Pentosan Polysulfate Sodium, Pioglitazone, Triamterene and Pulegone Listed Effective April 18, 2014 as Known to the State of California to Cause Cancer

Effective April 18, 2014, the Office of Environmental Health Hazard Assessment (OEHHA) is adding pentosan polysulfate sodium, pioglitazone, triamterene and pulegon to the list of chemicals known to the State of California to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 651). 

Health and Safety Code section 25249.8(a) incorporates California Labor Code sections 6382(b)(1) and 6382(d) into Proposition 65.  The law requires that certain substances identified by the International Agency for Research on Cancer (IARC) be listed as known to cause cancer under Proposition 65.  Labor Code section 6382(b)(1) refers to substances identified as human or animal carcinogens by IARC.  Labor Code section 6382(d) refers to chemicals that are within the scope of the federal Hazard Communications Standard.  The Federal Hazard Communications Standard relies on chemical designations made by IARC.  An explanation of the carcinogenicity classifications used by IARC, and the Monographs development and peer review by the international working groups of scientific experts convened by IARC, may be found at the following URL:  http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf (IARC Preamble).

The basis for the listing of pentosan polysulfate sodium, pioglitazone, and triamterene was described in a public notice published in the February 28, 2014, issue of the California Regulatory Notice Register (Register 2014, No. 9-Z).  The title of the notice was “Notice of Intent to List Chemicals by the Labor Code Mechanism.”  The publication of the notice initiated a public comment period that closed on April 1, 2014.  OEHHA did not receive any public comments. 

The basis for the listing of pulegone was described in a Notice of Intent to List published in the February 7, 2014, issue of the California Regulatory Notice Register (Register 2014, No. 6-Z).  The title of the notice was “Notice of Intent to List Pulegone by the Labor Code Mechanism.”  The publication of the notice initiated a public comment period that closed on March 10, 2014.  We received one public comment.  Responses to that comment are posted here.

A complete, updated Proposition 65 list is published elsewhere in this issue of the California Regulatory Notice Register and is available on the OEHHA website.

Chemical

CAS No.

Toxicological Endpoint

Listing Mechanism2

Pentosan polysulfate sodium

---

cancer

LC

Pioglitazone

111025-46-8

cancer

LC

Triamterene

396-01-0

cancer

LC

Pulegone

89-82-7

cancer

LC

Footnotes and References

1 Health and Safety Code, section 25249.5, et seq.

2 Listing mechanism:  LC – “Labor Code” mechanism (Labor Code sections 6382(b)(1) and (d))