Registration Dossier
Registration Dossier
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EC number: 209-909-9 | CAS number: 597-82-0
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
There are no toxicokinetic data avaliable. However, with state-of-the-art analytical methods it could be shown that the test item is not hydrolytically stable mostly in neutral and alkaline milieus. Phenol was found as the degradation product. It has to be taken into consideration that the degradation took place at very low concentrations due to the low water solubility. Based on repeat-dose and reprotoxicity studies, the test items are bioavailable to some extent. If metabolized, they might undergo the same biotransformation reactions. There was no indication of bioaccumulating potential.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Toxicokinetic, dynamics or metabolism of the test item was not determined. Thus, information on kinetic and distribution are derived from long-term studies, physico-chemical data and structure-activity-relationships.
Chemistry
The test item is solid which has the melting point at 53°C and a very low vapour pressure of 0.0015 Pa. Examination of the partition coefficient yielded a logPow of 5. In water the substance is expected to be instable and to hydrolyze slowly into phenol. High pH conditions (pH 9) and temperatures of 35°C may enhance this reaction. However, the degradation takes place at very low concentrations due to the low water solubility.
Toxicity profile
The test item and a structural analogue are not acute toxic after single oral or dermal application. Irritation of skin or eyes was also not observed; the analogue material was not found to be a skin sensitizer. There are no positive results when tested for genotoxicity in vitro (analogue). Tests for neurotoxicity in hens failed to show any effect on acetylcholine esterase activity or neuropathy target esterase activity. Subacute administration of the material to rats induced hypertrophy in liver and thyroid glands. At the top dose of 500 mg/kg bw notable decreases in bodyweight were observed.
Uptake and Distribution
At repeated dose administration a small portion of the material hydrolyzes presumably to phenol. Phenol will be rapidly absorbed from the gastrointestinal system; excretion occurs predominantly via the urine and only to a minor extend via feces. The non-hydrolyzed material is expected to be absorbed after oral application to be transported to the liver. Hepatocellular hypertrophy give reason to believe that the substance is bioavailable.
Metabolism and Kinetics
Following systemic exposure, hydroxylation of the phenyl residues followed by conjugation with glucuronic acid may be predicted from the chemical structure with excretion via the kidneys or via bile.
Excretion
Conjugation with activated glucuronic acid increases the molecular weight of the compound for 200 g/mol. The conjugated molecule then has a MW of app. 550 g/mol which supports biliary excretion. Bioaccumulation of the test item or the hydrolysis product phenol is not expected.
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