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Index of Cleared Science Reviews
Index for Baquacil (PC Code 111801)
June 15, 1978. Memorandum. 37 Pages.
William Dykstra. Toxicology Branch.
10182-EUP-11. Baquacil Swimming Pool Sanitizer [Containing
poly (hexamethylene biguanide hydrochloride)]. Experimental
Use Permit Application for the Evaluation of Baquacil in
Recreational Swimming Pools. Inert ingredient and quality
control info on pages 29, 31, 35 not included. TXR 003810.
July 11, 1978. Record. 1 Page.
William Dykstra. Toxicology Branch.
Meeting with Registrant Regarding 10182-EUP-11; Baquacil
for Swimming Pools.
October 12, 1978. Memorandum. 1 Page.
William Dykstra. Toxicology Branch.
Conference with ICI Representatives Regarding Baquacil
Swimming Pool Sanitizer; 10182-EUP-11. Caswell No. 676
(PHMB).
December 8, 1978. Review. 6 Pages.
John Tice. Ecological Effects Branch.
EUP Data Evaluation.
March 23, 1979. Memorandum. 1 Page.
William Dykstra. Toxicology Branch.
Meeting with ICI Regarding Baquacil. Caswell No. 676.
April 3, 1979. Review. 36 Pages.
Robert Carsel. Environmental Fate Branch.
Reg. No. 10182-19. Resubmission with Data. Swimming Pool
Use.
April 19, 1979. Review. 11 Pages.
Gunter Zweig. Environmental Fate Branch.
Resubmission with data. Swimming pool use.
Sewage Treatment Studies
Adsorption to Soil and Leaching
Degradation in Soil
Photodegradation in Water. Acc. No. 234289.
June 28, 1979. Letter. 7 Pages.
Arthur Castillo. Disinfectants Branch.
Baquacil, EPA File Symbol 10182-RO. Application of May 16,
1978.
August 7, 1979. Review. 14 Pages.
William Campbell. Disinfectants Branch.
Technical Support Section Efficacy Review I
10182-EUP-11
Acc. 238825.
September 20, 1979. Review. 8 Pages.
Ann Rosenkranz. Toxicology Branch.
Aquatic Acute Toxicity.
96 hour LC50, Bluegill (Lepomis macrochirus)
48 hour LC50, Water Flea (Daphnia magna).
September 20, 1979. Review. 4 Pages.
Ann Rosenkranz. Toxicology Branch.
96 hour LC50, Rainbow Trout.
November 8, 1979. Review. 7 Pages.
Ann Rosenkranz. Ecological Effects Branch.
Registration Data Evaluation for PHMB, Baquacil, for ICI
Americas, Inc.
November 15, 1979. Memorandum. 1 Page.
Robert Zendzian. Toxicology Branch.
Heavy Metals in Baquacil, Reg. No. 10182-19.
January 23, 1980. Memorandum. 1 Page.
John Doherty. Toxicology Branch.
EPA File No. 101-RO, Baquacil Swimming Pool Disinfectant.
February 11, 1980. Review. 18 Pages.
William Campbell. Disinfectants Branch.
10182-EUP-11
Acc. 241672, 241673.
4th Quarterly Report, Addendum - Efficacy.
February 14, 1980. Review. 5 Pages.
Anonymous. Registration Division (?).
Conference. ICI Baquacil (new product, new chemical
for swimming pool use) (page 3 - proposed 1980 Baquacil
EUP program outline).
March 14, 1980. Review. 7 Pages.
Ana Skapars. Disinfectants Branch.
Technical Support Section Chemistry Review - I&II
New Application.
March 31, 1980. Review. 6 Pages.
William Campbell. Disinfectants Branch.
Technical Support Section Efficacy Review - I
10182-RO, 10182-EUP-11. Extension of EUP.
Accession 241815.
April 4, 1980. Review. 4 Pages.
William Campbell. Disinfectants Branch.
Efficacy Review 1 and 2.
Acc. 241791.
New Registration/New Chemical.
April 7, 1980. Review. 2 Pages.
C.E. Laird. Ecological Effects Branch.
Acute Oral LD50 for Mallard Duck.
April 7, 1980. Review. 2 Pages.
C.E. Laird. Ecological Effects Branch.
Eight-Day Dietary LC50 for Mallard Duck.
April 8, 1980. Review. 2 Pages.
C.E. Laird. Ecological Effects Branch.
Eight-Day Dietary LC50-Bobwhite Quail.
April 18, 1980. Review. 11 Pages.
Curtis Laird. Ecological Effects Branch.
Reg. No. 10182-RO, 10182-EUP-11.
May 27, 1980. Review. 4 Pages.
Madeline Nawar. Environmental Fate Branch.
Reg. No. 10182-RO & 10182-EUP-11.
Registration of Swimming Pool Use.
Commercial/financial information pages 3, 4 not included.
June 17, 1980. Memorandum. 6 Pages.
William Dykstra. Toxicology Branch.
EPA Reg. No. 10182-RO; 10182-EUP-11; Baquacil.
Caswell No. 676.
July 31, 1980. Memorandum. 2 Pages.
A. E. Castillo. Disinfectants Branch.
Baquacil. EPA File Symbol 10182-RO. Request for conference
with members from HED.
August 25, 1980. Review. 5 Pages.
Curtis Laird. Ecological Effects Branch.
Acute toxicity of Vantocil P" to Rainbow Trout (Salmo
gairdneri). Fish acute 96-hour LC50.
August 25, 1980. Review. 3 Pages.
Curtis Laird. Ecological Effects Branch.
Daphnia magna Exposure to Vantosil IB. Daphnia acute
48-hour LC50.
August 25, 1980. Review. 2 Pages.
Curtis Laird. Ecological Effects Branch.
Daphnia magna Exposure to Vantosil IB. Daphnia acute
48-hour LC50.
August 26, 1980. Review. 3 Pages.
Curtis Laird. Ecological Effects Branch.
Acute Toxicity of Vantocil IB to Bluegill (Lepomis
macrochirus).
August 26, 1980. Review. 2 Pages.
Curtis Laird. Ecological Effects Branch.
Acute Toxicity of Vantocil IB to Bluegill (Lepomis
macrochirus). Fish acute 96-hour LC50.
October 9, 1980. Memorandum. 1 Page.
William Dykstra. Toxicology Branch.
Baquacil; EPA Reg. No. 10182-RO; Caswell No. 676;
Accession No. 243098.
October 31, 1980. Review. 3 Pages.
Curtis Laird. Ecological Effects Branch.
10182-RO.
Acc. 243099.
Data Validation - 96 hour LC50 Rainbow Trout; 96 hour LC50
Bluegill sunfish; 48 hour LC50 Daphnia magna.
November 21, 1980. Review. 13 Pages.
Curtis Laird. Ecological Effects Branch.
Reg. No. 10182-RO; Data Validation
Acc. 243099.
November 21, 1980. Review. 3 Pages.
Curtis Laird. Ecological Effects Branch.
10182-RO
Acc. 243099.
Data Validation 96 hour LC50 Rainbow trout; 96 hour
LC50 Bluegill; 48 hour LC50 Daphnia magna.
December 8, 1980. Letter. 1 Page.
A.E. Castillo. Disinfectants Branch.
Attention: Judith A. Gleve, ICI Americas
Subject: Baquacil, 10182-RO, Resubmission of Sept 11, 1980.
December 9, 1980. Review. 4 Pages.
Curtis Laird. Ecological Effects Branch.
96-hour Acute Toxicity to Rainbow trout.
December 19, 1980. Review. 3 Pages.
Curtis Laird. Ecological Effects Branch.
48-hour LC50 for Daphnia magna, 96-hour LC50 for Bluegill
Lepomis macrochirus, and 96-hour LC50 for coldwater fish
(Rainbow trout).
February 3, 1981. Memorandum. 1 Page.
Reto Engler. Disinfectants Branch.
Baquacil Swimming Pool Chemical (New Chemical) EPA File
Symbol 10182-RO.
February 27, 1981. Memorandum. 4 Pages.
William Dykstra. Toxicology Branch.
Baquacil; EPA Reg. No. 10182-RO; Additional Data.
Acc. 244217. Skin sensitization.
April 2, 1981. Memorandum. 1 Page.
William Dykstra. Toxicology Branch.
Baquacil; Mouse Teratology Study. Caswell No. 676.
April 30, 1981. Review. 7 Pages.
Curtis Laird. Ecological Effects Branch.
Reg. No. 10182-RO. Submission of Data in Support of
Conditional Registration.
Acc. 244855.
May 15, 1981. Review. 3 Pages.
Steve Palmateer. Terrestrial & Aquatic Biology/OTS.
96-hour Acute Toxicity to Rainbow trout, Biological Report
of Analysis.
May 21, 1981. Memorandum. 1 Page.
William Dykstra. Toxicology Branch.
EPA Reg. No. 10182-RO; Baquacil; Response to Request for
Additional Information.
July 21, 1981. Memorandum. 4 Pages.
Reto Engler. Disinfectants Branch.
Registration of a New Chemical for Use in Swimming Pools as
a Sanitizer and Algistat.
June 11, 1982. Review. 5 Pages.
William Campbell. Disinfectants Branch.
Technical Support Section Efficacy Review
10182-19, 10182-EUP-11
Final report/Results of the 1980 and 1981 EUP program.
Accession 247539.
July 8, 1982. Memorandum. 5 Pages.
George Ghali. Toxicology Branch.
Evaluation of Skin Sensitization Study in Human
Volunteers. EPA Reg. No. 10182-19.
Acc. 247255
Tox review 002116.
December 9, 1982. Review. 1 Page.
Anna Skapars. Disinfectants Branch.
Technical Support Branch Chemistry Review II
Inert ingredient information on page 1 is not included.
April 8, 1983. Review. 3 Pages.
James Wilson. Disinfectants Branch.
Technical Support Branch Chemistry Review - I
Resubmission - Tox Data
Eye irritation in Rabbits. ICI Central Toxicology Laboratory
Acc. 249561.
August 7, 1984. Memorandum. 4 Pages.
Carlos Rodriguez. Toxicology Branch.
Cosmocil FB-EPA Symbol 10182-IL
Registration as antimicrobial for treatment of fabrics.
January 6, 1988. Memorandum. 5 Pages.
Irving Mauer. Toxicology Branch.
Baquacil (Vantocil P) - Mutagenicity Study Submitted
in Response to the Antimicrobial Data Call-In Notice.
EPA Reg. No.'s 10182-19, -45.
MRID 40391901.
Tox review 006540.
August 16, 1989. Memorandum. 21 Pages.
John Chen. Toxicology Branch.
Mouse micronucleus test with Vantocil IB.
Inert ingredient info pages 2,4 not included.
Pages 8-21 removed, registration data.
MRID 410969-01.
Tox review 007438.
September 15, 1989. Review. 7 Pages.
Brian Montague. Ecological Effects Branch.
Proposed new use for oil field recovery systems for Vantocil
Inert ingredient information deleted from page 2.
May 27, 1990. Review. 29 Pages.
James Akerman. GCSB.
Reregistration Phase 2 response by ICI Americas for PHMB.
September 21, 1990. Review. 1 Page.
Anna Skapars. Registration Support Branch.
Product Chemistry Review
Baquacil Swimming Pool Sanitizer and Algistat
Inert ingredient information on page 1 is not included.
August 9, 1991. Review. 5 Pages.
Emil Regelman. Environmental Fate & Ground Water Branch.
Phase 2 Response submission.
August 14, 1991. Summary. 2 Pages.
Anonymous. Ecological Effects Branch.
Phase IV Data Requirements for Ecological Effects Branch.
December 9, 1991. Review. 2 Pages.
Lisa Anderson. Antimicrobial Program Branch.
Efficacy Review I&II
A label revision to add directions for use in
spas and hot tubs.
December 12, 1991. Memorandum. 2 Pages.
Bernice Slutsky. Science Analysis and Coordination Staff.
Amendment of EFED List C Review for PHMB (case number 3122).
July 2, 1992. Memorandum. 7 Pages.
Pamela Hurley. Toxicology Branch.
PHMB (Vantocil P). Response to Questions Concerning 21-Day
Dermal Study.
Pages 5-7 deleted - Registration data.
July 2, 1992. Memorandum. 4 Pages.
Timothy McMahon. Toxicology Branch.
Review of submitted metabolism protocols in support of
reregistration of PHMB.
July 2, 1992. Memorandum. 2 Pages.
Timothy McMahon. Toxicology Branch.
Review of proposals put forth by ICI for the conduct of
Toxicology studies with PHMB.
July 22, 1992. Memorandum. 2 Pages.
Timothy McMahon. Toxicology Branch.
Review of additional data submitted in support of MRID 65131
"PHMB ("Baquacil" SB): A Teratology Study in the Rat by
Dietary Administration".
September 22, 1992. Memorandum. 3 Pages.
Timothy McMahon. Toxicology Branch.
Review of data waiver requests submitted by ICI Specialty
Chemicals.
October 15, 1992. Memorandum. 4 Pages.
Douglas Urban. Ecological Effects Branch.
Correction of cited MRID. MRID 27491.
October 28, 1992. Review. 3 Pages.
Douglas Urban. Ecological Effects Branch.
EEB review of data waiver request.
November 5, 1992. Memorandum. 3 Pages.
Mah Shamim. Environmental Fate & Groundwater Branch.
Waiver Request/Data Submission for PHMB by ICI Americas, Inc.
March 9, 1993. Memorandum. 2 Pages.
Mah Shamim. Environmental Fate & Groundwater Branch.
Time Extension Request for PHMB by ICI Americas, Inc.
August 20, 1993. Memorandum. 7 Pages.
Timothy McMahon. Toxicology Branch.
Polyhexamethylene biguanide (Baquacil): Review of a Dermal
Sensitization Study Submitted by the Registrant.
MRID 42674201.
Tox review 010512.
November 29, 1993. Memorandum. 16 Pages.
Timothy McMahon. Toxicology Branch.
Polyhexamethylene Biguanide (PHMB, Baquacil): Review of
Toxicology Data Submitted by the Registrant. (Developmental
toxicity) Pages 15-16 removed, registrant data.
MRID 428659-01
Tox review 010677.
January 27, 1994. Memorandum. 4 Pages.
Timothy McMahon. Toxicology Branch.
Polyhexamethylene Biguanide (PHMB, Baquacil): Review of
Dietary Analysis Data Submitted by the Registrant.
MRID 429921-01
Tox review 010753.
March 24, 1994. Memorandum. 2 Pages.
Timothy McMahon. Toxicology Branch.
Polyhexamethylene Biguanide (Baquacil): Review of Data
Submitted by Registrant in Connection with a Two-Year
Carcinogenicity Study in Mice.
MRID 43121301.
June 7, 1994. Memorandum. 11 Pages.
Timothy McMahon. Toxicology Branch.
Polyhexamethylene Biguanide (PHMB, Baquacil): Review of a
21-Day Dermal Toxicity Study in Rats Submitted by Registrant
MRID 430477-01
Tox review 011032.
June 23, 1994. Memorandum. 16 Pages.
Larry Liu. Environmental Fate & Groundwater Branch.
Poly (hexamethylenebiguanide) - Environmental Fate
Data Requirement. Hydrolysis and photodegradation in water.
Pages 7-16 removed, registrant data.
MRID 30785.
July 28, 1994. Memorandum. 13 Pages.
Anthony Maciorowski. Ecological Effects Branch.
Freshwater fish flow-through toxicity test for Vantocil
P to the rainbow trout (MRID # 93191004/ 45698).
Pages 8-10 removed, registrant data.
August 4, 1994. Memorandum. 14 Pages.
Anthony Maciorowski. Ecological Effects Branch.
Baquacil - Avian single dose oral LD50 study for the
mallard duck (MRID # 93191001) and avian dietary LC50
study for the bobwhite quail (MRID # 93191002).
Pages 12-13 removed, registrant data.
January 10, 1995. Memorandum. 21 Pages.
Timothy McMahon. Toxicology Branch.
Polyhexamethylene biguanide (PHMB, Baquacil): Review of
a Mutagenicity Study Submitted by the Registrant.
Pages 10-21 removed, registrant data.
MRID 416870-05
Tox review 011380.
May 23, 1995. DER. 4 Pages.
James Goodyear. Ecological Effects Branch.
PHMB (Vantocil IB)
Bluegill Sunfish Flow-through Acute Toxicity test
MRID 427221-01.
August 18, 1995. Review. 16 Pages.
Anthony Maciorowski. Ecological Effects Branch.
Review waiver request.
('The waiver for the requirement 72-1d is granted.')
Pages 12-14 removed, registrant data.
Attachment(s) following:
August 14, 1994. Memorandum.
Anthony Maciorowski. Ecological Effects Branch.
Freshwater fish flow-through toxicity test for Vantocil
P (20%) to the rainbow trout (MRID # 9319003/ 74296).
*End of attachments*
November 7, 1995. Review. 5 Pages.
Anthony Maciorowski. Ecological Effects Branch.
Submission of additional data to upgrade acute
toxicity bluegill sunfish study (MRID No. 427221-01)
MRID 427221-01, 437597-01.
December 12, 1995. Letter. 2 Pages.
Bruce Sidwell. Accelerated Reregistration Branch.
Review of addendum submitted to upgrade status of guideline
72-1a, acute toxicity to bluegill sunfish, for... (PHMB).
MRID 43759701, 42722101.
June 24, 1996. Memorandum. 2 Pages.
William Dykstra. Residue Chemistry Action Branch.
Vantocil IB Microbicide (PHMB); EPA Registrtion No.
010182-00128; Registration Request to Use PHMB on Human
Textile End Use Products; Zeneca Ag Products.
MRID 43721701, -02.
October 16, 1996. Memorandum. 14 Pages.
Timothy McMahon. Toxicology Branch.
Review of Special Metabolism Studies with (PHMB)
MRID 43567001 and 43599901
Tox review 012077.
November 6, 1996. Memorandum. 22 Pages.
Timothy McMahon. Toxicology Branch.
Review of Chronic Toxicity Study in Dogs with (PHMB).
MRID 43620501
Tox review 012096.
December 2, 1996. Memorandum. 26 Pages.
Timothy McMahon. Toxicology Branch.
Review of a 2-Generation Reproduction Study in Rats with
Polyhexamethylene Biguanide (PHMB).
MRID 43617401
Tox review 012111.
July 23, 1997. Review. 1 Page.
Ecological Effects Branch.
Ecological Effects Information System
Tox One-Liner Report
PHMB (Baquacil).
November 12, 1997. Memorandum. 27 Pages.
Timothy McMahon. RASSB.
Vantocil IB (Baquacil): Review of Mutagenicity Data.
MRID 41404501, 42149905, 41404502, 42149903, 41096901,
41404503, 41687006, 42149906, 41687004.
November 20, 1997. Memorandum. 10 Pages.
Douglas Urban. Environmental Fate and Effects Division.
Reregistration, Data Evaluation - Acute Toxicity to Rainbow
Trout, Vantocil P (111801), D224336, REREG Case #3122...
Sponsor: ZENECA Inc.
MRID 439490-01.
February 25, 2000. Memorandum. 34 Pages.
Wallace Powell. Product Science Branch.
BAQUACIL Ultra Swimming Pool and Spa Sanitizer and Fungicide
EPA File Symbol 072674-EE.
acute toxicity, dermal, eye irritation studies.
MRID 449407-01 through -05 and 449639-02.
January 2, 2001. Memorandum. 5 Pages.
A. Najm Shamim. Risk Assessment Science Support Branch.
Review of Measurement of Poly(hexamethylenebiguanide
hydrochloride) (PHMB) in Cotton and Polyester/Cotton Cloths.
MRID 45187706.
January 2, 2001. Memorandum. 3 Pages.
Jonathan Chen. Risk Assessment Science Support Branch.
Polyhexamethyl Biguanide: Review of the Proposed Use
in Apparel.
January 3, 2001. Memorandum. 3 Pages.
Siroos Mostaghimi. Risk Assessment Science Support Branch.
Review of a Health Risk Assessment for PHMB (Vantocil IB)
Used on 100% Cotton Textile Application-Systemic Toxicity
by an Infant Suckling Textile.
MRID 45187701.
January 16, 2001. Memorandum. 3 Pages.
Ian Blackwell. Product Science Branch.
Acute Toxicity Review for EPA Reg. No.: 72674-5 /Vantocil IB
Dermal Sensitization. MRID 45187705.
April 18, 2001. Memorandum. 16 Pages.
Jonathan Chen. Risk Assessment Science Support Branch.
PHMB - Report of the Hazard Identification Assessment Review
Committee.
Tox review 014541.
June 1, 2001. Memorandum. 32 Pages.
Wallace Powell. Product Science Branch.
EPA File Symbols 72992-U, -G,-E,-O,-L,-T,-I,-A.
For all products, acute inhalation waivers were requested.
For T535, eye and skin irritation waivers were requested.
MRID 45325702 thru 04, 45326902 thru 04, 45325502 thru 04.
Inert info on pages 9, 13, 17, 22, 26, 30 is not included.
December 13, 2001. Memorandum. 6 Pages.
Wallace Powell. Product Science Branch.
EPA File Symbols 72992-E, -G,-L,-A,-T,-I,-O.
...papers in support of the acute toxicity data requirements
(mammalian) for registration of the subject products...
May 3, 2002. Mmeorandum. 6 Pages.
Nancy Whyte. Product Science Branch AD.
Efficacy Review EPA Reg. No. 72674-22.
Baquacil Ultra Swimming Pool Sanitizer & Fungicide.
MRID 45566601.
November 14, 2005. Memorandum. 5 Pages.
Norm Cook. Risk Assessment & Science Support Branch.
Risk Assessment & Science Support Branch Scoping Review
of PHMB For Use As A Sanitizer {ID No 1258-1253 ...]
DP Barcode D320916, D320917, D322475.
to identify science issues... including potential data
requirements.