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Index of Cleared Science Reviews
Index for Daminozide (Pc Code 035101)
Undated. Review. 2 Pages.
162-1 Aerobic Soil Metabolism.
Undated. Review. 4 Pages.
The work of Ames et al (1966) is covered under MRID 00009417.
Undated. Review. 6 Pages.
ALAR
Environmental Fate Summary.
Undated. Memorandum. 38 Pages.
Anne Lindsay. Registration Division.
United Kingdom's Document on Alar.
October 4, 1985. Memorandum. 4 Pages.
Philip Gray. FIFRA Scientific Advisory Panel.
Scientific Advisory Panel's Review of: 1) a set
of Scientific Issues Being Considered by the Agency
in Connection with the Special Review on Daminozide;
2) ... Issues... with the Special Review on Captan;
3) an Addendum to the Pesticide Assessment Guidelines...
October 30, 1985. Review. 10 Pages.
Dynamac Corporation.
Daminozide Addendum
Task 1: Review and Evaluation of Individual Studies.
October 31, 1985. Review. 5 Pages.
Emil Regelman. Exposure Assessment Branch.
EPA Reg. No. 400-117
Response to Registration Standard Hydrolysis;
Photolysis.
June 23, 1987. Memorandum. 8 Pages.
Henry Spencer. Toxicology Branch.
Additional Information on MTD for UDMH in mice.
August 27, 1987. Memorandum. 13 Pages.
Henry Spencer. Toxicology Branch.
Transmittal of Data Evaluation Record for the Rabbit
Teratology Study on Alar.
Accension No. 259215.
Tox Review No.006233.
September 30, 1987. Memorandum. 15 Pages.
Henry Spencer. Toxicology Branch.
Registrant Response to the Agency Review of the 1-Year
Interim Report on the 2-Year Rat Oncogenicity Study on Alar
(Daminozide).
MRID No. 402398-01.
October 26, 1987. Memorandum. 2 Pages.
Henry Spencer. Toxicology Branch.
Reply to Registrant Response to Data Call-In Notices for
Daminozide Dated February 10, 1986.
October 30, 1987. Memorandum. 10 Pages.
Henry Spencer. Toxicology Branch.
Transmittal of Dermal Absorption Study of Alar Male Sprague
- Dawley Rats.
MRID No. 402145-01.
Tox Review No. 006417.
November 10, 1987. Memorandum. 9 Pages.
William Greear. Toxicology Branch.
Daminozide (UDMH) - Evaluation of a 13-Week Subchronic Study
in Rats.
MRID No. 400326-07.
Tox Review No. 006451.
November 24, 1987. Memorandum. 40 Pages.
Henry Spencer. Toxicology Branch.
Transmittal of Review of a 2-Generation Rat Reproduction
Study on Alar.
MRID No. 402339-01. Tox Review No. 006475.
Registration Data information removed from pages 15-40.
January 13, 1988. Memorandum. 9 Pages.
Henry Spencer. Toxicology Branch.
(1) Daminozide Market Basket Survey (2) Protocols for Rat &
Mouse Water Feeding Studies & Rangefinding Studies on UDMH.
Accn. Nos. 264031, 264099 - 264102.
January 27, 1988. Memorandum. 18 Pages.
Henry Spencer. Toxicology Branch.
Transmittal of Review of 13-Week Water Feeding Study of UDMH
(Unsymmetrical Dimethyl Hydrazine) in Mice.
MRID No. 400326-06.
Tox Review No. 006562.
January 29, 1988. Memorandum. 2 Pages.
Henry Spencer. Toxicology Branch.
Review of Interim Report (8 Months) on the Water Feeding
Study of UDMH (Unsymmetrical Dimethyl Hydrazine) in the
Mouse.
MRID No. 404129-01.
Tox Review No. 006568.
February 11, 1988. Memorandum. 4 Pages.
Henry Spencer. Toxicology Branch.
Laboratory Review of Ongoing Studies on UDMH at
International Research & Development Corporation, (IRDC)
Mattawan, Michigan on January 5 to 7, 1988.
February 11, 1988. Memorandum. 2 Pages.
Henry Spencer. Toxicology Branch.
Submission of an Unaudited Draft Pathology Report on the
Mouse Alar 2-Year Feeding Oncogenicity Study.
MRID No. 404510-01.
March 3, 1988. Memorandum. 3 Pages.
Henry Spencer. Toxicology Branch.
Agency Reply to Registrant Responses Regarding Mutagenicity
Study Reviews.
MRID Nos. 403199-01 thru 04.
Tox Review No. 006614.
March 14, 1988. Memorandum. 2 Pages.
Henry Spencer. Toxicology Branch.
UDMH - 4-Week Pilot Study with UDMH in Rats (Preliminary
Report) in Unbuffered Drinking Water Solution.
MRID No. 400326-08.
Tox Review No. 006622.
April 8, 1988. Memorandum. 2 Pages.
Henry Spencer. Toxicology Branch.
Request for Submission of Tissue Slides on Studies of Alar &
UDMH.
May 20, 1988. Memorandum. 4 Pages.
Henry Spencer. Toxicology Branch.
Agency Comments on the Uniroyal Chemical Company Letter
Dated February 5, 1988 on the EPA Lab Audit Report Dated
January 25, 1988 - IRDC Lab Studies of Alar & UDMH.
August 4, 1988. DER. 19 Pages.
Robert Weir. Science Analysis & Coordination Branch.
(Daminozide/UDMH); Alar: In Vivo DNA Binding in Rats.
Registration Data information removed from pages 14-19.
October 24, 1988. Memorandum. 12 Pages.
C.J. Nelson. Toxicology Branch.
ALAR (Daminozide) - Preliminary Qualitative Risk Assessment
from a Mouse 2-Year Chronic/Oncogenicity Study.
Tox Review No. 007529.
November 15, 1988. Memorandum. 13 Pages.
Robert Tomerlin. Science Analysis & Coordination Branch.
Dietary Exposure Analysis of Daminozide and UDMH.
November 15, 1988. Memorandum. 22 Pages.
Henry Spencer. Toxicology Branch I.
Review of Interim Metabolism Report on the Mini Pig With
14C-Labeled Daminozide.
Tox Review No. 006922.
Registration Data information removed from pages 19-22.
April 5, 1989. DER. 17 Pages.
Robert Weir. Toxicology Branch I.
Alar: Chronic OralToxicity Study in Dogs (1Year).
Tox Review No. 009660.
April 12, 1989. Memorandum. 17 Pages.
Kerry Dearfield. Science Analysis & Coordination Branch.
Mutagenicity Overview of Alar and UDMH.
July 14, 1989. Memorandum. 8 Pages.
Robert Tomerlin. Science Analysis & Coordination Branch.
Dietary Exposure Analysis & Oncogenic Risk Assessment for
Two Daminozide Regulatory Scenarios.
July 21, 1989. Memorandum. 2 Pages.
Richard Levy. Science Analysis & Coordination Branch.
Consideration of Quantitation on Preliminary Pathology
Reported in Two Year UDMH Low Dose Mice Study.
July 25, 1989. Memorandum. 5 Pages.
Henry Spencer. Toxicology Branch.
Comments on the Preliminary Pathology Letter Report (final
sacrifice): Two Year UDMH Oncogenicity Study in Mice (low
dose study).
October 5, 1989. Memorandum. 14 Pages.
Henry Spencer. Toxicology Branch.
Transmittal of the Review of the final report of the mouse
Daminozide feeding study.
MRID No. 408131-02.
Tox Review No. 007529.
January 30, 1990. Memorandum. 7 Pages.
Henry Spencer. Toxicology Branch I.
HED Review of the Uniroyal Chemical Company, Inc. Letter of
April 12, 1988 to Dr. John Moore, EPA.
Attachment(s) following:
April 12, 1988. Letter.
Christopher Exton. Toxicology Branch I.
Uniroyal Chemical Company's reply to Dr. John Moore, EPA.
*End of attachments*
February 21, 1990. Memorandum. 6 Pages.
Henry Spencer. Toxicology Branch I.
Transmittal of Mutagenicity Study on UDMH (Unsymmetrical
Dimethyl Hydrazine).
MRID No. 408494-01.
Tox Review No. 007772,.
March 23, 1990. Memorandum. 1 Page.
Henry Spencer. Toxicology Branch I.
Alar: Protocol Change in the Alar Oncogenicity Study in
Mice. Re: Additional Tissue Slides and Recutting of Lung
Tissue.
April 13, 1990. Memorandum. 3 Pages.
Henry Spencer. Toxicology Branch I.
HED Comments on the United Kingdom's Document on Alar/UDMH.
October 2, 1990. DER. 22 Pages.
Henry Spencer. Toxicology Branch I.
UDMH; Chronic Oncogeniciity Study in Mice.
MRID No. 4122533-02.
Tox Review No. 009660.
October 26, 1990. DER. 31 Pages.
Henry Spencer. Toxicology Branch I.
UDMH; Chronic OncogenicityStudy in Mice.
MRID No. 413780-01.
Tox Review No. 009660.
March 4, 1991. DER. 21 Pages.
William McLellan. Toxicology Branch.
Oncogenicity dringing water study in rats.
MRID No. 412533-03.
Tox Review No. 009660.
July 26, 1991. Peer Review. 29 Pages.
Henry Spencer. Toxicology Branch.
Third Peer Review of Daminozide and its Metabolite/
Breakdown Product 1,1-Dimethylhydrazine - Caswell Nos.
808 and 366G.
August 15, 1991. Memorandum. 47 Pages.
Flora Chow. Science Analysis & Coordination Branch.
Daminozide Risk Assessment.
Registration Data information removed from pages 34-47.
Attachment(s) following:
July 18, 1991. Memorandum.
Bernice Fisher. Science Analysis & Coordination Branch.
UDMH - Quantitative Risk Assessment, Low & High Dose 2-Year
Dietary Studies in CD-1 Mice.
July 30, 1991. DER.
Robert Weir. Science Analysis & Coordination Branch.
Daminozide: Dermal Absorption in Rats.
*End of attachments*
August 20, 1991. Memorandum. 12 Pages.
Flora Chow. Science Analysis & Coordination Branch.
Dietary Exposure Analysis for Daminozide/UDMH.
Attachment(s) following:
February 7, 1989. Memorandum.
J.R. Tomerlin. Science Analysis & Coordination Branch.
Dietary Exposure Analysis for Daminozide/UDMH.
TAS Attached.
*End of attachments*
September 17, 1991. Memorandum. 2 Pages.
Reto Engler. Health Effects Division.
Dose Response Assessment for Daminozide.
September 27, 1991. Memorandum. 2 Pages.
Reto Engler. Science Analysis & Coordination Branch.
Dose Response Assessment for Daminozide.
Tox Review No. 008657.
January 30, 1992. Review. 3 Pages.
Emil Regelman. Environmental Fate & Ground Water Branch.
Review of batch equilibrium study (163-1)
MRID 40447701.
February 4, 1992. Memorandum. 11 Pages.
Stephanie Syslo. Environmental Fate & Ground Water Branch.
Review of Daminozide aerobic and anaerobic soil metabolism
studies (DP Barcode D168074) and a field dissipation study
(DP Barcode D168046)
MRID 00160675, 00160676.
February 11, 1992. Memorandum. 54 Pages.
Flora Chow. Science Analysis & Coordination Banch.
Addendum to Daminozide Risk Assessment.
Attachment(s) following:
September 17, 1991. Memorandum.
Reto Engler. Science Analysis & Coordination Branch.
Dose Response Assessment for Daminozide.
January 7, 1992. Memorandum.
Shanaz Bacchus. Special Review Branch.
Comments on Uniroyal's Response to PD 2/3 on Daminozide &
Response to Questions Raised at the Daminozide Meeting,
9/12/91: Previous Estimates & Recently Submitted Worker
Exposure Study for Labeled Uses of Daminozide on Greenhouse
Ornamentals.
August 15, 1991. Memorandum.
Flora Chows. Science Analysis & Coordination Branch.
Daminozide Risk Assessment.
July 18, 1991. Memorandum.
Bernice Fisher. Science Analysis & Coordination Branch.
UDMH - Quantitative Risk Assessment, Low & High Dose 2-Year
Dietary Studies in CD-1 Mice.
*End of attachments*
June 22, 1992. Memorandum. 2 Pages.
Henry Spencer. Toxicology Branch I.
HED Response to Comments Supplied by Registrant in Alar PD
2/3.
July 23, 1992. Memorandum. 5 Pages.
Henry Spencer. Toxicology Branch I.
Daminozide Risk Assessment.
Attachment(s) following:
July 6, 1992. Memorandum.
Jim Coglianor. Carcinogen Assessment Statistics Branch.
Notice of Final Determination for Non-Food Uses of
Daminozide.
*End of attachments*
August 8, 1992. Memorandum. 3 Pages.
Henry Spencer. Toxicology Branch I.
Transmittal of DERs of Studies on Alar (daminozide) & UDMH.
Tox Review No. 009660.
October 28, 1992. Memorandum. 10 Pages.
Karen Hamernik. Toxicology Branch.
Daminozide (Alar): Reevaluation of a Rat Teratology -
Developmental Study. Acc. 237850.
Pages 7-10 removed, registration data.
Tox Review 009810.
January 8, 1993. Memorandum. 9 Pages.
Henry Spencer. Toxicology Branch I.
RED Chapter for Daminozide: Toxicology.
April 16, 1993. DER. 6 Pages.
Mark Mossler. KBN for Ecological Effects Branch.
71-1A. Avian Single Dose Oral LD50 Test. Mallard duck.
Page 5 removed, registrant data.
MRID 424290-01.
April 21, 1993. Review. 12 Pages.
Stephanie Syslo. Environmental Fate & Ground Water Branch.
STUDY ID 42687201
Metabolism - Aerobic Soil
Pages 5-12 are removed-registrant data.
September 13, 1993. Memorandum. 81 Pages.
John Redden. Toxicology Branch.
Daminozide: Review of 1) "Salmonella/Mammalian-Microsome
Plate Incorporation Mutagenicity Assay (Ames Test) with a
Confirmatory Assay" 2)"Dermal Absorption... 3)"Chromosome
Aberrations... Pages 28-51, 70-81 removed, registrant data.
Tox review 010559. MRID 417956-01, -02, 417937-01.
January 19, 1994. DER Amendment. 2 Pages.
Harry Winnik. Ecological Effects Branch.
72-2. Freshwater Invertebrate Flow-Through
Acute Toxicity Test. Species Tested: Daphnia magna.
MRID 424290-02.
May 19, 1994. Memorandum. 16 Pages.
Stephanie Syslo. Environmental Fate & Groundwater Branch.
Daminozide - Review of Supplemental Information on Aerobic
Soil Metabolism - Characterization of Volatiles (DP D197174)
Pages 9-16 removed, registrant data.
MRID 43005601, 42687201.
December 19, 1994. Memorandum. 2 Pages.
Henry Spencer. Toxicology Branch.
Concern for the impurities in the CSF for Alar Technical.
Manufacturing Process information removed from pages 1 & 2.
April 12, 1995. Memorandum. 17 Pages.
David Ritter. Registration Support Branch, RD.
EPA Reg. # 400-117 8 Month response- Daminozide.
Review acute studies and review precautionary labeling.
MRID 433009-14 thru -19.