Registration Dossier
Registration Dossier
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EC number: 619-232-4 | CAS number: 96624-52-1
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other:
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Materials and methods
Test material
- Reference substance name:
- 4-trans-Butyl-4'-trans-propyl-[1,1'-bicyclohexyl]
- EC Number:
- 619-232-4
- Cas Number:
- 96624-52-1
- Molecular formula:
- C36H36
- IUPAC Name:
- 4-trans-Butyl-4'-trans-propyl-[1,1'-bicyclohexyl]
- Test material form:
- other: solid
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Executive summary:
Resorption
Because of the molecular structure, low molecular weight and octanol-water partition coefficient (>5.7), resorption of the test item via the gastrointestinal tract is considered to be likely. After single treatment of rats with the test item at a dose of 2000 mg/kg bw no signs of toxicity were observed (acute oral: key study).
Data from a subacute study are available.
Daily oral administration of 30 mg/kg or 100 mg/kg of the test material to rats for 4 weeks did not result in any adverse effects, whereas at 300 mg/kg increased numbers of foam cells in the lung, indicative of pneumocytes II / macrophage activation, were observed. Organ weights showed increased absolute liver weights in females of groups 3 (100 mg/kg) and 4 (300 mg/kg) and increased relative liver weights in both sexes of group 4 (300 mg/kg) after 28 days of treatment. From these effects it can be concluded that the structural analogue is resorbed after oral administration.
Distribution
Due to the low water solubility and the high octanol/water-coefficient, in combination with the low molecular weight, permeation of membranes is assumed to be possible. The toxicological effects found in the repeat dose toxicity study of the test item clearly show that this compound is distributed throughout the body after oral uptake and is thus systemically available.
Metabolism and Excretion
Specific information on the metabolism and excretion of the substance is not available. From the subacute study it can be conclududed, that metabolism in the liver can be assumed as a tendency towards an increase of absolute and relative liver weights in both sexes at 100/300 mg/kg/d was found. Due to the molecular properties, excretion via the kidneys is considered to be the main route of elimination.
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