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NO TOXICITY REPORT
ACUTE ORAL LD50 TOXICITY STUDY
ALOE GEL FOR ALOE CREME LABORATORIES, INC.
This Clinical Research Report is the sole property of ALOE CREME LABORATORIES, INC., Fort Lauderdale, Florida.
This Clinical Research Study was made by an Independent Testing Laboratory recognized by the FDA and represents positive conclusions and is based on TESTS of the fresh, pure gel of the ALOE VERA (true) Plane, which ALOE CREME LABORATORIES, INC. have been cultivating and formulating into ALOE-MEDICATIONS, ALO-COSMETICS and ALO-SUN SKIN CARE PRODUCTS for over twenty years.
These tests DO NOT apply to the OTHER 179 SPECIES and 2200 VARIETIES of Aloes that are found growing in various parts of the tropics or subtropics, some of which may BE TOXIC.
Each specie or variety should be tested by a FDA recognized Independent Laboratory for toxicity, after which it needs to be tested as to whether it has the same healing ingredients and enzymes and chemical composition as the ALOE VERA GEL, which was tested in this study.
THE ABOVE REFERENCED NAMES WAS PRIOR TO ADOPTING THE PRESENT TRADEMARKS.
THE ABOVE ARE PERSONAL PROPERTIES OF RODNEY M. STOCKTON P.H.D.
CLINICAL RESEARCH ASSOCIATES
DIVISION OF UNITED STATES CHEMICAL SERVICES CORPORATION
220 EAST 23rd STREET, NEW YORK, N.Y. 10010 – (212) 685-8788
ACUTE ORAL LD50 TOXICITY STUDY
ALOE GEL
for
ALOE CREME LABORATORIES, INC.
August 19, 1974
signed by: Kenneth J. Kohlhof, President
Mr. Rodney M. Stockton
President
Aloe Creme Laboratories, Inc.
5th Avenue & 42nd Street, N.E.
P.O. Box 5847
Fort Lauderdale, Florida 33310
Dear Mr. Stockton:
Following are the results of the experimental procedures conducted for Aloe Creme Laboratories, Inc.
| MATERIAL: | Aloe Gel |
| RECEIVED: | July 19, 1974 |
| EXPERIMENTAL PERIOD: | July 22, – August 12, 1974 |
| EXPERIMENTAL PROCEDURES: | Acute Oral LD50 Toxicity Study |
The conclusions in this report are based upon the results of the studies completed August 12, 1974.
This report is submitted for the exclusive use of Aloe Creme Laboratories, Inc.
Yours very truly,
Kenneth J. Kohlhof
President
(signed) KJK:1ge
CLINICAL RESEARCH ASSOCIATES
METHOD – ACUTE ORAL TOXICITY
A group of approximately 30 albino male and female rats, fasted for twenty-four hours were employed to establish an LD50 range for the product under test.
Young adult rats which had not been used for previous test purposes were assigned to various dose levels at random. Both sexes were equally distributed.
The product under test was placed in a glass syringe and introduced through the esophagus into the stomach with a stainless steel catheter.
Animals on the same dosage level were then placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No postmortem, or histopathology esaminations were performed in this particular study.
CLINICAL RESEARCH ASSOCIATES
SCORE SHEET
ALOE GEL
ACUTE ORAL TOXICITY ASSAY
ALOE GEL
EXPERIMENTAL DATA
| Dosages: 2.0 cc/Kg.-64.0 cc/Kg. | Animals: fasted male and female albino rats |
| Concentration: See below | Weights: 200-300 grams |
| Group No. | No. Animals | Dose Level | Number and Day of Deaths 1 2 3 4 5 6 7 8 9 10 11 12 13 14 | Total S** D** |
| I | 5 | 2.0 | 5 – 0 | |
| II | 5 | 4.0 | 5 – 0 | |
| III | 5 | 8.0 | 5 – 0 | |
| IV | 5 | 16.0 | 5 – 0 | |
| V | 5 | 32.0 | 5 – 0 | |
| VI | 5 | 64.0 | 5 – 0 |
Observations:
The leaves were pared and the flesh was placed in a Waring blender until liquified, then strained prior to dosing.
Animals did not exhibit any symptoms of toxicity; however, increased food consumption accompanied with unusually high weight gain was noted during the observation period.
Behavior patterns remained normal throughout the study.
Equally non-toxic to males and females.
| LD0 = | Over 64.0 cc/Kg |
| LD50 = | Over 64.0 cc/Kg (95% Confidence limits = not established) |
| LD100 = | Over 64.0 cc/Kg |
**D = Deaths
**S = Survival
CLINICAL RESEARCH ASSOCIATES
SUMMARY AND CONCLUSIONS
ALOE GEL
| Summary & Conclusion of Toxicity Data Sample: Aloe Gel | Study Performed Acute Oral Toxicity |
| Acute Oral Toxicity (single parenteral dose) | Acute Oral LD50 Study – 30 Albino Rats |
Acute Oral LD50 Study:
| LD50 Over 64.0 cc/Kg | 95% Confidence Limits Not Established |
Federal Hazardous Substances Act
Procedure:
Dosage: 5.0 cc or 5.0 gms/Kg
DEATHS: 0
DOES NOT REQUIRE LABELING UNDER THE FEDERAL HAZARDOUS SUBSTANCES ACT.
