Registration Dossier
Registration Dossier
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EC number: 229-542-8 | CAS number: 6600-31-3
Endpoint summary
Administrative data
Description of key information
3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane was administered by gavage to 5 male and 5 female Wistar rats per dose group in daily doses of 0, 100, 300 or 1000 mg/kg body weight for 29 days.
The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The no-observed-adverse-effect-level (NOAEL=NOEL) for 3,9-Di-3-cyclohexen-1-yl-2,4,8,10- tetraoxaspiro[5,5]undecane is set at 300 mg/kg based on effects on body weight development and food consumption (males) at 1000 mg/kg.
Justification for classification or non-classification
None of the animals died during the study and no severe functional or morphological changes were observed. Therefore a classification is not justified.
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