GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 108-91-8
Chemical Name Cyclohexylamine
Substance ID 24B6509
Classification year (FY) FY2012
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
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 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.
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
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 classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 265 deg C (Ullmanns (E) 6th, 2003).
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
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine.
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
-
-
- - 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.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
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)).
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
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.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - No data available.
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).
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).
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
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.
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)).
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.
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)).
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).
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).
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 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)).
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 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."
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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