FDA report on Searle's submission for NutraSweet approval 1977 - Part 10

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achieve the diet concentrations and batch sizes that were

reportedly used in the study. A total of 230.0 kg of DKP

was manufacturered by Searle Chemist Jack Drogt. Following

are tables showing the quantities of DKP manufactured,

calculalted quantity required for the study, and quantities

withdrawin from stock.





Lot #. Quantity (After Milling)





4R Another FDA gutted table!










Dose Group Calculated Quantity Required


Low Dose Males

Mid Dose Males

High Dose Males

Low Dose Females Another FDA gutted table!

Mid Dose Females

High Dose Females







Date Withdrawn From Stock Quantity Lot


10/29/71 kg 1R

1/4/72 kg 1R

2/28/72 kg 4R

3/11/72 kg 3R

3/29/72 kg 2R

9/11/72 kg 3R

10/10/72 kg 2R

* kg 2R

12/1/72 kg 3R

* kg 4R

12/27/72 kg 5R

* kg 2R

1/25/73 kg 5R

3/22/73 kg 6R

4/18/73 kg 5R

7/10/73 )5 kg 6R

8/10/73 )5 kg 6R

9/7/73 kg 6R

11/2/73 kg 7R

Another FDA gutted table!



* These three cards were not signed or dated.


It should be noted that only two of the 18 compound inventory cards

specified that the SKP withdrawn from stock was to be used in study

E-77/78 (PT 988S73). Thirteen of the cards list "Toxicity" or

"Toxicology" as the reason for withdrawal. Three of the cards have

no entries at all, except for the word "empty". (Copies of the

compound inventory cards are attached as Exhibit #28).


The total quantity withdrawn from stock is kg in excess of the

amount necessary to achieve the diet concentrations used in the study.

(Based on the diet calculation records attached as Exhibit #34, which we

used to construct the diet calculation summary table attached as Exhibit



It is not known whether any of the kg of DKP accounted for on the 18

compound inventory cards was withdrawn for use in studies other than

E-77/78. We could find no other records to verify the amount of DKP

withdrawn for, or used in this study.






Three hundred and sixty weanling albino rats, CD strain, 180 of each sex,

were used. The rats were 21 days old when received from the

Copies of shipping labels were obtained, and

are attached as Exhibit #10.


The rats were housed individually in wire cages an were given a one-week

acclimation period before being placed on treatment at the age of four



Rockland Rat/Mouse Diet (complete), , was fed for the first

62 weeks, and /Rat Chow was used from week 63 until the study was

terminated at 114 weeks.


The animals were housed in air conditioned rooms maintained at 72 degrees

F, with artificial fluorescent lighting at 12 hours per day exposure.


The rats were divided into 12 housing groups, (6 groups per sex), 30 rats

in each housing group. Initiation of treatment was staggered over a 2

week period, beginning 11/8/71.


Each housing group was composed of dosage groups as follows:


Multiples of No. of Rats Per

Treatment Dosage Estimated Daily Housing Group Total

Group gm/kg/day Human Dosage Male Female Rats





This entire table was blotted out prior to delivery







Computer-generated randomization tables were used for assigning the dose

and housing groups (copies of these tables were obtained and are attached

as Exhibit #6). Each housing group consisted of 30 animals (12 controls,

6 low, 6 medium, and 6 high dose). Each animal was assigned a letter to




designate the housing group (A through M), a cage number (1 through 30),

a letter to indicate dose group (C,L,M & H), and a letter to indicate sex

(M or F). For example, animal A30CM would be a control male, in housing

group A, occupying cage number 30 (Exhibit #69).


Each rack (30 animals) contained a random distribution of control and

treated animals. An example of a typical housing group is shown in the

diagram attached as Exhibit #7.


The specific problems of feeding animals housed in the above manner were

discussed in the report generated by the task force investigation of

Aspartame in l975/l976. We will reiterate them here:


Housing experimental animals in this manner (controls, low, medium, & high

dose animals randomly distributed on the same rack) would greatly increase

the chance of administering the wrong diet to the animals. The chance of

error was compounded by the method used to feed the animals which was as

follows: At the specified intervals, the animals were weighed, and the

empty food jars were removed, weighed and new food jars placed in the

cages. The new (filled) food jars were placed on a mobile cart in rows

corresponding to dose group (See Exhibit #8). The cart was wheeled to the

Intec Unit and placed up against it with the rows of high dose jars

farthest away from the operator. The operator started from the upper left

corner of the housing rack, (See Exhibit #7), removed the mylar card from

the cage and inserted it into the Intec Unit. This printed out the

animal's identification number. A color coded card for dose level, also

bearing the animal number, remained on the cage. The technician then

opened the cage, removed the animal, placed it on the scale pan, pushed

the button to register the weight and returned the animal to its cage. He

then removed the empty food jar, placed it on the scale and pushed the

button to record the empty feeder weight. The empty jar was placed on

another mobile cart provided for that purpose. The new (filled) jar was

selected from the appropriate row according to dose level (Exhibit #8),

placed on the scale, weight recorded, and the jaw placed in the cage. The

Card was then removed from the Unit and replaced on the cage.


Continue to Part 11


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