GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 110-91-8
Chemical Name Morpholine
Substance ID H29-B-042
Classification year (FY) FY2017
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) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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) 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
Based on a flash point of 31 deg C (closed cup) (GESTIS (Access on June 2017)), it was classified in Category 3. Besides, it is classified in Class 8, Subsidiary risk 3, PGI in UNRTDG (UN 2054).
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 275 deg C (GESTIS (Access on June 2017)).
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 in the molecule
16 Corrosive to metals Classification not possible
-
-
- - There is the information that it is corrosive to metals (HSDB (Access on June 2017)), 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) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
Based on the reports of LD50 values for rats of 1,050 mg/kg (EHC 179 (1996), IARC 47 (1989), ACGIH (7th, 2001), PATTY (6th, 2012)), 1,420 mg/kg (PATTY (6th, 2012)), 1,600 mg/kg (EHC 179 (1996), PATTY (6th, 2012), SIDS (2015)), 1,610 mg/kg (PATTY (6th, 2012)), and 1,900 mg/kg (EHC 179 (1996), SIDS (2015)), it was classified in Category 4.
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
Based on the reports of LD50 values for rabbits of 310 mg/kg (PATTY (6th, 2012)), 500 mg/kg (PATTY (6th, 2012)), 810 mg/kg (PATTY (6th, 2012)), and 0.5 mL/kg (504 mg/kg) (EHC 179 (1996), IARC 47 (1989), PATTY (6th, 2012), SIDS (2015)), it was classified in Category 3.
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
Based on the reports of LC50 values of 7.8 mg/L (2,192 ppm) (female) and 8.2 mg/L (2,304 ppm) (male) in a 4-hour inhalation test with rats (both in EHC 179 (1996)), it was classified in Category 3. Besides, since the LC50 values are lower than 90% of the saturated vapor pressure concentration (10,495 ppm), a reference value in the unit of ppm was applied as vapor with little mist.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
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
Based on the description that this substance is corrosive to the human skin (SIDS (2015)), and multiple test reports that necrosis occurred due to the application of this substance in skin irritation tests with rabbits (EHC 179 (1996), IARC 47 (1989), ACGIH (7th, 2001), PATTY (6th, 2012), SIDS (2015)), it was classified in Category 1. Besides, in the EU CLP classification, this substance was classified as "Skin Corr. 1B" (ECHA CL Inventory (Access on June 2017)).
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
Since it was classified in Category 1 for skin corrosive/irritation, it was classified in Category 1. Besides, as for humans, it is reported that corneal edema was caused by an application of this substance (IARC 47 (1989)), and there is a description of severe irritation (ACGIH (7th, 2001), IARC 47 (1989), PATTY (6th, 2012)). Also, in an eye irritation test with rabbits, an application of this substance caused edema, corneal opacity, and staphyloma (EHC 179 (1996)). The category was changed according to the GHS classification guidance for the Japanese government.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. There is a description that no sensitization was shown in the skin sensitization test by the modified Buehler method with guinea pigs (EHC 179 (1996), PATTY (6th, 2012)). However, since it is a result at a 2% concentration of this substance, and the information on the experimental conditions and results, etc. is not sufficient, it was classified as "Classification not possible."
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, it is reported that it was negative in a dominant lethal test with rats, negative in a micronucleus test, a chromosomal aberration test, and a gene mutation test with Syrian hamster fetuses, and negative in a chromosome aberration test (SIDS (2015), IARC 47 (1989), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). In addition, it is reported that chromosomal aberration tests with bone marrow cells of rats and guinea pigs were positive, but it is described that there were deficiencies in these tests (EHC 179 (1996)). As for in vitro, it was negative in many of bacterial reverse mutation tests, positive in a mouse lymphoma test, negative in a chromosome aberration test, and negative or positive results in sister chromatid exchange tests with mammalian cultured cells (IARC 47 (1989), SIDS (2015), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), EHC 179 (1996), PATTY (6th, 2012)). From the above, it was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government. Category 2 in the previous classification was reviewed, and the category was changed.
6 Carcinogenicity Classification not possible
-
-
- - Carcinogenicity tests with two strains of mice, one strain of rat and one strain of hamster dosed by feeding were conducted. Among them, tests in one strain of mice and hamsters are considered to be inadequate for evaluation due to the small number of animals or short administration period, etc. (IARC 47 (1989), IARC 71 (1999)). No increase in tumor incidence was observed in the test with the other strain of mouse. On the other hand, in the test with rats, a significant increase in incidence of tumors in the lung and liver was shown. Other than these, no significant increase in tumor incidence was seen in a two-year test with rats exposed by inhalation (IARC 47 (1989), IARC 71 (1999)). From the above, IARC classified it in Group 3 since evidence of carcinogenicity in experimental animals is inadequate (IARC 47 (1989), IARC 71 (1999)). Also, ACGIH classified it in A4 (ACGIH (7th, 2001)). Therefore, it was classified as "Classification not possible" for this hazard class.
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a report that as a result of gavage administration of this substance to pregnant rats during the organogenesis period (gestational day 6-15), transient clinical signs such as nasal discharge, smudges around the nose, and salivation were observed in the maternal animals, however, no effects on the embryo or fetus were observed (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)).
8 Specific target organ toxicity - Single exposure Category 1 (respiratory organs)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
It is reported that the liquid and vapor of this substance are irritating to the mucous membranes, and the researcher himself who handled this substance developed nasal irritation and cough (ACGIH (7th, 2001)). As for experimental animals, there is a report that in a 4-hour inhalation exposure test with rats, an increase in respiratory rate and the finding of lung irritation were observed at 73 ppm (0.252 mg/L) within the range of Category 1 (PATTY (6th, 2012)). The information on humans was not adopted as evidence since there is only one case, but in an animal test, the effect on the lung was seen at the dose of Category 1, therefore, it was classified in Category 1 (respiratory organs).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs)


Danger
H372 P260
P264
P270
P314
P501
No information on humans is available.
As for experimental animals, in a 13-week inhalation toxicity study with rats exposed to the vapour (6 hours/day, 5 days/week), focal necrosis and necrotic cell debris in the nasal cavity at or above 340 mg/m3 (converted guidance value: 0.25 mg/L) within the guidance value range for Category 2, increases in focal erosion and squamous metaplasia in the turbinate, maxilloturbinate, nasal septum, and anterior nasal cavity, and chronic pneumonia at 920 mg/m3 (converted guidance value: 0.66 mg/L) were observed (Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), EHC 179 (1996), ACGIH (7th, 2001), PATTY (6th, 2012), IARC 47 (1989)). In a 104-week inhalation toxicity study with rats exposed to the vapour, focal necrosis of the skin, necrosis of the turbinate bones at or above 180 mg/m3 within the guidance value range for Category 1, and inflammation and hyperplasia of the turbinate epithelium in the nasal cavity, corneal inflammation, edema and ulcer in the eyes etc. at 540 mg/m3 (0.54 mg/L) within the guidance value range (vapour) for Category 2 were observed (Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), EHC 179 (1996), ACGIH (7th, 2001), PATTY (6th, 2012)). Besides, significant necrosis of the turbinate bone was observed at 180 mg/m3 (0.18 mg/L) in this 104-week study, but in the evaluation documents other than Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), it is described that effects on the respiratory system were observed only at 540 mg/m3 (0.54 mg/L).
From the above, since effects on the nasal cavity considered to be due to irritation are observed as the main effect, it was classified in Category 1 (respiratory organs).
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, from the numerical data (viscosity: 2.23 mPa*s (20 deg C), density (specific gravity): 1.007) listed in HSDB (Access on June 2017), the kinematic viscosity was calculated to be 2.21 mm2/sec (20 deg C).

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 48-hour EC50 (immobile) = 45 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), it was classified in Category 3.
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - If chronic toxicity data are used, it was classified as "Not classified" due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 1979)), 21-day NOEC (reproduction inhibition) = 5.0 mg/L for crustacea (Daphnia magna) (OECD SIDS: 2013), and 72-hour NOEC (rate method) = 30.9 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)).
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 not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 1979)), and 96-hour LC50 >100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)).
From the above results, it was classified as "Not classified."
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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