A one-year oral toxicity study of sodium stearoyl lactylate (SSL) in rats

Food and Chemical Toxicology

Volumn 48, Issue 10, 2010, Pages 2663-2669

  Lamb, J ^a   Hentz, K ^a   Schmitt, D ^a   Tran, N ^a   Jonker, D ^b   Junker, K ^c  

^a EXPONENT INC   (United States)

^b TNO   (Netherlands)

^c GD ANIMAL HEALTH   (Netherlands)

Author keywords

Chronic toxicity; Endometrial stromal polyps; Rat; Sodium stearoyl lactylate

Indexed keywords

EMULSIFYING AGENT; SODIUM STEAROYL LACTYLATE; UNCLASSIFIED DRUG;

ANIMAL BEHAVIOR; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; AUTOPSY; BODY WEIGHT; CHRONIC TOXICITY; CLINICAL CHEMISTRY; CONTROLLED STUDY; DIETARY INTAKE; ENDOMETRIUM POLYP; EYE EXAMINATION; FEMALE; FLUID INTAKE; FOOD INTAKE; GROWTH; HEMATOLOGY; KIDNEY DISEASE; MALE; NONHUMAN; RAT; SURVIVAL; TOXICITY TESTING; URINALYSIS;

ANIMALS; BODY WEIGHT; CARCINOGENICITY TESTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRINKING; EATING; EMULSIONS; ENDOMETRIAL STROMAL TUMORS; FEMALE; LEUKOCYTE COUNT; MALE; NEOPLASMS; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RATS; RATS, INBRED F344; SEX CHARACTERISTICS; STEARATES; SURVIVAL; URINALYSIS;

RATTUS; RATTUS NORVEGICUS;

EID: 77956343504     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2010.06.037     Document Type: Article

References (14)

1. Chandra M., Riley M.G., Johnson D.E. Spontaneous neoplasms in aged Sprague-Dawley rats. Arch. Toxicol. 1992, 66:496-502.
2. Eiben R., Bomhard E.M. Trends in mortality, body weights and tumor incidences of Wistar rats over 20 years. Exp Toxicol Pathol 1999, 51:523-536.
3. JECFA., 1974. Toxicological evaluation of some food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers and thickening agents 539. Stearoyl lactylic acid, calcium and sodium salts. In: Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Food Additive Series 5.
4. Compendium of food additive specifications, FAO Food and Nutrition Paper, No. 52, Addendum 4.
5. Lin K.K. Progress report on the guidance for industry for statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals. J Biopharm Stat. 2000, 10:481-501.
6. Maita K., Hirano M., Harada T., Mitsumori K., Yoshida A., Takahashi K., Nakashima N., Kitazawa T., Enomoto A., Inui K., et al. Spontaneous tumors in F344/DuCrj rats from 12 control groups of chronic and oncogenicity studies. J Toxicol Sci. 1987, 12:111-126.
7. Mor N., Lutsky I. Spontaneous endometrial tumours of 'Sabra' rats. Lab Anim. 1986, 20:316-320.
8. Moser V.C., MacPhail R.C. International validation of a neurobehavioral screening battery: the IPCS/WHO collaborative study. Toxicol. Lett. 1992, 64(65):217-223.
9. Moser V.C., Becking G.C., MacPhail R.C., Kulig B.M. The IPCS Collaborative Study on Neurobehavioral Screening Methods. Fundam. Appl. Toxicol. 1997, 35:143-151.
10. Moser V.C., Tilson H.A., MacPhail R.C., Becking G.C., Cuomo V., Frantik E., Kulig B.M., Winneke G. The IPCS Collaborative Study on Neurobehavioral Screening Methods: II. Protocol Design and Testing Procedures. Neurotoxicology 1997, 18:929-938.
11. Poteracki J., Walsh K.M. Spontaneous neoplasms in control Wistar rats: a comparison of reviews. Toxicol Sci. 1998, 45:1-8.
12. Historical control data for the Fischer 344 rat in oral feeding studies. http://ntp.niehs.nih.gov/?objectid=92E61F1B-F1F6-975E-7D3BED551F07DC0A.
13. Guidance for Industry: Statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals. May. Accessed January 14, 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079272.pdf.
14. Walsh K.M., Poteracki J. Spontaneous neoplasms in control Wistar rats. Fundam Appl Toxicol. 1994, 22:65-72.