Chemicals Listed Effective August 7, 2009 as Known to the State of California to Cause Cancer or Reproductive Toxicity

Effective August 7, 2009, the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding the chemicals identified below to the list of chemicals known to the state to cause cancer or reproductive toxicity, for the purposes of Proposition 65.  

• Amsacrine, toxins derived from Fusarium moniliforme (Fusarium verticillioides) and zalcitabine are being added to the list as known to the state to cause cancer.  n-Butyl glycidyl ether, carbaryl, 2-chloropropionic acid, diglycidyl ether, 2‑ethylhexanoic acid, methyl n-butyl ketone, p,p'-oxybis(benzenesulfonyl hydrazide), phenylphosphine, 1,3,5-triglycidyl-s-triazinetrione are being added as known to the state to cause reproductive toxicity. 

Additional endpoints are being added for chemicals that are already on the Proposition 65 list. 

• Chloroform, dichloroacetic acid, phenyl glycidyl ether, and 4‑vinylcyclohexene are already listed under Proposition 65 as known to cause cancer, and as of August 7, 2009, these chemicals will be listed as known to cause reproductive toxicity.
• Methyl chloride and toluene are already listed under Proposition 65 as known to cause reproductive toxicity, based on the developmental toxicity endpoint.  As of August 7, 2009, the basis for the listing will include the male reproductive toxicity endpoint for methyl chloride and the female reproductive toxicity endpoint for toluene. 
• Ethylene oxide is already listed as known to cause cancer and reproductive toxicity based on the female reproductive toxicity endpoint.  As of August 7, 2009, the ethylene oxide listing will also be based on developmental and male reproductive toxicity.

Health and Safety Code section 25249.8(a) requires that certain substances identified by the International Agency for Research on Cancer (IARC) or the National Toxicology Program (NTP), as described in Labor Code section 6382(b)(1) and (d), be included on the Proposition 65 list as causing cancer.  Labor Code section 6382(b)(1) references substances identified as human or animal carcinogens by IARC, and Labor Code section 6382(d) references substances identified as carcinogens or potential carcinogens by IARC or NTP. 

Health and Safety Code section 25249.8(a) further requires that substances identified in Labor Code section 6382(d) as causing reproductive toxicity be included on the Proposition 65 list.  Labor Code section 6382(d) references chemicals within the scope of the federal Hazard Communication Standard that are identified as reproductive toxicants (Title 29, Code of Federal Regulations (CFR), section1910.1200, Toxic and Hazardous Substances, Occupational Safety and Health Administration).  Chemicals are listed under Proposition 65 if they are identified as causing developmental or reproductive toxicity in the latest edition of the American Conference of Governmental Industrial Hygienists (ACGIH) “Threshold Limit Values”. (Title 29, CFR, section 1910.1200(d)(3)).

The bases for these listings was described in two public notices both published in the June 12, 2009, issue of the California Regulatory Notice Register (Register 2009, No. 24-Z).  The titles of the notices were “Request For Comments on Chemicals Proposed For Listing By the Labor Code Mechanism (carcinogens)”; and “Request For Comments on Chemicals Proposed For Listing By the Labor Code Mechanism (reproductive and developmental toxicants)”.  The publication of the two notices initiated a 30-day public comment period that closed on July 13, 2009.

OEHHA did not receive comments from the public on the chemicals included in today’s notice.  Listing decisions for other chemicals identified in the June 12 notices will be published at a later date.

OEHHA has not established no-significant-risk-levels (NSRLs) for the carcinogens or the maximum allowable dose levels (MADLs) for reproductive toxicants included in this notice, with the exception of toluene and ethylene oxide.  OEHHA has not reviewed the MADLs for toluene and ethylene oxide to determine if they should be revised to reflect the new endpoints identified in this notice.  The priority status of the development of these NSRLs and MADLs will be announced in a future version of OEHHA’s Proposition 65 Status Report on No Significant Risk Levels for Carcinogens and Maximum Allowable Dose levels for Chemicals Causing Reproductive Toxicity.

A complete, updated Proposition 65 list is published elsewhere in this issue of the California Regulatory Notice Register.  The table below summarizes the changes made today to the Proposition 65 list.

Cancer

Reproductive toxicity

Chemical Reference

• Ethylene Oxide
• Toluene
• Chloroform
• Phenyl Glycidyl Ether
• 4-Vinylcyclohexene
• Amsacrine
• 2-Chloropropionic Acid
• Carbaryl
• Dichloroacetic Acid
• Methyl-n-Butyl Ketone
• Methyl Chloride
• Toxins derived from Fusarium moniliforme (Fusarium verticillioides)
• Phenylphosphine
• Zalcitabine
• 1,3,5-triglycidyl-s-triazinetrione
• Diglycidyl ether
• n-Butyl glycidyl ether
• 2-Ethylhexanoic acid
• p,p’‑oxybis(benzenesulfonyl hydrazide)

Related Notices

• Chemicals Proposed for Listing by the Labor Code Mechanism (Carcinogens)

  Jun 12, 2009
• Chemicals Proposed for Listing by the Labor Code Mechanism (Reproductive and Developmental Toxicants)

  Jun 12, 2009
• Request for Comments on Proposed Listing of Gallium Arsenide as Known to Cause Cancer and Hexafluoroacetone, Nitrous Oxide and Vinyl Cyclohexene Dioxide as Known to Cause Reproductive Toxicity

  Jun 15, 2007
• Chemicals Delisted Effective April 4, 2014 as known to the State of California to Cause Reproductive Toxicity: N-Butyl Glycidyl Ether, Diglycidyl Ether, Phenyl Glycidyl Ether, Methyl Isopropyl Ketone and α-Methyl Styrene

  Apr 4, 2014
• Change to Basis for Identification of Male Reproductive Toxicity as an Endpoint of Reproductive Toxicity for Methyl Chloride

  Mar 7, 2014
• Chemicals Delisted December 13, 2013 as Known to the State of California to Cause Reproductive Toxicity: tert‑amyl methyl ether, 2-ethylhexanoic acid, ethyl-tert-butyl ether, p,p’‑oxybis(benzenesulfonyl hydrazide) and 1,3,5-triglycidyl-s-triazinetrione

  Dec 5, 2013
• Notice of Intent to Change the Basis for Listing as Known to the State of California to Cause Reproductive Toxicity: Dichloroacetic Acid

  Sep 20, 2013

Footnotes and References

¹ Listing mechanism: Labor Code” mechanism (Labor Code sections 6382(b)(1) and (d))
² Already on the Proposition 65 list based on female reproductive toxicity.
³ Already on the Proposition 65 list based on developmental toxicity. 
⁴ Already on the Proposition 65 list as known to cause cancer.