Amended Safety Assessment of Aluminum Starch Octenylsuccinate
As Used in Cosmetics

Status:Re-Review for Panel Review
Release Date:
May 11, 2018
Panel Meeting Date: June 4-5 2018

The 2018 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V.
Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., Ronald
C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Executive Director is Bart Heldreth,
Ph.D. This safety assessment was prepared by Alice Akinsulie, Scientific Analyst/Writer.

© Cosmetic Ingredient Review
1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢cirinfo@cir-safety.org

Distributed for Comment Only -- Do Not Cite or Quote

Commitment & Credibility since 1976
Memorandum

To:
From:
Date:
Subject:

CIR Expert Panel Members and Liaisons
Alice Akinsulie
Scientific Analyst/Writer
May 11, 2018
Amended Safety Assessment of Aluminum Starch Octenylsuccinate as Used in Cosmetics

Enclosed is the Re-Review of Aluminum Starch Octenylsuccinate as Used in Cosmetics (starch062018rep). In
2002, the Panel published a safety assessment with the conclusion that Aluminum Starch Octenylsuccinate is safe as
used in cosmetic formulations provided that established limitations imposed on heavy metal concentrations are notexceeded; the limitations were identified in the Discussion of the report. The Expert Panel also acknowledged astudy reported an enhancement of the sun protection factor of a sunscreen formulation with the addition of
Aluminum Starch Octenylsuccinate.
Because it has been 15 years since the safety assessment on the above ingredients was published, the Panel is being
asked to determine whether the conclusion should be reaffirmed, or, if a re-review is necessary. Additionally, thefollowing 7 ingredients are being proposed for inclusion in this assessment:
Acacia Seyal Gum Octenylsuccinate
Calcium Starch Octenylsuccinate
Hydrolyzed Hydroxypropylsuccinate
Quinoa Starch Octenylsuccinate

Sodium Glycogen Octenylsuccinate
Sodium Hydroxypropyl Cyclodextrin Octenylsuccinate
Sodium Trehalose Octenylsuccinate

According to 2018 FDA VCRP data, Aluminum Starch Octenylsuccinate is reported to be used in 786 formulations,744 of which are in leave-on formulations; 699 uses are reported in formulations that result in dermal contact. Noneof the proposed add-ons are reported to the FDA VCRP as in use.
The frequency of use of Aluminum Starch Octenylsuccinate has increased since the original safety assessment was
prepared. In 1998, Aluminum Starch Octenylsuccinate was reported to be used in 172 formulations, the majority ofwhich resulted in dermal contact. A concentration of use survey is currently being conducted by the Council, andonce those data are received they will be incorporated into the report. However, according to the original report,
Aluminum Starch Octenylsuccinate was used in leave-on products at concentrations of 0.5-30%.
The original report is included with this submission for your review (starch062018prev). To facilitate your review,
relevant information from the original report are included throughout the text of the re-review document (indicated byitalics), and the original Discussion is also included. It should be noted that no new data were found in the publishedliterature.
The Panel is now being asked to consider whether a re-review is appropriate, first considering whether the original
conclusion is still valid. If the new data presented in the report simply reaffirms the original conclusion, then is it
appropriate to re-open the review to include the proposed “add-ons”?
__________________________________________________________________________________________
1620 L Street, NW, Suite 1200, Washington, DC 20036(Main) 202-331-0651 (Fax) 202-331-0088(Email) cirinfo@cir-safety.org (Website) www.cir-safety.org

Distributed for Comment Only -- Do Not Cite or Quote

RE-REVIEW FLOW CHART
INGREDIENT/FAMILY_____ Aluminum Starch Octenylsuccinate ______________________________MEETING _______ June 2018____________________________________________________________
Public Comment

CIR

Expert Panel
15 yearssince last
reviewannounce

Re-Review

Rpt Status

New Data; orrequestOR

IJT 21 (Suppl 1): 1-7;
2002

Re-reviewto Panel
PRIORITY LIST

June 2018

Are new data cause to reopen?

7 proposed addons

YESNO

DRAFT AMENDEDREPORTDAR

Are new ingredients
appropriate forinclusion/re-open?

Table
Table

IDA

TAR

Yes

IDA

IDA Notice

Draft TARNo

DRAFT TENTATIVEAMENDED REPORT

RE-REVIEW
SUMMARY

Admin Book

Table
Table

Tentative
Amended Report

Draft FAR
60 day Public comment period

Issue
TAR

DRAFT FINALAMENDED REPORT

Table
Table

PUBLISH

Final Amended
ReportDifferent Conclusion

Issue
FAR

*If Draft Amended Report (DAR) is available, the Panel may choose to review; if not, CIR staff prepares DAR for Panel Review.

Distributed for Comment Only -- Do Not Cite or Quote

CIR History of: Aluminum Starch Octenylsuccinate
A Rereview on Aluminum Starch Octenylsuccinate was issued on March, 2018.
67th CIR Expert Panel Meeting (May 18-19, 1998)
The Panel issued an Insufficient Data Announcement (IDA) with the following data requests on Aluminum Starch
Octenylsuccinate:(1) Concentration of use(2) Methods of manufacture and chemical characterization, including impurities(3) Dermal absorption; if significantly absorbed, then gross pathology
and histopathology in skin and other major organ systems associatedwith repeated exposures, and dermal reproductive and developmental
toxicity data may be needed(4) Dermal irritation and sensitization(5) Two genotoxicity assays, one in a mammalian system; if positive, then a
2-year dermal carcinogenesis study using NTP methods may be needed(6) Inhalation studies at use particle size
69th CIR Expert Panel Meeting (December 2-3, 1998)
The Panel issued a Tentative Report with the following conclusion: Based on the available data, the CIR Expert
Panel concludes that Aluminum Starch Octenylsuccinate is safe as used in cosmetic formulations. The available
data are insufficient to support the safety of this ingredient in cosmetic products in which a primary route of
exposure is inhalation.
71st CIR Expert Panel Meeting (June, 1999) – Dr. Belsito’s Team
According to the information received, the average particle size of Aluminum Starch Octenylsuccinate is ≈13.5 µ,and a particle of this size would not be respirable. The Panel voted unanimously in favor of issuing a Final Reportwith the following conclusion: Based on the available data, the CIR Expert Panel concludes that Aluminum Starch
Octenylsuccinate is safe as used in cosmetic formulations.
Rereview: June 4-5, 2018

Distributed for Comment Only -- Do Not Cite or Quote*“X” indicates that new data were available in this category for the ingredient; “O” indicates that old data were available in this category for the ingredient1

O

Ocular IrritationO

Phototox

DermalSensitization

O

Carcinogenicity

Genotox

Repro/Dev Tox

Animal Tox – Rptd
Dose, Inhalaiton

Animal Tox, Rptd
Dose, OralO

Dermal IrritationO

Animal Tox – Rptd
Dose, DermalO

Animal Tox, Acute,Inhalation

X,O

Animal Tox –Acute, Oral

Impurities

X,O

Animal Tox –Acute, Derrmal

Method ofManufacture

Aluminum Starch Octenylsuccinate
Acacia Seyal Gum Octenylsuccinate
Calcium Starch Octenylsuccinate
Hydrolyzed Hydroxypropyl Starch Octenylsuccinate
Quinoa Starch Octenylsuccinate
Sodium Glycogen Octenylsuccinate
Sodium Hydroxypropyl Cyclodextrin Octenylsuccinate
Sodium Trehalose Octenylsuccinate

Reported Use

Amended Safety Assessment of Aluminum Starch Octenylsuccinate – June 4th -5th, 2018 meeting– Alice Akinsulie

ODistributed for Comment Only -- Do Not Cite or Quote[Ingredient Family Name]
IngredientCAS #Aluminum Starch 9087-61-0
Octenylsuccinate
Acacia Seyal Gum 455885-22-0
Octenylsuccinate
374539-60-3
Calcium Starch
Octenylsuccinate
Hydrolyzed
Hydroxypropyl
StarchOctenylsuccinate
Quinoa Starch
Octenylsuccinate
Sodium Glycogen
Octenylsuccinate
SodiumHydroxypropyl
Cyclodextrin
Octenylsuccinate
Sodium Trehalose
Octenylsuccinate

InfoB

SciFinECHAIUCLIDSIDSECETOCHPVIS NICNAS NTIS

WHO

FAO

NIOSH

FEMA

1/1

216/0

PubMed TOXNET
2/1

1/1

0

FDA

0

0

0

0

0

0

0

0

0

0

0

0

0

1/1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1/1

25/0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1/1

9/0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1/1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1/1

2/0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1/1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1/1

1/0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Search Strategy[document search strategy used for SciFinder, PubMed, and Toxnet][identify total # of hits / # hits that were useful]Search Terms


Starch Octenylsuccinate

EU

NTP

Web

Distributed for Comment Only -- Do Not Cite or Quote

LINKS

Search Engines
 Pubmed (- http://www.ncbi.nlm.nih.gov/pubmed)
 Toxnet (https://toxnet.nlm.nih.gov/); (includes Toxline; HSDB; ChemIDPlus; DART; IRIS; CCRIS; CPDB; GENE-TOX)
 Scifinder (https://scifinder.cas.org/scifinder)
appropriate qualifiers are used as necessary
search results are reviewed to identify relevant documents

Pertinent Websites
 wINCI - http://webdictionary.personalcarecouncil.org
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FDA databases http://www.ecfr.gov/cgi-bin/ECFR?page=browse
FDA search databases: http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234631.htm;,
EAFUS: http://www.accessdata.fda.gov/scripts/fcn/fcnnavigation.cfm?rpt=eafuslisting&displayall=true
GRAS listing: http://www.fda.gov/food/ingredientspackaginglabeling/gras/default.htm
SCOGS database: http://www.fda.gov/food/ingredientspackaginglabeling/gras/scogs/ucm2006852.htm
Indirect Food Additives: http://www.accessdata.fda.gov/scripts/fdcc/?set=IndirectAdditives
Drug Approvals and Database: http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135688.pdf
FDA Orange Book: https://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm
OTC ingredient list: https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm135688.pdf(inactive ingredients approved for drugs: http://www.accessdata.fda.gov/scripts/cder/iig/

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HPVIS (EPA High-Production Volume Info Systems) - https://ofmext.epa.gov/hpvis/HPVISlogon
NIOSH (National Institute for Occupational Safety and Health) - http://www.cdc.gov/niosh/
NTIS (National Technical Information Service) - http://www.ntis.gov/
NTP (National Toxicology Program ) - http://ntp.niehs.nih.gov/
Office of Dietary Supplements https://ods.od.nih.gov/
FEMA (Flavor & Extract Manufacturers Association) - http://www.femaflavor.org/search/apachesolr_search/

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EU CosIng database: http://ec.europa.eu/growth/tools-databases/cosing/
ECHA (European Chemicals Agency – REACH dossiers) – http://echa.europa.eu/information-on-chemicals;jsessionid=A978100B4E4CC39C78C93A851EB3E3C7.live1
ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals) - http://www.ecetoc.org
European Medicines Agency (EMA) - http://www.ema.europa.eu/ema/
IUCLID (International Uniform Chemical Information Database) - https://iuclid6.echa.europa.eu/searchOECD SIDS (Organisation for Economic Co-operation and Development Screening Info Data Sets)- http://webnet.oecd.org/hpv/ui/Search.aspx
SCCS (Scientific Committee for Consumer Safety) opinions: http://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/index_en.htm
NICNAS (Australian National Industrial Chemical Notification and Assessment Scheme)- https://www.nicnas.gov.au/

Distributed for Comment Only -- Do Not Cite or QuoteInternational Programme on Chemical Safety http://www.inchem.org/
FAO (Food and Agriculture Organization of the United Nations) - http://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/en/
WHO (World Health Organization) technical reports - http://www.who.int/biologicals/technical_report_series/en/

www.google.com - a general Google search should be performed for additional background information, to identify references that are available, and for other general
information

Botanical Websites, if applicable Dr. Duke’s - https://phytochem.nal.usda.gov/phytochem/search Taxonomy database - http://www.ncbi.nlm.nih.gov/taxonomy
 GRIN (U.S. National Plant Germplasm System) - https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
 Sigma Aldrich plant profiler- http://www.sigmaaldrich.com/life-science/nutrition-research/learning-center/plant-profiler.html
 American Herbal Products Association Botanical Safety Handbook (database) - http://www.ahpa.org/Resources/BotanicalSafetyHandbook.aspx
 European Medicines Agency Herbal Medicines - http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/herbal_search.jsp
 National Agricultural Library NAL Catalog (AGRICOLA) https://agricola.nal.usda.gov/
 The Seasoning and Spice Association List of Culinary Herbs and Spices http://www.seasoningandspice.org.uk/ssa/background_culinary-herbs-spices.aspx

Fragrance Websites, if applicable IFRA (International Fragrance Association) – http://www.ifraorg.org/
 Research Institute for Fragrance Materials (RIFM)

Distributed for Comment Only -- Do Not Cite or Quote

67th CIR Expert Panel Meeting (May 18-19, 1998) – Dr. Schroeter’s Team
Aluminum Starch Octenylsuccinate
Dr. Schroeter stated that his Team determined that the following data are needed for completion of the Panel=s
safety assessment on Aluminum Starch Octenylsuccinate:(1) Concentration of use(2) Methods of manufacture and chemical characterization, including impurities(3) Dermal absorption; if significantly absorbed, then gross pathology
and histopathology in skin and other major organ systems associatedwith repeated exposures, and dermal reproductive and developmental
toxicity data may be needed1(4) Dermal irritation and sensitization(5) Two genotoxicity assays, one in a mammalian system; if positive, then a
2-year dermal carcinogenesis study using NTP methods may be needed(6) Inhalation studies at use particle size
1Gross pathology and histopathology in skin and other major organ systems associated with repeated exposures aredata that would be expected from what is commonly referred to as a A28- day dermal toxicity study.@ The CIR
Expert Panel is concerned that specifying a type of study may inhibit those who want to gather data using otherstudy designs. For example, the Expert Panel would consider a dermal reproductive and developmental toxicity
study in which gross pathology and histopathology data are gathered on the F0 generation to be sufficient if done ator abovecurrent concentrations of use of the ingredient.
Dr. Belsito noted that Aluminum Starch Octenylsuccinate is a GRAS ingredient, and that his Team determined that
if the cosmetic grade material meets the specifications established for the food grade material, then items 2, 3, and 5
above could be eliminated.
Dr. Schroeter agreed that Aluminum Starch Octenylsuccinate has been approved for use as a food additive, but
noted that such approval was based on ingestion studies and not dermal application studies.
The Panel voted unanimously in favor of issuing an Insufficient Data Announcement on Aluminum Starch
Octenylsuccinate with the following data requests1:(1) Current concentration of use(2) Dermal irritation and sensitization(3) Inhalation studies at use particle size
1This presumes that this ingredient would meet the food grade description of
purity, limitation on contaminants, etc.
Dr. Bergfeld noted that the minutes should reflect that if the descriptions of food and cosmetic grade Aluminum
Starch Octenylsuccinate are not identical, then the six data requests mentioned by Dr. Schroeter will be needed.

69th CIR Expert Panel Meeting (December 2-3, 1998) – Dr. Schroeter’s Team
Aluminum Starch Octenylsuccinate
Dr. Schroeter stated that the following data were received in response to the insufficient data announcement thatwas issued at the May 18-19, 1998 Panel meeting: (1) typical concentration of use, (2) method of manufacture, (3)UV absorption, and (4) skin irritation and sensitization. He noted that the only studies requested by the Panel thathave not been received are inhalation studies (at use particle size). Thus, Dr. Schroeter=s Team concluded that
Aluminum Starch Octenylsuccinate is safe as used, except for formulations that are aerosol products.

Distributed for Comment Only -- Do Not Cite or Quote

Dr. Belsito noted that the use concentrations of Aluminum Starch Octenylsuccinate are reported to be as high as
30% in some powders and 25% in some shaving products, but that the data available for evaluating skin irritationand sensitization potential were at test concentrations up to 3%. With this in mind, he said that his Team had
reservations about approving a safe as used concentration that is eight times higher than the test concentration in theskin irritation and sensitization study, taking into consideration that Aluminum Starch Octenylsuccinate is used in
172 cosmetic products. Thus, Dr. Belsito=s Team concluded that Aluminum Starch Octenylsuccinate is safe atconcentrations up to 3% in leave-on products, safe as used in rinse-off products, and that the data are insufficient forevaluating the safety of this ingredient in aerosolized products.
Dr. McEwen recalled that Aluminum Starch Octenylsuccinate powder (suspension in 2% Tween 80) was tested in aguinea pig maximization test.
Dr. Belsito said that the report text indicates that Aluminum Starch Octenylsuccinate, as it appears in a commercial
preparation, was tested, and that there is no indication of the ingredient concentration that is used in the commercial
preparation. Dr. Belsito said that he would be willing to accept the study if the ingredient concentration in thecommercial preparation is identified.
Dr. Bergfeld said that the report conclusion that will be issued could be modified, without further review by the
Panel, if the concentration in the commercial preparation is near 100% or higher than 3%.
The Panel unanimously approved the issuance of a Tentative Report.
Ms. Fise noted that the cosmetic use section of the report text contains information on use concentrations that isbased on the recommendations of a supplier of Aluminum Starch Octenylsuccinate. She recommended that thisinformation be deleted from the text, and asserted that the use concentration data in this section should reflect actual
ingredient use concentrations that have been reported. Ms. Fise wanted to avoid a potential worse case scenario in
which a safe as used conclusion would be based on use concentrations recommended by a supplier, rather thanactual reported use concentrations.
Dr. Andersen noted that the Panel should recognize that the recommended use concentrations from the supplier are
not necessarily indicative of any concentration in a real product.
Dr. Belsito also indicated his preference for actual use concentrations, but did not favor deleting the supplier=s
recommendation, taking into consideration that concentration of use data are no longer being provided to FDA.
Dr. Bailey said that Ms. Fise had raised a good point. He agreed that the term Asafe as used@ needs to qualified
such that the reader knows exactly which concentrations are being referred to as well as their origin.
Dr. Bergfeld asked Dr. Bailey to update the Panel as to what is happening at FDA. She wanted to know if any
programs that would provide the Panel with concentration of use data would be reinstated.
Dr. Bailey said that FDA=s intent at this point is to resume operation of the voluntary reporting program early in
1999.
Dr. Bergfeld thought that it would be appropriate for the Panel to send a letter to FDA, thanking the agency for this
proposal.
Dr. Andersen said that such a letter would be appropriate, particularly if concentration of use data will be reported in
the voluntary program.
Dr. Bailey said that if the Panel is interested in having the voluntary reporting system upgraded to include
concentration of use data, this level of interest can be communicated to FDA in detail.

Distributed for Comment Only -- Do Not Cite or Quote

71st CIR Expert Panel Meeting (June, 1999) – Dr. Belsito’s Team
Aluminum Starch Octenylsuccinate
Dr. Belsito noted that, at the December 2-3, 1998 Panel meeting, the Panel issued a Tentative Report withthe following conclusion: Based on the available data, the CIR Expert Panel concludes that Aluminum Starch
Octenylsuccinate is safe as used in cosmetic formulations. The available data are insufficient to support the safetyof this ingredient in cosmetic products in which a primary route of exposure is inhalation. Dr. Belsito also notedthat information on particle size was received since this conclusion was issued. According to the information
received, the average particle size of Aluminum Starch Octenylsuccinate is ≈13.5 µ, and a particle of this size would
not be respirable. Thus, Dr. Belsito’s Team concluded that the statement relating to inhalation exposure should bedeleted from the report conclusion.
The Panel voted unanimously in favor of issuing a Final Report with the following conclusion: Based on
the available data, the CIR Expert Panel concludes that Aluminum Starch Octenylsuccinate is safe as used incosmetic formulations.
Dr. Belsito recommended deletion of the last paragraph of the report discussion, which reads as follows:“The Expert Panel initially considered that the maximum concentration of 3.0% used in clinical sensitization tests
might be appropriate as a basis for limiting the safe concentrations of this ingredient. However, the availability ofanimal tests using a suspension of pure ingredients injected intracutaneously were negative. This suggests thatconcentrations much greater than 3.0% would not produce sensitization in clinical tests.” Dr. Belsito’s
recommendation was based on the fact that data at higher concentrations were received since the Tentative Report
was issued.
In response to Dr. Bergfeld’s question, Dr. Belsito confirmed that the issue of particle size will be
addressed in the report discussion.
Dr. Shank recommended deletion of the paragraph in the report discussion that addresses the Panel’s needfor inhalation toxicity data. The Panel agreed with Dr. Shank’s recommendation.
Dr. Andersen said that because the Tentative conclusion that was issued is being revised, the Panel needs todecide whether to issue the CIR report on Aluminum Starch Octenylsuccinate as a revised Tentative Report or a
Final Report.
Ms. Fise recommended that the Panel issue a revised Tentative Report, so that any interested parties may
have an opportunity to comment on the Panel’s revised conclusion on the safety of Aluminum Starch
Octenylsuccinate.
The Panel voted unanimously in favor of issuing a revised Tentative Report with the following conclusion:
Based on the available data, the CIR Expert Panel concludes that Aluminum Starch Octenylsuccinate is safe as usedin cosmetic formulations.

Distributed for Comment Only -- Do Not Cite or Quote

Amended Safety Assessment of Aluminum Starch Octenylsuccinate
As Used in Cosmetics

Status:Re-Review for Panel Review
Release Date:
May 11, 2018
Panel Meeting Date: June 4-5 2018

The 2018 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V.
Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., Ronald
C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Executive Director is Bart Heldreth,
Ph.D. This safety assessment was prepared by Alice Akinsulie, Scientific Analyst/Writer.

© Cosmetic Ingredient Review
1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢cirinfo@cir-safety.org

Distributed for Comment Only -- Do Not Cite or Quote

INTRODUCTION
The safety of Aluminum Starch Octenylsuccinate previously has been reviewed by the Cosmetic Ingredient Review(CIR) Expert Panel (Panel). A final report with a conclusion stating that Aluminum Starch Octenylsuccinate is safe as usedin cosmetic formulations provided that established limitations imposed on heavy metal concentrations are not exceeded, waspublished in 2002.1 Those limitations are outlined in the Discussion of the original report, and state that the Panel limited
concentrations of toxic metals in “cosmetic-grade” Aluminum Starch Octenylsuccinate to the same concentrations as havebeen established for food-grade modified starches. In accordance with its Procedures, the CIR evaluates the conclusions ofpreviously-issued reports every 15 years; therefore this re-review document has been prepared.
According to the web-based International Cosmetic Ingredient Dictionary and Handbook (wINCI; Dictionary),
Aluminum Starch Octenylsuccinate functions mostly as an absorbent, anticaking agent, and non-aqueous viscosity increasing
agent.2 (Table 1) These reported functions are mostly the same as those indicated in the 2002 assessment, althoughabsorbent is a new function for Aluminum Starch Octenylsuccinate.
Additionally, the following 7 ingredients are being proposed for inclusion in this assessment:
Acacia Seyal Gum Octenylsuccinate
Calcium Starch Octenylsuccinate
Hydrolyzed Hydroxypropyl Starch Octenylsuccinate
Quinoa Starch Octenylsuccinate
Sodium Glycogen Octenylsuccinate
Sodium Hydroxypropyl Cyclodextrin Octenylsuccinate
Sodium Trehalose Octenylsuccinate
Most of these ingredients are products obtained by the reaction of octenylsuccinic anhydride and have the viscosity
increasing agent/humectant function in cosmetics in common. A complete listing of the functions of all of theoctenylsuccinates included in this report, are presented in Table 1.
CIR has previously issued a Final Report on Polysaccharide Gums, which included several similar ingredients, i.e.,
Hydrolyzed Corn Starch Octenylsuccinate, Sodium Dextrin Octenylsuccinate, Sodium Starch Octenylsuccinate, and TEADextrin Octenylsuccinate.3 The Panel concluded that these ingredients are safe in the present practices of use andconcentration in cosmetics.
CIR safety assessments include relevant published and unpublished data that are available for each endpoint that isevaluated. Published data are identified by conducting an exhaustive search of the world’s literature. A listing of the searchengines and websites that are used and the sources that are typically explored, as well as the endpoints that CIR typicallyevaluates, is provided on the CIR website (http://www.cir-safety.org/supplementaldoc/preliminary-search-engines-andwebsites; http://www.cir-safety.org/supplementaldoc/cir-report-format-outline). Unpublished data are provided by thecosmetics industry, as well as by other interested parties.
It should be noted that no new data were found in the published literature; however summaries of safety test data
and the Discussion from the published 2002 report are italicized in this document. The complete report is available on the
CIR website. (http://www.cir-safety.org/ingredients )CHEMISTRY
Definition and Structure
Aluminum Starch Octenylsuccinate is an aluminum salt that is derived from the reaction product of octenylsuccinate
anhydride with starch2. (Figure 1.) The definitions of Aluminum Starch Octenylsuccinate and the proposed add-ons arepresented in Table 1. All of these ingredients are esters of a polysaccharide and 2-octenylsuccinic acid (Figure 1) (typicallyformed from the anhydride).

Figure 1. 2-octenylsuccinic acid

Distributed for Comment Only -- Do Not Cite or Quote

Physical and Chemical Properties
Physical and chemical properties of Aluminum Starch Octenylsuccinate are described in Table 2.
Unpublished data submitted by industry indicated that the average particle size for Aluminum Starch
Octenylsuccinate was 13.25μm, with 95% of particles between 4.74 and 21.81 μm in one run and an average size of 13.16
μm, with 95% between 6.05 and 21.81 μm in another run.1 Cosmetic-grade Aluminum Starch Octenylsuccinate did notabsorb light in the 200- to 400-nm range.
Method of Manufacture
Food-grade Aluminum Starch Octenylsuccinate is made by the treatment of granular form of starch with 2% starchbased octenylsuccinic anhydride in alkali.1 The mixture is then treated with aluminum sulfate, not more than 2% based on
starch.
Aluminum Starch Octenylsuccinate is an aluminum salt that is obtained as corn starch reacts with 2-octenylsuccinic
anhydride.4 It is produced by utilizing corn starch and deionizing water to prepare a 35 %( w/w) suspension. The suspension
was washed out with deionized water and then filtered and placed in an oven at 40 degree centigrade. Sodium hydroxide anddifferent of aluminum sulfate solution was gradually added to the suspension. The suspension is then washed with deionizedwater then filtered and placed in an oven to obtain it in powdered form.
Impurities
Impurities data were not found in the published literature, and unpublished data were not submitted. [Data from theoriginal safety assessment are summarized below.]
Food-grade Aluminum Starch Octenylsuccinate must comply with specified residue limits.1 At the time of theoriginal safety assessment, those limits were not more than (NMT) 3 mg/kg arsenic (as As), NMT 0.15% crude fat, NMT
0.002% heavy metals (as Pb), NMT 1 mg/kg lead, and NMT 0.5% protein, and NMY 0.005% sulfur dioxide; additionally, thepH of the dispersions were to be between 3.0 and 9.0. In the initial synthesis reaction, octenylsuccinic anhydride shall not
exceed 2% of starch, and, in the final synthesis reaction, aluminum sulfate shall not exceed 2% of starch.
USE
Cosmetic
The safety of the cosmetic ingredients included in this assessment is evaluated based on data received from the U.S.
Food and Drug Administration (FDA) and the cosmetics industry on the expected use of these ingredients in cosmetics. Use
frequencies of individual ingredients in cosmetics are collected from manufacturers and reported by cosmetic product thecosmetic industry in response to a survey, conducted by the Personal Care Products Council (Council), of maximum reported
use concentrations by product category.
According to 2018 VCRP data, Aluminum Starch Octenylsuccinate is reported to be used in 786 formulations; 744
of those uses are leave-on formulations, and 699 result in dermal contact.5 The frequency of use has increased since theoriginal report was issued; in 1998, VCRP data indicated that Aluminum Starch Octenylsuccinate was used in 172
formulations, 158 of which were leave-on formulations.1 None of the proposed add-on ingredients are listed in the VCRP as
in use.
A concentration of use survey is currently being conducted by the Council; these data will be included once they arereceived. In the original report, concentration of use data (1998/1999) indicated that Aluminum Starch Octenylsuccinate wasused at up to 30% in leave-on products.1 Both historical and current use data are provided in Table 3.
Aluminum Starch Octenylsuccinate is reported to be used in 138 formulations applied to the eye area, in 32
formulations that can result in incidental ingestion, and in 34 formulations that come into contact with mucous membranes.6
Additionally, it is reported to be used in 1 baby product formulation.
Aluminum Starch Octenylsuccinate is used in cosmetic sprays and could possibly be inhaled. In practice, 95% to
99% of the droplets/particles released from cosmetic sprays have aerodynamic equivalent diameters >10 µm, with propellant
sprays yielding a greater fraction of droplets/particles <10 µm compared with pump sprays7,8 Therefore, most droplets/particles incidentally inhaled from cosmetic sprays would be deposited in the nasopharyngeal and thoracic regions of therespiratory tract and would not be respirable (i.e., they would not enter the lungs) to any appreciable amount.9,10 Also,
Aluminum Starch Octenylsuccinate is reportedly used in powders, which could also result in possible inhalation.
Conservative estimates of inhalation exposures to respirable particles during the use of loose powder cosmetic products are

Distributed for Comment Only -- Do Not Cite or Quote

400-fold to 1000-fold less than protective regulatory and guidance limits for inert airborne respirable particles in theworkplace.11-13
The ingredients reviewed in this safety assessment do not appear on the list of substances that are prohibited incosmetic products that are marketed within the European Union and are not subject to any restrictions relating to their use inthese products.14
Non-Cosmetic
Aluminum Starch Octenylsuccinate is listed as a modified food starch in the Food Chemicals Codex.1
Food starch-modified is a direct food additive used as a multipurpose additive. [21CFR172.892]
TOXICOKINETIC STUDIES
Absorption, Distribution, Metabolism, and Excretion (ADME)
Oral
2-(2'-Octenyl) succinic acid and increased levels of glutarate and 2-ketoglutarate were detected in the urine of 17
infants and children that were fed formulas that used octenyl succinate modified cornstarch as an emulsifying agent.1 In fivechildren tested, blood concentrations of octenyl succinic acid ranged from 9.5-57.9 μmol/L. A 100 kcal/kg/day quantity of
formula was estimated to contain 50-70 mg/kg/day of octenyl succinic acid. Octenyl succinic acid was considered to havebecome at least partially liberated from the starch following ingestion and 10-25% was estimated to have been absorbed andultimately excreted in the urine.
TOXICOLOGICAL STUDIESNo additional toxicity studies were found in the published literature, and unpublished data were not submitted. Data
from the original safety assessment are summarized below. Only short-term toxicity studies were available.
Short-Term Toxicity Studies
OralGroups of ten male albino rats were fed 1.5 or 3.0 g of an aluminum octenylsuccinate derivative of a waxy thinboiling starch every day for four weeks.1 A control group was fed the non-modified starch. Weight gain, behavior andgrowth were comparable among test and control rats.
Groups of 12 albino weanling rats (5 female and 5 males) were fed a 35% starch diet which had 1 or 10%
Aluminum Starch Octenylsuccinate with complementary amounts of corn starch. The eight-week feeding study was conducted
to evaluate the safety of Aluminum Starch Octenylsuccinate for use in contact with food wrappings at an expected use
concentration of 0.1%. At week 4, the 1% dose was increased to 25% Aluminum Starch Octenylsuccinate due to lack of toxic
signs. Aluminum Starch Octenylsuccinate was considered safe for use in contact with food wrappings.
DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIESNo additional developmental and reproductive toxicity (DART) studies were found in the published literature, andunpublished data were not submitted. [Data from the original safety assessment are summarized below.]
In a DART study, a sodium starch octenyl succinate(provided as read-across for Aluminum Starch
Octenylsuccinate) was tested.1 Fischer 344 rats (56 days old) were fed nutritionally diets containing 30% starch (6, 12, or
30% of sodium starch octenyl succinate) ranging 3, 6, or 15 g/kg per day. Control rats were fed diets with 30% unmodified
starch. Twenty rats (10 each sex) of the control and high-dose group each were killed at 30 days post-weaning, and 100 rats
(50 each sex) from each group were killed at 90 days post weaning. An increased concentration of urinary magnesium andcalcium compared to male rats was observed in female rats of the dosed and control groups. Oral studies using Aluminum
Starch Octenylsuccinate or its related sodium salt produced no adverse systemic, reproductive, or developmental effects.
DERMAL IRRITATION AND SENSITIZATION
No additional dermal irritation and sensitization studies were found in the published literature, and unpublished data
were not submitted. [Data from the original safety assessment are summarized below.]Distributed for Comment Only -- Do Not Cite or Quote

Irritation
Human
The skin irritation potential of a lotion containing 3.0% Aluminum Starch Octenylsuccinate was evaluated using 12
women that reacted to a 10% aqueous solution of Lactic Acid in a facial sting study.1 The lotion was applied to the labial foldof the nose. Subjective stinging was evaluated at 2.5 and 5 minutes post-application. The 3.0% lotion had a cumulative scoreof 5 that resulted from reactions in two women (one had an individual score of 4 and another had a score of 1). The lotion
was considered to have little or no potential for sting during normal intended use.
A lotion containing 1.0% Aluminum Starch Octenylsuccinate was tested in a chamber scarification test
using ten women with Fitzpatrick skin types II and III.1 Sites on each forearm were scratched with a needle without drawing
blood. (Five other materials were tested in the same study.) The lotion was applied (0.3 ml) for three 24 h periods. Sites
were rinsed after patch removal and erythema was assessed 30 min later. The lotion was considered to have slight irritation
potential.
Irritation potentials of the two formulations containing Aluminum Starch Octenylsuccinate at 2.23% and 2.5% were
examined using 9 or 10 subjects with “sensitive skin.”1 Occlusive patches were applied for two consecutive 24-hour periods.
None of the lotions resulted in erythema. However, the crème containing Aluminum Starch Octenylsuccinate at 2.23%
showed some insignificant increase in trans epidermal water loss.
Sensitization
AnimalThe sensitization potential of Aluminum Starch Octenylsuccinate was investigated in a skin sensitization study using
ten albino guinea pigs and three albino rabbits.1 No abnormal skin reactions were observed. One guinea pig lost weightand died during the post-dosing period, but no lesions were noted at necropsy. Another guinea pig lost weight during thelatter part of the dosing period, but gained weight during the post-dosing period.
Human
In human sensitization studies, five hand and body lotions were tested under occlusive patch three times per week
for a total of nine induction exposures in separate human repeated insult patch tests (HRIPTs).1 Lotion A contained 1.0%
Aluminum Starch Octenylsuccinate, Lotion B contained 1.0% of the product (pH of 4.0), Lotion C contained 2.23%
Aluminum Starch Octenylsuccinate (pH 5.5), lotion D contained 3.0% Aluminum Starch Octenylsuccinate and lotion E
contained 2.5% of Aluminum Starch Octenylsuccinate (pH 5.3). A total of 103 male and female subjects completed eachstudy, except in the study of lotion D, for which 54(9 male and 45 females) subjects completed the study. No reactions werenoted during induction or challenge to lotions A, C, D, and E. One subject developed mild erythema to lotion B after the third
induction exposure. It was an isolated incidence. One subject also had a 1 score reaction to lotion B at the 48 h challenge
reading of the original exposure site; the erythema resolved by the 96 h scoring. None of the lotions were sensitizers.
OCULAR IRRITATION STUDIESNo additional ocular irritation studies were found in the published literature, and unpublished data were notsubmitted. [Data from the original safety assessment are summarized below.]
Aluminum Starch Octenylsuccinate, as it appears in a commercial powder preparation, was instilled (0.1 ml volume,~ 70 mg) into one conjunctival sac of each of six rabbits.1 Eyes were examined 1, 24, 48, and 72 h after dosing. The test
substance produced “very slight transient irritation to the conjunctivae” and was considered to be an “unlikely” ocular
irritant in humans.
In an ocular irritation study, two formulations containing 1.0% and 2.5% Aluminum Starch Octenylsuccinate wastested using the chorioallantoic membrane vascular assay (CAMVA).1 Each lotion was applied to the exposedchorioallantoic membrane (CAM) of ten fertile hen’s eggs. After a 30 minute incubation period, No induced damage wasnoted to the CAM. The RC50 (the concentration which induced damage in 50% of the eggs) was > 100% and the lotions
were considered non-irritating.
The ocular irritation potential of an eyeshadow containing 15% undiluted Aluminum Starch Octenylsuccinate was
evaluated in a study involving 6 rabbits.1 Each product was placed in the unrinsed eye(s) of the rabbits three times. On days
1, 2 and 3 after instillation, the conjunctiva of 1, 3 and 1 rabbit(s) were scored a 2. The ocular irritation potential of afoundation containing 25% of an undiluted Aluminum Starch Octenylsuccinate was evaluated. None of the rabbits that were
dosed with the blush had any irritation one day after dosing. One and two days after dosing with the foundation, 4 and 1
rabbit(s), respectively, had a score of 2. The eye irritation potential was considered minimal.

Distributed for Comment Only -- Do Not Cite or Quote

SUMMARY
In 2002, the Panel published a safety assessment of Aluminum Starch Octenylsuccinate with the conclusion that
Aluminum Starch Octenylsuccinate is safe as used in cosmetic formulations provided that established limitations imposed onheavy metal concentrations are not exceeded; those limitations were described in the Discussion of that report. Aluminum
Starch Octenylsuccinate is the aluminum salt of the reaction product of octenylsuccinic anhydride with starch, and 7 othercosmetic ingredients that are obtained by the reaction of octenylsuccinic anhydride, but have not been reviewed, have been
identified, and these ingredients are proposed for inclusion in this re-review.
Frequency of use has increased since the original report was issued. According to 2018 FDA VCRP data,
Aluminum Starch Octenylsuccinate is reported to be used in 786 formulations; in 1998, it was reported to be used in 172
formulations. A concentration of use survey is currently being conducted by the Council; these data will be included once
they are received. In the original safety assessment, concentration of use data (1998/1999) indicated that Aluminum Starch
Octenylsuccinate was used at up to 30% in leave-on products.
No new toxicity data were found in the published literature, and unpublished data were not submitted.
DISCUSSION FROM ORIGINAL REPORT1
In the absence of data indicating concentrations of toxic metals that can be found as contaminants in this ingredient,
the CIR Expert Panel limited concentrations of the toxic metals in cosmetic-grade Aluminum Starch Octenylsuccinate to thesame concentrations as has been established for food-grade modified starches. Thus, cosmetic grade Aluminum Starch
Octenylsuccinate must not contain more than 3 mg/kg of arsenic, not more than 0.002% heavy metals (as Pb), and not morethan 1 mg/kg of lead. These limits match the specifications listed in the Food Chemical Codex for modified food-starches.
The Expert Panel acknowledged the study that reported an enhancement of the sun protection factor of a sunscreen
formulation with the addition of Aluminum Starch Octenylsuccinate. Cosmetic-grade Aluminum Starch Octenylsuccinate did
not absorb light in the 200-400 nm range. Frequency of use data indicated that Aluminum Starch Octenylsuccinate is used informulations where inhalation is a route of exposure. Data on particle size distribution of Aluminum Starch
Octenylsuccinate demonstrated that this material is not respirable. The Expert Panel considered the absence of any skinirritation or sensitization at test concentrations as great as 30.5% to support the safety of even the largest concentration
reported to be used in cosmetic formulations.

Distributed for Comment Only -- Do Not Cite or Quote

TABLES
Table 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment2
Ingredient CAS No.
Definition & Structure
Aluminum Starch Octenylsuccinate
Aluminum Starch Octenylsuccinate is the aluminum salt of the reaction
9087-61-0
product of octenylsuccinic anhydride with starch.
Acacia Seyal Gum Octenylsuccinate
455885-22-0

Acacia Seyal Gum Octenylsuccinate is the product obtained by thereaction of Acacia Seyal Gum with octenylsuccinic acid anhydride.

Calcium Starch Octenylsuccinate
374539-60-3

Calcium Starch Octenylsuccinate is the calcium salt of the reaction
product of octenylsuccinic anhydride with Zea Mays (Corn) Starch.

Hydrolyzed Hydroxypropyl Starch
Octenylsuccinate

Quinoa Starch Octenylsuccinate

Function(s)Absorbents; Anticaking Agents;
Viscosity Increasing Agents Nonaqueous
Surfactants - Emulsifying
AgentsAbsorbents; Emulsion
Stabilizers; Viscosity Increasing
Agents - Aqueous
Hydrolyzed Hydroxypropyl Starch Octenylsuccinate is the product
Emulsion Stabilizers; Hair
obtained by the reaction of octenylsuccinic anhydride with the hydrolysate Conditioning Agents; Hairof Hydroxypropyl Starch derived by acid, enzyme or other method of
Fixatives; Humectants; Oralhydrolysis.
Care Agents; Skin-Conditioning
Agents - Miscellaneous;
Surfactants - Cleansing Agents;
Surfactants - Emulsifying
Agents; Surfactants - Foam
Boosters; Viscosity Increasing
Agents - Aqueous
Quinoa Starch Octenylsuccinate is the reaction product of octenylsuccinic Emulsion Stabilizers; Viscosity
anhydride with Chenopodium Quinoa Starch.
Increasing Agents - Aqueous

Sodium Glycogen Octenylsuccinate

Sodium Glycogen Octenylsuccinate is the sodium salt of the reaction
product of octenylsuccinic anhydride with Glycogen.

Sodium Hydroxypropyl Cyclodextrin
Octenylsuccinate

Sodium Hydroxypropyl Cyclodextrin Octenylsuccinate is the sodium salt Deodorant Agents; Emulsionof the reaction product of Hydroxypropyl Cyclodextrin andStabilizers; Humectants;
octenylsuccinic anhydride.
Surfactants - Cleansing Agents;
Surfactants - Emulsifying
AgentsSodium Trehalose Octenylsuccinate is the sodium salt of the product
Emulsion Stabilizers; Hair
obtained by the reaction of Trehalose with octenylsuccinic anhydride.
Conditioning Agents;
Humectants; Oral Care Agents;
Skin-Conditioning Agents Miscellaneous; Surfactants Emulsifying Agents

Sodium Trehalose Octenylsuccinate

Table 2. Physical and Chemical Properties of Aluminum Starch Octenylsuccinate
Property
Value
Physical Form
Powder
Color
White
Odor
Faint
Water Solubility (at 20 oC)
zero
Other Solubility
Neutral to slightly acidic (aqueous slurry)Skin-Conditioning Agents Humectant

Reference
15
15
15
15
15

Distributed for Comment Only -- Do Not Cite or Quote

Table 3. Current and historical frequency and concentration of use according to duration and exposure

Totals*Duration of Use
Leave-On
Rinse-Off
Diluted for (Bath) Use
Exposure TypeEye Area
Incidental Ingestion
Incidental Inhalation-Spray# of Uses
Max Conc of Use (%)
Aluminum Starch Octenylsuccinate20181619981
2018
1998/19991
786
172
**
30
744
42
NR

**
**
**

0.5-30
1-6
NR

138
11
32
9
a
14; 122 ; 3; 13a; 17b
115b
Incidental Inhalation-Powder 71;115b; 1c 55; 17b

**
**
**

Dermal Contact
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Mucous Membrane
Baby Products

**
**
**
**
**
**
**

0.5-3015
2; 1-5a; 0.510b
1-15; 0.510b;0.5-30
4a
NR
NR
NR
15
NR

699
4a
35
13
NR
34
1

158
12
2

159
NR
2
NR
NR
18
NR

**

*Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types may not equal the sum of total uses.
** -a concentration of use survey is currently being conducted; these data will be added once they are receiveda
It is possible these products are sprays, but it is not specified whether the reported uses are sprays..
b
Not specified whether a spray or a powder, but it is possible the use can be as a spray or a powder, therefore the information is captured in both categoriesc
It is possible these products are powders, but it is not specified whether the reported uses are powders
NR – no reported use

Distributed for Comment Only -- Do Not Cite or Quote

REFERENCES

1. Andersen FA (ed). Final Report on the Safety Assesment of Aluminum Starch Octenylsuccinate. Int J Toxicol.
2002;21(Suppl 1):1-7.
2. Nikitakis J and Lange B. Web-Based Ingredient Dictionary(wINCI): Aluminum Starch
Octenylsuccinate. https://online.personalcarecouncil.org/jsp/IngredientDetail.jsp?monoid=115.
Washington, DC. Last Updated 2018. Date Accessed 4-9-2018.
3. Johnson WJ, Heldreth BA, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC,
Slaga TJ, Snyder PW, and Gill LJ. Safety Assessment of Polysaccharide Gums as Used in Cosmetics. 2015.
Available from CIR: https://www.cir-safety.org/ingredients.
4. Khakbaz F, Heydari A, Asadzadeh H, and Biuki MM. Preparation and Synthesis of Aluminum Starch
Octenylsuccinate (ASO) and its use in sunscreen cream formulation. International Journal of Chemical andBiomedical Science. 2018;4(2):23-29.
5. Food and Drug Administration (FDA). Frequency of use of cosmetic ingredients. FDA Database. Last Updated
2018.
6. U.S. Food and Drug Administration (FDA) Center for Food Safety & Applied Nutrition (CFSAN). Food and Drug
Administration (FDA). Frequency of use of cosmetic ingredients. 2018. Obtained under the Freedom ofInformation Act from CFSAN; requested as "Frequency of Use Data" January 3 2018; received February 52018).
7. Johnsen MA. The influence of particle size. Spray Technol Marketing. 2004;14(11):24-27.
8. Rothe H. Special Aspects of Cosmetic Spray Evalulation. 9-26-2011. Unpublished data presented at the 26
September CIR Expert Panel meeting. Washington, D.C.
9. Bremmer HJ, Prud'homme de Lodder LCH, and Engelen JGM. Cosmetics Fact Sheet: To assess the risks for the
consumer; Updated version for ConsExpo 4. 2006. Report No. RIVM 320104001/2006. pp. 1-77.
10. Rothe H, Fautz R, Gerber E, Neumann L, Rettinger K, Schuh W, and Gronewold C. Special aspects of cosmetic
spray safety evaluations: Principles on inhalation risk assessment. Toxicol Lett. 2011;205(2):97-104.
11. CIR Science and Support Committee of the Personal Care Products Council (CIR SSC). 2015. (Nov 3rd) Cosmetic
Powder Exposure. Unpublished data submitted by the Personal Care Products Council.
12. Aylott RI, Byrne GA, Middleton J, and Roberts ME. Normal use levels of respirable cosmetic talc: preliminary
study. Int J Cosmet Sci. 1979;1(3):177-186. PM:19467066.
13. Russell RS, Merz RD, Sherman WT, and Siverston JN. The determination of respirable particles in talcum powder.
Food Cosmet Toxicol. 1979;17(2):117-122. PM:478394.
14. European Commission. European Commission. CosIng database; following Cosmetic Regulation No.
1223/2009. http://ec.europa.eu/growth/tools-databases/cosing/. Last Updated 2018. Date Accessed 5-12018.
15. National Starch and Chemical. DRY-FLO PC (28-1800)Aluminum Starch
Octenylsuccinate. https://www.mahachem.com/wp-content/uploads/2014/12/34.-DryFlo-PC.pdf. Last
Updated 2001. Date Accessed 4-23-2018.
16. Food and Drug Administration (FDA). Frequency of use of cosmetic ingredients. FDA Database. Last Updated
2018.

Distributed for Comment Only -- Do Not Cite or Quote

Final Report on the Safety Assessment of Aluminum
Starch Octenylsuccinate 1

Method of Manufacture
Aluminum Starch Octenylsuccinate is the aluminum salt of thereaction product of octenylsuccinic anhydride with starch. It is usedin cosmetics at concentrations as high as 30% as an anticaking
agent and a nonaqueous viscosity increasing agent. No information was available on the presence of impurities in the cosmeticgrade ingredient. When used in foods, Aluminum Starch Octenylsuccinate is identified as a modified food starch, and is subject tolimitations on heavy metal residues. Oral studies using Aluminum
Starch Octenylsuccinate or its related sodium salt produced no adverse systemic, reproductive, or developmental effects. Dermal injections produced no abnormal skin or systemic reactions in guinea
pigs. Ocular toxicity was assessed in rabbits and using an in vitro
test (chorioallantoic membrane vascular assay). In both cases notoxicity was seen. An acute inhalation toxicity study in rats was negative. Clinical tests indicated little irritation potential and no sensitization. Absent data on impurities in cosmetic-grade material, it
was determined that such material should meet the same impurities requirements established for modified food starches. Based onthese available data the Cosmetic Ingredient Review Expert Panelconcluded that Aluminum Starch Octenylsuccinate is safe as usedin cosmetic formulations provided that established limitations imposed on heavy metal concentrations are not exceeded.

INTRODUCTION
This report is a compilation of data concerning the safety ofAluminum Starch Octenylsuccinate (CAS no. 9087-61-0) for
use in cosmetics.
CHEMISTRY

Definition and Structure
Aluminum Starch Octenylsuccinate is the aluminum salt of
the reaction product of octenylsuccinic anhydride with starch(Wenninger and McEwen 1997). A synonym is starch octenylbutanedioate, aluminum salt (National Starch and Chemical Co.
1998).

Received 14 December 2001; accepted 6 March 2002.
1
Reviewed by the Cosmetic Ingredient Review Expert Panel. Bindu
Nair and Torill A. Yamarik, former Cosmetic Ingredient Review staff,
prepared this report. Address correspondence to F. Alan Andersen,
Director, Cosmetic Ingredient Review II 0 I 17th Street, NW, Suite
310, Washington, DC 20036, USA.
International Journal of Toxicology, 21(Suppl. 1):1-7, 2002
Copyright © 2002 Cosmetic Ingredient Review
1091-5818/02$12.00 + .00
DOl: 10.1080/10915810290096379

Food-grade Aluminum Starch Octenylsuccinate is preparedby treatment of granular form starch with not more than 2%
octenylsuccinic anhydride (based on starch), in the presence ofalkali. When the reaction has gone to completion, the mixture
is treated with aluminum sulfate, not more than 2% based on
starch. The granular product is recovered by filtration, washing,and drying. It conforms to the structure shown in Figure 1 (Association des Amidonneries de Mais 1969; National Starch andChemical Company 1998).
The substitution on the hydroxyls reduces the tendency of the
starch to associate in solution, lose clarity, and form gels. The
extent of substitution is low and polyelectrolyte properties result from the introduction of the succinate ester groups (Federation of American Societies for Experimental Biology [FASEB]
1979).

Chemical and Physical Properties
Cosmetic-grade Aluminum Starch Octenylsuccinate did notabsorb light in the 200 to 400-nm range (National Starch andChemical Company 1998). Unpublished data submitted by industry indicated that the average particle size for Aluminum
Starch Octenylsuccinate was 13.25 fLID, with 95% of particles
between 4.74 and 21.81 /LID in one run and an average size of
13.16{Lm, with 95% between 6.05 and 21.81{Lm in another run(Cosmetic, Toiletry, and Fragrance Association [CTFA] 1999a).
These particle dimensions are larger than the median aerodynamic diameter of 4 ± 0.3 {Lm established as a respirable particulate mass (Willeke and Baron 1993).

USE

Cosmetic
Aluminum Starch Octenylsuccinate is used in cosmetic formulations as an anticaking agent and a viscosity-increasing
agent-nonaqueous (Wenninger and McEwen 1997). As ofJanuary 1998, this ingredient was reported to be used in 172 formulations as shown in Table 1 (FDA 1998). Data submitted byindustry (CTFA 1998b, 1999b) indicated that Aluminium Starch
Octenylsuccinate was used at the concentrations listed in Table 1.
Companies that reported use of Aluminum Starch Octenylsuccinate in product categories that included sprays were asked if theyDistributed for Comment Only -- Do Not Cite or Quote

2

COSMETIC INGREDIENT REVIEWFIGURE 1
Aluminum Starch Octenylsuccinate. The R group is
CH3(CH2)4CH-CHCHz. The residual 2/3 of the aluminum
ion's valencies are satisfied by salt formation with sulfate ionor carboxylate ion from the starch octenyl succinate.

used this ingredient in sprays-the companies that responded
indicated that they did not use Aluminum Starch Octenylsuccinate in spray products (CTFA 1999b).
One supplier of Aluminum Starch Octenylsuccinate recommended the following concentrations of use: 2% to 4% in lotions
and creams (including sunscreens), 2% to 25% in powders, 2%
to 10% (or, in some instances up to 30%) in color cosmetics,
2% to 10% in antiperspirants, and 2% to 25% in shaving products (National Starch and Chemical Company 1998). Anothersource indicated use at 10% in a barrier ointment and 8% in a
lip treatment ointment (CTFA 1998a).
Aluminum Starch Octenylsuccinate is listed in the JapaneseComprehensive Licensing Standards of Cosmetics by Category(CLS) (Rempe and Santucci 1997). That which conforms to
the specification of the Japanese Cosmetic Ingredient Codex
has precedent for use without restriction in all CLS categories

TABLE 1Frequency of use of Aluminum Starch Octenylsuccinate (FDA 1998)

Product category(No. formulations in category) (FDA 1998)
Bubble baths (200)Other bath preparations (159)
EyelinerEye shadow (506)
Eye lotion (18)
Mascara (167)
Other eye makeup preparations (120)
Powders (247)
Other fragrance preparations (148)Hair sprays (aerosol fixatives) (261)
Blushers (all types) (238)
Face powders (250)Foundations (287)
Lipstick (790)
Makeup bases (132)
Other makeup preparations (135)Deodorants
Other personal cleanliness products (291)Aftershave lotion (216)
Other shaving preparation products (60)Skin cleansing (cold creams, cleansing
lotions, liquids, and pads)
Face and neck skin care (excluding shaving) (263)
Body and hand skin care (excluding shaving) (796)Moisturizing creams, lotions, powders, and sprays (769)Night creams, lotions, powders, and sprays
Paste masks (Mud packs) (255)
Other skin care preparations (692)Suntan gels, creams, and liquids ( 136)
Indoor tanning preparations (62)Other suntan preparations (38)
Total for 1998

No. containing
ingredient

7
2
1
16
1
2
8
39
15
9
2
6
7
5
2

Concentration of use (%)(CTFA 1998b, 1999b)

10
1-30
1.5-5
0.5

2
9-30
1-15
1-25
15
8
2.5-25
4
1.5-5
2

2
15
6
3
14
2
3
2
172

0.5-2
1.5-10
1-5
1-3
1-6
5
5

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ALUMINUM STARCH OCTENYLSUCCINATE

except eyeliner preparations, for which it has no precedent for
use.
Food

Aluminum Starch Octenylsuccinate is listed as a modified
food starch in the Food Chemicals Codex (National Academyof Sciences 1996). Modified food starches are defined as "products of the treatment of any of several grain or root -based native
starches (e.g., com, sorghum, wheat, potato, tapioca, sago, etc.)with small amounts of certain chemical agents, which modify
the physical characteristics of the native starches to produce desirable properties." Aluminum Starch Octenylsuccinate is identified as a starch ester. Food-grade Aluminum Starch Octenylsuccinate must comply with the residue limits listed in Table 2,
and, in the initial synthesis reaction, octenylsuccinic anhydride
shall not exceed 2% of starch, and, in the final synthesis reaction,
aluminum sulfate shall not exceed 2% of starch.
Modified food starches are cleared for use in food(Rothschild 1990) and function as thickeners, colloidal stabilizers, and binders (National Academy of Sciences 1996).
In 1979, FASEB evaluated starch and modified starches forstatus as generally recognized as safe (GRAS) food ingredients.
For the evaluation of Aluminum Starch Octenylsuccinate, thecommittee was presented with two oral dosing studies using albino rats: a 4-week nutritional study (Food and Drug ResearchLaboratories 1961), and an 8-week toxicity study (Food Research Laboratories 1950a). These studies are cited in the Animal Toxicology section of this report. The FASEB (1979) reportacknowledged the negative findings of these studies but notedthat the studies were short-term and therefore "insufficient to answer questions concerning the possible chronic toxicity of these
succinates particularly in view of the lack of information on theirconsumption levels. The Select Committee considers it desirable
to undertake long-term animal feeding studies with these modified starches." The report concluded that "while no evidence inthe available information on ... starch aluminum octenylsuccinate demonstrates a hazard to the public when (it is) used at levels
that are now current and in the manner now practiced, uncertainties exist requiring that additional studies should be conducted."

TABLE2
Residue limitations for food-grade Aluminum Starch
Octenylsuccinate (National Academy of Sciences, 1996)
Residue

Limit

Arsenic (as As)
Crude fatHeavy metals (as Pb)*
Lead*
pH of dispersions
Protein
Sulfur dioxide

Not more than 3 mg/kg
Not more than 0.15%
Not more than 0.002%
Not more than I mg/kg
Between 3.0 and 9.0
Not more than 0.5%
Not more than 0.005%*No further details given for the two limits on lead.

3

GENERAL BIOLOGY
Sun-Protection Factor Enhancement

Guth et al. (1991) reported that addition of 5% Aluminum
Starch Octenylsuccinate can enhance the sun-protection factor(SPF) of a titanium dioxide formulation by "as much as 40%." A
formulation containing I% titanium dioxide had an SPF of 5 .6; aformulation containing I% titanium dioxide and 5% Aluminum
Starch Octenylsuccinate had an SPF of 8.1.
Metabolism

Kelley (1991) reported detection of 2-(2'-octenyl)succinicacid and several metabolites in the urine of 17 infants and children fed formulas that used octenylsuccinate-modified comstarch as an emulsifying agent. Increased urine concentrationsof glutarate and 2-ketoglutarate were also detected and could
have arisen from other components of the formulas. In someinstances, the urinary organic acid pattern was "mistaken for a
primary metabolic disease." Blood concentrations of octenylsuccinic acid ranged from 9.5 to 57.9 {.Lmol/1 (five children
tested). A I 00 kcal/kg/day quantity of formula was estimatedto contain 50 to 70 mg/kg/day of octenylsuccinic acid. Octenylsuccinic acid was considered to have become at least partiallyliberated from the starch following ingestion and 10% to 25%
was estimated to have been absorbed and ultimately excreted
in the urine. The metabolism of octenylsuccinic acid was considered to be similar to that of the anticonvulsant, valproicacid.
ANIMAL TOXICOLOGY
Oral Toxicity

Short-Term
Groups of 10 male albino rats were fed 1.5 or 3.0 g of analuminum octenylsuccinate derivative of a waxy thin-boilingstarch every day for 4 weeks. A control group was fed thenonmodified starch. Weight gain, behavior, and growth werecomparable among test and control rats (Food and Drug Research Laboratories 1961).
An 8-week feeding study was conducted using albino weanling rats to evaluate the safety of Aluminum Starch Octenylsuccinate for use in contact with food wrappings at an expected use
concentration ofO.l %. Groups of 12 rats (6 each sex) were fed a
35% starch diet that had I% or 10% Aluminum Starch Octenylsuccinate with complementary amounts of com starch. Because
no toxic signs were observed, the I% dose was increased to 25%
Aluminum Starch Octenylsuccinate at week 4. Control rats were
fed com starch. Other aspects of the diet were nutritionally adequate. Water was provided ad libitum. Body weight and feed
consumption were measured weekly, observations were madeof normality of behavior and general physical condition, andcomplete blood counts and blood sugar and nonprotein nitrogen concentrations were measured at the end of study. All ofthese parameters were similar between rats fed sodium starch

Distributed for Comment Only -- Do Not Cite or Quote

4

COSMETIC INGREDIENT REVIEW

octenylsuccinate and those of the control group. Rats were notnecropsied. Aluminum Starch Octenylsuccinate was consideredsafe for use in contact with food wrappings (Food ResearchLaboratories 1950a).
Buttolph and Newbeme (1980) tested a related compound,sodium starch octenylsuccinate. It is prepared by treating granular starch with alkali and not more than 3% octenylsuccinic
anhydride. Fischer 344 rats (56 days old) were fed nutritionally adequate diets containing 30% starch. The diets of test rats
had 6%, 12%, or 30% of sodium starch octenylsuccinate (3, 6, or
15 g/kg/day) and a complementary amount of unmodified starch
if necessary. Control rats were fed diets with 30% unmodified
starch. Rats were mated and the females were fed their respective
diets throughout gestation and lactation. Litters were adjusted
to eight pups per litter. At weaning, four pups (two of each sex)
were randomly selected from the second litter of each dam andthese rats received the diets of their respective dams. Twenty
rats (10 each sex) of the control and high-dose group each were
killed at 30 days post weaning, and 100 rats (50 each sex) fromeach group were killed at 90 days post weaning. Blood andurine samples were obtained at necropsy. Growth parametersand hematologic values were unaffected but a dose-related increase in the weight of the liver (significant [p < .05] for femalesof the high-dose group at 30 days and for females of the midand high-dose group at 90 days), kidneys (significant [p < .05]
for males of the high-dose group at 30 days, and of males andfemales of the mid and high-dose groups at 90 days), and cecum (significant [p < .05] for females of the high-dose groupat 30 and 90 days) was noted. No treatment-related changes inserum chemistry values were observed. An increased incidenceof renal corticomedullary mineralization (and a corresponding
greater concentration of urinary magnesium and calcium compared to male rats) was observed in female rats of the dosed andcontrol groups. The investigators considered that, "no adverse
effects associated with feeding octenyl succinate starch occurredin rats under the conditions of this study."

Dermal Sensitization
Aluminum Starch Octenylsuccinate, as it appears in a "commercial preparation," was tested in a skin sensitization study
using 10 albino guinea pigs and 3 albino rabbits. The preparation was a "free-flowing modified food starch refined from com."
Daily suspensions were prepared of the test sample (powder) in
2% Tween 80 in physiological saline.
The suspension was injected intracutaneously into a depilatedsite on the back. Injections were given three times during the firstweek and once weekly for an additional 7 weeks. Sites were examined 24 hours after each injection and observations continued
for 2 weeks after the last injection. Rabbits were housed individually and guinea pigs were housed in groups of three or four.
Feed and water were available ad libitum.
No abnormal skin reactions were observed. One guinea pig
lost weight and died during the postdosing period, but no lesions
were noted at necropsy. Another guinea pig lost weight during

the latter part of the dosing period, but gained weight during thepostdosing period (Food Research Laboratories 1950b).

Ocular Toxicity
Aluminum Starch Octenylsuccinate, as it appears in a commercial powder preparation, was instilled (0.1-ml volume,,..._,70 mg) into one conjunctival sac of each of six rabbits. Eyes
were examined 1, 24, 48, and 72 hours after dosing. The corneas
appeared normal and unchanged at each observation. A slight
reddening of the conjunctivae was noted in all treated eyes
1 hour after dosing; the reddening was still present in five rabbits
24 hours later, but had cleared by the 48-hour observation. Slight
conjunctival swelling was noted in four treated eyes 1 hour after
dosing; the swelling cleared by 24 hours. All treated eyes werenormal at the 48- and 72-hour observations. The test substanceproduced "very slight transient irritation to the conjunctivae"
and was considered to be an "unlikely" ocular irritant in humans(Unilever Research 1984).
Two formulations containing 1.0% and 2.5% Aluminum
Starch Octenylsuccinate were tested using the chorioallantoic
membrane vascular assay (CAMVA). This in vitro assay relieson the similarity of the vascularized surface of a developing chickembryo to the conjunctiva. Each lotion was applied to the exposed chorioallantoic membrane (CAM) of 10 fertile hen's eggs.
The eggs were then incubated for 30 minutes. The CAM was
examined for damage such as hemorrhage, capillary injection,or the presence of ghost vessels. Neither lotion induced damage.
The RC 50 (the concentration which induced damage in 50% of
the eggs) was > 100% and the lotions were considered nonirritating (Stephens and Associates 1996; MB Research Labs 1997).
Aluminum Starch Octenylsuccinate was tested at a concentration of 100% in an eyeshadow that contained 15% of it in
the product. The product was placed in the unrinsed eye(s) of
six rabbits three times. On days 1, 2 and 3 after instillation,
the conjunctiva(s) of one, three, and one rabbit(s), respectively,
were scored a 2. The irritation potential was considered mild
according to the Draize classification system. Aluminum Starch
Octenylsuccinate was tested at a concentration of 100% of a
blush and a foundation that had 25% of it in each product. Each
product was placed in the conjunctival sac of six rabbits threetimes and the eyes were unrinsed. None ofthe rabbits that were
dosed with the blush had any irritation 1 day after dosing. Irritation potential was not demonstrated as determined by the Draize
classification system. One and 2 days after dosing with the foundation, four and one rabbit(s ), respectively, had a score of 2. The
eye irritation potential was considered minimal according to the
Draize classification system (CTFA 1999c).

Inhalation
Ten rats (5/sex) were exposed to Aluminum Starch Octenylsuccinate at an atmospheric concentration of 200 mg/1 for
1 hour. The animals were rinsed with tap water after the exposure to remove residual test compound. The animals wereobserved for pharmacologic activity and toxicity at 1, 3, 6 andDistributed for Comment Only -- Do Not Cite or Quote

ALUMINUM STARCH OCTENYLSUCCINATE

24 hours after exposure and daily thereafter for 14 days. All animals survived the observation period. No gross changes wereobserved at necropsy. According to the conditions of this test,
Aluminum Starch Octenylsuccinate was nontoxic to rats by inhalation (Consumer Product Testing Co. 1999).

CLINICAL ASSESSMENT OF SAFETY
Dermal Irritation

Twelve women participated in a facial sting study that tested
a lotion containing 3.0% Aluminum Starch Octenylsuccinate.
The women were selected because prescreening had identified
them as "stingers" (reacted to a 10% aqueous solution of Lactic Acid). However, none had any evidence of a dermatologicaldisease or hypersensitivity to topical products. During testing,the lotion was applied to the labial fold of the nose. Subjective
stinging was evaluated at 2.5 and 5 minutes post application.
Reactions were graded 0 to 3. A cumulative score was obtainedby adding grades for each woman from both evaluations. Thus,
the highest possible individual score was 6 and the highest possible cumulative score was 72. The 3.0% lotion had a cumulativescore of 5 that resulted from reactions in two women (one had
an individual score of 4 and another had a score of 1). The lotion
was considered to have "little or no potential for sting during
normal intended use" (Ivy Labs 1988).
A lotion containing 1.0% Aluminum Starch Octenylsuccinate was tested in a chamber scarification test using 10 womenwith Fitzpatrick skin types II and III. Sites on each forearm werescratched with a needle without drawing blood. (Five other materials were tested in the same study.) The lotion was applied(0.3 ml) for three 24-hour periods. Sites were rinsed after patch
removal and erythema was assessed 30 minutes later. Sites werescored on a scale of 0 to 4. The mean score on day 3 (used to determine irritancy potential) was 1.4. The lotion was considered
to have "slight" irritation potential (Skin Study Center 1995).
The irritation potential of two formulations containing 2.23%
and 2.5% Aluminum Starch Octenylsuccinate were tested using 9 or 10 "sensitive skin" panelists. Occlusive patches wereapplied for two consecutive 24-hour periods. Neither lotion induced erythema. The 2.23% lotion produced a nonsignificant
increase in transepidermal water loss (TEWL). The TEWL was
not measured for the 2.5% lotion because of equipment failure(CTFA 1996, 1997).
Dermal Sensitization

Five hand and body lotions were tested in separate humanrepeat-insult patch tests (RIPTs). Biosearch, Inc. (1994) studied
lotion A (pH not reported) containing 1.0% (w/w) Aluminum
Starch Octenylsuccinate in male and female (between 18 and65 years of age) panelists. Of 102 panelists, 104 completed thestudy. Stephens and Associates, Inc. (1998) studied lotion B(pH 4.0) containing 1.0% (w/w) Aluminum Starch Octenylsuccinate; 104 of 135 male and female panelists completed the study.

5

Clinical Research Services ( 1996) studied lotion C (pH 5 .5) containing 2.23% (w/w) Aluminum Starch Octenylsuccinate; 103
of 105 males and females (between 18 and 70 years of age)completed the study. Essex Testing Clinic, Inc. (1988) studied
lotion D (pH not reported), contained 3.0% (w/w) Aluminum
Starch Octenylsuccinate; 52 of 54 (9 males and 45 females,
between 23 and 63 years of age) panelists completed the study.
Clinical Research Services (1997) studied lotion E (pH 5.3) containing 2.5% (w/w) Aluminum Starch Octenylsuccinate; 102 of
104 male and female panelists (between 18 and 65 years of age)completed the study. Panelists were dropped from each study forreasons such as noncompliance with the test protocol, excessive
sensitivity to the adhesive tape used, medical conditions (unrelated to test material), participation in another study within thepast 2 weeks, or a preexisting allergy. One panelist tested withlotion B was removed from study because she had a reaction to
one of the other formulations that was being tested in the same
study.
During the 3-week induction period, each lotion was applied
under occlusive patch three times per week, for a total of nine
induction exposures. Patches containing lotions A (0.2 ml) andD (0.2 g) were applied for 24 hours; patches containing lotions
B, C, and E (100 or 200 ttl) were applied for 48 hours. All
patches were applied to the back except lotion A, which wasapplied to the arm. Following a 10- to 21-day nontreatment period, panelists were challenged at two sites-the original and apreviously unexposed site (in most studies the second site wason the arm). Sites were scored at the time of patch removal, andafter an additional 24 and 48 hours.
No reactions were noted during induction or challenge to lotions A, C, D, and E. One subject developed "mild erythema"(scored 1, the lowest nonzero score) to lotion B after the third induction exposure. It was an isolated incidence. One subject also
had a score 1 reaction to lotion B at the 48-hour challenge reading of the original exposure site; the erythema resolved by the
96-hour scoring. None of the lotions were sensitizers (Biosearch,
Inc. 1994 [lotion A]; Stephens and Associates, Inc. 1998 [lotion
B]; Clinical Research Services, Inc. 1996, 1997 [lotions C andE]; Essex Testing Clinic, Inc. 1988 [lotion D]).
Aluminum Starch Octenylsuccinate (30.5% in a "Dark Brown
Paste") was tested in an RIPT using 240 subjects. During the first
3 weeks patches of 0.02 g test material were applied three times
weekly for 48 to 72 hours to the upper arm and back of the panelists. Two weeks later, a challenge patch was applied to anothersite. The challenge patches were removed 72 hours following
application of the test material to the site and the reaction wasscored 96 hours after application. The test material produced
erythema (1) in two subjects and the reaction was not considered a clinically significant irritant or allergic contact dermatitis
in human subjects (CTFA 1998c).
Aluminum Starch Octenylsuccinate was tested in an RIPT at
a concentration of 20% using 121 men and women. Ten samples (0.3 ml) were applied to the upper arm of each subject for
24 hours for about 3 weeks using occlusive patches. Reactions

Distributed for Comment Only -- Do Not Cite or Quote

6

COSMETIC INGREDIENT REVIEW

were scored 48 or 72 hours after the application of each sample
under a 100-watt incandescent blue bulb. A 2-week nontreatment period followed the induction phase. The challenge patch
was applied to an untreated site for 24 hours and scored 48 or
96 hours later. No subjects demonstrated contact sensitization
to samples 2 to 10. Sample 1 was not applied at challenge at thesponsor's request (Hill Top Research, Inc. 1981).
An RIPT was conducted using 109 men and women and a
25% concentration of Aluminum Starch Octenylsuccinate in acommercial preparation. The occlusive patch with 0.1 ml of thetest material was applied to the upper back of the subject threetimes weekly for 3 weeks. The subjects removed the patch athome 24 hours after application. The patches were applied tothe same site unless a severe reaction developed. Following a
3-week nontreatment period, a single patch of the test material
was applied to an untreated site. The patch was removed 24 hours
after application and the reaction was scored 24 and 48 hours
after removal. No erythematous reactions occurred during theinduction or challenge phases of the study. Aluminum Starch
Octenylsuccinate did not have any potential for inducing allergic
sensitization (CTFA 1999d).
Aluminum Starch Octenylsuccinate (25%) was tested as acommercial preparation using 89 men and women using thesame protocol as described above. One subject had a reaction
scored as barely perceptible erythema. Aluminum Starch
Octenylsuccinate in this preparation did not have any potential
for inducing allergic sensitization (CTFA 1999d).
Aluminum Starch Octenylsuccinate (6%) was tested as acommercial preparation using 106 men and women and the same
protocol as described above. One subject had a reaction scoredas mild erythema. Aluminum Starch Octenylsuccinate in thispreparation did not have any potential for inducing allergic sensitization (CTFA 1999d).
A 4-day minicumulative irritancy test of a commercial preparation containing 25% Aluminum Starch Octenylsuccinate hada primary irritation index (PII) of 0.0 (CTFA 1999e).

SUMMARY
Aluminum Starch Octenylsuccinate is the aluminum salt of
the reaction product of octenylsuccinic anhydride with starch.
It is used in cosmetic formulations as an anticaking agent anda viscosity increasing agent-nonaqueous. In January 1998 it
was used in 172 cosmetic formulations. Current concentrationof use data indicated use at up to 30%. When used in foods,
Aluminum Starch Octenylsuccinate is identified as a "modified
food starch."
Aluminum Starch Octenylsuccinate is reported to enhance
the sun-protection factor of sunscreen formulations. Cosmeticgrade Aluminum Starch Octenylsuccinate did not absorb lightin the 200 to 400-nm range.
Oral doses of Aluminum Starch Octenylsuccinate at concentrations up to 25% and oral doses of a related compound
up to 30% produced no adverse effects in animal studies.

Aluminum Starch Octenylsuccinate was not an ocular irritant. A
commercial preparation of Aluminum Starch Octenylsuccinate
produced no abnormal skin reactions in guinea pigs and rabbits. Aluminum Starch Octenylsuccinate was nontoxic to rats byinhalation.
Clinical facial sting, chamber scarification, and closed patch
studies indicated little irritation potential with Aluminum Starch
Octenylsuccinate (tested up to 3% in formulation). Aluminum
Starch Octenylsuccinate, tested at up to 25% in formulation, was
not a sensitizer in clinical RIPTs.

DISCUSSION
In the absence of data indicating concentrations of toxic metals that can be found as contaminants in this ingredient, theCosmetic Ingredient Review (CIR) Expert Panel limited concentrations of the toxic metals in cosmetic-grade Aluminum Starch
Octenylsuccinate to the same concentrations as have been established for food-grade modified starches. Thus, cosmetic-grade
Aluminum Starch Octenylsuccinate must not contain more than
3 mg/kg of arsenic (as As), not more than 0.002% heavy metals (as Pb), and not more than 1 mg/kg of lead. These limits
match the specifications listed in the Food Chemicals Codex for
modified food starches.
The Expert Panel acknowledged the study that reported anenhancement of the sun-protection factor of a sunscreen formulation with the addition of Aluminum Starch Octenylsuccinate.
Cosmetic-grade Aluminum Starch Octenylsuccinate did not absorb light in the 200 to 400-nm range.
Frequency of use data indicated that Aluminum Starch
Octenylsuccinate is used in formulations where inhalation isa route of exposure. Data on particle size distribution of Aluminum Starch Octenylsuccinate demonstrated that this material
is not respirable.
The Expert Panel considered the absence of any skin irritationor sensitization at test concentrations as great as 30.5% to support
the safety of even the largest concentration reported to be usedin cosmetic formulations.
CONCLUSION
Based on the available data, the CIR Expert panel concludes
that Aluminum Starch Octenylsuccinate is safe as used in cosmetic formulations provided that established limitations imposed on heavy metal concentrations are not exceeded.
REFERENCES
Association des Amidonneries de Mais de Ia C.E.E. 1969. Circular letterno. 43/69: Modified Starches (additional submission to the FAO/WHO).
Submitted by FDA in response to 1997 FOI request. (12 pages concerning
aluminum starch octenylsuccinate.) 2

2 Available for review: Director, Cosmetic Ingredient Review, 1101 17th St,
NW, Suite 310, Washington, DC 20036-4702, USA.

Distributed for Comment Only -- Do Not Cite or Quote

ALUMINUM STARCH OCTENYLSUCCINATE
Biosearch, Inc. 1994. Human repeated insult patch test: Lotion A containing
1.0% aluminum starch octenylsuccinate. Study 93-7939H. Unpublished datasubmitted by CTFA. (23 pages.) 2
Buttolph, M. L., and P. M. Newbeme. 1980. Subchronic studies in rats fed
octenylsuccinate-modified food starch. Food Cosmet. Toxicol. 18:357-362.
Clinical Research Services. 1996. Human repeated insult patch test: Lotion E
containing 2.5% aluminum starch octenylsuccinate. Study C96-0002. Unpublished data submitted by CTFA. (33 pages.) 2
Clinical Research Services. 1997. Human repeated insult patch test: Lotion C
containing 2.23% aluminum starch octenylsuccinate. Study C97-0009. Unpublished data submitted by CTFA. (35 pages.) 2
Consumer Product Testing Co. 1999. Acute inhalation toxicity in rats. Unpublished data submitted by CTFA. (8 pages.) 2
Cosmetic, Toiletry and Fragrance Association (CTFA). 1996. Closed patch
test: Lotion E containing 2.5% aluminum starch octenylsuccinate. Study
96-28-SPG by unknown laboratory. Unpublished data submitted by CTFA.
(3 pages.) 2
CTFA. 1997. Closed patch test: Lotion C containing 2.23% aluminum starchoctenylsuccinate. Study 97-54-SPG by unknown laboratory. Unpublished datasubmitted by CTFA. (10 pages.) 2
CTFA. 1998a. Concentration of use of various ingredients. One entry regarding
Aluminum Starch Octenylsuccinate. 2
CTFA. 1998b. Concentration of use data on Aluminium Starch Octenylsuccinate
dated 11/18/98. (I page.) 2
CTFA. 1998c. Repeat Insult Patch Test dated 11/16/98. (3 pages.) 2
CTFA. 1999a. Particle size data for Aluminum Starch Octenylsuccinate dated
4/28/99. (4 pages. )2
CTFA. 1999b Concentration of use data. 4/29/99. (2 pages.) 2
CTFA. 1999c. Three eye irritation studies. 1/27/99 (3 pages.) 2
CTFA. 1999d. Three allergic contact sensitization tests. 1/27/99 (20 pages.) 2
CTFA. 1999e. 4-Day mini-cumulative. 1/27/99 (2 pages.i
Essex Testing Clinic, Inc. 1988. Repeated insult patch test: Lotion D containing
3.0% aluminum starch octenylsuccinate. Study 2079.02. Unpublished datasubmitted by CTFA. (II pages.) 2
Federation of American Societies for Experimental Biology (FASEB). 1979.
Evaluation of the health aspects of starch and modified starches asfood ingredients. Submitted by FDA in response to 1997 FOI request.
( 100 pages. )2
Food and Drug Administration (FDA). 1998. Cosmetic product formulation
data. FDA database. Washington, DC: FDA.
Food and Drug Research Laboratories. 1961. The caloric value of dry RX615-9:
Lower viscosity type of starch with starch aluminum octenyl succinate. Submitted by FDA in response to 1997 FOI request. 2

7

Food Research Laboratories. 1950a. Toxicological studies of certain starch products: Starch aluminum octenyl succinate. Submitted by FDA in response to
1997 FOI request. (II pages. )2
Food Research Laboratories. 1950b. Allergenicity test with dry flow: Aluminum
starch octenylsuccinate. Unpublished data submitted by CTFA. (4 pages.) 2
Guth, J., G. Martino, J. Pasapane, and D. Ronco. 1991. Polymeric approaches
to skin protection. Cosme!. Toiletries 106:71-74.
Hill Top Research, Inc. 1981. Repeat insult patch test-blush 21360-04 containing
20% Aluminum Starch Octenylsuccinate. Study 81-1227-74. Unpublisheddata submitted by CTFA. (15 pages.)2
Ivy Labs. 1988. Determination of the stinging potential of two materials: Lotion
D containing 3.0% aluminum starch octenylsuccinate. Study 1759. Unpublished data submitted by CTFA. (13 pages.) 2
Kelley, R.I. 1991. Octenylsuccinic aciduria in children fed protein-hydrolysate
formulas containing modified cornstarch. Pediatr. Res. 30:564-569.
MB Research Labs. 1997. Chorioallantoic membrane vascular assay: Lotion B
containing 1.0% aluminum starch octenylsuccinate. Study C97 -0164. Unpublished data submitted by CTFA. (10 pages.) 2
National Academy of Sciences (NAS). 1996. Food Chemicals Codex, 4th ed.,158-161. Washington, DC: National Academy Press.
National Starch and Chemical Company. 1998. Typical concentration of use,method of manufacture, and UV absorption regarding aluminum starchoctenylsuccinate. Unpublished data submitted by CTFA. (5 pages.)2
Rempe, J. M., and L. G. Santucci, eds. 1997. CTFA list of japanese cosmetic
ingredients, 3rd ed. Washington, DC: CTFA.
Rothschild, D. L., Jr. 1990. The food chemical news guide to the current statusof food additives and color additives. Washington, DC: Food and Chemical
News.
Skin Study Center. 1995. Chamber scarification test: Lotion A containing 1.0%
aluminum starch octenylsuccinate. Study 3681. Unpublished data submitted
by CTFA. (23 pages.)2
Stephens and Associates, Inc. 1996. Chorioallantoic membrane vascular assay:
Lotion E containing 2.5% aluminum starch octenylsuccinate. Study 96-0069.
Unpublished data submitted by CTFA. (15 pages.) 2
Stephens and Associates, Inc. 1998. Human repeated insult patch test: Lotion
B containing 1.0% aluminum starch octenylsuccinate. Study C97-0164. Unpublished data submitted by CTFA. (43 pages.) 2
Unilever Research. 1984. Eye irritation test: Aluminum starch octenylsuccinate.
Unpublished data submitted by CTFA. (12 pages.) 2
Wenninger, J. A., and G. N. McEwen, Jr., eds. 1997. International cosmetic
ingredient dictionary and handbook, 7th ed. Washington, DC: CTFA.
Will eke, K., and P. A. Baron. 1993. Aerosol measurement; principles, techniques
and applications. New York: John Wiley and Sons.

Distributed for Comment Only -- Do Not Cite or Quote2018 FDA VCRP RAW DATACATEGORY

MAINTERM

COUNT

01B - Baby Lotions, Oils, Powders, and Creams

ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCH

1

03A - Eyebrow Pencil
03B - Eyeliner
03C - Eye Shadow
03D - Eye Lotion
03F - Mascara
03G - Other Eye Makeup Preparations
04C - Powders (dusting and talcum, excluding
aftershave talc)
04E - Other Fragrance Preparation
05B - Hair Spray (aerosol fixatives)
05F - Shampoos (non-coloring)
05G - Tonics, Dressings, and Other Hair Grooming Aids
05I - Other Hair Preparations
06B - Hair Tints
06E - Hair Color Sprays (aerosol)
06H - Other Hair Coloring Preparation
07A - Blushers (all types)
07B - Face Powders
07C - Foundations
07E - Lipstick
07F - Makeup Bases
07G - Rouges
07H - Makeup Fixatives
07I - Other Makeup Preparations
10A - Bath Soaps and Detergents
10B - Deodorants (underarm)

5
8
82
13
7
23
5
7
1
25
7
2
2
6
5
70
66
58
32
11
1
2
40
1
4

Distributed for Comment Only -- Do Not Cite or Quote

OCTENYLSUCCINATE
10E - Other Personal Cleanliness Products
11A - Aftershave Lotion
11D - Preshave Lotions (all types)
11G - Other Shaving Preparation Products
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12E - Foot Powders and Sprays
12F - Moisturizing
12G - Night
12H - Paste Masks (mud packs)
12J - Other Skin Care Preps
13A - Suntan Gels, Creams, and Liquids
13B - Indoor Tanning Preparations
13C - Other Suntan Preparations

ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
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ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE
ALUMINUM STARCHOCTENYLSUCCINATE

1
43
1
4
2
42
72
1
93
17
1
20
1
3
1