GHS Classification Result (Revision of the past classification result)

Chemical Name:Ethanol, 2-(diethylamino)-
CAS:100-37-8

Result:
ID: 22B4511
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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: Flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Since its flash point 52 degC (closed-cup) (ICSC (J) (2002)) is >= 23 degC and <= 60 degC, it is classified into Category 3.
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 - - - - Since its autoignition temperature is 250 degC (ICSC (J) (2002)), it is considered that the substance does not ignite at room temperature.
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, C, 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
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Based on the rat LD50 values of 1320 mg/kg and 1300 mg/kg (SIDS (Access on Jun. 2009)), the substance was classified into Category 4.
1 Acute toxicity (Dermal) Category 4 Warning H312: Harmful in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Among three LD50 values of 1100 mg/kg (SIDS (Access on Jun. 2009)), 890 mg/kg (ACGIH (2001)) and 1260 mg/kg (DFGMAK-Doc.14 (2000)) for rabbits, one of them corresponded to Category 3, and the two corresponded to Category 4. The substance was classified as Category 4, since the majority of obtained data corresponded to it.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 3 Danger H331: Toxic if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
Based on the rat LC50 (4-hour exposure) value of 945 ppm (ACGIH (2001)), the substance was classified as Category 3. The LC50 value (945 ppm) was lower than 90% of the saturated vapor pressure concentration (1842 ppm), it was judged as "vapor hardly coexisting mists" and the criterion values for gas were adopted.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 1 Danger H314: Causes severe skin burns and eye damage P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
In the rabbit test (OECD TG 404), occlusive application of the substance for 3 minutes up to 4 hours caused necrosis and resulted that the substance was corrosive (SIDS (Access on Jun. 2009)). Similarly, in other reports of rabbit tests, necrosis was observed and resulted that the substance was corrosive (SIDS (Access on Jun. 2009)). Based on these test results, the substance was classified as Category 1. As relevant information, the substance was classified as "R34" in the EU classification (EU Annex I (2006)).
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
In the rabbit test, instillation of 50 microL of undiluted test substance caused corrosion of the conjunctiva and eyelids, these effects were not reversible after 8 days, and irreversible damage to corneal tissue was observed (SIDS (Access on Jun. 2009)). In the other rabbit test, severe corneal injury, iritis and severe conjunctival irritation with necrosis were observed (SIDS (Access on Jun. 2009)). Based on these results, the substance was classified as Category 1.
4 Respiratory sensitization Classification not possible - - - - No data were available. As relevant information, in the accidental case of the leak of the substance into the airflow of the heating system of the building, irritatiing symptoms of the upper respiratory tract were experienced by most of the 2,500 employees, and 14 workers developed asthma. And seven of the 14 cases were defined as occupational asthma (SIDS (Access on Jun. 2009)). But it was reported that these symptoms corresponded to "reactive airways dysfunction syndrome" rather than respiratory allergic reaction, so it was not the evidence indicating sensitization effects (DFGMAK-Doc.14 (2000)).
4 Skin sensitization Not classified - - - - The substance was classified as "Not classified" based on the documented cases of "non-sensitizing" from 2 reports of guinea pig maximization tests in which positive rate was 0% (0/20 and 0/40, respectively) (SIDS (Access on Jun. 2009)).
5 Germ cell mutagenicity Not classified - - - - The substance was classified as "Not classified" based on the negative results in the micronucleus test using bone marrow cells obtained from mice orally administered (in vivo mutagenicity test in somatic cells) (SIDS (Access on Jun. 2009)). As relevant information, as for in vitro studies, negative results were reported in the Ames test and HGPRT test using Chinese hamster V79 cells (SIDS (Access on Jun. 2009)).
6 Carcinogenicity Classification not possible - - - - Insufficient data were available. As relevant information, in the 2-year dietary administration test in rats, no evidence of carcinogenicity was found showing no increase in tumor incidence in the treatment groups compared with the control group (SIDS (Access on Jun. 2009)). However, the test was old in the 1960s, and not compliant with the current guidelines, therefore, these data was not proper to evaluable carcinogenicity.
7 Reproductive toxicity Classification not possible - - - - In the developmental toxicity study in which rats were exposed via inhalation during the organogenetic period, the general toxicity such as decreased body weight gain, decreased food consumption, and dry rale was observed in the high dose group in the dams, but no effects were observed in gestational parameters such as pre- and post-implantation loss, and no developmental effects containing teratogenicity were observed (SIDS (Access on Jun. 2009)). However, no data were available on the effects of the sexual functions and fertility of parental animals that were exposed prior to mating. Therefore, the substance was classified as "Classification not possible".
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system), Category 3 (respiratory tract irritation) Danger
Warning
H370: Causes damage to organs (central nervous system)
H335: May cause respiratory irritation (respiratory tract irritation)
P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
As for the effects in humans, a laboratory worker who was briefly exposed to approx. 100 ppm (480 mg/m3) of the substance resulted in nausea and vomiting within 5 minutes. The corrosion inhibitor containing the substance was used for boiler, and 65 workers who were exposed to the vapor of the substance via humid air complained the symptoms such as dizziness, nausea, and vomiting (SIDS (Access on Jun. 2009)). Moreover, there were descriptions mentioning that accidental human exposure to the substance at the concentration of below 200 ppm for few minutes resulted in nausea and vomiting (ACGIH (2001)) and that the symbol of "CNSconvul" was designated in the ACGIH-TLV (ACGIH (2009)). Thus, the substance was classified as Category 1 (central nervous system). While in the inhalation study in rats, clinical signs indicating severe irritation were noted, namely, attempts to escape from exposure, irritation in mucous membrane and dyspnea were observed (SIDS (Access on Jun. 2009). And it was reported that irritation of the mucous membrane of respiratory tract was caused in humans (DFGMAK-Doc.14 (2000)), and that throat irritation was caused in humans exposed occupationally (SIDS (Access on Jun. 2009)). Thus, the substance was classified as Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 2 (central nervous system) Warning H373: May cause damage to organs through prolonged or repeated exposure (central nervous system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In the oral study in dogs, weakness, tremors, convulsions and ataxia were observed accompanied with occurrence of deaths at the dose level of 200 mg/kg/day or more, and tremors and shaking of the head from side to side were observed at 40 mg/kg/day (SIDS (Access on Jun. 2009). In either 2-week inhalation study in rats at 1.438 mg/L/6hrs (DFGMAK-Doc. 14 (2000)) or in 5-month inhalation study in rats at 0.622 mg/L/4hrs (0.507 mg/L/6hrs) exposed by vapors (ACGIH (2001)), effects on the central nervous system such as decreased activity, incoordination and clonic-tonic convulsions were observed. Since the findings were observed at the dose levels equivalent to Category 2 of the guidance values, the substance was classified as Category 2 (central nervous system). Besides, no serious toxic effects were seen in any of the following repeated oral dose toxicity studies in rats: 4-week administration study via drinking water up to 500 mg/kg/day (converted value as that of 90-day study: 154 mg/kg/day), 6-month administration study via drinking water up to 300 mg/kg/day, or 2-year feeding study up to 50 - 400 mg/kg/day (SIDS (Access on Jun. 2009)). Likewise, in the 6-month oral dose study in rats, depression of body weight and slight elevation of relative kidney weight were merely noted at 100 mg/kg/day (ACGIH (2001)), but no effects on the liver or on any other organs were reported.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 3 from its 72h-ErC50 = 44 mg/L for algae (Scenedesmus subspicatus) (SIDS, 2004).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified as "Not classified" since it is rapidly degradable (22-day degradation rate tested by OECD TG301A: 95% (SIDS, 2002)) and the bioaccumulation potential is low (BCF < 6.1 (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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