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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	79-77-6
Chemical Name	Ionone
Substance ID	24A6138
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/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)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	From flash points of 127 deg C [closed-cup] (SIDS (Access on Dec. 2012)) and 110 deg C [test method; unknown] (Gangolli (2nd, 1999)), it was judged to be above 93 deg C. Therefore, it was classified as "Not classified."
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with self-reactive properties (unsaturated bond) present in the molecule, but it was judged to be Type G from the information: nicht explosionsgefaehrlich aufgrund der chemischen Struktur (IUCLID (2000)).
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 270 deg C (SIDS (Access on Dec. 2012)).
10	Pyrophoric solids	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 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 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 applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification or "Not classified") because no deaths were seen at or below 2,000 mg/kg/day in a 5-day repeated oral administration test with rats (doses: 500, 1,000, 2,000, 4,000, 8,000 mg/kg bw/day) (SIDS (Access on Dec. 2012)). Besides, there is a report on an LD50 value for rats of 4590 mg/kg/day for an isomer mixture containing 40% of this substance (beta-ionone) and 60% alpha-ionone (SIDS (Access on Dec. 2012)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because scores for erythema and edema were 0 at all observation time points, and it was not irritating in a test by a 4-hour semi-occlusive application of 0.5 mL of undiluted this substance to the rabbit skin (OECD TG 404, GLP) (SIDS (Access on Dec. 2012)). Besides, it is reported that a 24-hour patch test on an isomer mixture containing 40% of this substance (beta-ionone) and 60% alpha-ionone did not produce skin reactions in 11 humans (SIDS (Access on Dec. 2012)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It was classified as "Not classified" because it is reported that slight irritation was seen in a test in which 0.1 mL of undiluted this substance was applied to the rabbit eye (OECD TG 405, GLP), but the average score for 24, 48, and 72 hours was corneal opacity: 0.1, iritis: 0.2, conjunctival redness: 1.0, chemosis: 0.1, and all irritation reactions disappeared within 72 hours (SIDS (Access on Dec. 2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	It is reported that it was not sensitizing in a skin sensitization test with guinea pigs (a maximization test) (SIDS (Access on Dec. 2012)), but because it was a limited test in five animals in test groups (OECD guideline requires at least 10) and four in the control group, and it is questionable to classify it as "Not classified." Therefore, it was classified as "Classification not possible" due to lack of data.
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow cells after intraperitoneal administration to mice (OECD TG 474, GLP) (in vivo somatic cell mutagenicity test) (SIDS (Access on Dec. 2012)). Besides, as for in vitro tests, it was reported to be negative in an Ames test (SIDS (Access on Dec. 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	In a developmental toxicity test by oral administration to rats on gestational days 6-19 (doses: 25, 100, 400 mg/kg/day), salivation immediately after administration at or above 100 mg/kg/day and a significant decrease in mean body weights at 400 mg/kg/day were observed as general toxicity in parent animals, but there were no effects on gestational parameters, developmental toxicity, or teratogenicity (SIDS (Access on Dec. 2012)), and it was considered that this substance had no adverse effects on the development of offspring. On the other hand, in a two-generation reproductive test by oral administration to rats, there were no significant differences in maternal animals, offspring, and offspring from F1-generation after 3-time parturition, and no fertility effects were found (USEPA/HPV (2004)), but a test dose was 8-10 mg/kg/day, which was very low and only one, and was insufficient to check adverse effects on sexual function/fertility. Therefore, it was classified as "Classification not possible" due to lack of data.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	After oral administration of an isomer mixture containing 40% of this substance and 60% alpha-ionone (LD50 value: 4,940 mg/kg), deaths occurred between 4 hours and 4 days, and toxic signs of depression and tremors were reported (SIDS (Access on Dec. 2012)), but further details are unknown. Therefore, it was classified as "Classification not possible" due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 90-day diet administration test with rats (OECD TG 408, GLP, doses: 100, 1,000, 10,000 ppm (7.5, 77.5, 760.5 mg/kg bw/day)), the target organs were reported to be the liver, kidney, and thyroid. However, as for the liver, hypertrophy of hepatocytes was observed, which was regarded as an adaptive change to increase the metabolizing or excretory capacity (SIDS (Access on Dec. 2012)), and as for the kidney, the formation of alpha-2-micro globulin was confirmed immunohistochemically, which was a specific phenomenon in male rats and not extrapolated to other animal species (SIDS (Access on Dec. 2012)). Therefore, the effects on the liver and kidney do not indicate adverse effects in humans. On the other hand, thyroid effects were found at doses above the upper limit of the guidance value range (SIDS (Access on Dec. 2012)). From the above, no adverse effects were seen within the guidance value range, but effects around the upper limit (100 mg/kg/day) of the guidance value range are unclear. Furthermore, due to no data in the other routes, it was classified as "Classification not possible" for this hazard class.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 1.1 mg/L for crustacea (Daphnia magna) (SIDS, 2006).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (BIOWIN), and 72-hour ErC10 = 7.1 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2006). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (BIOWIN), and 48-hour EC50 = 1.1 mg/L for crustacea (Daphnia magna) (SIDS, 2006). From 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.

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