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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	100-51-6
Chemical Name	Benzyl alcohol
Substance ID	R01-B-005
Classification year (FY)	FY2019
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	FY2008
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)	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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	It was classified in Category 4 based on a flash point of 93 deg C (closed cup) (NFPA (2010)).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	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)).
10	Pyrophoric solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	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	*	- -	-	-	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)."
13	Oxidizing liquids	*	- -	-	-	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)."
14	Oxidizing solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	No data available.
17	Desensitized explosives	*	- -	-	-	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 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))
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))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[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.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[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))
2	Skin corrosion/irritation	*	- -	-	-	[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)).
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)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] There were data in (1)-(8), however, since positive and negative data on sensitization were mixed, classification was not possible. [Reference Data, etc.] (1) In a patch test in humans, there is a report of a positive result despite of the low incidence (0.3%) (HSDB (Access on May 2019)). (2) There were no sensitization reactions in 25 volunteers exposed to a 10% solution of this substance in five 48-hour patch tests during a 10-day period (PATTY (6th, 2012)). (3) It was reported that No Expected Sensitization Induction Level (NESIL) in humans was 5,900 microg/cm2, and it was concluded to be a weak sensitizer (Api et al., 2015, Benzyl alcohol). (4) Positive results were reported in sensitization tests with guinea pigs (FCA test and OET) (SIDS (2004)). (5) Negative results were reported in sensitization tests with guinea pigs (Draize test and maximization test) (SIDS (2004)). (6) In a local lymph node assay (LLNA; induction concentration: 5%, 10%, 25%, 50%) with CBA/Ca mice, no EC3 value could be determined, therefore, the result was evaluated as negative (DFGOT vol.3 (2018)). (7) The result of an in vitro sensitization test (KeratinoSens assay) was negative (DFGOT vol.3 (2018)). (8) From the results of LLNA and clinical observation, etc., it was concluded that this substance was not a sensitizer (DFGOT vol.3 (2018)).
5	Germ cell mutagenicity	*	- -	-	-	[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)).
6	Carcinogenicity	*	- -	-	-	[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)).
7	Reproductive toxicity	*	- -	-	-	[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.
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)).
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)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] 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 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)).
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."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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