NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	120-57-0
Chemical Name	Piperonal
Substance ID	R02-A-021-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)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (GESTIS (accessed Aug. 2020)).
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 (Not applicable)	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) 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)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	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.
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	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
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: 2,700 mg/kg (JECFA (1967), REACH registration dossier (Accessed Aug. 2020), HSDB (Accessed Aug. 2020)) [Reference Data, etc.] (2) An estimated lethal dose in humans was reported to be 500-5,000 mg/kg (HSDB (Accessed Aug. 2020)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 402) (ECHA RAC Opinion (2018), AICIS (formerly, NICNAS IMAP) (2018)) [Reference Data, etc.] (2) LD50 for rabbits: > 652 mg/kg (OECD TG 402, purity: 32.6% (medium: xylene)) (ECHA RAC Opinion (2018))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (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	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) It is reported that in a skin irritation test with guinea pigs (n = 8) (equivalent to OECD TG 404, occlusive, 24-hour application, 48-hour observation), no irritation reactions were seen at observation after 24, 48 hours (REACH registration dossier (Accessed Aug. 2020)). (2) It is reported that in an acute dermal toxicity test with rats (n = 16) (equivalent to OECD TG 402, GLP, open, 24-hour application of 5,000 mg/kg, 14-day observation), no toxic signs were found (REACH registration dossier (Accessed Aug. 2020)). [Reference Data, etc.] (3) It is reported that in a patch test in 112 persons, slight erythema was observed in four out of 112 during the induction period (REACH registration dossier (Accessed Aug. 2020)). (4) It is reported that in a patch test in 41 persons, irritation signs were seen in four out of 41 during the induction period, and slight erythema in 3 and moderate to severe irritation symptoms (erythema and eruption) in 1 were found (REACH registration dossier (Accessed Aug. 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) (equivalent to OECD TG 405, GLP, 7-day observation), no eye irritation was seen (corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0/0/0, conjunctival redness score: 0/0/0/0/0/0, chemosis score: 0/0/0/0/0/0) (REACH registration dossier (Accessed Aug. 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] It was negative in knowledge in humans in (1) - (3), while it was positive in knowledge in animals in (4). Because the results are contradicting, the classification is not possible. [Evidence Data] (1) It is reported that in a patch test in 112 persons (application of a 2.5% solution), no skin sensitization was seen (REACH registration dossier (Accessed Aug. 2020)). (2) It is reported that in a patch test in 25 persons, after induction by 5-time 48-hour applications of a 6% solution over 15 days followed by challenge by 48-hour occlusive application 10 days later, no skin sensitization was found (REACH registration dossier (Accessed Aug. 2020)). (3) It is reported that in a patch test in 41 persons, after induction by 9-time 24-hour applications of an ethanol solution of this substance (concentration: unknown) over 3 weeks followed by challenge by 24-hour semi-occlusive application about 2 weeks later, no skin sensitization was observed (REACH registration dossier (Accessed Aug. 2020)). (4) It is reported that in a maximization test with guinea pigs (n = 10) (equivalent to OECD TG 406, intradermal administration: 1.5% solution, challenge: 24-hour occlusive application of an 80% solution (acetone) 14, 21, 28, 42 days later), a positive rate at 24, 48 hours after challenge was 20%, 40% for the first challenge, 40%, 40% for the second, 40%, 40% for the third, and 10%, 20% for the fourth (REACH registration dossier (Accessed Aug. 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a dominant lethal test with mice (OECD TG478), negative results were reported (REACH registration dossier (Accessed Aug. 2020)). (2) In a bacterial reverse mutation test (equivalent to OECD TG 471), negative results were reported (REACH registration dossier (Accessed Aug. 2020)). (3) In an in vitro mammalian chromosomal aberration test (equivalent to OECD TG 473), negative results were reported (REACH registration dossier (Accessed Aug. 2020)). (4) In an in vitro mammalian cell gene mutation test (equivalent to OECD TG 476), negative results were reported (REACH registration dossier (Accessed Aug. 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. [Reference Data, etc.] (1) In two-year combined chronic toxicity/carcinogenicity studies with rats dosed by feeding (OECD TG453, GLP), no evidence of carcinogenicity was observed at doses of up to 0.5% (approx. 250 mg/kg/day) (Accessed Aug. 2020). However, the number of rats in the 0.1% dosed group was only 20 and no systemic effects such as the effects on body weight were observed. Therefore, it was judged that the test did not meet the current standards for carcinogenicity tests.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. In (1), no reproductive toxicity was observed, while there was no data available on developmental toxicity. [Evidence Data] (1) It was reported that in a reproduction/developmental toxicity screening test with rats dosed by gavage (untreated (males), for 39 days (from 7 days prior to mating until day 4 of lactation) (females)), reduced body weight gain was observed at 500 mg/kg/day in parental animals, while only a tendency of lower body weight was observed in the offspring (REACH registration dossier (Accessed Aug. 2020)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), depression, ataxia and tremors were observed in the oral route, but the dose was not clear. In addition, there was no information on toxicity in the other routes, and classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats, depression, ataxia and tremors were observed and LD50 was 2,700 mg/kg (REACH registration dossier (Accessed Aug. 2020)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was considered to be classified as "Not classified" in the oral route, but there was no information on toxicity in the other routes. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in a 15-week repeated oral dose test with rats dosed by feeding, no effects were observed at 10,000 ppm (500 mg/kg/day, in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 2020)). (2) It was reported that in two-year combined chronic toxicity/carcinogenicity studies with rats dosed by feeding, no effects were observed at 5,000 ppm (250 mg/kg/day, in the range corresponding to "Not classified") (JECFA (1967), REACH registration dossier (Accessed Aug. 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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 2.5 mg/L for fish (Cyprinus carpio) (REACH registration dossier, 2021).
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" because it was rapidly degradable (a 2-week degradation rate by BOD: 88.0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1978)) and due to 72-hour NOEC = 1.1 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021). 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" because it was rapidly degradable (a 2-week degradation rate by BOD: 88.0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1978)) and due to a low bioaccumulation estimate (log Kow = 1.05 (SRC PhysProp Database)), despite 96-hour LC50 = 2.5 mg/L for fish (Cyprinus carpio) (REACH registration dossier, 2021). From the above results, it was classified as "Not classified."
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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