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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	18127-01-0
Chemical Name	3-(4-tert-Butylphenyl)propanal
Substance ID	R02-A-008-METI, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
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)
Model SDS by MHLW (External link)
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.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	A flash point was 73.5 deg C (closed-cup) (GESTIS (Accessed June 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 360 deg C (GESTIS (Accessed June 2020)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	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).
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.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" (Category 5 in UN GHS classification) from (1). [Evidence Data] (1) LD50 for rats: 2,551 mg/kg (2.66 mL/kg) (REACH registration dossier (Accessed May 2020))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rabbits (females): > 5,000 mg/kg (REACH registration dossier (Accessed May 2020))
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)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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) It is reported that in a skin irritation test with rabbits (n = 6) (open, 72-hour application, 72-hour observation), focal hemorrhages, slight to distinct ischemia and incrustation, and very slight edema were observed, and severe skin irritation was seen (REACH registration dossier (Accessed May 2020)). (2) It is reported that in an in-vitro skin irritation test (OECD TG 439), cell viability, R = 19.5% (REACH registration dossier (Accessed May 2020)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 6) (7-day observation), the substance was not considered to be an eye irritant (REACH registration dossier (Accessed May 2020)). [Reference Data, etc.] (2) It is reported that in an in-vitro eye irritation test (OECD TG 437), in vitro irritation score (IVIS) = 11.6 (no precision can be made) (REACH registration dossier (Accessed May 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). [Evidence Data] (1) It is reported that in a local lymph node assay (LLNA) with mice (n = 4/group) (OECD TG 429), irritation index (SI values) was 0.9 (1%), 1.4 (2.5%), 3.6 (5%), 4.2 (10%), 9.8 (25%), and the EC3 value was caluculated as 4.3% (REACH registration dossier (Accessed May 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on data (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a bacterial reverse mutation test (OECD TG471, GLP), negative results were reported (REACH registration dossier (Accessed May 2020)). (2) In a micronucleus test (OECD TG 487, GLP) using cultured human lymphocytes, negative results were reported (REACH registration dossier (Accessed May 2020)). (3) In a mammalian cell gene mutation test (MLA, OECD TG 490, GLP), negative results were reported (REACH registration dossier (Accessed May 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Since (1) was a screening test, classification was not possible due to lack of data. Also, in (1), no reproduction toxicity was observed, while there was no data available on developmental toxicity. [Evidence Data] (1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG422, GLP, for 42 to 45 days (males), 38 to 56 days (females)), no reproduction toxicity was observed at 5 mg/kg/day (REACH registration dossier (Accessed May 2020)).
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified as Category 3 (narcotic effects). [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats, sedation, ataxia, emaciation, encrustations around the eyes and nostrils and coma were observed at 2,302 to 4,028 mg/kg (2.4 to 4.2 mL/kg) (REACH registration dossier (Accessed May 2020)). (2) It was reported that in an acute dermal toxicity test (occlusive application) with rabbits, 1/6 rabbits died at 5,000 mg/kg, in which pre-death toxic signs such as diarrhea, tachypnea, prostration, flaccid muscle tone, and spasm were observed. Toxic signs in the survivors included lethargy and diarrhea, and slight to moderate erythema was noted on Days 1 and 7 and was absent or slight on Day 14 (REACH registration dossier (Accessed May 2020)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. In (1), since the doses used in the test were low, it was difficult to make an appropriate assessment. [Evidence Data] (1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422, GLP) (males: for 42 to 45 days, females: for 38 to 56 days), no toxicity effects were observed at the highest dose of 5 mg/kg/day (converted guidance value: 2.5 mg/kg/day (males) and 3.11 mg/kg/day (females), within the range for Category 1) (REACH registration dossier (Accessed May 2020)).
10	Aspiration hazard	Classification not possible	- -	-	-	[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)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.
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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