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Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

Two generation studies were identified but are considered unreliable and of no value in a weight of evidence adaptation. The only relevant and reliable information for sexual function and fertility is the information on reproductive organs as investigated in the study Landry et al. (1990). In this study, no exposure-related differences noted in reproductive organs/tissues evaluated.


In the absence of reliable information on most of the key elements of sexual function and fertility, no conclusion can be drawn on sexual function and fertility.


A study following the OECD TG 443 is currently ongoing to allow a conclusion on these endpoints.

Effect on fertility: via oral route

Effects on developmental toxicity

Description of key information

Information regarding Toxicity to Development for 1,3-dioxolane comes from a number of studies, including an embryo-fetal development study (Barnett, 2018) a Pre-Natal Developmental study (Hoberman, 1991) and an in vitro study on embryonic development. There is also a published study on Developmental Toxicity (Sitarek, et al., 1992) but considered as not reliable due to documentation insufficient for assessment and inappropriate dosing schedule.


The first reliable study (Hoberman, 1991) was conducted similar to guideline OECD TG 414. The maternal and developmental NOAELs for 1,3-Dioxolane in this study were established as 250 mg/kg bw/day and 500 mg/kg bw/day, respectively. The test substance, 1,3-Dioxolane, was not a unique developmental toxicant because fetal alterations only occurred at the highest of two dosages that were toxic to the dams. 


The second reliable study (Barnett, 2018) was conducted according to guideline OECD TG 414.The maternal and developmental NOAELs for 1, 3-Dioxolane in this study were established as 60 mg/kg/day and 200 mg/kg bw/day, respectively. The test substance in this study is not a selective developmental toxicant because fetal effects only occurred at the 500 mg/kg/day dose that was toxic to the does.


The supporting in vitro study showed that embryos cultured in the presence of 1,3-dioxolane exhibited no adverse effects on growth, development or morphology. It was concluded, therefore, that 1,3-dioxolane showed no potential embryo toxicity or teratogenicity.


Based on the available data, it is possible to conclude that 1,3-dioxolane is not a unique developmental toxicant.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
60 mg/kg bw/day
Study duration:
subacute
Species:
rabbit

Justification for classification or non-classification

Based on the available data, the classification assessment for 1,3-dioxolane according to CLP does not meet the criteria for reproductive or developmental toxicity.

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