Shining a (partly shaded) light on nanomaterials that present "substantial risk"

Richard Denison, Ph.D., is a Senior Scientist.

Section 8(e) of the Toxic Substances Control Act (TSCA) requires any company that manufactures, imports, processes or distributes chemicals in the U.S. to notify EPA within 30 days if it obtains new information that "reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment."  Are there Section 8(e) notices for nanomaterials?

EPA posts "sanitized" versions of Section 8(e) notices on its website, stripped of any information deemed confidential by the submitter – which, as allowed under TSCA, frequently includes the identity of the substance, the submitter or both.

So how many of these "substantial risk" notices have been received for nanomaterials?

EPA provides no ability to search for such documents on its Section 8(e) notice website, so we had to do examine each of EPA's month-by-month listings.  These postings extend from September 2008 back to January 2004 – excluding, for some strange reason, the second half of 2004.  (A note that has been on the site for a long time now optimistically states:  "Attention: The 2000-2004 submissions will be posted on this page in the near future.")

Our search found eight Section 8(e) notices that were identified as pertaining to nanomaterials (though there may be others that claimed the nanomaterial identity confidential).  Here they are:

Date
posted

Doc #

Substance
name(s)

CAS #(s)

Submitter

Description

Aug
08

8EHQ- 0808- 17208A Carbon Nano
Tube
Confidential BASF Chemical Company Results of a subchronic inhalation study in rats.

Apr
08

8EHQ- 0408- 17079B Sepiolite and
Sepiolite
nanoclay
63800-37-3
None
Confidential Supplemental results from a pulmonary bioassay screening study in rats.

Mar
08

8EHQ- 0308- 17088A Confidential* Confidential* DuPont AirProducts NanoMaterials LLC Results of an acute oral (gavage) toxicity study in female rats.

Mar
08

8EHQ- 0308- 17109A Multi-walled
carbon
nanotubes
7782-42-5 Arkema Inc. Results of a 5-day repeated-inhalation toxicity test in male rats.

Mar
08

8EHQ- 0308- 16999B Confidential* Confidential* DuPont AirProducts NanoMaterials LLC Results of an acute oral toxicity study in rats.

Nov
07

8EHQ- 1107- 17000A Amorphous
silica and
Tetramethyl-
ammonium
hydroxide
7631-86-9 and
75-59-2
DuPont AirProducts NanoMaterials LLC Results of an acute dermal toxicity study in rats.

Nov
07

8EHQ- 1107- 16999A Amorphous
silica and
Tetramethyl-
ammonium
hydroxide
7631-86-9 and
75-59-2
DuPont AirProducts NanoMaterials LLC Results of an acute dermal toxicity study in rats.

Jul
07

8EHQ- 0707- 16911A Surface-
modified
nanoparticle
Confidential 3M Company Preliminary data from a 2-week repeated-inhalation toxicity study in rats.
* While the listing indicates this information is confidential, the company's notice indicates it pertains, as do the other DuPont notices, to a mixture containing amorphous silica.

In my next post, I'll look more closely at the Section 8(e) notices EPA has received for carbon nanotubes.

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