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Q: Pharmaceutical or Cosmetic Use of Storax ( Answered 5 out of 5 stars,   0 Comments )
Question  
Subject: Pharmaceutical or Cosmetic Use of Storax
Category: Science > Chemistry
Asked by: jaleva-ga
List Price: $200.00
Posted: 07 Jan 2006 14:27 PST
Expires: 06 Feb 2006 14:27 PST
Question ID: 430452
What is the safety profile of USP Storax for topical/dermatological
use?  In what range of concentrations in a given formulation (eg
cosmetics, soap) is Storax safe vs an irritant?  In what
concentrations is Storax effective as an adhesive?  What role does the
Storax that is used in Compound Tincture of Benzoin play?
Answer  
Subject: Re: Pharmaceutical or Cosmetic Use of Storax
Answered By: welte-ga on 29 Jan 2006 09:18 PST
Rated:5 out of 5 stars
 
Hi jaleva-ga, and thanks for your question.

One of the most complete descriptions of the safety of Storax can be found here:
http://europa.eu.int/comm/health/ph_risk/committees/04_sccp/docs/sccp_o_025a.pdf

This document from the EU Scientific Committee on Consumer Products
discusses multiple varieties of Storax (derived from different
species) and multiple uses.  Of importance, Styrax is a synonym for
Storax.

The following guidelines are given (see page 6) for Storax concentrations:

"Storax preparations are widely used fragrance ingredients of many
fragrance compounds used in perfumery. Based on the positive results
of maximization tests by industry, the IFRA standard recommends:
 
"Crude gums of American and Asian styrax should not be used as
fragrance ingredient. Only extracts or distillates (resinoids,
absolutes and oils), prepared from exudations of Liquidambar
styraciflua L. var. macrophylla or Liquidambar orientalis Mill., can
be used and should not exceed a level of 0.6 % in consumer products.
This is equivalent to 3 % in a fragrance compound used at 20% in the
consumer product.
  
This recommendation is made in order to promote good manufacturing
practice (GMP) for the use of styrax derivatives as fragrance
ingredients. It is based on a wide variety of RIFM test data with
gums, resinoids, absolutes and oils of American and Asian styrax
(private communication to IFRA)." "

"In the updated EU Inventory, Section II: Perfume and Aromatic Raw
Materials (doc. SCCNFP/0389/00), the above restriction (previously
flagged with one asterisk) is summarized as follows:
 
"The final concentration of Styrax extracts or distillates (resinoids,
absolutes, oils) from exudates shall not exceed 0.6 % in the finished
product." "


Because Storax is a resin, it also has adhesive properties that are
roughly proportional to its concentration (gram/cm^2) within the
limits above for safety and irritative effects.  Of course, in
adhesive formulations, particularly those used for example in
operating room applications, the concentration of Storax can be above
the recommended 0.6% for fragrances.  This is the case with tincture
of benzoin, discussed below, where it is 8%.

__________

In terms of sensitization, the above document also discusses topical
testing with multiple varieties and qualities of Storax (see pages
7-12).

The SCCP goes on to give their conclusions for safety guidelines in
the context of the rather poor quality data currently available:

"However, under the conditions of its anticipated use as a fragrance
ingredient (maximum 0.6 % in the finished cosmetic product), the risk
of sensitisation is low.
 
Nevertheless, Storax extracts/oils may contain one or more fragrance
chemicals, which have been identified as contact allergens and for
which information should be provided to consumers about the known
presence in cosmetic products (Opinion of the SCCNFP concerning
fragrance allergy in consumers, doc n° SCCNPF/0017/98). "

There are 52 references near the bottom of this document for further
reading or more details.

You can find MSDS safety profile sheets here:
http://www.spectrumchemical.com/MSDS/S4930.pdf
http://www.sciencelab.com/xMSDS-Storax_gum-9926921


Also, as there are many types of Storax, the following overview from
Columbia University Press may be useful:

"benzoin ... , balsamic resin, the dried exudation from the pierced
bark of various species of the benzoin tree (Styrax) native to
Sumatra, Java, and Thailand; appearing as red-brown to yellow-brown
tears. Because of its fragrant odor it is used in perfume and
sometimes in incense. The benzoic acid present in it gives it value in
medicine as an antiseptic, as a stimulant, and, in certain respiratory
diseases, as an inhalant. Among the several varieties are Siam benzoin
and Sumatra benzoin. Siam benzoin is considered finer, since it has a
high content of benzoic acid; Sumatra benzoin contains cinnamic acid."

http://www.answers.com/topic/benzoin

__________

From the Review of Natural Products, 


==============
Tincture of Benzoin

"Storax has been used as an expectorant, especially in inhalation with
warm air vaporizers. It has also been used to treat parasitic
infections. The leaves are rich in tannins and have been used to treat
diarrhea and to relieve sore throat.[2] In Latin America, the gum is
used to promote sweating and as a diuretic. It is also applied
topically to sores and wounds.[2] Storax had been used in the US as a
component of hemorrhoid preparations, but today its only official use
is as an ingredient in compound tincture of benzoin,[2] where it is
used as a topical protectant.[3] Resins derived from storax have been
used in perfumes, incense and as food flavors."

The Review of Natural Products, DerMarderosian, Ara, Beutler, John A.
Eds., Facts and Comparisons, 2006.
http://www.factsandcomparisons.com/index.aspx

This text also describes the chemical makeup of storax:

"Crude storax is a gray, thick liquid with a pleasing odor but a
bitter taste. About 85% of the crude material is alcohol soluble.[1]
Purified storax forms a brown semi-solid mass that is completely
soluble in alcohol. Storax is high in free and combined cinnamic acid.
Purified storax yields up to 47% total balsamic acids.[1] Its major
components include phenylethylene (styrene), cinnamic esters, and
vanillin.[1]

Upon steam distillation, the leaf yields an oily liquid containing
about three dozen components, the major ones being terpinen-4-ol,
alpha-pinene, and sabinene.[5] Benzaldehyde is produced from certain
chemical reactions with the cinnamic acid in storax. Storax also
contains an aromatic liquid (styrocamphene).[2]"

In terms of being a protectant,

"The leaf oil is rich in terpinen-4-ol, and the oil has a composition
that is similar to that of the essential oil of Melaleuca alternifolia
(Australian tea tree oil, see monograph), which has been investigated
clinically as a topical antiseptic. Although the leaf oil of
Liquidambar styraciflua has not yet been bioassayed, its similarity in
composition indicates that it may demonstrate similar antibacterial
and protectant properties to tea tree oil.[5]"


There is also a recent patent (#6899897) that claims styrax as a skin
protectant in a general gum resin formulation intended to act as a
carrier for various treatment agents:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/srchnum.htm&r=1&f=G&l=50&s1=6899897.WKU.&OS=PN/6899897&RS=PN/6899897

__________

The USP formulation, as described in the Federal Register of June 4,
2003 (page 33364), is as follows:

"Compound benzoin tincture is included in the USP as a fixed
formulation containing 10 percent benzoin, 2 percent aloe, 8 percent
storax, 4 percent tolu balsam, and 74 to 80 percent ethanol (Ref. 8)."

DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Parts 310, 347, and 352 
[Docket Nos. 78N-0021 and 78N-021P] 
RIN 0910-AA01 
Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph 


The Register goes on to describe the problems associated with Tincture
of Benzoin applied topically, stating that it's use as a general over
the counter (OTC) skin protectant ingredient is not safe.

"In addition, the published literature contains numerous other reports
of allergic contact dermatitis and sensitivity attributed to compound
benzoin tincture and benzoin tincture. Cullen, Tonkin, and May (Ref.
10) stated that the literature was replete with reports of cutaneous
sensitivity to compound benzoin tincture and its components, citing
reports following local application. Rademaker and Kirby (Ref. 11)
reported two cases of bullous contact dermatitis to a skin adhesive
spray and mentioned that Fisher (Ref. 12) recommends that benzoin no
longer be used as a skin adhesive. Marks and Rainey (Ref. 13) and
James, White, and Yanklowitz (Ref. 14) reported other cases of
allergic contact dermatitis. Sixteen cases resulted when benzoin was
applied to prevent friction blisters. Other authors report contact
dermatitis from benzoin used as an ingredient in greasepaint makeup
(Ref. 15) and as an antioxidant in food additives (Ref. 16). In
addition, benzoin provokes pemphigus erythematosus (Ref. 17),
complicates management of venous leg ulcers (Ref. 18), and adversely
affects wound healing after circumcision in children (Ref. 19).

Based on these reports of adverse events and the availability of other
monograph skin protectant ingredients, the agency concludes that
compound benzoin tincture is not safe for use as a general OTC skin
protectant ingredient and would be inappropriate for many of the uses
included in this final monograph."


You can find an MSDS safety sheet for Tincture of Benzoin here:
http://www.cumberlandswan.com/bentinc.pdf

__________

An article from Australia describes in detail potential sensitivities
caused by Tincture of Benzoin.

Scardamaglia L. Nixon R. Fewings J. Compound tincture of benzoin: a
common contact allergen?. [Journal Article] Australasian Journal of
Dermatology. 44(3):180-4, 2003 Aug.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12869042&query_hl=2&itool=pubmed_docsum

You can request a reprint from the Contact Dermatitis Clinic at the
Skin and Cancer Foundation in Victoria, Australia:
skincanc@netspace.net.au

This study describes reactions to the standard USP formulation
tincture of benzoin in Table 4, which you can see here:

http://img359.imageshack.us/img359/5235/snapshot200601291059534ju.jpg

These reactions are based on test exposures in 477 patients using
tincture of benzoin containing 8% storax.

__________

As this article also states, "benzoin" is a bit of a generic term:

"Benzoin is a common designation for various solid resins differing in
composition and odour. Benzoin, like balsam of Peru, is a pathological
secretion formed only after lesions to the bark of the tree. [3]"


Interestingly, these reactions may not actually be directly due to storax:

"There have been few reports of contact allergy to CTB, and none in
the last decade, suggesting that CTB is in fact not a strong
sensitizer. It would appear that the large number of positive
reactions to CTB we found in our study population, where allergy to
CTB was third most frequent after nickel and fragrance mix, was caused
by cross-reactions. Compound tincture of benzoin is known to
cross-react with several chemicals because of the similarity in their
chemical structures, and the fact that CTB includes a number of resins
apart from benzoin. [3,4]

Benzoin itself contains not only benzoic acid but also cinnamic acid,
as well as esters of cinnamic acid, and vanillin, adding further to
its ability to cross react with other compounds, particularly
fragrances and some medicaments. [3]  In our study, the most common
cross-reactions were between CTB and fragrance and balsam of Peru,
where we found approximately half of our patients reacted to both CTB
and one of these."

=========

If you're interested in the various types of Styrax, I recommend the
following articles:

Phylogeny and biogeography of the styracaceae.(Statistical Data
Included). Peter W. Fritsch, Cynthia M. Morton, Tao Chen and Candice
Meldrum. International Journal of Plant Sciences 162.6 (Nov 2001):
pS95(22).

Phylogeny of the Styracaceae based on four data sets: implications for
the historical biogeography of the northern hemisphere and
amphi-Pacific tropical disjunctions.(Statistical Data Included). PETER
W. FRITSCH and CYNTHIA M. MORTON. The American Journal of Botany 87.6
(June 2000): pS100.

__________

Search strategy:
(storax OR styrax) {safety, adhesive, MSDS}
"tincture of benzoin" 

Using Google, Ovid (PubMed), JSTOR, InfoTrac, and online natural
product, toxicology, and pharmacology textbook searches.

========================

I hope this information is useful.  Please feel free to request any
clarification prior to rating.

      -welte-ga
jaleva-ga rated this answer:5 out of 5 stars
exceptional. thanks.

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