med 10

Petrolatum and lanolin alcohols is a soft solid used in topical pharmaceutical formulations and cosmetics as an ointment base with emollient properties. It is also used in the preparation of creams and lotions. Petrolatum and lanolin alcohols can be used to absorb wound exudates. See Table I.

Table I: Uses of petrolatum and lanolin alcohols.

Use Concentration (%)

Absorption base component 10.0–50.0

Emollient and plasticizer in ointments 5.0–50.0

Description

A pale ivory-colored, soft solid with a faint, characteristic sterol odor.

Pharmacopeial Specifications

Heavy metals: 420 ppm

HLB value: ≈9

Hydroxyl value: 11–15

Melting range: 40–468C

Microbiological count: the total bacterial count, when pack- aged, is less than 10 per gram of sample.

Moisture content: 40.2%

Saponification value: 42

Solubility: soluble 1 in 20 parts of chloroform, and 1 in 100 parts of mineral oil; precipitates at higher concentrations. Precipitation occurs in ethanol (95%), hexane, and water. May be dispersed in isopropyl palmitate. Forms a gel in castor oil and corn oil.

Stability and Storage Conditions

Petrolatum and lanolin alcohols is stable and should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Lanolin alcohols is incompatible with coal tar, ichthammol, phenol, and resorcinol.

Method of Manufacture

Lanolin alcohols is blended with petrolatum.

Safety

Petrolatum and lanolin alcohols is generally regarded as an essentially nontoxic and nonirritant material. However, lanolin alcohols may be irritant to the skin and cause hypersensitivity in some individuals.

Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled.

Regulatory Status

Accepted for use in topical pharmaceutical formulations and cosmetics. Included in the Canadian List of Acceptable Non- medicinal Ingredients.

Related Substances

Lanolin alcohols; lanolin alcohols ointment; mineral oil and lanolin alcohols; petrolatum.

Lanolin alcohols ointment

Synonyms: Argobase EU; wool alcohols ointment.

Appearance: white-colored ointment if prepared using white petrolatum, a yellow-colored ointment if yellow petrolatum is used in its preparation.

Comments: the BP 2004 describes lanolin alcohols ointment (wool alcohols ointment BP) as a mixture consisting of:

Lanolin alcohols 60 g Paraffin 240 g

Petrolatum and Lanolin Alcohols 513

Yellow or white petrolatum 100 g Mineral oil 600 g

However, the proportions of paraffin, petrolatum, and mineral oil may be varied to produce an ointment of the desired physical properties.

Comments

See individual monographs on Lanolin Alcohols, and Petrola- tum for further information.

Specific References

—

General References

Davis SS. Viscoelastic properties of pharmaceutical semisolids I: ointment bases. J Pharm Sci 1969; 58: 412–418.

BP: Phenol JP: Phenol

PhEur: Phenolum USP: Phenol

Synonyms

Carbolic acid; hydroxybenzene; oxybenzene; phenic acid; phenyl hydrate; phenyl hydroxide; phenylic acid; phenylic alcohol.

Chemical Name and CAS Registry Number

Phenol [108-95-2]

Empirical Formula and Molecular Weight

C6H6O 94.11

istic odor. When heated gently phenol melts to form a highly refractive liquid. The USP 28 permits the addition of a suitable stabilizer; the name and amount of substance used for this purpose must be clearly stated on the label.

9 Pharmacopeial Specifications

See Table II.

Table II: Pharmacopeial specifications for phenol.

Structural Formula

Organic volatile impurities

— — +

Functional Category

Antimicrobial preservative; disinfectant.

Applications in Pharmaceutical Formulation or Technology

Phenol is used mainly as an antimicrobial preservative in parenteral pharmaceutical products. It has also been used in topical pharmaceutical formulations and cosmetics; see Table I. Phenol is widely used as an antiseptic, disinfectant, and therapeutic agent, although it should not be used to preserve

preparations that are to be freeze-dried.(1)

Table I: Uses of phenol.

Use Concentration (%)

Disinfectant 5.0

Injections (preservative) 0.5

Local anesthetic 0.5–1.0

Mouthwash 41.4

Description

Phenol occurs as colorless to light pink, caustic, deliquescent needle-shaped crystals or crystalline masses with a character-

Assay 598.0% 99.0–100.5% 99.0–100.5%

Typical Properties

Acidity/alkalinity: pH = 6.0 (saturated aqueous solution)

Antimicrobial activity: phenol exhibits antimicrobial activity against a wide range of microorganisms such as Gram- negative and Gram-positive bacteria, mycobacteria and some fungi, and viruses; it is only very slowly effective against spores. Aqueous solutions of 1% w/v concentration are bacteriostatic, while stronger solutions are bactericidal. Phenol shows most activity in acidic solutions; increasing temperature also increases the antimicrobial activity. Phenol is inactivated by the presence of organic matter.

Autoignition temperature: 7158C

Boiling point: 181.88C

Density: 1.071 g/cm3

Dissociation constant: pKa = 10 at 258C

Flash point: 798C (closed cup)

Explosive limits: 2% lower limit; 9% upper limit.

Freezing point: 40.98C

Melting point: 438C

Osmolarity: a 2.8% w/v solution is iso-osmotic with serum.

Partition coefficient: octanol:water = 1.46

Refractive index: n41 = 1.5425

Solubility: see Table III.

Vapor density (relative): 3.24 (air = 1)

Vapor pressure: 133 Pa (1 mmHg) at 408C

Stability and Storage Conditions

When exposed to air and light, phenol turns a red or brown color, the color being influenced by the presence of metallic impurities. Oxidizing agents also hasten the color change. Aqueous solutions of phenol are stable. Oily solutions for

Phenol 515

Table III: Solubility of phenol.

Solvent Solubility at 208C

Carbon disulfide Very soluble

Chloroform Very soluble

Ethanol (95%) Very soluble

Ether Very soluble

Fixed oils Very soluble

Glycerin Very soluble

Mineral oil 1 in 70

Volatile oils Very soluble

Water 1 in 15

injection may be sterilized in hermetically sealed containers by dry heat. The bulk material should be stored in a well-closed, light-resistant container at a temperature not exceeding 158C.

Incompatibilities

Phenol undergoes a number of chemical reactions characteristic of alcohols; however, it possesses a tautomeric enol structure that is weakly acidic. It will form salts with sodium hydroxide or potassium hydroxide, but not with their carbonates or bicarbonates.

Phenol is a reducing agent and is capable of reacting with ferric salts in neutral to acidic solutions to form a greenish- colored complex. Phenol decolorizes dilute iodine solutions, forming hydrogen iodide and iodophenol; stronger solutions of iodine react with phenol to form the insoluble 2,4,6-triiodo- phenol.

Phenol is incompatible with albumin and gelatin as they are precipitated. It forms a liquid or soft mass when triturated with compounds such as camphor, menthol, thymol, acetamino- phen, phenacetin, chloral hydrate, phenazone, ethyl amino- benzoate, methenamine, phenyl salicylate, resorcinol, terpin hydrate, sodium phosphate, or other eutectic formers. Phenol also softens cocoa butter in suppository mixtures.

Method of Manufacture

Historically, phenol was produced by the distillation of coal tar. Today, phenol is prepared by one of several synthetic methods, such as the fusion of sodium benzenesulfonate with sodium hydroxide followed by acidification; the hydrolysis of chloro- benzene by dilute sodium hydroxide at high temperature and pressure to give sodium phenate, which on acidification liberates phenol (Dow process); or the catalytic vapor-phase reaction of steam and chlorobenzene at 5008C (Raschig process).

Safety

Phenol is highly corrosive and toxic, the main effects being on the central nervous system. The lethal human oral dose is estimated to be 1 g for an adult.

Phenol is absorbed from the gastrointestinal tract, skin, and mucous membranes and is metabolized to phenylglucuronide and phenyl sulfate, which are excreted in the urine.

Although there are a number of reports describing the toxic effects of phenol, these largely concern instances of accidental poisoning(2,3) or adverse reactions during its use as a therapeutic agent.(4,5) Adverse reactions associated with phenol used as a preservative are less likely owing to the smaller quantities that are used; however, it has been suggested that the

body burden of phenol should not exceed 50 mg in a 10-hour period.(6) This amount could be exceeded following adminis- tration of large volumes of phenol-preserved medicines.

LD50 (mouse, IV): 0.11 g/kg(7) LD50 (mouse, oral): 0.3 g/kg LD50 (rabbit, skin): 0.85 g/kg LD50 (rat, skin): 0.67 g/kg LD50 (rat, oral): 0.32 g/kg LD50 (rat, SC): 0.46 g/kg

Handling Precautions

Phenol is toxic on contact with the skin or if swallowed or inhaled. Phenol is strongly corrosive, producing possibly irreversible damage to the cornea and severe skin burns, although the skin burns are painless owing to the anesthetic effects of phenol.

Phenol should be handled with caution, particularly when hot, owing to the release of corrosive and toxic fumes. The use of fume cupboards, enclosed plants, or other environmental containment is recommended. Protective polyvinyl chloride or rubber clothing is recommended, together with gloves, eye protection, and respirators. Spillages on the skin or eyes should be washed with copious amounts of water. Affected areas of the skin should be washed with water followed by application of a vegetable oil. Medical attention should be sought.

Phenol poses a slight fire hazard when cold and a moderate hazard when hot and exposed to heat or flame.

In the UK, the occupational exposure limits for phenol are 2 ppm long-term (8-hour TWA).(8) In the USA, the permissible exposure limit is 19 mg/m3 long-term and the recommended exposure limits are 20 mg/m3 long-term, and a maximum of 60 mg/m3 short-term.

Regulatory Status

Included in the FDA Inactive Ingredients Guide (injections). Included in medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

Related Substances

Liquefied phenol.

Liquefied phenol

Appearance: liquefied phenol is phenol maintained as a liquid by the presence of approximately 10% water. It is a colorless liquid, with a characteristic aromatic odor, which may develop a red coloration on exposure to air and light.

Specific gravity: 1.065 at 258C

Comments: liquefied phenol is often more convenient to use in a formulation than the crystalline form. However, liquefied phenol should not be used with fixed or mineral oils, although the crystalline solid may be used. Caution should be observed when handling liquified phenol to avoid contact with skin, as this could cause serious burns.

Comments

Although phenol is soluble in approximately 12 parts of water at ambient temperatures, larger amounts of phenol in water produce a two-phase system of phenol solution floating on a lower layer of wet phenol. At 208C, 100 parts of phenol may be liquefied by the addition of 10 parts of water. At 848C phenol is miscible with water in all proportions.

The EINECS number for phenol is 203-632-7.

516 Phenol

Specific References

FAO/WHO. WHO expert committee on biological standardiza- tion. Thirty-seventh report. World Health Organ Tech Rep Ser 1987; No. 760.

Foxall PJD, Bending MR, Gartland KPR, Nicholson JR. Acute renal failure following accidental cutaneous absorption of phenol: application of NMR urinalysis to monitor the disease process. Hum Toxicol 1989; 9: 491–496.

Christiansen RG, Klaman JS. Successful treatment of phenol poisoning with charcoal hemoperfusion. Vet Hum Toxicol 1996; 38: 27–28.

Warner MA, Harper JV. Cardiac dysrhythmias associated with chemical peeling with phenol. Anesthesiology 1985; 62: 366–367.

Ho SL, Hollinrake K. Acute epiglottitis and Chloraseptic. Br Med J 1989; 298: 1584.

Brancato DJ. Recognizing potential toxicity of phenol. Vet Hum Toxicol 1982; 24: 29–30.

Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 2885.

Health and Safety Executive. EH40/2002: Occupational Exposure Limits 2002. Sudbury: Health and Safety Executive, 2002.

General References

Karabit MS. Studies on the evaluation of preservative efficacy V. Effect of concentration of micro-organisms on the antimicrobial activity of phenol. Int J Pharm 1990; 60: 147–150.

BP: Phenoxyethanol PhEur: Phenoxyethanolum USPNF: Phenoxyethanol

Synonyms

Arosol; Emerescence 1160; ethyleneglycol monophenyl ether; b-hydroxyethyl phenyl ether; 1-hydroxy-2-phenoxyethane; Phenoxen; b-phenoxyethyl alcohol; phenyl cellulose.

Chemical Name and CAS Registry Number

2-Phenoxyethanol [122-99-6]

Empirical Formula and Molecular Weight

C8H10O2 138.16

Structural Formula

Functional Category

Antimicrobial preservative; disinfectant.

Applications in Pharmaceutical Formulation or Technology

Phenoxyethanol is an antimicrobial preservative used in cosmetics and topical pharmaceutical formulations at a concentration of 0.5–1.0%; it may also be used as a preservative and antimicrobial agent for vaccines.(1,2) Ther- apeutically, a 2.2% solution or 2.0% cream has been used as a disinfectant for superficial wounds, burns, and minor infections of the skin and mucous membranes.(3–5)

Phenoxyethanol has a narrow spectrum of activity and is thus frequently used in combination with other preservatives, see Section 10.

Description

Phenoxyethanol is a colorless, slightly viscous liquid with a faint pleasant odor and burning taste.

Pharmacopeial Specifications

See Table I.

Table I: Pharmacopeial specifications for phenoxyethanol.

Test PhEur 2005 USPNF 23

Identification + +

Characters + —

Refractive index 1.537–1.539 —

Relative density 1.105–1.110 1.105–1.110

Phenol + 40.1%

Chromatographic purity — +

Related substances + +

Assay 99.0–100.5% 98.0–102.0%

Typical Properties

Acidity/alkalinity: pH = 6.0 for a 1% v/v aqueous solution.

Antimicrobial activity: phenoxyethanol is an antibacterial preservative effective over a wide pH range against strains of Pseudomonas aeruginosa and to a lesser extent against Proteus vulgaris and other Gram-negative organisms. It is most frequently used in combination with other preserva- tives, such as parabens, to obtain a wider spectrum of antimicrobial activity.(6–8) See also Section 12. For reported minimum inhibitory concentrations (MICs) see Table II.(9)

Table II: Minimum inhibitory concentrations (MICs) of phenoxyethanol.

Microorganism MIC (mg/mL)

Aspergillus niger ATCC 16404 3300

Candida albicans ATCC 10231 5400

Escherichia coli ATCC 8739 3600

Pseudomonas aeruginosa ATCC 9027 3200

Staphylococcus aureus ATCC 6538 8500

Autoignition temperature: 1358C

Boiling point: 245.28C

Flash point: 1218C (open cup)

Melting point: 148C

Partition coefficients:

Isopropyl palmitate : water = 2.9; Mineral oil : water = 0.3;

Peanut oil : water = 2.6.

Refractive index: n20 = 1.537–1.539

Solubility: see Table III.

Specific gravity: 1.11 at 208C

Stability and Storage Conditions

Aqueous phenoxyethanol solutions are stable and may be sterilized by autoclaving. The bulk material is also stable and should be stored in a well-closed container in a cool, dry place.

Incompatibilities

The antimicrobial activity of phenoxyethanol may be reduced by interaction with nonionic surfactants and possibly by

518 Phenoxyethanol

Table III: Solubility of phenoxyethanol.

Solvent Solubility at 208C

Acetone Miscible

Ethanol (95%) Miscible

Glycerin Miscible

Isopropyl palmitate 1 in 26

absorption by polyvinyl chloride.(10) The antimicrobial activity of phenoxyethanol against Pseudomonas aeruginosa may be reduced in the presence of cellulose derivatives (methylcellu- lose, sodium carboxymethylcellulose, and hypromellose (hydroxypropylmethylcellulose)).(11)

Method of Manufacture

Phenoxyethanol is prepared by treating phenol with ethylene oxide in an alkaline medium.

Safety

Phenoxyethanol produces a local anesthetic effect on the lips, tongue, and other mucous membranes. The pure material is a moderate irritant to the skin and eyes. In animal studies, a 10% v/v solution was not irritant to rabbit skin and a 2% v/v solution was not irritant to the rabbit eye.(12) Long-term exposure to phenoxyethanol may result in CNS toxic effects similar to other organic solvents.(13)

LD50 (rabbit, skin): 5 g/kg(14) LD50 (rat, oral): 1.26 g/kg

Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. Phenoxyethanol may be irritant to the skin and eyes; eye protection and gloves are recommended.

Regulatory Status

Included in the FDA Inactive Ingredients Guide (topical preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non- medicinal Ingredients.

Related Substances

Chlorobutanol; chlorophenoxyethanol; phenoxypropanol.

Chlorophenoxyethanol Empirical formula: C8H9ClO2 Molecular weight: 172.60

CAS number: [29533-21-9]

Phenoxypropanol

Empirical formula: C9H12O2

Molecular weight: 152.18

CAS number: [4169-04-4]

Synonyms: 1-phenoxypropan-2-ol.

Comments

Aqueous solutions are best prepared by shaking phenoxyetha- nol with hot water until dissolved, followed by cooling and adjusting the volume to the required concentration.

The EINECS number for phenoxyethanol is 204-589-7.

Specific References

Pivnick H, Tracy JM, Tosoni AL, Glass DG. Preservatives for poliomyelitis (Salk) vaccine III: 2-phenoxyethanol. J Pharm Sci 1964; 53: 899–901.

Lowe I, Southern J. The antimicrobial activity of phenoxyethanol in vaccines. Lett Appl Microbiol 1994; 18(2): 115–116.

Thomas B, Sykes L, Stickler DJ. Sensitivity of urine-grown cells of Providencia stuartii to antiseptics. J Clin Pathol 1978; 31: 929– 932.

Lawrence JC, Cason JS, Kidson A. Evaluation of phenoxetol- chlorhexidine cream as a prophylactic antibacterial agent in burns. Lancet 1982; i: 1037–1040.

Bollag U. Phenoxetol–chlorhexidine cream as a prophylactic antibacterial agent in burns [letter]. Lancet 1982; ii: 106.

Abdelaziz AA, El-Nakeeb MA. Sporicidal activity of local anaesthetics and their binary combinations with preservatives. J Clin Pharm Ther 1988; 13: 249–256.

Denyer SP, Hugo WB, Harding VD. Synergy in preservative combinations. Int J Pharm 1985; 25: 245–253.

Onawunmi GO. In vitro studies on the antibacterial activity of phenoxyethanol in combination with lemon grass oil. Pharmazie 1988; 43: 42–44.

Hall AL. Cosmetically acceptable phenoxyethanol. In: Kabara JJ, ed. Cosmetic and Drug Preservation Principles and Practice. New York: Marcel Dekker, 1984: 79–108.

Lee MG. Phenoxyethanol absorption by polyvinyl chloride. J Clin Hosp Pharm 1984; 9: 353–355.

Kurup TRR, Wan LSC, Chan LW. Interaction of preservatives with macromolecules part II: cellulose derivatives. Pharm Acta Helv 1995; 70: 187–193.

Nipa Laboratories Ltd. Technical literature: Phenoxetol, 1992.

Morton WE. Occupational phenoxyethanol neurotoxicity: a report of three cases. J Occup Med 1990; 32(1): 42–45.

Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 2904.

General References

Baird RM. A proposed alternative to calamine cream BPC. Pharm J

1974; 213: 153–154.

Denyer SP, Baird RM, eds. Guide to Microbiological Control in Pharmaceuticals. Chichester: Ellis Horwood, 1990.

Fitzgerald KA, Davies A, Russell AD. Effect of chlorhexidine and phenoxyethanol, alone and in combination, on leakage from Gram- negative bacteria. J Pharm Pharmacol 1990; 42 (Suppl.): 104P.

Gilbert P, Beveridge EG, Crone PB. The action of phenoxyethanol upon respiration and dehydrogenase enzyme systems in Escherichia coli. J Pharm Pharmacol 1976; 28 (Suppl.): 51P.

Hall AL. Phenoxyethanol: a cosmetically acceptable preservative.

Cosmet Toilet 1981; 96(3): 83–85.

USP: Phenylethyl alcohol

Synonyms

Benzeneethanol; benzyl carbinol; benzylmethanol; b-hydroxy- ethyl benzene; PEA; phenethanol; b-phenylethyl alcohol; 2- phenylethyl alcohol; phenylethanol.

Chemical Name and CAS Registry Number

2-Phenylethanol [60-12-8]

Empirical Formula and Molecular Weight

C8H10O 122.17

Structural Formula

Functional Category

Antimicrobial preservative.

Applications in Pharmaceutical Formulation or Technology

Phenylethyl alcohol is used as an antimicrobial preservative in nasal, ophthalmic, and otic formulations at 0.25–0.5% v/v concentration; it is generally used in combination with other preservatives.(1–3) Phenylethyl alcohol has also been used on its own as an antimicrobial preservative at concentrations up to 1% v/v in topical preparations. At this concentration, mycoplasmas are inactivated within 20 minutes, although enveloped viruses are resistant.(4) Phenylethyl alcohol is also used in flavors and as a perfumery component, especially in rose perfumes.

Description

Phenylethyl alcohol is a clear, colorless liquid with an odor of rose oil. It has a burning taste that irritates and then anesthetizes mucous membranes.

Pharmacopeial Specifications

See Table I.

Table I: Pharmacopeial specifications for phenylethyl alcohol.

Test USP 28

Identification +

Specific gravity 1.017–1.020

Refractive index 1.531–1.534

Residue on ignition 40.005%

Chlorinated compounds +

Aldehyde +

Organic volatile impurities +

Typical Properties

Antimicrobial activity: phenylethyl alcohol has moderate antimicrobial activity although it is relatively slow acting; it is not sufficiently active to be used alone.(5) Greatest activity occurs at less than pH 5; it is inactive above pH 8. Synergistic effects have been reported when combined with benzalkonium chloride, chlorhexidine gluconate or diace- tate, polymyxin B sulfate, and phenylmercuric nitrate.(6–10) With either benzalkonium chloride or chlorhexidine, synergistic effects were observed against Pseudomonas aeruginosa and apparently additive effects against Gram- positive organisms. With phenylmercuric nitrate, the effect was additive against Pseudomonas aeruginosa. Additive effects against Pseudomonas cepacia in combination with either benzalkonium chloride or chlorhexidine have also been reported.(11) See also Section 12.

Bacteria: fair activity against Gram-positive bacteria; for Staphylococcus aureus, the minimum inhibitory concentra- tion (MIC) may be more than 5 mg/mL. Greater activity is shown against Gram-negative organisms.(12) Typical MIC values are: Salmonella typhi 1.25 mg/mL; Pseudomonas aeruginosa 2.5 mg/mL; Escherichia coli 5.0 mg/mL.

Fungi: poor activity against molds and fungi.

Spores: inactive, e.g., at 0.6% v/v concentration, reported to be ineffective against spores of Bacillus stearothermophilus at 1008C for 30 minutes.

Boiling point: 219–2218C Flash point: 1028C (open cup) Melting point: —278C Partition coefficients:

Chloroform : water = 15.2; Heptane : water = 0.58; Octanol : water = 21.5.

Solubility: see Table II.

Stability and Storage Conditions

Phenylethyl alcohol is stable in bulk, but is volatile and sensitive to light and oxidizing agents. It is reasonably stable in both acidic and alkaline solutions. Aqueous solutions may be sterilized by autoclaving. If stored in low-density polyethylene containers, phenylethyl alcohol may be absorbed by the containers. Losses to polypropylene containers have been reported to be insignificant over 12 weeks at 308C. Sorption to rubber closures is generally small.

520 Phenylethyl Alcohol

Table II: Solubilty of phenylethyl alcohol.

Solvent Solubility at 208C

Benzyl benzoate Very soluble

Chloroform Very soluble

Diethyl phthalate Very soluble

Ethanol (95%) Very soluble

Ether Very soluble

Fixed oils Very soluble

Glycerin Very soluble

Mineral oil Slightly soluble

Propylene glycol Very soluble

Water 1 in 60

The bulk material should be stored in a well-closed container, protected from light, in a cool, dry place.

Incompatibilities

Incompatible with oxidizing agents and protein, e.g., serum. Phenylethyl alcohol is partially inactivated by polysorbates, although this is not as great as the reduction in antimicrobial activity that occurs with parabens and polysorbates.(13)

Method of Manufacture

Phenylethyl alcohol is prepared by reduction of ethyl phenyl- acetate with sodium in absolute alcohol; by hydrogenation of phenylacetaldehyde in the presence of a nickel catalyst; or by addition of ethylene oxide or ethylene chlorohydrin to phenylmagnesium bromide, followed by hydrolysis. Phenyl- ethyl alcohol also occurs naturally in a number of essential oils, especially rose oil.

Safety

Phenylethyl alcohol is generally regarded as a nontoxic and nonirritant material. However, at the concentration used to preserve eye-drops (about 0.5% v/v) or above, eye irritation may occur.(14)

LD50 (rabbit, skin): 0.79 g/kg(15) LD50 (rat, oral): 1.79 g/kg

Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. Phenylethyl alcohol is combustible when exposed to heat or flame, and emits acrid smoke when heated to decomposition. Eye protection and gloves are recommended.

Regulatory Status

Included in the FDA Inactive Ingredients Guide (nasal, ophthalmic, and otic preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

Related Substances

Chlorobutanol.

Comments

The EINECS number for phenylethyl alcohol is 200-456-2.

med 10

728x90

468x60

mob

Wednesday, November 6, 2024

No comments:

Post a Comment

اتصل بنا