Dipropylene glycol (SIDS)

OECD SIDS PROPYLENE GLYCOL
5. Toxicity
Id 25265-71-8
Date 30.05.2001
Type : other: Carcinogenicity
Method : Species: rat
Sex: male/female
Strain: Charles River, CD strain
Route of admin.: oral feed
Exposure period: 104 wk
Frequency of treatment: daily
Post. obs. period: none
Doses: 6250, 12500, 25000 or 50000 ppm
Result: negative
Control group: yes, concurrent vehicle
Year: 1972
GLP: No
Method: Animals
30 male (bw 120 - 150g) and 30 female (bw 120 - 140g) rats
General
Individual body weights were recorded at 2-wk intervals, with food intake
measured over the preceding 24 hr.
Hematology
Blood was collected (tail vein) from 8 male and 8 female rats fed diets
containing 0, 25000 or 50000 ppm propylene glycol at wk 13, 21, 52 and
80. Additional samples were collected from 6250 and 12500 ppm groups
at wk 54. Samples were analysed for Hb content, PCV and counts of
erythrocytes, and
total and differential leucocytes. Reticulocyte counts were determined at wk
52, 54 and 80. Terminal observations (wk 104) were limited to Hb
concentration and microscopic examination of a stained smear.
Renal function
A urinary concentration test was conducted on 6 - 10 rats from the control,
25000 and 50000 ppm groups. Measurements included specific gravity,
urine volume under different water loading conditions and a urinary cell
count.
Terminal observations
Surviving animals were killed at wk 104 (exsanguination under barbiturate
anesthesia) and subject to a full necropsy, including macroscopic
observations and key organ weights. Samples of the following tissues were
preserved for subsequent histopathological assessment : brain, heart, liver,
spleen, kidneys, adrenals, gonads, stomach, small intestine, cecum,
salivary gland, trachea, aorta, thymus, lymph nodes, pituitary, urinary
bladder, colon, rectum, pancreas, uterus, muscle and any additional tissue
that
appeared abnormal.
Statistical methods
Applied, but details not given.
Remarks: Because this study was conducted before any standardized
guidelines were established, the question of guideline methodology and
GLP conduct is not applicable.
Remark : Current guidelines indicate that the concentration of test substance should
not exceed 5% of the diet to avoid any concerns about nutritional
imbalances.
Source : Lyondell Chemical Co. Houston, Texas
Test substance : structurally related propylene glycol
Conclusion : Result: There was a high incidence of mammary fibroadenomas and
pituitary adenomas, affecting mostly female rats, but this did not differ
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