GHS Classification Result (Revision of the past classification result)

Chemical Name:Propyleneglycol monomethyl ether
CAS:107-98-2

Result:
ID: 21B3053
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 32 degC (closed-cup) (HSDB (2009)) is >=23 degC and <=60 degC and initial boiling point is 120 degC. The substance is classified into Class 3, PG III in UNRTDG (UN3092).
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 270 degC (ICSC (J) (1997)) 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 contains oxygen (but not fluorine or chlorine) in the molecule which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Containing no bivalent -O-O- structure in the molecule
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 6100, 5200, >5000, and 5900 mg/kg (SIDS (2001)), 7350 (ACGIH (2001)) and 7510 mg/kg (DFGOT vol. 14 (2000)) for rats, the substance was classified into "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Based on LD50 values of 13000 and 14100 mg/kg (SIDS (2001)) for rabbits, the substance was classified as "Not classified".
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.
Although a LC50 value is >6 mg/L/4h (>1626 ppm) or >24 mg/L/1h (>3252 ppm/4h) for rats (SIDS (2001)), determination of category is impossible. Based on a LC50 value of 6038 - 7559 ppm/6h (7395 - 9258 ppm/4h) for rats (male) (GLP, (SIDS (2001))), the substance was classified into Category 4. Since the test concentrations was lower than 90% of saturated vapour pressure concentration (16,435 ppm: 60.6 mg/L), the classification criteria for gas (ppmV) was adopted.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - Based on a result of no appreciable irritation to the skin (primary skin irritation grade: 2, very mild irritation) in a Draize test with application to the skin of rabbits for 24-hour (SIDS (2001)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 in GHS classification).
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 results of "low irritating" and "slightly irritating" in rabbit tests (SIDS (2001)), the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - There is a result of "not sensitizing" in a guinea pig skin sensitizing test (modified Maguire test) (SIDS (2001)). Since the test method used is not approved by OECD and the detailed data (such as positive rates) are unknown, classification was not possible due to lack of sufficient data.
5 Germ cell mutagenicity Not classified - - - - Based on a negative result in an intraperitoneal mouse micronucleus test using erythrocytes harvested from the bone marrow (in vivo somatic cell mutagenicity test) (SIDS (2001)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of negative Ames tests, a negative gene mutation test, a negative chromosomal aberration test and a negative micronucleus test using Chinese hamster CHO cells or V79 cells (SIDS (2001)).
6 Carcinogenicity Not classified - - - - In 2-year inhalation tests in rats and mice (OECD TG453 (GLP)), no exposure-related increases in incidences of tumors in any tissue were observed in males and females of either species (SIDS (2001)). The substance was classified as "Not classified".
7 Reproductive toxicity Not classified - - - - In two-generation reproductive tests by oral exposure to mice and inhalation exposure to rats, lengthened estrous cycles, decreased fertility, reduced pup survival and litter size were observed at the highest dose (3000 ppm) group of rats. However, the result was not used as the basis of classification, since these findings accompanied marked toxicity, as evidenced by persistent sedation and decreased body weights which were as much as 21% lower than the control group. For the other dose level rat and the mice dose groups, there were no effects on sexual function and fertility (SIDS (2001)). In developmental toxicity tests by inhalation exposure to rats and rabbits during organogenesis period (SIDS (2001)) and by oral exposure to rats, mice or rabbits during gestation period (SIDS (2001)), delayed sternebral ossification was observed in some tests but no adverse effects on fetal development including teratogenicity were detected. Since it is clear from appropriate tests with multiple animal species and by multiple exposure routes that the substance has no reproductive or developmental toxicity, it was classified as "Not classified".
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects) Warning H336: May cause drowsiness or dizziness (narcotic effects) 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.
P405: Store locked up.
P501: Dispose of contents/container to ...
Acute toxic signs related to narcotic action of the substance are reported as follows; somnolence, uncoordinated gait and ataxia by oral administration to rats (ECETOC 95 (2005)); laterally recumbent, generally unresponsive and central nervous system depression by inhalation exposure to rats (SIDS (2001)); and slight weakness and signs of general narcosis varying in intensity from slight drowsiness to deep anaesthesia by dermal exposure to rabbits (ECETOC 95 (2005)). Based on the data, the substance was classified into Category 3 (narcotic effects). In human volunteers, nasal and throat irritation was reported (SIDS (2001), DFGOT vol. 14 (2000)), however, the influence of the substances' strong odor on the results was not excluded, therefore the data was not used as the basis of classification.
9 Specific target organ toxicity - Repeated exposure Not classified - - - - In 13-week inhalation tests (6 hour/day), rats, mice and rabbits exhibited transient CNS depression and transient mild degenerative changes in the livers following high level exposure (SIDS (2001)). The NOEL/NOAELs were reported to be 300 ppm (1.11 mg/L) and 1000 ppm (3.68 mg/L), respectively, in rats; 1000 ppm (3.68 mg/L) in mice and 1000 ppm (3.68 mg/L) in rabbits (SIDS (2001)). Since the NOELs exceed the upper limit of the guidance value range, the substance corresponds to "Not classified" with inhalation exposure. In a 35-day oral test in rats, the NOEL was 919 mg/kg bw/day (90-day equivalence: 357 mg/kg bw/day) (SIDS (2001)). In a 90-day dermal test in rabbits the NOEL was 2 mL/kg bw/day (1840 mg/kg bw/day) (SIDS (2001). Since the NOELs exceed the upper limit of the guidance value range, the substance corresponds to "Not classified" with oral and dermal routes. Overall, the substance was classified as "Not classified" since it corresponds to "Not classified" with inhalation, oral and dermal exposure routes.
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 >1000 mg/L for fish (Rainbow trout) (EU-RAR, 2006), 48h-EC50 >500 mg/L for Crustacea (Daphnia magna) (SIDS, 2003, etc) and 96h-EC50 >1000 mg/L for algae (Pseudokirchneriella subcapitata) (EU-RAR, 2006).
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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