits, it was reported as moderately irritating (SIDS (2004)).	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 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1) to (6), it was classified in Category 1A. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) The Japan Society For Occupational Health (JSOH) classified this substance in occupational skin sensitizers Group 2 (OEL Documentations (Occupational Sensitizer classification) (Japan Society For Occupational Health (JSOH), 2019). (2) In a patch test on 5,202 patients with suspected contact dermatitis, 48 (0.9%) of all the patients and 2 (1.3%) of 156 patients who developed allergic reaction to cosmetics were sensitized to this substance (OEL Documentations (Occupational Sensitizer classification) (Japan Society For Occupational Health (JSOH), 2019). (3) In an open test with 19 healthy volunteers and 31 patients having dermatitis, 15 healthy people and 17 patients developed skin hives as immediate reactions. In addition, in a patch test, all of the healthy people and patients showed negative results for allergic contact dermatitis as delayed allergy to this substance (OEL Documentations (Occupational Sensitizer classification) (Japan Society For Occupational Health (JSOH), 2019). (4) The Research Institute for Fragrance Materials (RIFM) conducted a maximization test with human volunteers and all the subjects showed negative results, and it was concluded that there was no evidence for irritation or sensitization from the 10% substance contained in petrolatum. In a repeated skin sensitization inducing test with human volunteers, sensitization was observed in 5 of 56 people with 20% solution of this substance, 5 of 46 people with 15% solution, 3 of 110 people with 7.5% solution, 2 of 101 people with 5% solution, and no sensitization was observed in any of 107 people with 3% solution (OEL Documentations (Occupational Sensitizer classification) (Japan Society For Occupational Health (JSOH), 2019). (5) It was reported that results of human repeated insult patch tests (HRIPT) with doses of 3 to 20% (3,543 micro g/cm2 to 23,622 micro g/cm2) for induction and challenge pointed towards a weak to moderate skin sensitizing potential of this substance and increasing doses of this substance from 8,858 micro g/cm2 (7.5%) to 23,622 micro g/cm2 (20%) led to increasing numbers of sensitized subjects (EU REACH CoRAP Substance Evaluation Conclusion (2020)). (6) There were a number of case reports which reported positive reactions to this substance to a varying degree (EU REACH CoRAP Substance Evaluation Conclusion (2020)). [Reference Data, etc.] (7) It was reported that, in a Local Lymph Node Assay (LLNA) (OECD TG 429, GLP) with mice (n=4), the stimulation index (SI values) were 1 (2.5%), 0.9 (5%), 0.5 (10%), 0.6 (25%), and 1.2 (50%) (CLH Report (2020), EU REACH CoRAP (2020), REACH registration dossier (Accessed Oct. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in accordance with expert judgement. [Evidence Data] (1) As for in vivo, it was negative in a micronucleus test with mouse bone marrow by intraperitoneal injection (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), SIDS (2004)). (2) As for in vitro, it was negative in bacterial reverse mutation tests. A mouse lymphoma test and a chromosomal aberration test were positive with metabolic activation, however, they were observed at very high and cytotoxic concentrations, and an in vitro micronucleus test was negative (NTP TR343 (1989), NTP DB (Access on May 2019), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012), SIDS (2004), JECFA FAS48 (2001), DFGOT vol.3 (2018)). [Reference Data, etc.] (3) It was concluded in DFGOT vol.3 (2018) and SIDS (2004) that since positive results in the chromosomal aberration test was obtained at very high and cytotoxic concentrations, there was no concern about genetic toxicity of this substance (DFGOT vol.3 (2018), SIDS (2004)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There were no classification results by domestic and international organizations. There was no available report on humans. Based on (1), it was classified as "Not classified." [Evidence Data] (1) In carcinogenicity studies in which rats and mice were dosed by gavage for 2 years, there was no evidence of carcinogenicity in both sexes of both species (NTP TR343 (1989)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), as for developmental toxicity, only slight effects were observed at doses at which maternal toxicity was observed, and it corresponded to "Not classified." However, there was no information on sexual function and fertility, therefore, classification was not possible due to lack of data. [Evidence Data] (1) In a developmental toxicity test in which female mice were dosed by gavage on gestational days 6-15, maternal toxicity (death in 1/50 animals) was observed, but no developmental effects were observed (SIDS (2004), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). (2) In a developmental toxicity test in which female mice were dosed by gavage on gestational days 7-14, maternal toxicity (death in 19/50 animals, cyanosis, tremors, prostration, ataxia, etc.), reduction in pup weight at birth, and subsequent reduced body weight gain were observed (SIDS (2004), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). [Reference Data, etc.] (3) The 4-generation oral study with rats cited in the previous classification was not for this substance but for benzoic acid.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, kidney), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1 (central nervous system, kidney) and Category 3 (narcotic effects). By using new information sources, the classification result was changed from the previous classification. [Evidence Data] (1) A 45-year-old man who inhaled a paint-peeling agent containing 34.8% of this substance and developed a consciousness disturbance was urgently transported to a hospital in a comatose condition. His symptoms were hypotension, progressive metabolic acidosis, and polyuria caused by tubular disorder, and he was diagnosed with acute benzyl alcohol poisoning (Ito et al., Journal of Japanese Association for Acute Medicine vol. 29, p.254 (2018)). Other constituents (and contents) in the peeling agent which was the cause of the accident were water (50% or more), phosphoric acid (1-5%), and naphthalene and hydrogen peroxide (both less than 1%) according to the product's SDS, therefore, the effects mentioned above were thought to be caused by this substance. (2) This substance was historically used as a local anesthetic by swabbing on the skin or by subcutaneous injection of a 1% solution (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). (3) In a single oral dose toxicity test with rats, depression, excitability and coma were observed. There was no description of doses at which these effects were observed. If the effects could be observed around 1,230 mg/kg (LD50 value), it corresponded to Category 2 (SIDS (2004)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), since intravenous administration to human infants caused effects on the central nervous system, it was classified in Category 1 (central nervous system). [Evidence Data] (1) This substance, which was used as a preservative in intravascular flush solutions, caused neurological deterioration and deaths in very low birth weight infants (PATTY (6th, 2012)). (2) By intravenous administration of fluids containing 0.9% of this substance, low birth weight infants developed poisoning symptoms (gasping, acidosis, neurological deterioration, etc.) (PATTY (6th, 2012)). [Reference Data, etc.] (3) As a result of a 13-week oral administration to rats or mice at 50-800 mg/kg/day, signs indicative of neurotoxicity (staggering, respiratory difficulty and lethargy) were observed at 800 mg/kg/day (exceeding Category 2), and additionally in rats, lesions, etc. in the brain, thymus, skeletal muscle and kidney were observed (NTP TR343 (1989), SIDS (2004), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). (4) As a result of a 2-year oral administration to rats at 200, 400 mg/kg/day, or to mice at 100 and 200 mg/kg/day, no dose-related nonneoplastic lesion was observed (NTP TR343 (1989)).	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 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 10 mg/L for fish (Lepomis macrochirus) (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to being rapidly degradable (a degradation rate by BOD: 94% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)), and 21-day NOEC = 51 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997), Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to being rapidly degradable (a degradation rate by BOD: 94% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)), and a low bioaccumulation estimate (log Kow = 1.1 (PHYSPROP Database, 2019)), despite 96-hour LC50 = 10 mg/L for fish (Lepomis macrochirus) (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). From the above results, it was classified as "Not classified."	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.

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