Registration Dossier
Registration Dossier
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EC number: 603-006-7 | CAS number: 124728-62-7
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Objective of study:
- other: Repeated Dose and Reproductive Screening Toxicity Study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422
- GLP compliance:
- yes (incl. QA statement)
- Type:
- absorption
- Results:
- well absorbed
- Type:
- distribution
- Results:
- systemically distributed
- Metabolites identified:
- no
Reference
Resorption
Because of the molecular structure, low molecular weight and octanol-water partition coefficient (>6.5), 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 treatment with 100, 300 and 1000 mg/kg bw/d of this test item to rats was clinically tolerated over 28 days. Dose-related changes were observed in liver, comprising increased hepatic weights and correlating hepatocellular hypertrophy, and in the thyroid gland, i.e. follicular cell hypertrophy. Based on these systemic findings it can be concluded that the substance is well absorbed after oral administration.
Distribution
The toxicological effects found in the repeat dose toxicity study of the test item (OECD 422: key study) 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 at 1000 mg/kg bw/d was found. The liver weight changes did not show a clear dose-response-relationsship. Only minimal degree of hepatocellular hypertrophy have ben noted at 1000 mg/kg bw/d, therefore the slight changes are considered non adverse. Due to the molecular properties, excretion via the kidneys is considered to be the main route of elimination.
Description of key information
Resorption
Because of the molecular structure, low molecular weight and octanol-water partition coefficient (>6.5), 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 treatment with 100, 300 and 1000 mg/kg bw/d of this test item to rats was clinically tolerated over 28 days. Dose-related changes were observed in liver, comprising increased hepatic weights and correlating hepatocellular hypertrophy, and in the thyroid gland, i.e. follicular cell hypertrophy. Based on these systemic findings it can be concluded that the substance is well absorbed after oral administration.
Distribution
The toxicological effects found in the repeat dose toxicity study of the test item (OECD 422: key study) 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 sbacute 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 at 1000 mg/kg bw/d was found. The liver weight changes did not show a clear dose-response-relationsship. Only minimal degree of hepatocellular hypertrophy have ben noted at 1000 mg/kg bw/d, therefore the slight changes are considered non adverse. Due to the molecular properties, excretion via the kidneys is considered to be the main route of elimination.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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