GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 100-74-3
Chemical Name N-Ethylmorpholine
Substance ID H26-B-016, R-006
Classification year (FY) FY2014
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)
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 was classified in Category 3 based on a flash point of 30 deg C (closed cup) (GESTIS (Access on July 2014)).
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 240 deg C (GESTIS (Access on July 2014)).
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
-
-
- - 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) Category 4


Warning
H302 P301+P312
P362+P364
P264
P270
P330
P501
Based on reports of LD50 values of 1,500-2,000 mg/kg (male), 2,000 mg/kg (female) (JECDB (Access on June 2014), SIDS (2007)), 1,638 mg/kg (SIDS (2007)) and 1,780 mg/kg (ACGIH (7th, 2001), SIDS (2007), Environmental Risk Assessment for Chemical Substances vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009)) for rats, it was classified in Category 4.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
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 a report of an LC50 value (4 hours) of 2,000 ppm for rats (ACGIH (7th, 2001), SIDS (2007), Environmental Risk Assessment for Chemical Substances vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009)), it was classified in Category 3. Besides, since the LC50 value was lower than the saturated vapor concentration (6,618 ppm), the reference value in units of ppm was applied. New information sources (SIDS (2007), Environmental Risk Assessment for Chemical Substances vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009)) were added, and the classification was revised.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 1B


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
In a skin irritation test with rabbits (equivalent to OECD TG 404), moderate to severe irritation such as erythema and edema were observed 24 hours after application on application of this substance for 1-15 minutes or 20 hours, and necrosis was observed after 8 days on application for 5 minutes or above (SIDS (2007)). Based on this newly added test information, this substance was judged to be corrosive, and it was classified in Category 1B. The category was changed by adding the test information.
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
In an eye irritation test (equivalent to OECD TG 405) with rabbits, erythema, edema and corneal opacity were observed by application of 0.05 mL of this substance, and erythema and edema persisted until 24 hours after application, with corneal opacity until 8 days after application. In addition, there are reports that reversible corneal edema was observed by exposure to this substance at 40 ppm or above in humans (ACGIH (2001), SIDS (2007)), and that it was irritating to the eyes and may cause visual disturbance (Environmental Risk Assessment for Chemical Substances vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009)). In the workplace where this substance was handled, irritation to the eyes, corneal disorder, effects on color vision, etc. were reported. This substance was classified in Category 1B in the classification for Skin corrosion/irritation. From the above results, it was classified in Category 1.
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.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. There was no in vivo data. As for in vitro, it was negative in a chromosomal aberration test with cultured mammalian cells, and it was negative and weakly positive in bacterial reverse mutation tests (JECDB (Access on June 2014), SIDS (2007), NTP DB (Access on July 2014)). Besides, the findings of weakly positive were those at 6,667 and 10,000 microg/plate under the presence of a metabolic activation system in TA1535, and it was negative at the highest dose (5,000 microg/plate) in the current guideline.
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - In a reproduction/developmental toxicity screening test with rats by the oral route (gavage), at a dose (500 mg/kg/day) where parental toxicities (transient salivation, decreased body weight gain, decreased food consumption, death of 1 female animal on Day 2 of lactation) were observed, decreases in number of implantations and indexes for implantations, and 1 maternal animal which delivered 2 dead pups on Day 24 of gestation were observed without significant difference, and decreases in the number of live birth, indexes for live birth and indexes for birth were found without significant difference (JECDB (Access on June 2014), SIDS (2007)).
As in the above, although slight effects on fertility were observed at the dose where parental toxicities were observed, these effects were not statistically significant, therefore, they were not adopted. Since these were the results in the screening test, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Category 2 (nervous system), Category 3 (respiratory tract irritation)



Warning
H371
H335
P308+P311
P260
P264
P270
P405
P501
P304+P340
P403+P233
P261
P271
P312
In humans, irritation to the respiratory tract was the main effect by the inhalation route (Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009), SIDS (2007), ACGIH (7th, 2001), HSDB (Access on June 2014)).
In rats, dyspnea, strong irritation of the mucous membranes, trembling and staggering by inhalation exposure around the saturated concentration (1,100 ppm), and convulsions, ventral and lateral posture, hemorrhagic gastroenteritis, and at or above 1,000 mg/kg, tonic and/or clonic convulsions followed by decreased locomotor activity by oral administration were observed (SIDS (2007)). These effects were observed within the guidance value range corresponding to Category 1 by inhalation exposure and to Category 2 by oral administration.
From the above, although relatively strong effects were reported in rats, similar findings were not reported in human findings, and emphasizing that the effects on the nervous system and respiratory tract irritation were the main effects, it was classified in Category 2 (nervous system), Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 2 (nervous system)


Warning
H373 P260
P314
P501
Although some findings of the hazards by occupational exposures in humans were described in ACGIH (7th, 2001) and Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009), most of them were reports on the effects by acute exposure to this substance including those by acute combined exposure to other substances, and it was described in SIDS (2007) that there were no available data on effects by repeated exposure in humans.
As for experimental animals, in a test (OECD TG 407) with rats dosed by gavage for 28 days, cage-licking and chewing were observed in the administration groups of 200 and 800 mg/kg/day, and increased relative weights and histological changes (hypertrophy of the centrilobular hepatocytes, vacuolation of the tubular epithelium) were observed as effects on the liver and kidney in addition to tremors, eyelid closure, crouching position and decreased body weight gain in the administration group of 800 mg/kg/day (SIDS (2007), JECDB (Access on June 2014), Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009)). In evaluations of SIDS (2007) and the Ministry of the Environment (2009), behavioral changes at 200 mg/kg/day (converted guidance value: 62.2 mg/kg/day) were regarded as adverse effects and the NOAEL was calculated to be 50 mg/kg/day. That is, although behavioral changes (cage-licking and chewing) in the administration group of 200 mg/kg/day were intermittent changes of symptoms observed in 1-2 of 5 males and 1-4 of 5 females, and these were symptoms not necessarily observed in all animals, changes were considered to be a type of stereotypical behavior, therefore, they were judged to be toxicologically significant findings. Furthermore, since tremor and eyelid closure, etc. were also observed in the high dose group, it was considered appropriate to classify it in Category 2 (nervous system).
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) Not classified
-
-
- - It was classified as "Not classified" due to 72-hour ErC50 > 53 mg/L from for algae (Pseudokirchneriella subcapitata) (SIDS, 2005), 48-hour EC50 > 92 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, 2002), SIDS, 2005), 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, 2002)).
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 72-hour NOEC (growth rate) = 23 mg/L for algae (Pseudokirchneriella subcapitata) and 21-day NOEC = 99 mg/L for crustacea (Daphnia magna) (both SIDS, 2005), although it is not rapidly degradable (a degradation rate by BOD = 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2004)).
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" because it corresponds to "Not classified" in acute toxicity for fish and is not water-insoluble (water solubility = 1000000 mg/L, PHYSPROP Database, 2009).
From the above, 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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