> ## Content Index
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> Use this file to discover other available public pages before exploring further.

# Uncovered: 1970s BTMPS tox studies
- URL: https://www.opioiddata.org/btmps-toxicity-foia/
- Published: 2024-09-11T02:05:01.000Z
- Updated: 2024-09-11T13:04:09.000Z
- Description: Freedom of Information Act information from FDA on bis(2,2,6,6,-tetramethyl-4-piperidyl) sebacate
- Author: Nabarun Dasgupta
- Tags: Adulterants, Watchlist, Collaboratory

Over the summer we filed a Freedom of Information Request with the US Food and Drug Administration to obtain the toxicology studies filed by the manufacturer of Tinuvin® 770 in order to get it approved to be an additive in adhesives and pharmaceutical-grade plastics. Most of the documents are from 1975-76.

We received the tranche of documents on September 10, 2024\. While almost all are animal studies, *there is way more information than in the academic literature*. (Which is why we always caution against drawing inferences from what little leaks from industry to scientific journals.) We are posting all the documents we received here without comment so our community can learn from them. 

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## Summary of Safety

This is the Summary of Safety information submitted by the manufacturer in 1976\. These tables summarize the the studies in PDFs that follow.

![](https://storage.ghost.io/c/5b/77/5b77aa04-fe0b-45a2-a796-af3d64e3ea66/content/images/2024/09/image-11.png)

![](https://storage.ghost.io/c/5b/77/5b77aa04-fe0b-45a2-a796-af3d64e3ea66/content/images/2024/09/image-12.png)

![](https://storage.ghost.io/c/5b/77/5b77aa04-fe0b-45a2-a796-af3d64e3ea66/content/images/2024/09/image-13.png)

## Cardiac Tissue

This was as a surprising conclusion to me:

![](https://storage.ghost.io/c/5b/77/5b77aa04-fe0b-45a2-a796-af3d64e3ea66/content/images/2024/09/image-14.png)

[DATA SUMMARY\_000789\_RedactedCardiac tissue studies (guinea pig)DATA SUMMARY\_000789\_Redacted.pdf191 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/DATA-SUMMARY%5F000789%5FRedacted.pdf "Download")

[DATA SUMMARY\_000791\_Redacted3H binding to heart membranes (guinea pig)DATA SUMMARY\_000791\_Redacted.pdf189 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/DATA-SUMMARY%5F000791%5FRedacted.pdf "Download")

[DATA SUMMARY\_000793\_RedactedForce of contraction of atria (guinea pig)DATA SUMMARY\_000793\_Redacted.pdf155 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/DATA-SUMMARY%5F000793%5FRedacted.pdf "Download")

[DATA SUMMARY\_000795\_RedactedVascular effects on mesenteric artery (rat)DATA SUMMARY\_000795\_Redacted.pdf167 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/DATA-SUMMARY%5F000795%5FRedacted.pdf "Download")

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# Specific Toxicity Studies

## Acute Oral Toxicity to Rats

[PRIMARY DATA\_000018\_RedactedAcute Oral Toxicity to RatsPRIMARY DATA\_000018\_Redacted.pdf306 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000018%5FRedacted.pdf "Download")

## Acute Dermal LD50 in Rat

[PRIMARY DATA\_000024\_RedactedPRIMARY DATA\_000024\_Redacted.pdf232 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000024%5FRedacted.pdf "Download")

## Acute Dust Inhalation Toxicity and Acute Vapor Inhalation Toxicity Society

[PRIMARY DATA\_000027\_RedactedInhalationPRIMARY DATA\_000027\_Redacted.pdf353 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000027%5FRedacted.pdf "Download")

## Acute Vapor Inhalation Toxicity in Albino Rats

[PRIMARY DATA\_000034\_RedactedPRIMARY DATA\_000034\_Redacted.pdf237 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000034%5FRedacted.pdf "Download")

## Acute Dust Toxicity

[PRIMARY DATA\_000039\_RedactedPRIMARY DATA\_000039\_Redacted.pdf302 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000039%5FRedacted.pdf "Download")

[PRIMARY DATA\_000050\_RedactedPRIMARY DATA\_000050\_Redacted.pdf302 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000050%5FRedacted.pdf "Download")

## Acute Vapor Inhalation Toxicity

[PRIMARY DATA\_000045\_RedactedPRIMARY DATA\_000045\_Redacted.pdf236 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000045%5FRedacted.pdf "Download")

[PRIMARY DATA\_000056\_RedactedPRIMARY DATA\_000056\_Redacted.pdf227 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000056%5FRedacted.pdf "Download")

## Skin Irritation, Sensitization, Phototoxicity

[PRIMARY DATA\_000060\_RedactedSkin irritationPRIMARY DATA\_000060\_Redacted.pdf653 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000060%5FRedacted.pdf "Download")

[PRIMARY DATA\_000083\_RedactedSkin sensitizationPRIMARY DATA\_000083\_Redacted.pdf887 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000083%5FRedacted.pdf "Download")

[PRIMARY DATA\_000121\_RedactedSkin phototoxicityPRIMARY DATA\_000121\_Redacted.pdf704 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000121%5FRedacted.pdf "Download")

[PRIMARY DATA\_000130\_RedactedSkin photoallergenicityPRIMARY DATA\_000130\_Redacted.pdf561 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000130%5FRedacted.pdf "Download")

## Acute Eye Irritation

[PRIMARY DATA\_000070\_RedactedEye irritationPRIMARY DATA\_000070\_Redacted.pdf829 KBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000070%5FRedacted.pdf "Download")

## Human Skin "Repeated Insult"

[PRIMARY DATA\_000097\_RedactedSkin insultPRIMARY DATA\_000097\_Redacted.pdf1 MBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000097%5FRedacted.pdf "Download")

## Salmonella/Mammalian Mutagenicity

[PRIMARY DATA\_000139\_RedactedMutagenicityPRIMARY DATA\_000139\_Redacted.pdf1 MBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000139%5FRedacted.pdf "Download")

## Dietary Toxicity

[PRIMARY DATA\_000624\_Redacted90 Day dietary toxicity in dogsPRIMARY DATA\_000624\_Redacted.pdf17 MBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000624%5FRedacted.pdf "Download")

[PRIMARY DATA\_000817\_RedactedOral toxicity in ratsPRIMARY DATA\_000817\_Redacted.pdf2 MBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PRIMARY-DATA%5F000817%5FRedacted.pdf "Download")

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# FDA Review as Food Adhesive

Review of studies by FDA in August 1998 for the use of Tinuvin® 770 as an adhesive for food.

[PDER\_000872\_RedactedFDA Review 1998PDER\_000872\_Redacted.pdf9 MBdownload-circle](https://www.opioiddata.org/content/files/2024/09/PDER%5F000872%5FRedacted.pdf "Download")