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SECTION 1. CHEMICAL IDENTIFICATION

CHEMINFO Record Number: 501
CCOHS Chemical Name: 1,2-Propylene glycol

Synonyms:
1,2-Dihydroxypropane
2-Hydroxypropanol
1,2-Propanediol
alpha-Propylene glycol
Monopropylene glycol
Methylethylene glycol
Methyl glycol
Propylene glycol (non-specific name)
PG 12
Propane-1,2-diol
Propanediol (non-specific name)
Methylethyl glycol

Chemical Name French: 1,2-Propylène glycol
Chemical Name Spanish: 1,2-Propilenglicol
CAS Registry Number: 57-55-6
RTECS Number(s): TY2000000
EU EINECS/ELINCS Number: 200-338-0
Chemical Family: Aliphatic polyhydric alcohol / aliphatic dihydric alcohol / aliphatic diol / glycol
Molecular Formula: C3-H8-O2
Structural Formula: CH3-CH(OH)-CH2-OH

SECTION 2. DESCRIPTION

Appearance and Odour:
Clear, colourless, viscous, practically odourless liquid.(11) Strongly hygroscopic (absorbs moisture from the air).(16,33)

Odour Threshold:
Not applicable; practically odourless.

Warning Properties:
NONE - 1,2-propylene glycol is essentially odourless and non-irritating.

Composition/Purity:
1,2-Propylene glycol is available commercially in two high purity grades, Industrial grade and "super pure" or USP grade, which have at least 99.5% purity. Impurities include chlorides (1-10 ppm max), iron (0.5-1.0 ppm max), heavy metals (5 ppm max), arsenic (3 ppm max), sulfate (0.006 wt% max) and water (0.2 wt% max).(16) Lower grades may contain small amounts of dipropylene glycol.

Uses and Occurrences:
1,2-Propylene glycol is used to manufacture unsaturated polyester resins, polyether polyols and low molecular mass polyethers; to produce alkyd resins for paints and varnishes, ester lubricants, emulsifiers, polymeric plasticizers and a polyester-type fluorescent resin matrix; as an intermediate in the synthesis of organic compounds, such as 1,2-propylene diamine and polypropylene glycol; as a solvent and plasticizer in printing inks; as a humectant (moisture-retaining agent), solvent and preservative in food products; as a humectant in tobacco and cosmetics; as a preservative in floral arrangements; as a stabilizer in hydraulic fluids; in the formulation of heat-transfer fluids that contain corrosion inhibitors; as an automotive coolant; as an airplane and runway deicing agent; as a substitute for ethylene glycol and glycerol; as a solvent for aromatics in the flavour concentrate industry; as a wetting agent for natural gums; in cosmetics, personal hygiene and pharmaceutical preparations; and as a lubricant.(11,16)
1,2-Propylene glycol is a component of special effect fog/smoke used during theatrical events and in fire training programs to simulate fire-training conditions.(20) Water solutions of 1,2-propylene glycol containing a corrosion inhibitor are used for low-temperature protection of fresh-water plumbing in recreational vehicles and boats.(12)


SECTION 3. HAZARDS IDENTIFICATION

EMERGENCY OVERVIEW:
Clear, colourless, viscous, practically odourless liquid. Strongly hygroscopic. Not combustible, but can burn if strongly heated. No unusual hazard in a fire situation. Essentially non-toxic.



POTENTIAL HEALTH EFFECTS

Effects of Short-Term (Acute) Exposure

Inhalation:
1,2-Propylene glycol does not readily form a vapour at room temperature. Therefore, it must be heated or misted before inhalation exposure would occur. Exposure to the vapour or mist is unlikely to cause significant health effects. Humans exposed to saturated and supersaturated atmospheres have not reported harmful effects.(4, unconfirmed)

NOTE: 1,2-Propylene glycol may be a component of a mixture of glycols used to generate a special effect fog/smoke during theatrical performances and in fire training programs. Information on the potential health effects of this fog/smoke is not reviewed here, since exposure is to a mixture of chemicals, which is heated to a high temperature (releasing thermal decomposition products).

Skin Contact:
1,2-Propylene glycol is not considered a skin irritant, based on human and animal evidence. However, 1,2-propylene glycol may cause irritation if sealed to the skin for a prolonged period by gloves, shoes or tight clothing.
Irritation was seen in 16% of 866 dermatitis patients, 48 hours after application of undiluted 1,2-propylene glycol to covered skin. Excessive dehydration of the skin by 1,2-propylene glycol may have been an important predisposing factor to the reactions.(1) Patches containing 0.05 mL of 100% 1,2-propylene glycol were applied to the backs of 50 men for 48 hours, open or under cover. Severe irritation was observed in the covered test, while no irritation was observed in the open test. The skin reaction disappeared rapidly.(8) Application of 100% 1,2-propylene glycol to the forearms of 10 men for 48 hours did not produce significant irritation.(24) Application of 200 microL of 30% 1,2-propylene glycol under cover to the backs of 9 women for 4 days was judged to be non-irritating.(26)
A detailed review has examined numerous studies of humans dermally exposed to 1,2-propylene glycol. Irritant contact dermatitis was determined to be the most commonly observed effect, although it appears to be related to prolonged exposure to very high concentrations of 1,2-propylene glycol. The possibility of an allergic reaction or hives developing is considered rare. Subjective or sensory irritation, with itching, burning or stinging sensations, but no signs of inflammation, is considered to be a fairly common reaction among users of cosmetics containing propylene glycol or in volunteers following application of 1,2-propylene glycol.(30)
1,2-Propylene glycol is not absorbed through the skin to a significant extent.

Eye Contact:
The undiluted liquid causes no to mild irritation, based on animal and limited human information. A drop applied to the human eye caused stinging, twitching of the eyelid and tearing which subsided after a few seconds. This was followed by mild, temporary congestion of the inner eyelid, with no residual discomfort or injury.(3, personal observation)

Ingestion:
1,2-Propylene glycol is not expected to produce harmful effects if ingested, based on animal toxicity information. Ingestion is not a typical route of occupational exposure.

Effects of Long-Term (Chronic) Exposure

Exposure to the vapour or mist is unlikely to pose a health hazard. Animals exposed on a long-term basis to high vapour/mist mixtures did not develop any adverse health effects.

NOTE: 1,2-Propylene glycol may be a component of a mixture of glycols used to generate a special effect fog/smoke during theatrical performances and in fire training programs. Information on the potential health effects of this fog/smoke is not reviewed here since exposure is to a mixture of chemicals, which is heated to a high temperature (releasing thermal decomposition products).

Skin:
Repeated or prolonged contact with the concentrated liquid can cause drying and irritation.(8,19,20,30)
In a 21-day patch test with 24 men, 1,2-propylene glycol caused a skin reaction which peaked on days 15-17 and then gradually decreased. It was concluded that the reaction was due to primary irritation rather than an allergic response.(8)

Skin Sensitization:
1,2-Propylene glycol is not considered an occupational skin sensitizer.
No occupational case reports were located and negative results have been obtained in animal tests. Sensitization reactions have been reported in cosmetics users, volunteers, and dermatology patients exposed to 1,2-propylene glycol. Controversy exists regarding the incidence of 1,2-propylene glycol allergy. However, high concentrations (10% and greater) may be capable of producing skin sensitization, especially in sensitive populations (individuals with pre-existing skin disorders).(19,20,30,32)

Carcinogenicity:

There is no human information available. 1,2-Propylene glycol is not considered carcinogenic based on animal information.

The International Agency for Research on Cancer (IARC) has not evaluated the carcinogenicity of this chemical.

The American Conference of Governmental Industrial Hygienists (ACGIH) has no listing for this chemical.

The US National Toxicology Program (NTP) has not listed this chemical in its report on carcinogens.

Teratogenicity and Embryotoxicity:
There is no human information available. Animal information indicates that 1,2-propylene glycol does not cause developmental effects.

Reproductive Toxicity:
There is no human information available. Animal information indicates that 1,2-propylene glycol does not cause reproductive effects.

Mutagenicity:
There is no human information available. Animal information indicates that 1,2-propylene glycol is not mutagenic. Negative results are reported for 3 tests (host-mediated, dominant lethal and bone marrow chromosomal aberration) using rats and mice exposed to 1,2-propylene glycol orally.(12, unconfirmed) These unpublished studies were reviewed by an expert panel and determined to be well conducted. Other animal studies report positive and negative results, but the route of exposure (intraperitoneal administration) is not considered relevant to occupational situations.

Toxicologically Synergistic Materials:
There is no information available.

Potential for Accumulation:
1,2-Propylene glycol does not accumulate. It is rapidly absorbed from the gastrointestinal tract. In most mammals, part of the absorbed 1,2-propylene glycol is eliminated unchanged by the kidneys, while another portion is excreted by the kidneys as a glucuronic acid conjugate. Metabolism, primarily in the liver and kidney, commences within 2-4 hours after exposure. 1,2-Propylene glycol is oxidized to lactic acid, which is then converted to pyruvic acid. Both of these chemicals are normal constituents of the energy-generating process for humans. Pyruvic acid can be further metabolized to carbon dioxide and water. The majority of 1,2-propylene glycol and its breakdown products are excreted within 48 hours.(20,32)


SECTION 4. FIRST AID MEASURES

Inhalation:
If symptoms are experienced, remove source of contamination or move victim to fresh air. If symptoms persist, obtain medical advice.

Skin Contact:
Flush with lukewarm, gently flowing water for at least 5 minutes or until the chemical is removed. Under running water, remove contaminated clothing, shoes and leather goods (e.g. watchbands, belts). Completely decontaminate clothing, shoes and leather goods before re-use or discard.

Eye Contact:
Immediately flush the contaminated eye(s) with lukewarm, gently flowing water for 5 minutes, or until the chemical is removed, while holding the eyelid(s) open. If irritation persists, obtain medical advice.

Ingestion:
If irritation or discomfort occur, obtain medical advice immediately.

First Aid Comments:
All first aid procedures should be periodically reviewed by a doctor familiar with the material and its conditions of use in the workplace.



SECTION 5. FIRE FIGHTING MEASURES

Flash Point:
99 deg C (210 deg F) (closed cup).(34,35) Also reported as 103-104 deg C (217.4-219.2 deg F) (closed cup) (11,16)

Lower Flammable (Explosive) Limit (LFL/LEL):
2.6% (16,34)

Upper Flammable (Explosive) Limit (UFL/UEL):
12.5% (34,36)

Autoignition (Ignition) Temperature:
371 deg C (700 deg F) (34,36); also reported as 410 deg C (770 deg F) (16)

Sensitivity to Mechanical Impact:
Probably not sensitive. Stable material.

Sensitivity to Static Charge:
1,2-Propylene glycol will not accumulate static charge, since it has a high electrical conductivity.(16) Mixtures of 1,2-propylene glycol vapour and air at concentrations in the flammable range will not be ignited by a static discharge, since it has a high flash point.

Electrical Conductivity:
4.4 X 10(6) pS/m at 20 deg C (16)

Minimum Ignition Energy:
Not available

Combustion and Thermal Decomposition Products:
Carbon monoxide and carbon dioxide. Incomplete combustion may also produce toxic and irritating fumes and acrid smoke.

Fire Hazard Summary:
1,2-Propylene glycol is not combustible, but can burn if strongly heated. During a fire, irritating fumes and acrid smoke may be generated. Closed containers may rupture violently and suddenly release large amounts of product when exposed to fire or excessive heat for a sufficient period of time.

Extinguishing Media:
Carbon dioxide, dry chemical powder, "alcohol" foam, water spray or fog. Water or foam may cause frothing. Special "alcohol-resistant fire fighting foams" are recommended for use with any polar flammable liquid that is soluble in water, such as 1,2-propylene glycol.(34) Fire fighting foam manufacturers should be consulted for recommendations regarding types of foams and application rates.

Fire Fighting Instructions:
This material should pose no special hazard in a fire situation. Therefore, the following general precautions should be followed.
Evacuate area and fight fire from a safe distance or protected location. Approach fire from upwind to avoid toxic decomposition products.
Water or foam may cause frothing. The frothing may be violent and could endanger personnel close to the fire, particularly when solid streams of water are directed into the hot, burning material. However, a water spray or fog that is carefully applied to the surface of the liquid, preferably with a fine spray or fog nozzle, will cause frothing that will blanket and extinguish the fire.
Closed containers may rupture violently when exposed to the heat of the fire and suddenly release large amounts of products. Stay away from ends of tanks, involved in fire, but be aware that flying material from ruptured tanks may travel in any direction.
If possible, isolate materials not yet involved in the fire, and move containers from the fire area if this can be done without risk, and protect personnel. Otherwise, fire-exposed containers or tanks should be cooled by application of hose streams. Cooling should begin as soon as possible (within the first several minutes) and should concentrate on any unwetted portions of the container. Apply water from the side and from a safe distance. Cooling should continue until well after the fire is out. If this is not possible, use unmanned monitor nozzles and immediately evacuate the area.
If a leak or spill has not ignited, use water spray in large quantities to disperse the vapours and to protect personnel attempting to stop the leak. Water spray can be used to dilute spills to nonflammable mixtures and flush spills away from ignition sources. Dike fire control water for appropriate disposal. Solid streams of water may be ineffective and spread material.
For an advanced or massive fire in a large area, use unmanned hose holders or monitor nozzles; if this is not possible, withdraw from fire area and allow fire to burn. Withdraw immediately in case of rising sound from venting safety device or any discolouration of tank. Tanks or drums should not be approached directly after they have been involved in a fire, until they have been completely cooled down.
After the fire has been extinguished, toxic atmospheres may remain. Before entering such an area especially confined areas, check the atmosphere with an appropriate monitoring device while wearing full protective suit.

Protection of Fire Fighters:
1,2-Propylene glycol is not toxic. Firefighters may enter the area if positive pressure self-contained breathing apparatus (NIOSH approved or equivalent) and full Bunker Gear is worn.



NATIONAL FIRE PROTECTION ASSOCIATION (NFPA) HAZARD IDENTIFICATION

NFPA - Health: 0 - Exposure, under fire conditions, would be no more hazardous than an ordinary combustible material.
NFPA - Flammability: 1 - Must be preheated before ignition can occur.
NFPA - Instability: 0 - Normally stable, even under fire conditions, and not reactive with water.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

Molecular Weight: 76.10

Conversion Factor:
Not applicable

Physical State: Liquid
Melting Point: -60 deg C (-76 deg F) (35,39); supercools (11)
Boiling Point: 187.6 deg C (369.7 deg F) (35,39)
Relative Density (Specific Gravity): 1.036 at 20 deg C (36,39); 1.033 at 25 deg C (39) (water = 1)
Solubility in Water: Soluble in all proportions (35,36)
Solubility in Other Liquids: Soluble in all proportions in ethanol, acetone and chloroform; soluble in diethyl ether and benzene; sparingly soluble in petroleum ethers and carbon tetrachloride.(16,35,36)
Coefficient of Oil/Water Distribution (Partition Coefficient): Log P(oct) = -0.92 (experimental) (40)
pH Value: Not available
Acidity: Very weak acid.
Dissociation Constant: pKa = 14.8 at 25 deg C (39)
Viscosity-Dynamic: 56 mPa.s (56 centipoises ) at 20 deg C (39); 48.6 mPa.s (48.6 centipoises) at 25 deg C (11)
Viscosity-Kinematic: 54.05 mm2/s ( 54.05 centistokes) at 20 deg C; 47.09 mm2/s ( 47.09 centistokes) at 25 deg C (calculated)
Saybolt Universal Viscosity: Approximately 220-250 Saybolt Universal Seconds at 37.8 deg C (100 deg F) (calculated)
Surface Tension: 38 mN/m (38 dynes/cm) at 20 deg C (16); 36.51 mN/m (36.51 dynes/cm) at 25 deg C (39)
Vapour Density: Not applicable
Vapour Pressure: 0.011 kPa (0.08 mm Hg) at 20 deg C (7); 0.017 kPa (0.129 mm Hg) at 25 deg C (calculated from experimentally derived coefficients) (38)
Saturation Vapour Concentration: Approximately 105 ppm (0.01%) at 20 deg C; approximately 170 ppm (0.02%) at 25 deg C (calculated)
Evaporation Rate: 0.01 (n-butyl acetate = 1) (39)
Henry's Law Constant: 1.31 X 10(-3) Pa.m3/mol (cited as 1.29 X 10(-8) atm.m3/mol) at 25 deg C (38); log H = -6.28 (dimensionless constant; calculated)

SECTION 10. STABILITY AND REACTIVITY

Stability:
Normally stable.

Hazardous Polymerization:
Does not occur.

Incompatibility - Materials to Avoid:

NOTE: Chemical reactions that could result in a hazardous situation (e.g. generation of flammable or toxic chemicals, fire or detonation) are listed here. Many of these reactions can be done safely if specific control measures (e.g. cooling of the reaction) are in place. Although not intended to be complete, an overview of important reactions involving common chemicals is provided to assist in the development of safe work practices.


STRONG OXIDIZING MATERIALS (e.g. chromium trioxide, calcium hypochlorite, nitric acid, potassium permanganate, peroxides) - reacts violently. Can increase the risk of fire and explosion.(33)
PERCHLORIC ACID - can undergo violent decomposition in contact with approximately 70% perchloric acid, probably due to the formation of the unstable glycol perchlorate ester.(41)
HYDROFLUORIC ACID, NITRIC ACID AND SILVER NITRATE - mixture can explode, probably due to the formation of the explosive salt, silver fulminate.(41)

Hazardous Decomposition Products:
None reported.

Conditions to Avoid:
High temperatures (above 99 deg C).

Corrosivity to Metals:
1,2-Propylene glycol is not corrosive to the common metals, such as carbon steel (e.g. types 1010 and 1020), cast iron, stainless steel (300 series and 400 series), aluminum (types 3003 and Cast B-356), copper, brass, admiralty brass, naval brass, bronze, naval bronze, silicon bronze, nickel, nickel-base alloys, such as Hastelloy, tantalum and titanium at normal temperatures.(42,43)

Corrosivity to Non-Metals:
1,2-Propylene glycol attacks plastics such as chlorinated polyvinyl chloride (CPVC), polyvinyl chloride (PVC) and the polyester fibre Dacron at normal temperatures, and epoxy at temperatures greater than 95 deg C (44); and elastomers (e.g. polyacrylate) at normal temperatures.(45) It does not attack most plastics (e.g. nylon, Teflon, other fluorocarbon plastics, polypropylene, bisphenol-A and isophthalic polyesters), polyethylene and polystyrene (42,44); most elastomers (e.g. neoprene, Nitrile Buna-N (NBR), chloroprene, ethylene-propylene, Viton A, other fluorocarbon elastomers, styrene-butadiene (SBR), isoprene, natural rubber, fluorosilicone and silicone) and coatings (e.g. epoxy, phenol, polyester and vinyls).(42,44,45)


SECTION 11. TOXICOLOGICAL INFORMATION

LD50 (oral, rabbit): 14800 mg/kg (cited as 14.3 cc/kg) (28)
LD50 (oral, rat): 21800 mg/kg (cited as 21.0 cc/kg) (28)
LD50 (oral, female rat): 22800 mg/kg (31)

LD50 (dermal, rabbit): 20800 mg/kg (7, unconfirmed)

Eye Irritation:

Propylene glycol is a minimal to mild irritant.

Application of 0.1 mL of 100% propylene glycol produced essentially no irritation in rabbits (corneal opacity: 0/4; iris injury: 0/4; redness: 0.28/4; chemosis: 0/4).(18) Application of 0.5 mL of undiluted propylene glycol caused no or mild irritation in rabbits (scored 0-1 where 5 is severe injury; graded 1/10).(9) In a standard Draize test, application of 0.1 mL produced minimal irritation in rabbits (scored 0.7/110 at 24 hours; 0.3/110 at 72 hours and 0.0/110 at 96 hours).(31)

Skin Irritation:

Propylene glycol is essentially non-irritating.

Application of 0.5 mL propylene glycol, under semi-occlusive cover for 4 hours, produced essentially no irritation in rabbits (scored 0.02/8). Application of 0.5 mL propylene glycol, with and without scarification, under an occlusive cover for 4 hours, produced essentially no irritation in rabbits (0.14/8). Exposure to 0.5 mL propylene glycol, with and without scarification, under occlusive cover for 23 hours, produced essentially no irritation in rabbits (0.17/8).(23) In a standard Draize test, application of 0.5 mL propylene glycol to intact and abraded skin produced minimal irritation in rabbits (scored 0.1/8).(31) Application of 0.1 mL to guinea pigs or 0.3 mL to rabbits for 48 hours, under cover or open, failed to produce any irritation.(8) Other tests have produced similar results.(19)

Effects of Short-Term (Acute) Exposure:

Extremely large oral doses have caused signs of central nervous system depression. Minor changes in blood and clinical chemistry parameters have been observed at lower doses.

Inhalation:
Rabbits were exposed to 10% propylene glycol aerosol for 20 and 120 minutes. Signs of irritation (alteration of cilial cells) were observed at 120 minutes. Alterations in goblet cells in the tracheal lining were observed at both exposure durations.(20,32-unconfirmed) These findings are not supported by a later, longer term study.(22)

Ingestion:
In acute lethality studies, extremely large oral doses have caused signs of central nervous system depression (increased respiratory rate and incoordination).(20,32) Male rats were given 0 or 4 mL/kg/day undiluted propylene glycol orally for 30 days. There were no significant differences in body or liver weights or in a number of clinical chemistry parameters (total phospholipids, total cholesterol, triglycerides). There was a moderate but significant increase in total cholesterol in the livers of treated animals.(25) Minor blood cell changes (a significant and progressive decrease in hemoglobin, packed cell volume and red blood cell counts for 2 days, returning to normal by day 8) were observed in female rats given a single oral dose of 730 or 2940 mg/kg propylene glycol (cited as 73 or 294 mg/100 g). Significant increases in reticulocyte counts, plasma hemoglobin and spleen weights were also observed.(27) Male rats were given oral doses of 0.09 mg/kg/day (cited as 284 microlitres/100 g) for 30 days. A significant reduction in the rate of sedimentation of erythrocytes, total leukocyte count and glutathione content was observed.(19,32) No signs of kidney injury were observed in male rats given 40 g/L in their drinking water for 2 weeks.(

Effects of Long-Term (Chronic) Exposure:

Inhalation of high aerosol concentrations has caused minor effects (nasal bleeding and irritation of the nasal cavity), probably related to the dehydrating effects of propylene glycol. Ingestion of very large oral doses for up to 2 years has also produced minimal effects.

Inhalation:
Rats were exposed by nose-only inhalation to 0, 0.16, 1.0 or 2.2 mg/L propylene glycol aerosol for 13 weeks (particle size: 2.22 and 1.96 micrometres for the medium and high doses; not available for the low dose). Reversible nasal bleeding appeared in the medium and high exposure groups during the second week of exposure, suggesting that propylene glycol acts as a dehydrating agent. A reduction in weight gain associated with reduced food consumption was observed in females exposed to the highest concentration. Inconsistent, but statistically significant changes were observed in selected blood and clinical chemistry parameters and in absolute organ weights. These changes were not clearly associated with propylene glycol exposure concentrations. Signs of physical irritation of the nasal cavity due to the propylene glycol aerosol exposure were observed in males and females in the medium and high exposure groups.(22) No adverse effects in rats and monkeys exposed by inhalation for 12-18 months to atmospheres saturated with propylene glycol vapour (0.10-0.35 mg/L). Propylene glycol related increases in red blood cell counts and hemoglobin content were reported, but parasites and lung mites infected the monkeys and many had anemia, were sick or died during the experiment. Therefore, the reported effects cannot be attributed to propylene glycol.(5)

Ingestion:
Rats, cats, and dogs were orally administered propylene glycol in their diets or drinking water for up to 2 years. Extremely high doses (greater than 25%) in drinking water were lethal to rats within 2 months and diets containing 40% or greater were lethal to rats in a few days. Very slight changes (e.g. minor blood effects) were observed in rats and dogs at very high doses (5000 mg/kg/day or 5%). Cats exposed to somewhat lower but still high doses have shown blood effects. However, cats metabolize propylene glycol differently, which may make them more susceptible to blood effects.(4,19,20,32) No significant effects were observed in rats fed 2.45% in their diets for up to 24 months. Slight liver damage was reported at 4.9%. Approximate doses were 1225 and 2450 mg/kg/day for females and 1470 and 2940 mg/kg/day for males.(46) This study is limited, since the results were not statistically analyzed.

Skin Sensitization:
Negative results have consistently been obtained in guinea pigs in studies using different test protocols.(19,32) Negative results were obtained in a Local Lymph Node Assay.(48)

Carcinogenicity:
The available information indicates that propylene glycol is not carcinogenic.
No tumours were observed in rats or mice following the repeated application of propylene glycol to the skin.(4,12,19-unconfirmed) No tumours were observed in lifetime dietary feeding studies.(4,12,19,20)

Teratogenicity, Embryotoxicity and/or Fetotoxicity:
The available information indicates that propylene glycol does not cause developmental effects.
In a well-conducted, unpublished study, no significant developmental effects were observed in the offspring of mice exposed to up to 10360 mg/kg/day (cited as 10.0 mL/kg/day) on days 6-15 or pregnancy.(12, unconfirmed) In unpublished studies, no fetal abnormalities (soft tissue or skeletal) and no effects on maternal or fetal survival were noted in in mice and rats orally exposed to up to 1600 mg/kg/day on days 6-15 of pregnancy, in hamsters orally exposed to up to 1550 mg/kg/day on days 6-10 of pregnancy or in rabbits orally exposed to up to 1230 mg/kg on days 6-18 of pregnancy.(12,22,32-unconfirmed) This study is limited by factors such as poor reporting, and inappropriate positive controls and it is not clear if statistical analysis of the data was conducted.(12) No significant effects were observed in a screening test where mice were given oral doses of 10000 mg/kg/day on days 8-12 of pregnancy.(21) This study is limited by the use of a single one dose.

Reproductive Toxicity:
The available information indicates that propylene glycol does not cause reproductive effects.
Mice were exposed to 0, 1.0, 2.5 or 5.0% (approximately 1820, 4800 or 10100 mg/kg/day) in their drinking water in a continuous breeding (2-generation) study. No significant effects on fertility or reproduction were observed.(15)

Mutagenicity:
The information available indicates that propylene glycol is not mutagenic.
Negative results are reported for 3 tests (host-mediated, dominant lethal and bone marrow chromosomal aberration) using rats and mice exposed to propylene glycol orally.(12, unconfirmed) These unpublished studies were reviewed by an expert panel and determined to be well conducted. Positive and negative results have been reported in other studies using live animals.(4,12,14,19,29) However, the route of exposure (intraperitoneal injection) used in these studies is not considered relevant to occupational situations.
Positive and negative results were observed in cultured mammalian cells.(10,12,19,20) Negative results were obtained in cultured human cells.(19) Negative results were obtained in bacteria and yeast.(4,10,12,19,20)


SECTION 16. OTHER INFORMATION

Selected Bibliography:
(1) Warshaw, T.G., et al. Studies of skin reactions to propylene glycol. The Journal of Investigative Dermatology. Vol. 19 (1952). p. 423-430
(2) National Institute for Occupational Safety and Health (NIOSH). 1,2-propanediol. Last updated: 2000-12. In: Registry of Toxic Effects of Chemical Substances (RTECS(R)). [CD-ROM]. Canadian Centre for Occupational Health and Safety (CCOHS). Issue: 2002-1. Also available from World Wide Web: <http://ccinfoweb.ccohs.ca/rtecs/search.html>
(3) Grant, W.M., et al. Propylene glycol. In: Toxicology of the eye. 4th ed. Charles C. Thomas, 1993. p. 1209-1210
(4) Cavender, F.L., et al. Propylene glycol. In Patty's industrial hygiene and toxicology. 4th ed. Edited by G.D. Clayton, et al. Vol. II. Toxicology. Part F. John Wiley & Sons, 1994. p. 4646-4647, 4672-4679
(5) Robertson, O.H., et al. Tests for the chronic toxicity of propylene glycol and triethylene glycol on monkeys and rats by vapor inhalation and oral administration. Journal of Pharmacology and Experimental Therapeutics. Vol. 91 (Sept. 1947). p. 52-76
(6) Browning, E. Toxicity and metabolism of industrial solvents. Elsevier Publishing Company, 1965. p. 642-644
(7) Propylene glycol. Data Sheet 1-101. NPIRI Raw Material Data Handbook. Vol. 1: Organic Solvents. NPIRI, 1974. p. 101
(8) Motoyoshi, K., et al. The safety of propylene glycol and other humectants. Cosmetics & Toiletries. Vol. 99, no. 10 (Oct. 1984). p. 83-91
(9) Carpenter, C.P., et al. Chemical burns of the rabbit cornea. American Journal of Ophthalmology. Vol. 29 (1946). p. 1363-1372
(10) Ishidate, M., et al. Primary mutagenicity screening of food additives currently used in Japan. Food and Chemical Toxicology. Vol. 22, no. 8 (1984). p. 623-636
(11) Martin, A.E., et al. Glycols: propylene glycols. In: Kirk-Othmer encyclopedia of chemical technology. 4th ed. Vol. 12. John Wiley and Sons, 1994. p. 715-726
(12) Center for the Evaluation of Risks to Human Reproduction (CERHR). NTP-CERHR Expert Panel report on the reproductive and developmental toxicity of propylene glycol. Reproductive Toxicology. Vol. 18 (2004). p. 533-579
(13) Forsberg, K., et al. Quick selection guide to chemical protective clothing. 3rd ed. Van Nostrand Reinhold, 1997
(14) Razvi, F., et al. Effect of aflatoxin B1 and propylene glycol on mice spermatocytes. Arogya--J. Health Sci. Vol. V (1979). p. 60-62
(15) Chapin, R.E., et al. Reproductive assessment by continuous breeding: Evolving study design and summaries of ninety studies. Environmental Health Perspectives. Vol. 105, Suppl. 1 (Feb. 1997). p. 199-205, 231-232
(16) Sullivan, C.J. Propanediols. In: Ullmann's encyclopedia of industrial chemistry. 5th completely revised ed. Vol. A 22. VCH Publishers, 1993. p. 163-171
(17) National Institute for Occupational Safety and Health (NIOSH). Glycols. In: NIOSH Manual of Analytical Methods (NMAM(R)). 4th ed. Edited by M.E. Cassinelli, et al. DHHS (NIOSH) Publication 94-113 (Aug. 1994). Available from World Wide Web: <http://www.cdc.gov/niosh/nmam/nmammenu.html>
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Information on chemicals reviewed in the CHEMINFO database is drawn from a number of publicly available sources. A list of general references used to compile CHEMINFO records is available in the database Help.


Review/Preparation Date: 2005-01-06



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