GHS Classification Result

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 141-43-5
Chemical Name 2-Aminoethanol
Substance ID H26-B-007, -
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 FY2007   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 4
-
Warning
H227 P370+P378
P403+P235
P210
P280
P501
It was classified in Category 4 based on a flash point of 85 deg C (closed cup) and a boiling point of 171 deg C (ICSC (2014)).
Besides, it is classified in Class 8, PG II (UN2491) in UNRTDG.
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 410 deg C (ICSC (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) Not classified
-
-
- - There are 6 reports of LD50 values of 1,720 mg/kg (PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on May 2014)), 3,320 mg/kg (PATTY (6th, 2012), ACGIH (7th, 2001)), 10,200 mg/kg, 20,000 mg/kg, 1,515-3,320 mg/kg (DFGOT vol. 12 (1999)) and 500-20,000 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rats. According to the GHS classification guidance for the Japanese government, It was classified as "Not classified" to which the larger number of values corresponded (one value corresponded to Category 4, and 3 values to "Not classified" (among of them, one value corresponded to Category 5 in UN GHS classification)). In addition, 2 values were not included in the number since they were aggregations of multiple data).
New information (PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on May 2014), PATTY (6th, 2012), DFGOT vol. 12 (1999), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) were added, and it was classified as "Not classified" to which the larger number of values corresponded according to the revised GHS classification guidance for the Japanese government.
1 Acute toxicity (Dermal) Category 4


Warning
H312 P302+P352
P280
P312
P321
P362
P364
P501
There are 3 reports of LD50 values of 1,000 mg/kg (ACGIH (7th, 2001)), 1,018 mg/kg (PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)) and 1,025 mg/kg (DFGOT vol. 12 (1999)) for rabbits. It was classified in Category 4 to which the larger number of values corresponded (one value corresponded to Category 3, and 2 values to Category 4) based on the GHS classification guidance for the Japanese government.
New information (PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), DFGOT vol. 12 (1999)) were added, and it was classified in Category 4 to which the larger number of values corresponded based on the revision of the GHS classification guidance for the Japanese Government.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a report that by exposure to the saturated vapour with rats for 8 hours (converted 4-hour equivalent value: 739 ppm), poisoning symptoms were not observed (DFGOT vol. 12 (1999)).
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 1A


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
In a test in which the undiluted solution was applied to the skin of rabbits for 1 minute or 5 minutes and washed, bleeding and application time-dependent redness and necrosis were observed in the skin 1 day after application, and from 8 days after application, formation of desquamation was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, necrosis was observed at the site of application in the other two tests where the undiluted solution was applied to the skin of rabbits and in 1 study by application to the auricles of rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Moreover, there is a report that redness and edema were observed in a 1.5-hour semi-occlusive dermal application test in human volunteers (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above results, it was classified in Category 1A. Besides, this substance was classified as "C; R34" in the EU DSD classification, and as "H314 Skin corr. 1B" in the EU CLP classification.
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
In an eye irritation test with rabbits, severe chemical burns, corneal opacity and severe edema were observed from the nictating membrane to the conjunctiva and lid margin after administration of the undiluted solution and these did not disappear at 8 days (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, severe irritation was observed in an other two eye irritation tests with rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above results, it was classified in Category 1. Besides, in a test where one drop of a 30% aqueous solution was instilled into human eyes, temporary irritation and hyperemia were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
4 Respiratory sensitization Classification not possible
-
-
- - There is a report that inflammation of the upper respiratory organs and chronic bronchitis were observed in workers exposed to 1 mg/m3 or above of this substance used as a corrosion inhibitor for metals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, there is a description that when an aerosol inhalational provocation test was conducted against 14 patients who developed an asthmatic attack due to a hair care product containing this substance, a positive reaction was observed in all patients (BUA 202 (1996)). However, it is concluded in BUA 202 (1996) that symptoms observed by occupational exposure were not proven to originate from monoethanolamine alone. From the above, the data in humans were judged to be inadequate data for classification because of the lack of conditions and results to determine the relationship between exposure to this substance alone and developed symptoms.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
There is a report that in a skin sensitization test with guinea pigs, moderate sensitization (4/5 animals) was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, in epidemiological information, a strong positive result was observed in a patch test on a lathe operator using water-soluble oil containing this substance (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Moreover, there is a report that allergic skin disease and eczema were observed in 104 workers (64 men, 40 women) exposed to the vapour of this substance used as a corrosion inhibitor for metals for 1-3 years (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above results, it was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a micronucleus test with mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), DFGOT vol.12 (1999)). As for in vitro, it was negative in bacterial reverse mutation tests and chromosomal aberration tests and a sister chromatid exchange test with cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), DFGOT vol.12 (1999), PATTY (6th, 2012), NTP DB (Access on July 2014)). There were no data in in-vitro gene mutation test.
6 Carcinogenicity Classification not possible
-
-
- - There were no carcinogenicity classifications by international organizations. Besides, in a carcinogenicity study with males and females of F344 rats dosed with drinking water for 2 years (0, 800, 2,400 or 7,200 ppm (w/w)), or in a carcinogenicity study with males and females of B6D2F1 mice dosed with drinking water for 2 years (0, 800, 2,000 or 5,000 ppm (w/w)), no carcinogenicity was observed in either study (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on May 2014)). There were no other data. Therefore, classification was not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - No abnormalities were observed in fetuses and neonates even at a dose (450 mg/kg bw/day) where maternal toxicity (decreased body weight gain) was observed in a teratogenicity test with rats by the oral route. In a study in which pregnant mice were administered by gavage on Days 6-15 of pregnancy and were allowed to deliver, at a dose (850 mg/kg bw/day) where maternal toxicities (death of 16%; hypoactivity, hunched posture, labored breathing or tachypnea, wheezing, rare tremors, piloerection and hemorrhagic secretion from the vagina, etc, a significant decrease in body weights 3 days after delivery) were observed, and a significant decrease in birth rate were observed, but no effects on litter size, survival rate of the pups, birth weight and body weight gain were observed (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)).
Besides, other than these, there is a report that embryotoxicity/fetotoxicity (fetal resorption or fetal death, lower weight) and increases in variations and malformations (variations of the sternum, nephropathy/hydroureter) were observed at doses where no maternal toxicity was observed in a teratogenicity test with rats by the oral route by Mankes (1986). However, there was a significant difference between the results of this report and other tests conducted under the GLP, and as causes for this, it is pointed out that the experimental design was not intended for safety evaluation, the number of animals in one group was as small as 10, classification for malformations was not general, and the findings in the kidneys during usual developmental stages were also regarded as abnormal, etc. (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). Therefore, this report was not used for GHS classification.
As in the above, although no teratogenicity was observed, no information on fertility was available, therefore, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, respiratory organs, liver), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
In humans, there are reports of cough, headache, shortness of breath, sore throat, vomiting, weakness, dizziness, numbness of the upper extremities and chest pains by inhalation exposure, and of inflammation of the upper respiratory organ, chronic bronchitis, acute liver damage and subsequent chronic hepatitis by inhalation exposure to 1 mg/m3 or above (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), DFGOT vol.12 (1999)). In addition, by oral ingestion, it caused abdominal pain, burning sensation, shock/prostration, effects on the central nervous system, and lowering of consciousness (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)).
As for experimental animals, there are reports of apathy, reduced mobility, staggering gait, tonic-clonic spasms, dyspnea, abdominal position, paralysis of motor nerves, hypertension, sedation, muscle tremors and delayed death by the oral route, and there is a report of necrosis in the liver parenchyma at autopsy (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), BUA 202 (1996)). These symptoms were observed within the guidance values corresponding to Category 2 or 3. In addition, there is a description that this substance was a respiratory irritant and a neurotoxin (PATTY (6th, 2012)).
From the above, although symptoms were observed within the guidance value corresponding to Category 2 or 3 in experimental animals, with an emphasis on effects on humans, it was classified in Category 1 (central nervous system, respiratory organs, liver), Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system), Category 2 (respiratory organs)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
No data were available for classification in humans. As for experimental animals, since both in a 13-week test with rats dosed by feeding (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), ACGIH (7th, 2001), DFGOT vol.12 (1999), PATTY (6th, 2012)), and in 13-week and 104-week tests with rats and mice dosed by drinking water (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on May 2014)), at doses far exceeding Category 2, mainly, effects on the kidneys (increased weight, increased blood urea nitrogen, with urine protein positive, renal papillary degeneration/necrosis) were observed, it was considered equivalent to "Not classified" by the oral route.
By the inhalation route, in tests in which, varying concentrations and duration of exposure, rats, guinea pigs and dogs were exposed to the vapour of this substance by inhalation for 24 hours/day (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2001), DFGOT vol.12, 1999), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), PATTY (6th, 2012), the description contents were confirmed by an original source (Weeks, M. H. et al. (1960))), in rats and dogs, a decrease in activity by exposure to 12-15 mg/m3 for 40 days or 60 days (converted guidance value: 0.021-0.04 mg/L/6 hours), and lethargy by exposure with rats, guinea pigs and dogs at 29-64 mg/m3 for 90 days (converted guidance value: 0.12-0.26 mg/L/6 hours) were observed. Therefore, effects on the central nervous system were observed within the range of Category 1. In addition, in the high-concentration exposure groups, by exposure with rats to 162 mg/m3 for 30 days and exposure with guinea pigs to 184 mg/m3 for 24 days, many death cases occurred (83% in rats (37/45 animals), 75% in guinea pigs (23/30 animals)), and pathological examinations including those of dead animals revealed gross or histological changes in the gastrointestinal tract, liver, kidney, lung, bone marrow and testis, but they were excluded from the target organs because they may have been findings including postmortem changes, or exhaustion changes observed in a state of general fatigue. Besides, as described in the hazard class of specific target organ toxicity (single exposure), since this substance was a respiratory irritant, Category 2 (respiratory organs) was added in addition to Category 1 (central nervous system) also as a target organ for repeated exposure.
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) -
-
-
- - -
11 Hazardous to the aquatic environment (Long-term) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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.

To GHS Information