NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	80-26-2
Chemical Name	Terpinyl acetate
Substance ID	R02-A-063-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	Not classified	- -	-	-	There are flash point data of 93 deg C, the upper limit for Category 4, but there are the same number of data with flash points above 93 deg C, and the average is above 93 deg C. Therefore, it was classified as "Not classified."
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 284 deg C (ECHA (Accessed Sep. 2020)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	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	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" from (1). [Evidence Data] (1) LD50 for rats: about 5,075 mg/kg (REACH registration dossier (Accessed Oct. 2020))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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	Classification not possible	- -	-	-	[Rationale for the Classification] From (1) - (4), irritation effects did not disappear during the 7-day observation period, and reversibility after 14 days could not be determined. Therefore, the classification is not possible. [Evidence Data] (1) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 7-day observation), erythema and edema persisted for 7 days in all the animals (erythema/eschar score: 1.7/2/2, edema score: 1/2/2) (REACH registration dossier (Accessed Oct. 2020)). (2) It is reported that in a skin irritation test with rabbits (n = 4) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 7-day observation), erythema and edema persisted for 7 days in all the animals (erythema/eschar score: 2/2/2/2, edema score: 3/2/2/2) (REACH registration dossier (Accessed Oct. 2020)). (3) It is reported that in a skin irritation test with rabbits (n = 4) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 7-day observation), irritation effects resolved in 1 animal after 7 days, but irritation effects persisted in 3 (erythema/eschar score: 2/1.7/2/1.3, edema score: 2/1/0.7/0.3) (REACH registration dossier (Accessed Oct. 2020)). (4) It is reported that in a skin irritation test with rabbits (n = 4) (equivalent to OECD TG 404, GLP, semi-occlusive, 4-hour application, 7-day observation), very slight effects persisted in 3 animals for 7 days, and desquamation was seen in all the animals (mean erythema score after 24/48/72 hours for all the animals: 1.75, mean edema score after 24/48/72 hours for all the animals: 1) (REACH registration dossier (Accessed Oct. 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 in-vitro isolated chicken eye test (OECD TG 438, GLP), the highest mean corneal swelling was 4% after 75, 120, 180 minutes (ICE Class: I), the highest mean corneal opacity score was 1.2 after 120, 180, 240 minutes (ICE Class: II), the mean fluorescein retention score was 0.7 at 30 minutes after exposure (ICE Class: II), and the combination of 3 parameters was 2 x II, 1 x I (considered to be "Not Classified") (REACH registration dossier (Accessed Oct. 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in a local lymph node assay (LLNA) with mice (n = 5/group) (OECD TG 429, GLP), stimulation index (SI values) was 1.3 (25%), 2.2 (50%), 2.4 (100%) (REACH registration dossier (Accessed Oct. 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence and Reference Data, etc.] (1) In a bacterial reverse mutation test (OECD TG 471, GLP), negative results were reported (REACH registration dossier (Accessed Sep. 2020), RIFM Hazard Assesment Report for Terpinyl acetate (Accessed Sep. 2020)). (2) In an in vitro micronucleus test using the human lymphocytes (OECD TG 487, GLP), negative results were reported (RIFM Hazard Assesment Report for Terpinyl acetate (Accessed Sep. 2020)). [Reference Data, etc.] (3) In a chromosomal aberration test of terpineol (CAS RN 8000-41-7), which is a structural analog of this substance, using the human lymphocytes (OECD TG 473, GLP) and a gene mutation test (OECD TG 490) of alpha Terpineol (CAS RN 98-55-5) using the L5178Y mouse lymphoma cells, negative results were reported (REACH registration dossier (Accessed Sep. 2020).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. [Reference Data, etc.] (1) It was reported that in a subacute oral toxicity test with rats dosed by feeding (for 20 weeks), no effect on fertility was observed (REACH registration dossier (Accessed Sep. 2020)). (2) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test of terpineol (CAS RN 8000-41-7), which is an analog of this substance, with rats dosed by gavage (OECD TG422, GLP, for at least 5 weeks (males), from 2 weeks before mating until day 6 of lactation (females)), at 750 mg/kg/day, lower body weight, effects on the liver, kidney, etc., pregnancy not achieved (all females), and severe testicular toxicity effects (a decrease in the number of sperms or a complete absence of spermatozoa, seminiferous tubular atrophy or degeneration, spermatid multinucleated giant cells and seminiferous tubular degeneration) (males) were observed in parental animals (REACH registration dossier (Accessed Sep. 2020)). (3) In a test for investigating testicular toxicity effects of terpineol by comparing oral dose methods, the animals which were given terpineol by oral gavage (750 mg/kg/day) exhibited greater effects than those which were given by feeding at the maximu of 10,000 ppm. In the group dosed by feeding, a slight reduction of sperm motility was observed. On the other hand, in the group dosed by oral gavage, a reduction in sperm motility, a decrease in the number of sperms in the epididymis, an increased incidence of abnormal sperm morphology, and degeneration of tissues and sperms in the testes and/or the epididymis were clearly observed (REACH registration dossier (Accessed Sep. 2020)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. With respect to the oral route, the doses at which the symptoms appeared were not reported in (1). [Reference Data, etc.] (1) It was reported that in an acute oral toxicity test with rats dosed by gavage, depression, scrawny appearance, and porphyrin-like deposits around the eyes and the nose were observed (REACH registration dossier (Accessed Oct. 2020)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes. [Evidence Data] (1) It was reported that in a 20-week oral toxicity test with rats dosed by feeding, no effect was observed at 10,000 ppm (400 mg/kg/day, in the range corresponding to "Not classified") (REACH registration dossier (Accessed Oct. 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 3	- -	H402	P273 P501	From mortality of 45% at an exposure level of 11 mg/L in an acute toxicity test with fish (Pimephales promelas) (REACH registration dossier, 2021), the expert judged that it had toxicity equivalent to Category 3. Therefore, it was classified in Category 3.
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified as "Not classified" because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 3.2 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021). However, it was classified in Category 3 because it was classified in Category 3 in acute toxicity.
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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