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Administrative data

Description of key information

One subacute oral (gavage) toxicity study with rats is available. For the inhalation route, two subacute toxicity studies with rat and one subchronic study with rats is available. No repeated dose toxicity data for the dermal route are available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
75 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
903 mg/m³
Study duration:
subchronic
Species:
rat

Additional information

In an oral gavage study, male and female rats were given 0, 75, 250, 750 or 2000 mg/kg bw 1,3-Dioxolane during 14 days. For repeated dose oral toxicity, a NOAEL systemic of 75 mg/kg bw/day was observed in a subacute study with rats, based on observed reduced body weight gain in males and females, reduced leucocyte and lymphocyte counts in females and reduced platelet count in males observed at 250 mg/kg bw/day. No local effects were observed.

In a 13-week inhalation toxicity study, male and female rats were exposed to targeted concentrations of 0, 300, 1000 or 3000 ppm 1,3-Dioxolane vapour. Satelite groups were allowed to recover for 8 weeks after the exposure period. For repeated dose inhalation toxicity, an overall NOAEC systemic of 298 ppm (0.90 mg/L or 903 mg/m³) was observed in the 90-day rat study, based on reduced WBC and lymphocyte count and increased platelet count in males and females, and reduced spleen weights in females at and above 1000 ppm (3.03 mg/L or 3030 mg/m³).

No local effects were observed.


Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other

Repeated dose toxicity: inhalation - systemic effects (target organ) cardiovascular / hematological: other

Justification for classification or non-classification

Based on the oral NOAEL and NOAEC for systemic effects in the repeated dose toxicity studies, 1,3 -Dioxolane needs no classification for danger of serious health effects after prolonged exposure (DSD and CLP).