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Alkyl Phthalates and Benzyl Butyl Phthalate Test Results

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CAS Nos. Appendix A

ITC Designation - First and Seventh Reports
42 FR 55026; October 12, 1977
45 FR 78432; November 25, 1980

Proposed Negotiated Testing Agreement (NTA)
46 FR 53775; October 30, 1981

Final Negotiated Testing Agreement (FAN)
47 FR 335; January 5, 1982
Chemical Manufacturers Association (CMA) Phthalates Ester Program Panel (PEPP)

Proposed Test Rule/Benzyl Butyl Phthalate - Environmental Fate and Effects (PRM)
50 FR 36446; September 6, 1985

Decision Not To Test/Benzyl Butyl Phthalate (DNT)
52 FR 41593; October 29, 1987

Consent Order/Alkyl Phthalates - Environmental Effects (CO)
54 FR 618; January 9, 1989
Producers and Processors of Alkyl Phthalates

51 FR 46718; December 24, 1986/Notice of Proposed Consent Order (NCO)
55 FR 3058; January 30, 1990/Technical Amendment
56 FR 23228; May 21, 1991/Test Procedures and Deadlines

Project Manager: J. Schaeffer (Environmental Effects), S. Roan (Health Effects), R. Troast (Benzyl Butyl Phthalate)

Section Chief: J. Schaeffer

Status: Closed. All required tests have been completed on FAN. DNT on BBP because desired testing had been performed and data are adequate to reasonably determine or predict risk. All required tests have been completed on consent order. Test results have been forwarded to the Risk Assessment Division for review and disposition.

Announced Receipt of Test Data

Analytical validation of 14 phthalate test esters (47 FR 54160; December 1, 1982).

PEPP submitted the following studies on DEHP: Ames Salmonella/microsome plate test; mouse micronucleus test; in vitro transformation of BALB/3T3 cell assay; mouse lymphoma forward mutation assay; primary rat hepatocyte unscheduled DNA synthesis; and Midwest Research Institute submitted hypolipidemic peroxisome proliferation studies on DEHP (48 FR 12124; March 23, 1983).

Water solubility of 13 of 14 scheduled esters with DMP and DEPH also determined in well water and sea water (48 FR 34119; July 27, 1983).

Shake flask biodegradation tests for 14 esters; acute aquatic static toxicity tests on fathead minnows and 13 esters on bluegill; flow-through acute toxicity tests for 13 esters in fathead minnow (48 FR 53159; November 25, 1983).

Addendum to water solubility tests (49 FR 5187; February 10, 1984). In vitro cell transformation study on 2-ethylhexanol, a metabolite of DEHP, and aquatic toxicity studies (rainbow trout) for 13 alkyl phthalates and butyl benzyl phthalate (49 FR 18779; May 2, 1984).

Acute aquatic toxicity study on mysid shrimp (Mysidopsis bahia) and midge (Paratanytarus parthenogenica) for 12 alkyl phthalates (49 FR 30114; July 26, 1984).

Acute aquatic toxicity test on Sheepshead minnow (Cyprinidon variegatus) and Daphnia magna for 12 alkyl phthalates and BBP; vapor pressure, octanol/water partition coefficient, and activated sludge biodegradation (49 FR 44142; November 2, 1984).

Acute toxicity on algae (Selanastrum capricornutum) and a chronic toxicity test on Daphnia magna for 14 phthalates (50 FR 5421; February 6, 1985).

CHO/HGPRT forward mutation assay on mono-2-ethylhexyl phthalate (MEHP), DEHP, and 2-ethylhexanol (2-EH)) (50 FR 1892?; May 3, 1985).

In vitro transformation of BALB/3T3 cells on 8 esters (DUP, DIDP, 711P, DINP, 610P, BBP, DBP, and DMP) and an in vivo metabolism study on DEHP (50 FR 46699; November 12, 1985).

In vitro transformation of BALB/3T3 cells and a mouse lymphoma forward mutation assay on the 8 esters mentioned above and a CHO/HGPRT on DEHP, MEHP, and 2-EH; and a 21-day dose-response study on DEHP (51 FR 6468; February 24, 1986).

Feeding study (rats) for 711P, BBP, DINP, DIDP, and 610P (also 2-ethylhexyl adipate) (51 FR 16203; May 1, 1986).

CMA submitted a mouse lymphoma mutagenicity test for DINP, 711P, DIDP, and DUP (51 FR 39799; October 31, 1986).

Monsanto submitted an aquatic toxicity test (hydra) and solubility in well water, both for BBP (51 FR 27598; August 1, 1986) and acute toxicity of BBP (freshwater crayfish) (51 FR 39799; October 31, 1986).

Monsanto submitted the following tests for BBP: an experimental freshwater microcosm biodegradability study and addendum; bioconcentration and acute toxicity in Eastern oyster (Crassostrea virginica); early life stage toxicity to rainbow trout (Salmo gairdneri); acute toxicity (grass shrimp [Paleomoneter vulgaris] and pink shrimp [Penaeus duorarum] and Polychaetes [Nereir/Neanthea virens] and mayfly); chronic toxicity to mysid shrimp (Mysidopaia bahia) and CMA submitted a mouse lymphoma mutagenicity test DMP, DBP, 610P, and BBP (52 FR 2151; January 20, 1987).

CMA submitted analytical characterization of DBP, DMP, and DEP (54 FR 51322; December 14, 1989).

CMA described the analytical characterization of unlabelled and [14C]-labelled and unlabelled 711P and DHP (55 FR 13956; April 13, 1990) and DEHP (55 FR 17670; April 26, 1990).

CMA described the analytical characterization of DUP, DINP, DTDP, and DIDP (55 FR 50055; December 4, 1990).

CMA submitted sediment adsorption isotherms for ditridecyl-, diisodecyl-, di(2-EH)- and dihexyl phthalate (56 FR 42623; August 28, 1991).

Results of Testing Table

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