irritation. Test results for these materials did not meet the testing laboratories' criteria for primary skin irritants, but they provided evidence of an irritant response. Because most studies did not include comparison groups exposed to plain paper, it is unclear whether this potential for skin irritation would have been much different from that of paper alone.
Tests Under Simulated Conditions of Use. Three industry-sponsored tests evaluating the irritation potential of CCP under simulated conditions of office use were submitted to the NIOSH docket in response to the 1987 and 1997 Federal Register notices.
Hill Top Research, Inc., conducted a double-blind placebo study in which subjects were provided with scissors and asked on 4 consecutive days to cut up samples of paper for 60 min under controlled temperature and humidity (Hilltop Research, Inc., Report 83–0965–70). Three types of CCP and a control ("white") paper were tested in random order by two groups of 10 and 9 subjects. After the 19 study subjects were exposed to one of the CCP samples (sample B), 10 (53%) reported irritation of the eyes, nose, or skin. When exposed to the second and third of the remaining CCP samples, 3 subjects (16%) and 2 subjects (10%), respectively, reported irritation symptoms. One subject (5%) reported irritation following exposure to the control paper. The authors concluded that their results demonstrated an unequal distribution of irritation symptoms among the samples tested and that the number of symptoms reported was particularly high with exposure to one of the CCP samples. The eyes were the most sensitive indicator, and some symptoms persisted for 24 hr. The authors recommended that studies of this type allow greater separation in time between samples to prevent carryover effects from preceding samples.
Hill Top Research, Inc., (Report 83–0123–70) conducted another double-blind study in which 20 subjects were recruited to handle a stack of 120 sheets of test paper. Every 30 sec, the subjects ran their hands over each side of another piece of paper until all the pieces had been handled at the end of 1 hr. The testing was done in a single room, with four different types of paper being handled each day. Subjects were examined for signs of irritation and were questioned regarding symptoms before exposure and 30 min, 60 min, and 24 hr after exposure. One subject dropped out. No irritation responses were reported or observed for the eyes, forearms, or face with any of the test papers. Seven subjects reported respiratory symptoms, but four of them demonstrated these effects with all four samples. These latter symptoms appear to have resulted from preexisting cold symptoms rather than from exposure to the paper samples. The results of this study are difficult to interpret in light of the coexisting cold symptoms and pretest symptoms present even for the control exposure.
In 1998, Moore Business Forms, Inc., reported on tests for scoring irritation or sensitization as a result of challenge with Moore Clean Print® CB, CF, and CFB. This test was performed by Biosearch in 1983 (Table 4–12). The volunteers included 200 men and women aged 16 to 68. Of the 200 subjects, 33 had allergies to typical materials. Subjects were instructed to rub a sheet of the test paper (CFB) on their hands and wrists using a hand-washing motion. The procedure was performed over a 4-week period using 8 sheets of paper per day for 5 days per week. The subjects were examined weekly and were instructed to report any unusual interim occurrences. After day 20 of treatment, the subjects rested for 2 weeks and again performed the same procedure with 8 sheets of CCP. They were examined immediately after the challenge and 4 and 24 hr later. The commercial laboratory that performed the test reported that none of the 200 subjects had any
