2-Phenoxyethanol

Table of Contents:

1. Summary
2. Vaccines containing 2-Phenoxyethanol
3. Toxicology Report on 2-Phenoxyethanol
4. German Study on 18 month old with eczema caused by 2-PE (including references)
5. Web links on 2-PE
a. Government Transcript of the 8/12/99 Workshop on Thimerisol Vaccines
b. PubMed Abstracts
c. Environmental Fact Sheets
d. Efficacy of 2-PE as a preservative

1. Summary:

2-Phenoxyethanol (2-PE) is a chemical substance presently used as a preservative in several vaccines. 2-PE contains phenol, which has the ability to inhibit phagocyte activity, meaning it is toxic to all cells. The phenol in 2-PE is capable of disabling the immune system's primary response mechanism. It can also cause systemic poisoning, headache, shock, weakness, convulsions, kidney damage, cardiac failure, kidney failure, or death. 2-PE also contains ethylene oxide, which is an irritant causing dermatitis, burns, blisters, and eczema.

2. Vaccines containing 2-Phenoxyethanol

Havrix® Hepatitis A Vaccine, Inactivated SmithKline Beecham Biologicals

PEDIARIX™ GlaxoSmithKline

DAPTACEL Manufactured by: Aventis Pasteur

IPOL Poliovirus Vaccine Inactivated Manufactured by: Aventis Pasteur

INFANRIX ® HepB Combined Diphtheria-Tetanus-acellular Pertussis (DTPa) and Hepatitis B Vaccine SmithKline Beecham Biologicals

TETRAVAC® Suspension for i.m. (intramuscular?) Injection - Used only in Germany.

There may be more, but at this time the situation is clouded because of the removal of Thimerasol. There is no way of knowing which vaccines have been replaced with
2-Phenoxyethanol. When the information becomes available it will be added to the site.

3. Toxicology report on 2-Phenoxyethanol

General
Synonyms: phenoxetol, phenoxyethyl alcohol, phenoxyethanol, 1-hydroxy-2-phenoxyethane, rose ether, phenylmonoglycol ether, 2-phenoxyethanol, glycol monophenyl ether, beta-hydroxyethyl phenyl ether, various trade names

Uses: Used as a fixative for perfumes, a bactericide (in conjunction with quaternary ammonium compounds), a insect repellent, a topical antiseptic, a solvent for cellulose acetate, dyes, inks and resins, in organic synthesis of plasticizers, in germicides, in pharmaceuticals, in cosmetics and in preservatives.

Molecular formula: C8H10O2
CAS No: 122-99-6
EINECS No: 204-589-7
Physical data
Appearance: colourless or light yellow viscous liquid
Melting point: 14 C
Boiling point: 245 C
Vapour density: 4.76 (air = 1)
Vapour pressure: <0.01 mm Hg at 20 C
Density (g cm-3): 1.102
Flash point: 130 C
Explosion limits:
Autoignition temperature:
Water solubility:
Stability: Stable. Incompatible with acid chlorides, acid anhydrides, strong oxidizing agents. Combustible.
Toxicology: Harmful by inhalation, in contact with skin and if swallowed. Skin, eye and respiratory irritant. May cause serious eye damage.
Toxicity data:
ORL-RAT LD50 1260 mg kg-1 Oral Rat 50% Lethal Dose
SKN-RBT LD50 5000 mg kg-1 Skin Rabbit 50% Lethal Dose

Irritation data:
SKN-RBT 500 mg/24h mld Skin Rabbit 500 mg 24 hours mild
EYE-RBT 6 mg mod Eye Rabbit 6 mg moderate
EYE-RBT 0.25 mg/24h sev Eye Rabbit 24 hours severe

Risk Phrases: R20 R21 R22 R36 R37 R38 R41.
R20 Harmful by inhalation
R21 Harmful by contact with skin
R22 Harmful if swallowed
R36 Irritating to eyes
R37 irritating to respiratory system
R38 irritating to skin
R41 Risk of serious damage to eyes
Reference: Safety (MSDS) data for ethylene glycol monophenyl ether

4. German Study on 18 month old with eczema caused by 2-PE

Generalized eczema in an 18-month-old boy due to phenoxyethanol in DPT vaccine.

5. Web links on 2-PE

a. Government Transcript of the 8/12/99 Workshop on Thimerosol Vaccines

{PRIVATE } THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE CENTERS FOR DISEASE CONTROL AND PREVENTION convenes
THE NATIONAL VACCINE ADVISORY COMMITTEE SPONSORED WORKSHOP ON THIMEROSAL VACCINES DAY TWO - VOLUME I AUGUST 12th, 1999
The verbatim transcript of the Sponsored Workshop on Thimerosal Vaccines held Wednesday, August 12th, 1999, at the National Institutes of Health, Lister Hill Auditorium, Bethesda, Maryland. Click to read the full transcript of this document

The National Vaccine Advosory Committe sponsored workshop on Thimersol in Vaccines

Quote from Dr. Mary Teeling, Medical Director of the Ireland Medicines Board, during the above workshop: "Perhaps I'm getting old and a bit cynical, but I'm really not sure that we have the full safety picture on 2-phenoxyethanol. It certainly does look to be a safe and efficacious vaccine -- preservative, but we're actually not 100 percent sure about either of these at this point in time. Formaldehyde has also been used. Now, there are other preservatives that have been used
in other medicinal products, like benzochromium chloride. I think the important thing is that for a
preservative to be used, they must fulfill the European Pharmacopeia specifications. That's a requirement in order to get a license either nationally or at community level in the European Union. So they do have -- So they will, more or less, fulfill the PH Euro requirements. But we're not really -- Ever how much information we have on thimerosal, I think we have less on the others. So you're into a situation, or are you -- You know the phrase, "The devil you know is better than the devil you don't know." And I think that's a very important aspect of this whole review."

b. PubMed Abstracts

In vitro induction of apoptosis vs. necrosis by widely used preservatives: 2-phenoxyethanol, a mixture of isothiazolinones, imidazolidinyl urea and 1, 2-pentanediol.

Phenoxyethanol-induced urticaria.

2-Phenoxyethanol: a neurotoxicant?

Full Study: Page 1 Page 2

c. Environmental Fact Sheets

Phenol

2-Phenoxyethanol (2PE) Test Results

d. Efficacy of 2-PE as a preservative

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