commercially purchased. No other details were provided.
4.3.2 NIOSH Docket Submissions
Most information submitted to the NIOSH docket concerned animal testing of CCP or its components in extensive, widely accepted toxicology test procedures. The coded submissions did not allow specific identification of chemicals or formulations. Each of the approximately 1,500 animal studies submitted to the docket was reviewed independently by a NIOSH toxicologist. Most materials had been tested in a series of protocols such as inhalation LC50, cutaneous and/or oral LD50, skin and/or eye irritation, and skin sensitization. Some materials had been tested for mutagenesis, reproductive toxicity, or upper airway irritation. Not all materials were tested using every protocol. Most test results were negative; but positive results that were reported during the NIOSH review summarized as follows:
- The Mead Corporation sent summaries of eight reports to the NIOSH 1987 docket. The material tested was code 151 (chemical identification code), and all tests were negative except for a 1980 study of acute dermal toxicity in rabbits that estimated the acute dermal LD50 to be greater than 2 g/kg body weight. However, slight to well-defined erythema was noted in all animals on days 1, 3, and 7; it continued in most of the animals through day 14.
- Hazelton Laboratories in Madison, Wisconsin, and Vienna, Virginia, submitted a series of 22 reports to the NIOSH 1987 docket. Irritation was produced by some of the samples, but sensitization did not occur. Inhalation experiments were negative, but exposure concentrations were very low in most cases.
- Biosearch evaluated CCP constituents from Moore Business Forms, Inc., and submitted the results to the NIOSH 1987 docket for acute oral toxicity, primary eye irritation, primary skin irritation, and 5-day repeated dermal irritation. All products tested were considered nontoxic, with LD50s greater than 5 g/kg. None of the materials were classified by the Food and Drug Administration’s regulatory definition as primary eye irritants, primary skin irritants, or dermal sensitizers. Several of the materials acted as mild or moderate skin and eye irritants.
- A series of toxicological test reports on a variety of CCP constituents were submitted to the NIOSH docket and reviewed. These test reports (Documents 002 through 148) were originally prepared for the Monsanto Company in St. Louis, Missouri. The tests had been conducted between 1956 and 1980. Test material ranged from "white paper" to "yellow liquid" or "white powder." The toxicological tests included acute oral and dermal toxicity and dermal and eye irritation. They also included a few 90-day feeding studies, mutagenesis assays, and inhalation studies as well as two aquatic studies with trout fry and midge larvae. Most substances were nontoxic or exhibited mild toxicity. Some caused mild or moderate irritation to the skin or eyes. However, in most cases, the low scores on the dermal or ocular irritation assays resulted in their classification as nonirritants. A few of the tests (2/69 primary irritation assays and 3/69 primary eye irritation assays) were graded as positive. From the other tests, NIOSH could infer that the product would cause mild irritation in humans. However, it must be recognized that such testing of pure compounds may produce more exaggerated results than testing the
