NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	105-87-3
Chemical Name	Geranyl acetate
Substance ID	R02-A-060-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	- -	-	-	A flash point was 109.5 deg C (Closed cup) (GESTIS (Accessed Sep. 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene group) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 252 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 6,330 mg/kg (JECFA (1967), NTP TR252 (1987)) [Reference Data, etc.] (2) LD50 for rats (a mixture of 71% of this substance and 29% of citronellyl acetate): between 4,000-8,000 mg/kg (NTP TR252 (1987), NICNAS IMAP (2017))
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] Classification not possible due to lack of data. [Reference Data, etc.] (1) It is reported that in a skin irritation test with rabbits (n = 6) (two open applications, 24-hour application, 72-hour observation), irritation of relative score 3 (severe irritation) was observed (REACH registration dossier (Accessed Oct. 2020)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 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 4.95 (25%), 7.33 (50%), 7.56 (100%) (REACH registration dossier (Accessed Oct. 2020)). [Reference Data, etc.] (2) It is reported that in a maximization test in 25 persons (4% in petrolatum), this substance was not considered sensitizing, but hypersensitivity was observed in certain individuals (AICIS (formerly, NICNAS IMAP) (2017)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (7), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using mouse bone marrow cells (intraperitoneal injection, 3 days), negative results were reported (REACH registration dossier (Accessed Oct. 2020), NICNAS IMAP (2017)). (2) It was reported that in a mouse bone marrow chromosomal aberration test (by single-dose intraperitoneal administration), positive results were obtained, but in a confirmation test which was conducted under the same conditions, the results were negative and no reproducibility was observed (REACH registration dossier (Accessed Sep. 2020)). (3) In a sister chromatid exchange test using mouse bone marrow cells, negative results were obtained, and in a comet assay with the bone marrow, brain, lung, liver, kidney and stomach etc. from mice as the target organs, negative results were obtained (REACH registration dossier (Accessed Sep. 2020)). (4) In a bacterial reverse mutation test, negative results were reported (REACH registration dossier (Accessed Oct. 2020)). (5) It was reported that in a chromosomal aberration test using Chinese hamster ovary cells (CHO), negative results were reported (REACH registration dossier (Accessed Oct. 2020)). (6) In a sister chromatid exchange test using CHO, weakly positive (S9-) results were reported (REACH registration dossier (Accessed Oct. 2020)). (7) In unscheduled DNA synthesis tests using rat primary cultured hepatocytes, negative results were reported (REACH registration dossier (Accessed Oct. 2020)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a two-year carcinogenicity study by oral administration of a mixture containing this substance by 71% and citronellyl acetate (CAS RN 150-84-5) by 29% to rats or mice dosed by gavage (5 days/week), no clear evidence of carcinogenic effects was observed in either males or females of rats or mice. However, the survival rate of male rats and male and female mice in the high dose groups and that of female mice in the low dose group decreased, and there was a possibility that the sensitivity for detecting tumors was lowered. It was reported that there was a possibility that the slight increases in renal tubular cell adenomas in male rats in the low dose group and squamous carcinomas of the skin in male rats in the low dose group were associated with the administration of this substance (NTP TR252 (1987)). (2) Although renal tubular cell adenomas in male rats and skin tumors in male mice were observed as described in the NTP test results above, the symptoms did not show a significant increase in the high dose groups and were not dose-related. Therefore, the effects were not considered to be related to the administration. It was concluded that this substance was not considered to have carcinogenicity (REACH registration dossier (Accessed Sep. 2020), NICNAS IMAP (2017)).
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 reproduction/developmental toxicity screening test with rats by dermal administration of geraniol (CAS RN 106-24-1), which was a hydrolysate of this substance and used as the test substance (OECD TG 421, from 2 weeks before mating until day 3 of lactation), no reproductive toxicity was observed at the doses where no severe dermal irritation was observed (REACH registration dossier (Accessed Sep. 2020)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in the oral route. The findings in (2) were considered to be nonspecific symptoms that appeared near the lethal dose. 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 an acute oral toxicity test with rats and mice dosed by feeding, the animals became inactive immediately after the substance was administered at each dose from 500 to 4000 mg/kg (from the range for Category 2 to the range corresponding to "Not classified") (NTP TR252 (1987), NICNAS IMAP (2017)). (2) It was reported that in an acute oral toxicity test with rats dosed by feeding, depression and coma were observed before death. The LD50 was reported to be 6,330 mg/kg (JECFA (1967), NTP TR252 (1987)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), 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 13-week oral administration test with rats dosed by gavage (5 days/week), no effect was observed at doses of up to 2,000 mg/kg/day (converted 7 days/week equivalent value: 1,430 mg/kg/day, in the range corresponding to "Not classified"), but death (2/10 males, 1/10 females), depression, reduced body weight gain, and reddened mucosa of the stomach (males) were observed at 4,000 mg/kg/day (converted 7 days/week equivalent value: 2,860 mg/kg/day, in the range corresponding to "Not classified"). However, no treatment-related abnormality was observed in a histopathological examination (NTP TR 252 (1987), NICNAS IMAP (2017)). (2) It was reported that in a 13-week oral administration test with mice dosed by gavage (5 days/week), no effect was observed at doses of up to 1,000 mg/kg/day (converted 7 days/week equivalent value: 714 mg/kg/day, in the range corresponding to "Not classified"), but death, effects on the liver, kidney, myocardium (cytoplasmic vacuolization, accumulation of lipid in the vacuoles and cells), and stomach effects (focal suppurative inflammation, focal ulcerative inflammation, submucosal edema) were observed at 2,000 mg/kg/day (converted 7 days/week equivalent value: 1,430 mg/kg/day, in the range corresponding to "Not classified") (NTP TR 252 (1987), NICNAS IMAP (2017)).
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 72-hour ErC50 = 3.72 mg/L for algae (Desmodesmus subspicatus) (REACH registration dossier, 2021).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 because sufficient data on rapid degradability were not obtained and due to 72-hour NOErC = 0.585 mg/L for algae (Desmodesmus subspicatus) (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 in Category 3 because sufficient data on rapid degradability were not obtained and due to 48-hour EC50 = 14.1 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021). By drawing a comparison between the above results, it was classified in Category 2.
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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