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Index of Cleared Science Reviews for Imazalil (Pc Code 111901)
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October 13, 1978. Review. 20 Page(s).
Carlos A. Rodriguez. Toxicology Branch.
Request for a tolerance of 2 PPM of Imazalil in whole bananas and 0.2
PPM in the edible pulp. PP#8E2100. Petitioner: Chevron Chemical Co.
Manufacturing process info on page 2 not included.
Inert ingredient info on pages 2, 3 not included.
TXR No. 000065.
Document (PDF) (811 KB PDF).
April 20, 1984. Memorandum. 5 Page(s).
Carlos A. Rodriguez. Toxicology Branch.
PP #4G3017 - Imazalil Temporary Tolerance Petition.
Tox Review 003769.
Document (PDF) (130 KB PDF).
September 13, 1984. Memorandum. 6 Page(s).
David Ritter. Toxicology Branch.
PP# [illegible]; EPA File Symbol [illegible] Request registration
of Fungaflor 50 EC for postharvest treatment of pome fruits at
7 ppm and apple pomace (wet/dry) at 10 ppm.
Inert ingredient information on pages 1, 2, 5 deleted.
Tox review No. 003966.
Document (PDF) (348 KB PDF).
Attachment(s) Following:
September 13, 1984. Memorandum.
David Ritter. Toxicology Branch.
Oral Embryotoxicity and Teratogenicity Study in Cobs
Mice (Janssen Le Brun Research Lab... 11/28/83)
Inert ingredient info on pages 1, 2 and 5 not included.
Tox review 003966.
*End of Attachments*
November 20, 1985. Memorandum. 11 Page(s).
Carlos A. Rodriguez. Toxicology Branch.
773-EUP-E, Imazalil (Clinafarm 15% EC).
Caswell No. 496AB, Accession No. 258173. Tox Review No. 004795.
Document (PDF) (275 KB PDF).
December 06, 1985. Memorandum. 4 Page(s).
Carlos A. Rodriguez. Toxicology Branch.
Imazalil (Fungaflor/Fecundal). Addendum to PP#5F3250. Janssen Pharmceutica...
has been requested to submit a teratology study in a second species for Imazalil.
Acc 258128. Tox review 004853.
Document (PDF) (80 KB PDF).
May 15, 1987. Memorandum. 7 Page(s).
Carlos A. Rodriguez. Toxicology Branch.
Imazalil/PP #5F3250. Fecundal 6.5L - EPA Registration No. 43813-5.
Pages 5-7 removed, registrant data. Tox review 005884.
Document (PDF) (59 KB PDF).
August 11, 1987. Memorandum. 4 Page(s).
Mary Waller. Fungicide Herbicide Branch.
EPA File Symbol 2935-UUN. Nu-Zone 10ME.
Page 4 removed, draft label. Tox review 006377.
Document (PDF) (106 KB PDF).
March 09, 1988. Memorandum. 18 Page(s).
W. T. Chin. Residue Chemistry Branch.
PP #7F3530. Imazalil In or On Melons, Citrus and Sweet
Corn Evaluation of Analytical Methods and Residue Data.
(MRID #40176401; 40204901; 40204902); RCB #2524 and #2740.
Document (PDF) (541 KB PDF).
March 23, 1988. Memorandum. 2 Page(s).
Mary Waller. Fungicide Herbicide Branch.
EPA File Symbol 773-LL. Clinafarm EC Primary eye irritation.
MRID 401521-02.
Document (PDF) (32 KB PDF).
July 29, 1988. Memorandum. 4 Page(s).
Mary Waller. Fungicide Herbicide Branch.
EPA File Symbol 773-LL. Clinafarm EC.
Document (PDF) (56 KB PDF).
January 09, 1989. Memorandum. 3 Page(s).
Mary Waller. Registration Support Branch.
EPA File Symbol 773-LL. Clinafarm EC 15%.
Document (PDF) (44 KB PDF).
April 18, 1990. Memorandum. 9 Page(s).
Lucy Markarian. Registration Support Branch.
EPA File Symbol 773-LL. Clinafarm EC (Enilconazole)
MRID 414308-01, 02.
Document (PDF) (338 KB PDF).
April 20, 1990. Memorandum. 35 Page(s).
Henry Spencer. Toxicology Branch.
EPA ID# 43813-2 Review of Studies (DERs) on Imazalil, Current Status
of the Toxicity Data Base MRID Nos.: 410266-01 thru -04 [mutagenicity,
3-generation reproduction, rat teratology, 90 day mouse subchronic range]
Tox review 007865.
Document (PDF) (1737 KB PDF).
Attachment(s) Following:
May 01, 1989. Memorandum.
Judith Hauswirth. Toxicology Branch.
Imazalil - Dose Selection for Mouse Oncogenicity Study.
Submitted by Janssen Pharmaceutica by Fax on April 7, 1989.
May 14, 1989. Memorandum.
Irving Mauer. Toxicology Branch.
IMAZALIL - Company Response to TB Evaluation of a Mutagenicity Study.
MRID 40729302.
October 04, 1989. Memorandum.
David Anderson. Toxicology Branch.
Re-evaluation of the 3-Generation Study of Imazalil on Reproduction in
the Rat (Study no 736), and the Addendum and Responses to the Sponsor
Acc. 097233, addendum MRID 410266-04.
*End of Attachments*
January 31, 1992. Memorandum. 4 Page(s).
Leung Cheng. Chemistry Branch.
ID # 111901-43813. Imazalil. Response to Phase IV Review.
MRID # 420120-05 through -09. CBRS # 8933. DP Barcode: D171401.
Document (PDF) (121 KB PDF).
December 03, 1992. Memorandum. 3 Page(s).
Stephen Funk. Chemistry Branch.
Reregistration of Imazalil. Time Extension Requests for Nature
of the Residue in Poultry and Wheat Field Trail/ Processing.
DP Brcode D1843389. MRID No. None.
Document (PDF) (68 KB PDF).
February 17, 1993. Memorandum. 17 Page(s).
John Abbotts. Chemistry Branch.
Imazalil, Reregistration. Nature of the Residue in Ruminant
(MRID Nos. 42454801, 42454802, and 42593602), and Analytical
Methods for Plants (MRID Nos. 42454803 and 04).
Document (PDF) (331 KB PDF).
March 02, 1993. Memorandum. 3 Page(s).
Henry Spencer. Toxicology Branch I.
The Requested Reevaluation of the RFD for Imazalil
(ID#s 5F03250, 7F03530, 4F03096, 4H05434).
Barcodes: D177305, D177309, D177306, D177308.
Document (PDF) (47 KB PDF).
May 24, 1993. Memorandum. 28 Page(s).
David G. Anderson. Toxicology Branch I.
EPA ID No. : 111901; Imazalil - 6(a) (2) Data on a study of Reproduction
in the Rat/2337 (83-4). Pages 22-28 removed, registration data.
MRID No. 425707-01. Tox review 010278.
Document (PDF) (464 KB PDF).
June 24, 1993. Memorandum. 9 Page(s).
Stephen Funk. Chemistry Branch.
Imazalil (List B; Case 2325; Chemical 111901): Analytical Method for the
Determination of Imazalil & R14821 in/on Bananas, Citrus, and Citrus
Processed Commodities. Research Method and Enforcement Method Comparison...
MRIDs 42454803, 42454804, & 42454805.
Document (PDF) (159 KB PDF).
August 10, 1993. Memorandum. 13 Page(s).
Henry Spencer. Toxicology Branch I.
Imazalil: Review of 21 day Dermal Toxicity study in the New Zealand White Rabbit.
MRID No. 42085201. Tox review 010474.
Document (PDF) (216 KB PDF).
August 11, 1993. Memorandum. 29 Page(s).
Henry Spencer. Toxicology Branch I.
Imazalil: Metabolism in the Wistar Rat.
Pages 17-29 removed, registration data.
MRID 42012003. Tox review 010485.
Document (PDF) (286 KB PDF).
September 16, 1993. Memorandum. 15 Page(s).
John C. Redden. Toxicology Branch I.
Imazalil Sulphate: review of a developmental toxicity study in rabbits.
MRID No. 42593601. Tox review 010581.
Document (PDF) (288 KB PDF).
November 29, 1993. Memorandum. 17 Page(s).
Henry Spencer. Toxicology Branch I.
Submission by the Registrant of 6-a-2 Data (Interim Report) on the Mouse
Carcinogenicity study with Imazalil. Pages 6-17 removed, registration data.
MRID # 42890301 and 42972000.
Document (PDF) (106 KB PDF).
December 21, 1993. Memorandum. 12 Page(s).
Stephen Funk. Chemistry Branch.
Reregistration of Imazalil (List B, Case 2325, Chem. 111901)
Magnitude of the Residue in Wheat and Barley (171-4(k))
and in Processed Commodities of Wheat and Barley (171-4(1)).
DP Barcode D194151. MRID Nos. 42868101, 42852001, and 42852002.
Document (PDF) (442 KB PDF).
Attachment(s) Following:
November 10, 1993. Final Report.
Dynamac Corporation.
Task 4 Registrant's Response to Residue Chemistry Data Requirements.
*End of Attachments*
January 11, 1994. Memorandum. 14 Page(s).
Leung Cheng. Chemistry Branch.
Imazalil. Case No. 2325. Registrant's Response to Reregistration.
MRID No. 42626901, -02, -03. CBRS No. 11295. DP Barcode: D187506.
Document (PDF) (185 KB PDF).
March 16, 1994. Memorandum. 7 Page(s).
Robert P. Zendzian. Toxicology Branch I.
Imazalil, Dermal absorption in rats. Pages 5-7 removed, registratio data.
MRID No. 429134-01. Tox review 010845.
Document (PDF) (103 KB PDF).
May 03, 1994. Memorandum. 5 Page(s).
Leung Cheng. Chemistry Branch.
Imazalil. Case No. 2325. Phase IV Review of Orange and Banana Memtabolism Studies.
MRID 42012008 & 42012009. DP Barcode: D198235. CBRS No. 13072.
Document (PDF) (78 KB PDF).
June 02, 1994. Memorandum. 8 Page(s).
David G. Anderson. Toxicology Branch I.
Subject: EPA ID No. 111901-043813; Imazalil - company response to upgrade
(MRID# 429494-02) Data o a study of Reproduction in the Rat/2337 (83-4).
Tox review 011019.
Document (PDF) (140 KB PDF).
August 04, 1994. Memorandum. 4 Page(s).
Leung Cheng. Chemistry Branch.
Imazalil. Hen and Ruminant Metabolism Studies.
To be Presented to the HED Metabolism Committee on August 8, 1994.
Document (PDF) (63 KB PDF).
August 12, 1994. Memorandum. 2 Page(s).
Edwin R. Budd. Toxicology Branch I.
Imazalil Registration; Reregistration case No. 2325; Review of
supplemental data related to Carcinogenicity study in mice and
to 3-month oral mechanistric toxicity study in mice.
MRID No. 432424-01, 432424-02. Tox review 011162.
Document (PDF) (34 KB PDF).
August 17, 1994. Memorandum. 245 Page(s).
Esther Rinde. Carcinogenicity Peer Review.
Carcinogenicity Peer Review Meeting Package on Imazalil.
Inert ingredient information on pages 7, 18, 52, 54, 83, 84, 121,
169, 194, and 195 has been deleted. Pages 19-21, 32-35, 152-154,
155-163, 207-210, 212-213, and 215 deleted - registration data.
Document (PDF) (4411 KB PDF).
August 30, 1994. Memorandum. 2 Page(s).
Leung Cheng. Chemistry Branch.
Imazalil. Laying Hen and Lactating Goat Metabolism.
The Metabolism Committee Meeting Held on August 18, 1994.
Document (PDF) (28 KB PDF).
September 20, 1994. Memorandum. 4 Page(s).
Henry Spencer. Toxicology Branch I.
Imazalil Sulfate: Evaluation of supplement to MRID 42593601
Embryotoxicity and Teratogenicity study in Albino Rabbits.
DP Barcode: D200774. Tox review 011239.
Document (PDF) (82 KB PDF).
September 22, 1994. Memorandum. 1 Page(s).
Leung Cheng. Chemistry Branch.
Imazalil. Case No. 2325. Supplemental Data to Orange Metabolism Study.
MRID No. 433084-01. CBRS No. 14111. DP Barcode: D205954.
Document (PDF) (17 KB PDF).
September 27, 1994. Memorandum. 21 Page(s).
Henry Spencer. Toxicology Branch I.
Imazalil: Review of submitted Acute Toxicity Studies performed with
Imazalil Technical (MRIDs 416061-04, 416061-05, and 417187-01).
Pages 7-9 & 15-16 removed, registration data. Tox review 011248.
Document (PDF) (297 KB PDF).
November 03, 1994. Memorandum. 6 Page(s).
Henry Spencer. Toxicology Branch I.
Review of Supplemental information to MRID# 42085201, a repeated 21 day dermal
toxicity study in New Zealand White Rabbits & the Supplemental information to
MRID# 42012003,... in the rat. Page 6 removed, registration data.
MRID No. 43016802, 43016803.
Document (PDF) (193 KB PDF).
January 03, 1995. Memorandum. 4 Page(s).
Leung Cheng. Chemistry Branch.
Imazalil. Case No. 2325. Metabolism on Banana - Postharvest Treatment.
Review of Protocol. No MRID #. CBRS No. 14816. DP Barcode: D209996.
Document (PDF) (46 KB PDF).
January 20, 1995. Memorandum. 3 Page(s).
Leung Cheng. Chemistry Branch.
Imazalil. Case No. 2325. Magnitude of Residue in Winter
Wheat Forage, Straw and Grain Grown from Treated Seed.
MRID No. 43285001. CBRS No. 14026. DP Barcode: D205092.
Document (PDF) (124 KB PDF).
March 07, 1995. Memorandum. 2 Page(s).
Bernice Fisher. Science Analysis Branch.
Imazalil, Quantitative Risk Assessment, Two-Year
Charles River SPF Swiss Albino mouse dietary study.
Document (PDF) (47 KB PDF).
June 12, 1996. Memorandum. 11 Page(s).
Leung Cheng. Chemistry Branch.
Imazalil. Case 2325. Metabolism on Bananas From Post-Harvest Treatment.
MRID 43965701. CBRS 17087. DP Barcode: D224876.
Document (PDF) (123 KB PDF).
September 14, 1996. Memorandum. 17 Page(s).
Edwin R. Budd. Toxicology Branch I.
PP 7F03530, Imazalil, Adequacy of submitted data with Regard to second
Carcinogenicity peer review. DP Barcode: D225180.
Document (PDF) (423 KB PDF).
September 14, 1996. Memorandum. 4 Page(s).
Edwin R. Budd. Toxicology Branch I.
Imazalil, registration case No. 2325. Review of Protocols for Combined
Chronic Feeding/Carcinogenicity study in Rats and Concurrent study to
develop Contemporary Historical Control Data. DP Barcode: D225939.
Document (PDF) (72 KB PDF).
September 04, 1998. Memorandum. 42 Page(s).
Edwin Budd. Health Effects Division.
Cancer Assessment Document. Second Evaluation of the Carcinogenic Potential of Imazalil.
Tox review 012870.
Document (PDF) (1815 KB PDF).
June 29, 1999. Memorandum. 20 Page(s).
Abdallah Khasawinah. Reregistration Branch HED.
IMAZALIL: - Report of the Hazard Identification Assessment Review Committee.
Tox review 013539.
Document (PDF) (773 KB PDF).
September 28, 1999. Memorandum. 5 Page(s).
Brenda Tarplee. Health Effects Division.
IMAZALIL - Report of the Safety Factor Committee. Tox review 013762.
Document (PDF) (193 KB PDF).
October 04, 1999. Memorandum. 8 Page(s).
Abdallah Khasawinah. Reregistration Branch HED.
IMAZALIL: - Reassessment of the Requirement for a Developmental Neurotoxicity
Study in Rats- Report of the Hazard Identification Assessment Review Committee.
Tox review 013778.
Document (PDF) (198 KB PDF).
December 07, 1999. Memorandum. 13 Page(s).
Sanjivani Diwan. Health Effects Division.
Imazalil - 3rd Report of the Cancer Assessment Review Committee.
Tox review 013885.
Document (PDF) (411 KB PDF).
January 06, 2000. Memorandum. 3 Page(s).
Abdallah Khasawinah. Reregistration Branch 4 HED.
Imazalil: Evaluation of Supplementary Data to Combined Chronic/Carcinogenicity
Study in Rats and Evaluation of Teratogenicity Studies in Mice
MRIDs 448558001, 44567801, 445678703, 44567802.
Document (PDF) (38 KB PDF).
February 08, 2000. DER. 3 Page(s).
Abdallah Khasawinah. Reregistration Branch 4 HED.
Supplement to Document No. 004853 - DER for Accession No. 000258128:
Oral Embryotoxicity and Teratogenicity of Imazalil in Cobs Mice.
Document (PDF) (25 KB PDF).
February 08, 2000. DER. 3 Page(s).
Abdallah Khasawinah. Reregistration Branch 4 HED.
Supplement to Document No. 007865 - DER for MRID No. 41026603: Embryotoxicity
and Teratogenicity Study in Sprague Dawley Rats (Imazalil Sulphate 27180).
Document (PDF) (30 KB PDF).
February 08, 2000. DER. 3 Page(s).
Abdallah Khasawinah. Reregistration Branch 4 HED.
Supplement to HED Document No. 000065 & 007865 - DER for Accession No. 097233
(amendment MRID No. 41026604): 3- Generation Reproduction Study in Rats.
Document (PDF) (38 KB PDF).
February 08, 2000. DER. 4 Page(s).
Abdallah Khasawinah. Reregistration Branch 4 HED.
Supplement to Document No. 010278 and 011019 - DER for
MRID 42570701: 2-Generation Reproduction Study in Rats.
Document (PDF) (51 KB PDF).
February 08, 2000. Memorandum. 17 Page(s).
Abdallah Khasawinah. Reregistration Branch 4 HED.
Imazalil: Review and Update of Toxicology Studies to Support
Re-registration Eligibility Decision.
Document (PDF) (273 KB PDF).
February 09, 2000. Memorandum. 43 Page(s).
Abdallah Khasawinah. Reregistration Branch 4 HED.
Imazalil: The HED Toxicology Chapter for the Reregistration
Eligibility Decision Document (RED).
Document (PDF) (803 KB PDF).
November 13, 2000. Memorandum. 2 Page(s).
Abdallah Khasawinah. Reregistration Branch HED.
IMAZALIL: Re-define the Short Term Dermal Exposure for
Assessing Seed Treatment Exposure Scenario. Tox review 014374.
Document (PDF) (46 KB PDF).
November 30, 2000. Memorandum. 6 Page(s).
Abdallah Khasawinah. Reregistration Branch 4 HED.
Imazalil: Response to the Registrant's Comments to the Human
Health Risk Assessments and Science Chapter Reviews.
DP Barcode D270787. Submission No.: S582653.
Document (PDF) (85 KB PDF).