Table B3Statistical Analysis of Primary Neoplasms in Female Tg.AC Hemizygous Mice in the 6-Month Dermal Study of Pentaerythritol Triacrylate

Vehicle Control0.75 mg/kg1.5 mg/kg3 mg/kg6 mg/kg12 mg/kg
Skin: Squamous Cell Papilloma
Overall ratea0/15 (0%)0/15 (0%)1/15 (7%)10/15 (67%)12/15 (80%)13/15 (87%)
Adjusted rateb0.0%0.0%7.9%68.4%85.1%92.8%
Terminal ratec0/12 (0%)0/14 (0%)1/12 (8%)9/12 (75%)11/13 (85%)8/9 (89%)
First incidence (days)—e—186 (T)17718298
Poly-3 testdP<0.001—fP=0.496P<0.001P<0.001P<0.001
Skin: Squamous Cell Carcinoma
Overall rate0/15 (0%)0/15 (0%)0/15 (0%)0/15 (0%)0/15 (0%)1/15 (7%)
Adjusted rate0.0%0.0%0.0%0.0%0.0%9.3%
Terminal rate0/12 (0%)0/14 (0%)0/12 (0%)0/12 (0%)0/13 (0%)1/9 (11%)
First incidence (days)—————186 (T)
Poly-3 testP=0.090————P=0.462
Skin: Squamous Cell Papilloma or Squamous Cell Carcinoma
Overall rate0/15 (0%)0/15 (0%)1/15 (7%)10/15 (67%)12/15 (80%)13/15 (87%)
Adjusted rate0.0%0.0%7.9%68.4%85.1%92.8%
Terminal rate0/12 (0%)0/14 (0%)1/12 (8%)9/12 (75%)11/13 (85%)8/9 (89%)
First incidence (days)——186 (T)17718298
Poly-3 testP<0.001—P=0.496P<0.001P<0.001P<0.001
Stomach (Forestomach): Squamous Cell Papilloma
Overall rate5/15 (33%)4/15 (27%)5/15 (33%)7/15 (47%)7/15 (47%)4/15 (27%)
Adjusted rate38.6%28.5%39.3%48.3%46.9%37.3%
Terminal rate5/12 (42%)4/14 (29%)5/12 (42%)7/12 (58%)6/13 (46%)4/9 (44%)
First incidence (days)186 (T)186 (T)186 (T)186 (T)85186 (T)
Poly-3 testP=0.409P=0.442NP=0.640P=0.451P=0.478P=0.637N
Tooth: Odontogenic Tumor
Overall rate4/15 (27%)0/15 (0%)3/15 (20%)2/15 (13%)1/15 (7%)0/15 (0%)
Adjusted rate30.6%0.0%23.6%13.4%7.1%0.0%
Terminal rate3/12 (25%)0/14 (0%)3/12 (25%)0/12 (0%)1/13 (8%)0/9 (0%)
First incidence (days)177—186 (T)167186 (T)—
Poly-3 testP=0.077NP=0.036NP=0.518NP=0.264NP=0.139NP=0.070N
All Organs: Benign Neoplasms
Overall rate5/15 (33%)4/15 (27%)6/15 (40%)11/15 (73%)13/15 (87%)13/15 (87%)
Adjusted rate38.6%28.5%47.2%75.2%86.7%92.8%
Terminal rate5/12 (42%)4/14 (29%)6/12 (50%)10/12 (83%)11/13 (85%)8/9 (89%)
First incidence (days)186 (T)186 (T)186 (T)1778598
Poly-3 testP<0.001P=0.442NP=0.484P=0.052P=0.006P<0.001
All Organs: Malignant Neoplasms
Overall rate1/15 (7%)0/15 (0%)0/15 (0%)1/15 (7%)0/15 (0%)3/15 (20%)
Adjusted rate7.2%0.0%0.0%6.9%0.0%24.2%
Terminal rate0/12 (0%)0/14 (0%)0/12 (0%)0/12 (0%)0/13 (0%)1/9 (11%)
First incidence (days)70——180—27
Poly-3 testP=0.028P=0.498NP=0.518NP=0.750NP=0.498NP=0.254
All Organs: Benign or Malignant Neoplasms
Overall rate9/15 (60%)4/15 (27%)6/15 (40%)13/15 (87%)13/15 (87%)14/15 (93%)
Adjusted rate64.1%28.5%47.2%86.7%86.7%93.3%
Terminal rate7/12 (58%)4/14 (29%)6/12 (50%)10/12 (83%)11/13 (85%)8/9 (89%)
First incidence (days)70186 (T)186 (T)1678527
Poly-3 testP<0.001P=0.059NP=0.314NP=0.162P=0.162P=0.063

(T)Terminal sacrifice

a

Number of neoplasm-bearing animals/number of animals examined. Denominator is number of animals examined microscopically for skin; for all other tissues, denominator is number of animals necropsied.

b

Poly-3 estimated neoplasm incidence after adjustment for intercurrent mortality

c

Observed incidence at terminal kill

d

Beneath the vehicle control incidence is the P value associated with the trend test. Beneath the dosed group incidence are the P values corresponding to pairwise comparisons between the vehicle controls and that dosed group. The Poly-3 test accounts for the differential mortality in animals that do not reach terminal sacrifice. A negative trend or a lower incidence in a dosed group is indicated by N.

e

Not applicable; no neoplasms in animal group

f

Value of statistic cannot be computed.

From: APPENDIX B, SUMMARY OF LESIONS IN FEMALE Tg.AC HEMIZYGOUS MICE IN THE 6-MONTH DERMAL STUDY OF PENTAERYTHRITOL TRIACRYLATE

Cover of NTP Genetically Modified Model Report on the Toxicology Studies of Pentaerythritol Triacrylate (Technical Grade) (CASRN 3524-68-3) in F344/N Rats, B6C3F1 Mice, and Genetically Modified (FVB Tg.AC Hemizygous) Mice (Dermal Studies)
NTP Genetically Modified Model Report on the Toxicology Studies of Pentaerythritol Triacrylate (Technical Grade) (CASRN 3524-68-3) in F344/N Rats, B6C3F1 Mice, and Genetically Modified (FVB Tg.AC Hemizygous) Mice (Dermal Studies): NTP GMM 04 [Internet].
Chhabra RS, Mahler J, Bristol DW, et al.
Research Triangle Park (NC): National Toxicology Program; 2005 Oct.
Copyright Notice

This is a work of the US government and distributed under the terms of the Public Domain

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.