Registration Dossier
Registration Dossier
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EC number: 447-060-8 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
The available experimental data in animals show oral absorption and systemic distribution of the test substance. No systemic effects were observed when the test substance was dermally applied in the acute dermal toxicity study. However, the results of this test showed that the substance had likely been absorbed by cutaneous route. In the repeat-dose toxicity study, slight liver metabolism alterations were observed, but no indication on the test substance excretion was obtained.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
No specific toxicokinetic (TK) study using DV6850 has been performed. Therefore, the assessment of absorption, distribution, metabolism and excretion of DV6850 is based on the physico-chemical properties of the test substance and on the results of the different toxicity studies available.
Physico-chemistry data:
The test substance is a solid (powder), with a molecular weight of 480.78, soluble in water (0.6 g/L), and with a very low vapour pressure (3.24 E-04 Pa at25°C). Its relative density is1.08.The distribution of particle sizes indicates 0% substance mass with a size below 10 µm. Boiling point was not determined because the test substance decomposes at230°Cwithout boiling. The log Poe value (> 4.99 at20°C, as estimated by structure-activity relationship based on determination of log Koc > 4.09) indicates that the test substance is potentially bioaccumulable.
Absorption:
The decrease in bodyweight gain, in food conversion efficiency and the clinical chemistry changes observed in the 28-day repeat-dose toxicity study in rats can be considered as an indication of absorption of the test substance following oral administration. However, the forestomach histological lesions noted in both sexes at the dose level of 1000 mg/kg/day, as weel as in one female at 150 mg/kg/day, are considered related to local irritation effects of the test substance rather than to systemic effects. It is also likely that increased prothrombin time, decreased platelet count and increased monocyte count at 1000 mg/kg/day be a consequence of the forestomach lesions seen at this dose level. The results of acute dermal toxicity and skin irritation studies illustrate the irritation potential of the test substance, but no systemic effects was observed in the acute dermal toxicity study. However, the results of the skin sensitisation test show that the test substance may also be absorbed following dermal application.
Distribution:
In the 28-day repeat-dose toxicity study in rats, observations during the dosing period did not evidence changes in appearance and behaviour indicative of any neurotoxic effects or any distribution of the test substance to the peripheral or central nervous systems. However, some changes in clinical biology parameters and thymic microscopic changes may indicate a systemic distribution of the test substance.
Metabolism:
In the 28-day repeat-dose toxicity study in rats, increased liver Aspartate Aminotransferase (AST) activity, decreased plasma glucose, cholesterol and protein concentrations observed at the dose level of 1000 mg/kg/day may be related to a test-substance related alteration of hepatic function, although there was no apparent histopathological correlate.
However, the results of the in vitro genotoxicity assays (Ames test and chromosomal aberration assay in human lymphocytes) were not affected by the presence or absence of an exogenous metbaolic activation system. The Ames test did not show any mutagenic effect of the test substance, either with or without metabolic activation. In vitro chromosomal aberration assay in human lymphocytes did not show any clastogenic effect of the test substance, either with or without metabolic activation.
Excretion:
No data are available with regards to the test substance excretion.
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