NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	60-12-8
Chemical Name	beta-Phenylethyl alcohol; Phenethyl alcohol
Substance ID	m-nite-60-12-8_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)	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified	- -	-	-	Its flash point reported 96 degC (closed-cup) (Lide (90th, 2009)) is >= 93 degC.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	Since its autoignition temperature is 410 degC (IUCLID (2000)), it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

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	Six LD50 values for rats of 1800, 1500, 1800, 2500, 1700 mg/kg (above JECFA (2003)) and 2509 mg/kg (PATTY, 5th (2001)) were reported, and four of them were equivalent to Category 4. Thus, the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	Based on the rabbit LD50 value of 805 mg/kg bw (PATTY, 5th (2001)), the substance was classified as Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	The rat LC50 value of > 1.38 mg/L/4hrs was reported (IUCLID (2000)). Since the value did not provide a basis for classification, the substance was classified as "Classification not possible". According to the description of the "aerosol" exposure (IUCLID (2000)), the criterion values for mist/dust were adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	In duplicate rabbit tests that 4-hour application of 0.5 ml of the test substance to the skin, the primary skin irritation index value (PII) were 2.22 and 0.92 (ECETOC TR66 (1995)). In human case report, 24-hour application of undiluted substance to 20 subjects caused no irritation (IUCLID (2000)). Based on these documents, the substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In the rabbit test, application of 0.005 mL of undiluted substance or 0.05 mL of 5 - 15% of the substance in propylene glycol solution to the eye caused severe corneal irritation and iritis (PATTY, 5th (2001)). Based on these documents, the substance was classified as Category 2. As relevant notes, instillation to the human eye with 0.75% or 0.6% of aqueous solution caused irritation (PATTY, 5th (2001)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	Insufficient data were available. As for the results of the skin sensitization tests in guinea pig, positive results in the optimization test and negative results in the open epicutaneous test were reported (IUCLID (2000)). These were reciprocal results, and neither of the test methods were authorized by the OECD. As relevant notes, sensitization test on 25 test subjects, the substance was not sensitizing (PATTY, 5th (2001)). On the other hand, local reaction suggesting sensitization was reported in patients who have various types of skin disease (PATTY, 5th (2001)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro study, negative results in the Ames test were reported (JECFA (2003)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the oral administration study using pregnant rats during the organogenetic period, while no information on maternal toxicity was reported, dose-related increases in the incidence of malformations were reported, the malformations were mainly ocular changes, neural tube defects, hydronephrosis and amelia (JECFA (2003)). In the dermal administration study using pregnant rats during the organogenetic period, the highest dose induced both maternal toxicity, containing lethality, suppression of body weight gain, and embryo/fetal toxicity, indicated by resorption, loss of embryos, reduction in mean litter size and various types of changes in internal organs and skeleton. The morphological changes were considered by the authors to be more severe than those that would occur merely as a secondary consequence of the maternal response (JECFA (2003)). Therefore, the substance was classified as Category 2.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (liver, kidney), Category 3 (narcotic effects)	Warning	H371 H336	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	In the acute oral toxicity study in rats (LD50 value: 650 - 1430 mg/kg), degeneration of the liver and kidneys was observed (IUCLID (2000)). In the liver, hyperemia and slight fatty change were observed (IUCLID (2000)). In the kidneys, tubular necrosis was found in the renal medulla, and cloudy swelling of tubular cells and cast formation were found in the renal cortex (IUCLID (2000)). In consideration of LD50 values, the findings were thought to belong to Category 2, thus, the substance was classified as Category 2 (liver, kidneys). Moreover, in the acute oral toxicity study in mice, most of the animals received 1.0 to 2.0 mg/kg exhibited narcotic effects within 1 and 5 minutes after administration (IUCLID (2000)). Category 3 (narcotic effects) was, thus, added.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 4-month oral (gavage) dose study in rats at the dose level of 51 mg/kg/day, increased activities of cholinesterase and ALT, and decrease in serum protein concentration were reported (JECFA (2003)). In the 30-day repeated oral dose study in rats, the changes at 200 mg/kg/day (converted dose level as that of 90-day study: 66.7 mg/kg bw/day) containing the damage to internal organs, increased hemoglobin and leukocyte count were reported (IUCLID (2000)). However, these studies were insufficient due to no referring to histopathological effects and no details of the results shown. Additionally, in the 13-week dermal toxicity study in rats, while decreases in hemoglobin concentration and leukocyte count were observed in males at 2040 mg/kg/day, no treatment-related histopathological effects were observed and any other toxicological effects were detected (PATTY, 5th (2001)). Although the "Not classified" category was concluded for dermal route, the classification for specific target organ toxicity (repeated exposure) was conclusively justified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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)	Not classified	- -	-	-	Classified as "Not classified" from its 48h-EC50 = 287 mg/L for crustacea (Daphnia magna) (IUCLID, 2000).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility: 22200 mg/L (PHYSPROP Database, 2011)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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