NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	108-91-8
Chemical Name	Cyclohexylamine
Substance ID	m-nite-108-91-8_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It corresponds to Category 3 from a flash point of 26.5 deg C [closed-cup] (Ullmanns (E) 6th, 2003) >= 23 deg C and <= 60 deg C.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 265 deg C (Ullmanns (E) 6th, 2003).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	There is the information that zinc, lead, and aluminum are resistant to amines (Hommel (1996)), it attacks aluminum, copper, and zinc (ICSC (2003)), and it is corrosive to copper, aluminum, zinc, and galvanized steel (HSDB (2009)). However, due to no data in the prescribed test on the corrosion rate, the classification is not possible.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Six LD50 values for rats (11, 590, 610, 156, 237, 278 mg/kg (all DFGMAK-Doc. 22 (2006))) were used for classification, and one to Category 2, three to Category 3, and two to Category 4 corresponded. Therefore, it was classified in Category 3, to which most corresponded.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	It was classified in Category 3 based on an LD50 value of 277 mg/kg for rabbits (DFGMAK-Doc. 22 (2006)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	There is a report on an LC50 value of 7,500 mg/m3 (= 1,850 ppm) by 7-hour exposure of rats [converted 4-hour equivalent value: 2,447 ppm] (PATTY (5th, 2001)). And because 6-hour exposure of rats resulted in no deaths in three animals at 1,000 ppm and deaths in 3/3 animals at 1,200 ppm (DFGMAK-Doc. 22 (2006)), an LC50 value was estimated to be 1,000-1,200 ppm (converted 4-hour equivalent value; 1,225-1,470 ppm). Both of these LC50 values correspond to Category 3. Besides, because the test concentrations were lower than 90% of the saturated vapour pressure concentration (13,289 ppm), the reference value of gas (ppm) was applied.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	Open application to the rabbit skin resulted in a damage level of 7 on a scale of 1 to 10 within 24 hours, necrosis was seen (DFGMAK-Doc. 22 (2006)), and it is reported that this substance was found to be corrosive after 4-hour or 24-hour semi-occlusive application of 0.5 mL to the rabbit skin (DFGMAK-Doc. 22 (2006)). Furthermore, by 24-hour occlusive application of undiluted this substance to the guinea pig skin, edema, necrosis, and persistent eschars were observed, and severe irritation was shown (ACGIH (2001)). It was classified in Category 1 based on the above findings. Besides, pH is 11.5 (100 g/L).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is reported that application to the rabbit eye caused necrosis (level 10 on a scale of 1 to 10) (DFGMAK-Doc. 22 (2006)), a single drop of a 50% solution administered to the rabbit eye resulted in complete destruction of the eye (DFGMAK-Doc. 22 (2006)), and a corrosive effect was observed after application of 0.1 mL to the rabbit eye (DFGMAK-Doc. 22 (2006)). Therefore, it was classified in Category 1. Besides, pH is 11.5 (100 g/L).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	It is described that attempts to sensitize guinea pigs by application of a 1% solution of this substance failed (ACGIH (2001)), and it is reported that as a result of applying a 25% solution of this substance to the dorsal skin of volunteers and a challenge 2 weeks later, sensitization reactions were observed in 13% of the subjects (Initial Risk Assessment Report Ver. 1.0, 135 (NITE, CERI, NEDO, 2008)). However, because neither of the above has descriptions of the test methods, and the details of the test results are unknown, it was classified as "Classification not possible" due to lack of data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 1B because a positive result in a dominant lethal test by intraperitoneal administration to mice (in vivo heritable germ cell mutagenicity test) (Initial Risk Assessment Report Ver. 1.0, 135 (NITE, CERI, NEDO, 2008)) and a positive result in a chromosomal aberration test with spermatogonial cells after intraperitoneal administration to rats (in vivo germ cell mutagenicity test) (Initial Risk Assessment Report Ver. 1.0, 135 (NITE, CERI, NEDO, 2008)) were obtained. Besides, other than the above, there are also reports on negative results in dominant lethal tests by intraperitoneal administration to mice or oral administration to rats (Initial Risk Assessment Report Ver. 1.0, 135 (NITE, CERI, NEDO, 2008)) and negative results in chromosomal aberration tests with spermatogonial cells after intraperitoneal administration to mice or Chinese hamsters (Initial Risk Assessment Report Ver. 1.0, 135 (NITE, CERI, NEDO, 2008)). And there are both negative and positive results also in in-vivo chromosomal aberration tests with somatic cells (bone marrow). As for in vitro tests, an Ames test was negative, but both negative and positive results were reported in chromosomal aberration tests with cultured cells (Initial Risk Assessment Report Ver. 1.0, 135 (NITE, CERI, NEDO, 2008), NTP DB (1982)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because ACGIH classified it in A4 for carcinogenicity. Besides, it is reported that in tests by long term diet administration of this substance or its hydrochloride to rats or mice, there were no treatment-related tumors (DFGMAK-Doc 22 (2006), Initial Risk Assessment Report Ver. 1.0, 135 (NITE, CERI, NEDO, 2008)) although they were not according to the current guidelines.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	As for reproductive toxicity, there are reports on reduced fertility in male in the first of three matings in a one-generation reproductive test by oral administration to rats (DFGMAK-Doc 22 (2006)), increased postnatal mortality in a four-generation reproductive test by diet administration to mice (DFGMAK-Doc 22 (2006)), increased fetal mortality in a developmental toxicity test by oral administration to pregnant mice on gestational days 6-11 (Initial Risk Assessment Report Ver. 1.0, 135 (NITE, CERI, NEDO, 2008)), and increased resorptions in a developmental toxicity test by intraperitoneal administration to pregnant mice on a gestational day 11 (DFGMAK-Doc 22 (2006)). However, because neither of the above has descriptions of general toxicity in parent animals, it was classified in Category 2. Besides, there is also a report on reproductive effects such as a decrease in the number of live birth, and an increase in postnatal mortality, and a decrease in implants in a six-generation reproductive test by diet administration of the sulfate of this substance to mice (DFGMAK-Doc 22 (2006)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, cardiovascular system), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	Among three workers exposed to the vapour of this substance in a workplace accident, one person complained of restlessness, cardiac palpitations, and sleeplessness after about 1-hour exposure, a second person splashed this substance with a potent alkaline solution into his face developed nausea, repeated vomiting, incoherence of speech, and distension of his pupils, but a third person only had a symptom of nausea (DFGMAK-Doc. 22 (2006)). It is described that this substance is considered a nerve poison and causes central nervous system depression (PATTY (5th, 2001)), and it acts on the spinal motor centers and medulla, producing delayed convulsions several hours after administration (JECFA 202 (1970)). Therefore, it was classified in Category 1 (nervous system). On the other hand, it was classified in Category 1 (cardiovascular system) because it is reported that there was a dose-dependent and significant increase in the mean systolic and diastolic blood pressure one hour after a single oral dose of 5 or 10 mg/kg to healthy male volunteers, and the vasopressant effect was accompanied by a slight drop in heart rate (DFGMAK-Doc. 22 (2006)), and sympathomimetic and cardiovascular effects are described for this substance (DFGMAK-Doc. 22 (2006)). And because the chief acute effects of this substance include respiratory tract irritation (ACGIH (2001)), it was classified in Category 3 (respiratory tract irritation).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In multiple 13-week diet administration tests with rats and mice (two each for rats and mice), only reduced weight gain and decreases in food consumption were observed within the guidance value range, and treatment-related adverse effects were findings in the testis such as testicular atrophy, degeneration of the seminiferous tubules, and vacuolation of the Sertoli cells found in rats at doses exceeding the upper limit of the guidance values (DFGMAK-Doc. 22 (2006)). Therefore, it is classified as "Not classified" in the oral route. On the other hand, it is reported that after 2-month inhalation exposure of rats to 700 mg/m3, there were decreases in hemoglobin and erythrocyte counts and an increased number of reticulocytes, and necropsy revealed a deposit of hemosiderin in the liver, spleen, and lung as well as elongated follicles with squamous epithelium in the thyroid (DFGMAK-Doc. 22 (2006)). However, it was not used for classification because it is described that the study is not useful for evaluation purposes, as the effects obtained could not be reproduced in other studies (DFGMAK-Doc. 22 (2006)). From the above, for the other routes, due to lack of data in the inhalation route and no data in the dermal route, it was classified as "Classification not possible" for specific target organ toxicity (repeated exposure).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 72-hour ErC = 32.7 mg/L for algae (Pseudokirchneriella subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to being rapidly degradable (readily biodegradable (a 2-week degradation rate by BOD: 61.8%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1979)), and 21-day NOEC = 1.6 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)). 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" due to being rapidly degradable (readily biodegradable (a 2-week degradation rate by BOD: 61.6%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1979)), and a low bioconcentration estimate (Log Kow = 1.49 (PHYSPROP Database, 2009)). From the above results, it was classified as "Not classified."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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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