In March 2019, EPA released 24 studies used in the draft risk evaluation of pigment violet 29. The release of these studies does not change the Agency’s proposed “no unreasonable risk” determination as concluded in the draft risk evaluation published in November.
In light of these studies and updates to the systematic review documents, EPA re-opened the public comment period on the draft risk evaluation. The public has from April 17, 2019 until May 17, 2019 to provide comments in docket EPA-HQ-OPPT-2018-0604 on www.regulations.gov.
The draft risk evaluation, updated systematic review documents, and the 24 studies released in March 2019 are available below and in docket EPA-HQ-OPPT-2018-0604 on www.regulations.gov.
Return to the risk evaluation page for pigment violet 29.
You may need a PDF reader to view some of the files on this page. See EPA’s About PDF page to learn more.- Draft Risk Evaluation for Pigment Violet 29 (PDF)(43 pp, 1 MB, November 2018)
- Memo Transmitting Updated Systematic Review Documents (PDF)(4 pp, 1 MB)
- Systematic Review Document for PV29, Updated April 2019 (PDF)(49 pp, 1 MB)
- Memo Transmitting Materials Previously Claimed as CBI for Reviewing the Draft Risk Evaluation of PV29 and Attachment A (PDF)(10 pp, 616 K)
- Study #s 1, 2, 5-10, 12, 13 Toxicological Investigation Summaries (PDF)(10 pp, 196 K)
- Study #3 Acute Dermal Irritant (PDF)(11 pp, 323 K)
- Study #4 Acute Irritant on Eye (PDF)(12 pp, 321 K)
- Study #11 Acute Oral Toxicity (PDF)(11 pp, 247 K)
- Study #14 Ames Test (PDF)(21 pp, 1 MB)
- Study #15 Gene Mutation Assay (PDF)(42 pp, 7 MB)
- Study #16 Local Lymph Node Assay (PDF)(22 pp, 3 MB)
- Study #17 Reproductive/Developmental Toxicity Screening Test (PDF)(432 pp, 45 MB)
- Study #18 Acute Toxicity Zebra Danio (PDF)(14 pp, 246 K)
- Study #19 Lemna Gibba Growth Inhibition Test (PDF)(74 pp, 12 MB)
- Study #20 Daphnia Magna Acute Immobilization Test (PDF)(48 pp, 7 MB)
- Study #21 Determination of Inhibition of Oxygen Consumption by Activated Sludge (PDF)(12 pp, 2 MB)
- Study #22 Determination of Biodegradability (PDF)(14 pp, 3 MB)
- Study #s 23 and 24 Physical Chemical Properties LogKOW and Melting Point (PDF)(20 pp, 3 MB)