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EC number: 692-614-6
CAS number: 5660-53-7
Combined Repeated Dose Toxicity Study with the Reproduction /
Developmental Toxicity Screening Test conducted according to OECD
Guideline 422 and in compliance with GLP, 2,2-Dimethyl-1,3-dioxolane-4-methanol
in Phosphate Buffer Saline solution was administered daily by oral
gavage to male and female Sprague-Dawley rats (10/sex/dose), for 2 weeks
before mating, during mating and (for females) throughout gestation and
until day 5 post-partum, at dose-levels of 250, 500 or 1000 mg/kg
bw/day. A control group was treated with Phosphate Buffer Saline
solution. During the study, data was recorded on mortality, clinical
signs, behavioural assessments, body weight change, food consumption,
haematology, blood chemistry, mating performance, fertility and
gestation length. All animals were subjected to a gross necropsy
examination, selected organs were weighed and histopathological
evaluation of selected tissues was performed. The clinical condition of
offspring, litter size and survival, sex ratio and offspring bodyweight
were assessed and macroscopic pathology investigations were undertaken.
item-related deaths or clinical signs were noted in any group and sex.
No toxicologically relevant effects on mean body weight, mean food
consumption, mean Functional Observation Battery and motor activity data
and mean clinical pathology parameters in any group and sex. The
increase in the absolute and relative liver weights recorded in males
given 1000 mg/kg bw/day was considered not to be adverse in view of the
slight magnitude of the changes and the absence of microscopic
correlates. None of the macroscopic findings were attributed to the test
item administration. At histopathology, tubular hyaline droplets in the
kidneys (consistent with rat-specific alpha-2u-globulin) were seen with
increased incidence and severity in males treated at 1000 mg/kg bw/day
compared to controls (presence of dense eosinophilic droplets in
proximal tubular epithelium). This finding was not observed at 250 or
500 mg/kg bw/day. These kidney effects were considered to be related to
alpha-2u globulin nephropathy and of no relevance to humans. There were
no toxicologically relevant effects on mean mating, fertility and
delivery data in any group. There were no test item-related effects on
pups by day 5 post partum (viability, clinical signs, sex ratio,
macroscopic post-mortem findings).
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