Registration Dossier

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 the test substance has been performed. Therefore, the assessment of absorption, distribution, metabolism and excretion of the test substance 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, with a representative molecular weight of 424, soluble in water (39.9mg/L at 20°C), and with a very low vapour pressure (9.9 x 10-7 Pa at 25°C). Its relative density is 1.11. Although the substance is a solid it is not in granular form. Boiling point was not determined because the test substance decomposes at 200°C without boiling. The log Pow value (Log Kow (Log Pow): 0.8 at 20°C) indicates that the test substance is not potentially bioaccumulable.

 

Absorption

The normal increase in bodyweight gain from day 1 to 91 and the normal food consumption for male and female rats over the course of study can be considered as an indication of absorption of the test substance following oral administration. Forestomach gastritis was seen in high and mid dose groups, are considered related to local irritation effects of the test substance rather than to systemic effects. 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 sensitization test show that the test substance may also be absorbed following dermal application.

 

Distribution

In the 90-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 system. Furthermore, there were no changes in clinical biology parameters indicating minimal distribution of the test substance round the body

 

Metabolism

In the 90-day repeat-dose toxicity study in rats, no increase in clinical biochemistry findings were observed suggesting the test substance had little to no impact on hepatic function. Furthermore, 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 metabolic 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 effects of the test substance, either with or without metabolic activation.

 

Excretion:

No data are available with regards to the test substance excretion.