Jyllian,

The following information and resources may be helpful to female and male scientists. Reproductive health hazards may affect both male and female fertility as well as the growth and development of the unborn child.

·         GHS has three hazard categories for reproductive toxicity (plus an additional one for lactation effects). Categories 1a and 1b are assigned to substances known to have produced an adverse effect in humans based on epidemiological evidence (1a), or presumed to produce an adverse effect based on animal studies (1b). Both hazard categories carry the same hazard statement H360, “May damage fertility or the unborn child.” H361, “Suspected of damaging fertility or the unborn child,”  is used for category 2, denoting that there is some evidence from humans or experimental animals of an adverse effect.

·         Although in theory GHS provides objective criteria for assigning these hazard categories, in practice there is no definitive list of reproductive hazards (and that includes CA Prop 65). For some compounds, if you look at SDS from 10 different manufacturers or vendors, you may find them roughly equally divided between those that assign a reproductive toxicity hazard and those that do not.

·         More descriptive information (and context) for chemicals or classes of chemicals that have public health hazards may be found on so-called ToxFAQs sheets published by the Agency for Toxic Substance and Disease Registry (ATSDR) division of the CDC. http://www.atsdr.cdc.gov/toxfaqs/index.asp

·         For example, boric acid (and sodium borate or borax) are reliably listed as GHS Category 1, H360 on most SDS. The ToxFAQ for boron states: “We do not know whether boron causes birth defects in people. Low birth weights, birth defects, and developmental delays have occurred in newborn animals whose mothers were orally exposed to high doses of boron (as boric acid) during pregnancy. The doses that produced these effects in pregnant animals are more than 800 times higher than the average daily intake of boron in food by adult women in the U.S. population.”

·         ATSDR provides a searchable database but not a specific list of possible reproductive hazards.

·         National Toxicology Program (NTP) Teratology Studies has information on a very limited number of substances that have been tested according to specific protocols. http://ntp.niehs.nih.gov/testing/types/dev/abstracts/index.html

·         The Developmental and Reproductive Toxicity Database (DART) is a service provided by the NIH National Library of Medicine and Toxnet. DART is a searchable database of chemicals that returns published literature citations concerning reproductive health studies primarily in animals for each chemical. The citations provide hyperlinked access to the abstracts and conclusions for each study. The information itself is not further classified by DART. http://toxnet.nlm.nih.gov/newtoxnet/dart.htm

·         Catalog of Teratogenic Agents, 13^th Edition, by Thomas Shepard and R.J. Lemire (2010) is considered a comprehensive one-volume reference with information on 3200 teratogenic agents. Some information may be accessed online.

Sincerely,

 

Irene Cesa

 

Irene G. Cesa, Ph.D.

Technical Consultant

Flinn Scientific, Inc.

icesa**At_Symbol_Here**flinnsci.com

800-452-1261

 

 

 

 

Dear Jyllian:
 The Committee on Chemical Safety issued the guidance on Developing Reproductive Protection Programs in Industrial and Academic Setting .

The document can be downloaded at

http://www.acs.org/content/dam/acsorg/about/governance/committees/chemicalsafety/developing-reproductive-protection-programs-in-industry-and-academic-settings.pdf