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 |
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 |
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. |
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. |
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. |
|