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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	2216-51-5
Chemical Name	(1R,2S,5R)-2-Isopropyl-5-methylcyclohexan-1-ol
Substance ID	25A0092
Classification year (FY)	FY2013
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)	GHS Classification Guidance by the Japanese Government (July, 2013)
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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solid	Classification not possible	- -	-	-	It is combustible, but the classification is not possible due to no data.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	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 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	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 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.

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" (Category 5 in UN GHS classification) based on a report on LD50 values of 2,615 mg/kg and 2,426 mg/kg for rats (SIDS (2004)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	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	It was classified in Category 2 because it is reported that the average scores for erythema and edema were 3.0, 2.9, respectively in a test in which undiluted this substance was applied to rabbits (according to OECD TG 404), and recovery was seen 14 days after application (SIDS (2004)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In two eye irritation tests (OECD TG 405) on 29% and 64% solutions of this substance in diethyl phthalate, it was assessed to be moderately irritating (SIDS (2004)). The average scores were 0.2 for corneal opacity, 0.6 for conjunctival redness, and 0.1 for chemosis for a 29% solution, and 1.0 for corneal opacity, 2.0 for conjunctival redness, and 0.6 for chemosis for a 64% solution, and all the findings disappeared within seven days for a 64% solution. Furthermore, it is reported in SIDS (2004) that undiluted menthol liquid (unknown which isomer was used) was slightly irritating. It was classified in Category 2B based on the above results.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	The results of a Buehler test, an LLNA test, and a modified Draize test were described in SIDS (2004). In the Buehler test (according to OECD TG 406), it was negative in all ten animals. Negative results were obtained in the LLNA test using 6-8 animals per group. In the modified Draize test, a positive reaction was observed only after the second induction and challenge, and it was assessed to be an ambiguous result. Because it is concluded in SIDS (2004) that this substance is not sensitizing based on the above results, it was classified as "Not classified."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a micronucleus test with mice (SIDS (2004)). As for in vitro, it was negative in all of a bacterial reverse mutation test, a chromosomal aberration test with cultured mammalian cells, and a mouse lymphoma test (SIDS (2004)).
6	Carcinogenicity	Classification not possible	- -	-	-	There is no classification of carcinogenicity by international organizations. Besides, two 2-year carcinogenicity tests in mice and rats are reported for the D/L isomer (CAS 89-78-1), the isomer of this substance, and both were negative (SIDS (2004)).
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, no maternal toxicity or developmental toxicity was observed in developmental toxicity tests with rats, mice, rabbits, and hamsters (SIDS (2004)). No fertility data were obtained.
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	It was classified in Category 3 (narcotic effects) because it is described that narcotic effects were observed after oral administration (1,000-4,000 mg/kg) to rats (SIDS (2004)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There are descriptions of two oral administration tests and one inhalation exposure test with rats in SIDS (2004), neither of which gave data usable for classification. Therefore, it was classified as "Classification not possible" due to lack of data. In a 28-day gavage administration test with rats, effects on the liver (weight increase and vacuolization of hepatocytes) were observed at the dose (200 mg/kg/day; converted guidance value: 62.2 mg/kg/day) corresponding to Category 2, but it was judged that the changes in the liver were not toxicity findings but adaptive responses in the body based on the reasons including the poor dose-response relationship and unknown degree of weight increase. On the other hand, in a 5.5-week diet administration test with rats, no effects were found at up to the highest dose (200 mg/kg/day), but it is unknown whether there is toxicity at the upper limit of guidance values because the doses did not cover the range for Category 2. Furthermore, in a repeated inhalation (71-79 days) toxicity test with rats, irritation symptoms in the respiratory organs were seen, but it is described that the measurement of the exposure concentrations was not reliable. Therefore, it was impossible to adopt respiratory organs as the target organs.
10	Aspiration hazard	Classification not possible	- -	-	-	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 (Acute)	Category 3	- -	H402	P273 P501	From 96-hour LC50 = 15.6 mg/L for fish (Danio rerio) (SIDS, 2004), it was classified in Category 3.
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 79-92% (SIDS, 2004)), and 96-hour NOEC = 9.65 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2004). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, there are data: 96-hour LC50 = 15.6 mg/L for fish (Danio rerio) (SIDS, 2004). However, it is rapidly degradable (a degradation rate by BOD: 79-92% (SIDS, 2004)), and low bioaccumulation is estimated (log Kow = 3.3 (HSDB, 2013)). Therefore, it is classified as "Not classified." By drawing a comparison between 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.

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