Document ZJ8MvEG0R9qneGK3bvv289vMZ
/VUA6 _ 134-6
Telomer Research Program V
^ Clariant
Report Title: Purified 8-2 Alcohol: Salmonella - Escherichia co///M ammalian - M icrosome Reverse Mutation Assay with a Confirmatory Assay
Author(s): Leon F. Stanlcowski, Jr.
Contractor: Covance Laboratories, Inc., Vienna, Virginia
Study Dates: Initiation: October 23, 2001 In Life: October 29, 2001 - December 10, 2001 Completion: February 11, 2002
Study Objective: To evaluate the test article for the ability to induce reverse mutations at the histidine locus in several strains of Salmonella typhimurium (TA98, TA100, TA1535, and TA1537), and at the tryptophan locus in Escherichia coli tester strain W P2vrA in the presence or absence o f an exogenous metabolic activation system (S9 microsomes).
Materials and Methods: The tester strains were exposed to the test article via plate incorporation both with and without the S9 mix. All doses (including a vehicle and positive control) were plated in triplicate. The plates were incubated for 524 hr at 372C prior to counting using an automated colony counter. Criteria were in place to assure assay validity. To be considered positive, the test article needed to produce at least a 2-fold increase in the mean number of revertants per plate over the appropriate vehicle control.
Findings: No increase in revertants was seen in any of the tester strains. Data table follows.
Does not contain TSCA CBI
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TRJP 23-Apr-03
Mean Revertants Per Plate with Standard Deviation
Dose/Plate
Microsome: Rat Liver Vehicle Control (DMSOl
TA98
Mean
S.D
30 3
T e s t A r t i c l e 3 3 .3 fj.g 1 0 0 J_Lg 3 3 3 Mg 1 0 0 0 Mg
3 3 3 0 (.tg 5 0 0 0 Mg
P ositive C o n tro l"
29 24 29 .31 32 34
543
4 4 10 4 12 9
31
M icrosom es: N one V ehicle C ontrol (D M SO )
15
9
T e s t A rtic le 3 3 .3 (rg 1 0 0 Mg 3 3 3 Mg 10 0 0 Mg
3 3 3 0 Mg 5 0 0 0 Mg
P o s i t i v e C o n t r o l 1'
14 15 16 18 21 16
205
4 3 7 2 9 5
12
TA100 Mean S.D.
117
102 109 103 117 106 116
1041
7
11 8 14 2 8 5
53
97 16
82 10 79 8 90 6 94 4 9 2 18 95 2
999 44
TA1535 Mean S.D.
13 5
16 1 10 1 12 3 15 5 16 3 13 4
148 15
13 4
12 6 11 5 12 2 92 14 4 14 3
633 47
TA1537 Mean S.D.
82
10 5 83 10 1 93
11 3 11 2
169 18
52
63 64 74 82 75 63
943 106
WPVuvrA Mean S.D.
1 5 11
15 4 19 0 14 6 16 9 20 2
20 1
256 33
16 2
16 3 16 1 10 3 11 2 17 6 21 4
125 35
"T A 9 8 TA 100 T A I 535 TA 1537 W P 2m rA
benzojajpyrene 2-aminoanthracene 2-aminoanthracene 2-aminoanthracene 2-aminoanthracene
2.5 pg/piate 2.5 M g/plate 2.5 M g/plate 2.5 M g/plate
2 5 .0 Mg/plate
bT A 9 8 T A 100 TA 1535 TA 1537 W P2r/i/rA
2-nitrofluorene sodium azide sodium azide
IC R -191
4-nitroquinolone-Noxide
1.0 Mg/plate 2 .0 Mg/plate 2 .0 Mg/plate 2 .0 Mg/plate 1.0 Mg/plate
Conclusion: Purified 8-2 Alcohol was not mutagenic in this test system.
Publications / Presentations: A) Covance Study 22900-0-409 OECD, Dated 2/11/02.
B) Results cited in: Kennedy, G. L., Jung, R., Iwai, H., Shin-Ya, S., M urphy, S., Drouot, N., Finlay, C., Donner, M., Erexson, G., and Stankowsld, L., Jr., "Genetic Toxicology of 8-2 Telomer B Alcohol", Toxicol. Sci. 72(S-1):209:2003.
Does not contain TSCA CBI
2 TRP 23-Apr-03
