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Notice of Addition of Documents and Information to Rulemaking File, OAL FILE No. Z-05-0614-06 Amendment to Section 12805, MADL for DEHP by Oral Exposure

Notice of Addition of Documents and Information to Rulemaking File, OAL FILE No. Z-05-0614-06 Amendment to Title 22, California Code of Regulations, Section 12805, Specific Regulatory Levels: Chemicals Causing Reproductive Toxicity (Proposition 65 Maximum Allowable Dose Level (MADL) for Reproductive Toxicity for Di(2-ethylhexyl)phthalate (DEHP) by Oral Exposure)

Pursuant to the requirements of Government Code sections 11346.8(d), 11346.9(a)(1), and 11347.1, the Office of Environmental Health Hazard Assessment (OEHHA) is providing notice that documents and other information which the agency has relied upon in proposing an amendment to Title 22, California Code of Regulations, Section 12805, have been added to the rulemaking file and are available for public inspection and comment.

The documents and information added to the rulemaking file are listed below. These documents are available for inspection at the OEHHA’s office located at 1001 “I” Street, 19th Floor, Sacramento, CA from August 17, 2005 through September 1, 2005, between the hours of 8:00 a.m. and 5:00 p.m. If you have any comments regarding the documents and other information, OEHHA will accept written comments between August 17, 2005 and September 1, 2005. All written comments must be submitted to OEHHA by mail, fax, courier or hand-delivered, no later than 5:00 p.m. on September 1, 2005, and addressed to:

Office of Environmental Health Hazard Assessment
Street Address: 1001 I Street, 19th Floor
Sacramento, CA 95814
Mailing Address: P.O. Box 4010
Sacramento, CA 95812

Fax No.: (916) 323-8803
Telephone: (916) 445-6900

Comments may also be transmitted via email addressed to: P65Public.Comments@oehha.ca.gov. It is requested but not required that written statements or arguments be submitted in triplicate. All written comments received by September 1, 2005, which pertain to the above-listed documents and other information will be reviewed and responded to by OEHHA’s staff as part of the compilation of the rulemaking file. Inquiries concerning the action described in this notice may be directed in writing at the address given above, or by telephone at (916) 445-6900.

 

Documents and information added to Notice File No. Z-05-0614-06:

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Albro PW, Corbett JT, Schroeder JL, Jordan S, Matthews HB (1982a). Pharmacokinetics, interactions with macromolecules and species differences in metabolism of DEHP. Environ Health Perspect 45, 19-25.

Albro PW, Hass JR, Peck CC, Jordan ST, Corbett JT, Schroeder J (1982b). Applications of isotope differentiation for metabolic studies with di-(2-ethylhexyl) phthalate. J Environ Sci Health B 17, 701-14.

Albro PW, Hass JR, Peck CC, Odam DG, Corbett JT, Bailey FJ, Blatt HE, Barrett BB (1981). Identification of the metabolites of di-(2-ethylhexyl) phthalate in urine from the African green monkey. Drug Metab Dispos 9, 223-5.

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American Chemistry Council (ACC, 2004). Information pertaining to development of a maximum allowable dose level for di(2-ethylhexyl) phthalate. Submitted to the Office of Environmental Health Hazard Assessment, California Environmental Protection Agency, Sacramento, on May 12, 2004.

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Borch J, Ladefoged O, Hass U, Vinggaard AM (2004). Steroidogenesis in fetal male rats is reduced by DEHP and DINP, but endocrine effects of DEHP are not modulated by DEHA in fetal, prepubertal and adult male rats. Reprod Toxicol 18, 53-61.

Borch J, Dalgaard M, Ladefoged O (2005). Early testicular effects in rats perinatally exposed to DEHP in combination with DEHA-apoptosis assessment and immunohistochemical studies. Reprod Toxicol 19, 517-25.

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Duty SM, Singh NP, Silva MJ, Barr DB, Brock JW, Ryan L, Herrick RF, Christiani DC, Hauser R (2003b). The relationship between environmental exposures to phthalates and DNA damage in human sperm using the neutral comet assay. Environ Health Perspect 111, 1164-9.

Duty SM, Calafat AM, Silva MJ, Ryan L, Hauser R (2005). Phthalate exposure and reproductive hormones in adult men. Hum Reprod 20, 604-10.

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Gray LE Jr, Wolf C, Lambright C, Mann P, Price M, Cooper RL, Ostby J (1999). Administration of potentially antiandrogenic pesticides (procymidone, linuron, iprodione, chlozolinate, p,p'-DDE, and ketoconazole) and toxic substances (dibutyl- and diethylhexyl phthalate, PCB 169, and ethane dimethane sulphonate) during sexual differentiation produces diverse profiles of reproductive malformations in the male rat. Toxicol Ind Health 15, 94-118.

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Gray TJ, Butterworth KR (1980). Testicular atrophy produced by phthalate esters. Arch Toxicol Suppl 4, 452-5.

Gray TJ, Gangolli SD (1986). Aspects of the testicular toxicity of phthalate esters. Environ Health Perspect 65, 229-35.

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Kijima K, Toyosawa K, Yasuba M, Matsuoka N, Adachi T, Komiyama M, Mori C (2004). Gene expression analysis of the rat testis after treatment with di(2-ethylhexyl) phthalate using cDNA microarray and real-time RT-PCR. Toxicol Appl Pharmacol 200, 103-10.

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