Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Adequacy of study:
supporting study
Study period:
1943
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline available with which to compare the study design. Study pre-dates GLP. Sufficient reporting of results.

Data source

Reference
Reference Type:
publication
Title:
THE UTILIZATION OF d-GLUCONO-delta-LACTONE BY THE ORGANISM OF THE YOUNG WHITE RAT
Author:
Eyles R & Lewis HB
Year:
1943
Bibliographic source:
Journal of Nutrition. 1943. Volume 26: 309-317

Materials and methods

Type of study / information:
Biological significance of glucono-delta-lactone in the promotion of growth was assessed in young rats.
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
After weaning, young white rats (strain not reported) received a stock diet of milk, whole wheat bread, and lettuce, or of a commercial rat chow. When the rats reached the weight of 65 to 80 g, they were fed a basal diet low in calorific value (approximately 14 Cal. daily). Extra calories in the form of glucose monohydrate or glucono-delta-lactone were added as a supplement to the basal diet and the effects on growth were observed.
GLP compliance:
no
Remarks:
Study pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): d-Glucono-delta-lactone.

Results and discussion

Any other information on results incl. tables

In earlier experiments, an attempt was made to add, as a supplement, 1.5 g of the glucono-delta-lactone daily. This resulted in a rather severe diarrhea, so that the amount of lactone was reduced to 0.75 g (Diet 3). With this diet, no diarrhea of significance was observed. 

After 2 or 3 weeks, the results show that the glucono-delta-lactone was almost as effective in the promotion of growth as was glucose. Thus with Litter A, the average daily gains was supplementary glucose and glucono-delta-lactone were 208 and 213%, respectively, of that of the control group (Diet 1); with Litter B, the corresponding values were 217 and 191%. 

After first crossover, the animals which had previously shown fair or good growth on Diets 2 or 3 ceased to gain significantly and, for the most part, lost weight slightly. The loss in weight was not unexpected, since the basal diet supplied the minimal calories for the animals at the beginning of the experiments and could hardly be expected still to be adequate for the animals after fair growth had proceeded for 2 or 3 weeks. On the other hand, the animals previously fed the basal diet grew satisfactorily when placed on the diet containing supplementary glucono-delta-lactone. 

After another crossover, the growth rate was not as great with these now heavier animals. 

Two of the rats of group 3 of Litter B showed prompt loss of weight, although in one case the loss of weight was no greater than the loss of an animal of the same group which was fed the basal diet. 

Applicant's summary and conclusion