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4 HEALTH EFFECTS

**Table 4–12. Analysis of repeated insult patch test (RIPT) studies submitted by industry clients in response to 1987 and 1997 *Federal Register* notices on CCP and its components**
					Irritancy
Study year	Report number^[1]	Laboratory	Test material	Response rate^[2]	Score^[3]	No. of subjects with score	Classification as irritant (Y/N)^[4]^[5]	Current use of material

1955	E–107	Hill Top Research, Inc.	"Internal phase" diluted 50% w/oil, CB, CF, carbon, and base paper	ND	ND	—	N	Solution of CCP component; end-user not exposed; discontinued^[6] after 1971
1972	SH–72–4	Shelanski Holding Co.	Monsanto Co. Lot QA-I-SHC No. M–77 (100% Santosol 100 solvent only)	1/50	ND	—	N^[7]	Component of CCP; end-user would not be exposed
1977	77–512–70	Hill Top Research, Inc.	A. Paper, CF surface colored by transfer from ruptured CB surface	0/71	NR	—	N	Test materials discontinued in late 1970s
			B. Paper, CF surface not colored	0/71	NR	—	N
			C. Blue liquid	5/71			Y^[7]
					1	3
					2	1
					5	1
			D. Dark liquid	3/71			N
					1	1
					2	2
			E. Brown granules	7/71^[8]			Y
					1	1
					2	2
					6	4

________________
See footnotes at end of table.

(Continued)

76

Carbonless Copy Paper

Adapted from Graves and Tardiff [1999] supplemental submission of peer review comments.

↑ The report numbers refer to submissions to the NIOSH docket; they are not listed in the references. Except in Report 86–5436H, no test results for control materials are included in this table.
↑ Number of responders/total number of persons who completed the study.
↑ Highest recorded grade of skin reaction per study participant for a particular test material (based on multiple applications). Before 1980, Hill Top Research, Inc. employed a scoring scale that ranged from 0 to 7 (a score of 5 or greater=primary skin irritant; less than 5=nonirritating). Since 1980, Hill Top has used a scoring scale that ranges from 0 to 5 (a score of 3 or greater=primary skin irritant; less than 3=nonirritating). Inveresk Research International used a scoring system of 0 to 8, with a score of 5 or greater indicating irritancy. This laboratory scoring system is more analogous to the Hill Top pre-1980 system, even though it is a post-1980 study.
↑ Abbreviations: CB=coated back; CF=coated front; CFB=coated front and back; N=no; NA=not applicable; ND=no data provided; NR=no reaction; Y=yes.
↑ Y and N were determined by NIOSH according to the scoring system listed in footnote 3.
↑ Discontinued means that (1) the ingredient is no longer used to make CCP, or (2) the formulation as constituted is no longer used to make CCP, or (3) the CCP product is no longer sold in the United States.
↑ ^7.0 ^7.1 The study director described skin reactions as sensitization.
↑ Responders to sample E (grade 2 and grade 6 reactions) were dropped from the study (77–512–70).

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[table-4-12-1a-1] The report numbers refer to submissions to the NIOSH docket; they are not listed in the references. Except in Report 86–5436H, no test results for control materials are included in this table.

[table-4-12-1d-2] Number of responders/total number of persons who completed the study.

[table-4-12-1dd-3] Highest recorded grade of skin reaction per study participant for a particular test material (based on multiple applications). Before 1980, Hill Top Research, Inc. employed a scoring scale that ranged from 0 to 7 (a score of 5 or greater=primary skin irritant; less than 5=nonirritating). Since 1980, Hill Top has used a scoring scale that ranges from 0 to 5 (a score of 3 or greater=primary skin irritant; less than 3=nonirritating). Inveresk Research International used a scoring system of 0 to 8, with a score of 5 or greater indicating irritancy. This laboratory scoring system is more analogous to the Hill Top pre-1980 system, even though it is a post-1980 study.

[table-4-12-1S-4] Abbreviations: CB=coated back; CF=coated front; CFB=coated front and back; N=no; NA=not applicable; ND=no data provided; NR=no reaction; Y=yes.

[table-4-12-1P-5] Y and N were determined by NIOSH according to the scoring system listed in footnote 3.

[table-4-12-1s-6] Discontinued means that (1) the ingredient is no longer used to make CCP, or (2) the formulation as constituted is no longer used to make CCP, or (3) the CCP product is no longer sold in the United States.

[table-4-12-1+-7] 7.0 ^7.1 The study director described skin reactions as sensitization.

[table-4-12-1h-8] Responders to sample E (grade 2 and grade 6 reactions) were dropped from the study (77–512–70).

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