GHS Classification Result (Revision of the past classification result)

Chemical Name:Ethylene glycol monoisopropyl ether
CAS:109-59-1

Result:
ID: 21B3019
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

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 molecules.
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 ...
Classified into Category 3 since flash point 44 degC (ICSC (J) (2004)) is >=23 degC and <=60 degC.
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 - - - - Auto-ignition point is 240 degC (ICSC (J) (2004)) exceeding 70 degC.
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
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) Not classified - - - - Based on LD50 values of >2000 mg/kg (OECD TG401 (GLP)) ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2009)), 500 - 5600 mg/kg (DFGOT vol. 5 (1993)), 500 - 1000 mg/kg and 5660 mg/kg (PATTY (5th, 2001)) for rats, the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 or "Not classified" in GHS classification) since most of the values are in this category.
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 ...
Based on LD50 values of 1.6 mL/kg (1440 mg/kg) (DFGOT vol. 5 (1993)) and 1080 - 2370 mg/kg (PATTY (5th, 2001)) for rabbits, the substance was classified into Category 4.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 4 Warning H332: Harmful if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
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.
Based on a LC50 value of 4000 ppm for rats (ECETOC TR64 (1995)), the substance was classified into Category 4. Since the test was conducted at lower than 90% of saturated vapour pressure concentration (6842 ppmV), the classification criteria for gas was adopted.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
Based on a report that skin primary irritation index was 4.8 (24-hour application) in a rabbit test (ECETOC TR95 (2005)) and a report that the effects caused by the substance have been reported to reverse within 7 days (ECETOC TR4 (1982)), the substance was classified into Category 2.
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
Based on a report that the undiluted substance caused marked irritative effects in a rabbit eye with iritis and corneal damage which healed within 7 days (DFGOT vol. 5 (1993)), the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on a result of "not sensitizing" in a guinea pig maximization test (Magnusson-Kligman test) (ECETOC TR No. 95 (2005)), the substance was classified as "Not classified".
5 Germ cell mutagenicity Classification not possible - - - - Classification not possible due to lack of data from in vivo mutagenicity tests. From in vitro mutagenicity tests, there are reports of a negative Ames test and a negative CHO cell chromosomal aberration test ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2009)).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Not classified - - - - In an oral preliminary reproductive toxicity test in rats (OECD TG421 (GLP)), at doses in which parental general toxicity (increased spleen weight and extramedullary hematopoiesis) was noted, no treatment-related effects on estrus cycle of females, mating and fertility performance of both sexes, gestation length, viability of pups or morphological findings were found ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2009)). In developmental toxicity tests in rats and rabbits by inhalation exposure during organogenesis period, an increased number of fetuses showing reduced fetal weight and signs of delayed maturation was observed at doses in which dams showed reduced weight gain and food consumption. No other effects or teratogenic effects were observed (ECETOC TR64 (1995)). Based on these data, the substance was classified as "Not classified". Although the above reproductive toxicity test is a preliminary test (OECD TG421 (GLP)), the effects on parental sexual function and fertility as well as effects on development of the offspring were examined. The data are considered to be sufficient for use as the basis for classification.
8 Specific target organ toxicity - Single exposure Category 1 (blood) Danger H370: Causes damage to organs (blood) 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 ...
In an inhalation test in rats exposed to the vapour of the substance (4-hour), bloody urine and slight to moderate kidney injury were observed at a dose level of 160 ppm (0.68 mg/L) (PATTY (5th, 2001)). In another inhalation test in rats exposed to the vapour (4-hour), haemolytic activity occurred at a dose level of 80 ppm (0.34 mg/L), which led to kidney damage caused by haemoglobin cylinders (DFGOT vol. 5 (1993)). Based on the data, the blood system was regarded as a target organ and the substance was classified into Category 1 (blood system). As relevant information, there is a report of haemoglobinuria as a sign of oral toxicity in rats (ECETOC TR4 (1982)).
9 Specific target organ toxicity - Repeated exposure Category 2 (blood) Warning H373: May cause damage to organs through prolonged or repeated exposure (blood) 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 a 26-week inhalation test in rats exposed to the vapour of the substance (6 hour/day), Hb levels were decreased, and splenic haemosiderosis and anaemia were observed at 200 ppm (0.87 mg/L) (ECETOC TR No. 95 (2005)). In a 28-day oral test in rats, anemia was observed in the 125 mg/kg/day (90-day equivalence: 37.5 mg/kg/day) and higher concentration groups ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2009)). Since these effects were observed at dose levels within the guidance value range for Category 2, the substance was classified into Category 2 (blood system).
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) Not classified - - - - Classified into Not classified from its 96h-LC50 >100 mg/L for fish (Oryzias latipes) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2001), 48h-EC50 >1000 mg/L for Crustacea (Daphnia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2001) and 72h-ErC50 >1000 mg/L for algae (Pseudokirchneriella subcapitata) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2001).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since its acute toxicity is Not classified and it is not non-water soluble (Water solubility = 1000000 mg/L (PHYSPROP Database, 2009)).
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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