Dipropylene glycol (SIDS)

OECD SIDS PROPYLENE GLYCOL
5. Toxicity
Id 25265-71-8
Date 30.05.2001
statistically between the treated and control animals and no dose-response
relationship was present. There was no evidence of any treatment-related
increase in tumors.
Conclusion: No carcinogenic potential was detected under the conditions
of this study following dietary administration up to 50000 ppm (approx 1700
- 2100 mg/kg bw/day).
Reliability : (1) valid without restriction
Flag : Critical study for SIDS endpoint
29.05.2001 (21)
Type : other: Continuous Breeding
Method : Species: mouse
Sex: male/female
Strain: CD-1
Route of admin.: drinking water
Exposure period: continuous (see methods)
Frequency of treatment: daily
Premating exposure period
Male: 7 days prior to first mating, then continuous exposure
Female: 7 days prior to first mating, then continuous exposure
Doses: 1%, 2.5%, 5% in drinking water
Control group: yes, concurrent vehicle
NOAEL Parental: = 5%
NOAEL F1 Offspr.: = 5%
NOAEL F2 Offspr.: = 5%
Method: NTP Reproductive Assessment by Continuous Breeding
Year: 1989
GLP: no data
Method: Animals
There were 40 controls per sex, along with 20 males and 20 females per
treatment group in the F0 generation. The F1 mating groups comprised 20
animals per sex from the control and high dose groups only. Animals were
housed in single sex groups during a one week pre-mating period, then in
breeding pairs or individually. Deionised filtered water and ground rodent
chow were available ad libitum.
Treatment
The mice were exposed during a 7-day premating period, after which they
were randomly assigned to mating pairs and cohabited and treated
continuously for 98 days. At the end of the cohabitation period, the pairs
were separated but treatment continued. Any litters born during this time
(F1) were delivered, and kept until weaning on PND21 : treatment of the
mothers continued throughout this period. Treatment of high dose animals
from the F1 generation continued until mating at around 74 days of age
Parental observations
Body weight and water consumption data were collected at unspecified
times during the study.
Pup observations
Data (body weight, proportion of males, number of litters per pair, number
of live and dead pups) were collected on all new born animals within 12 hr
of birth. Litters were then discarded, with the exception of the final F1
generation which was used for breeding purposes. The F2 litters were
examined for litter size, sex and pup weight.
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Necropsy observations
No necropsy data were collected on the F0 generation, however the F1
adults were subjected to a detailed examination after delivery of the F2
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