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basic toxicokinetics
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:

Description of key information

Based upon the physico-chemicals and toxicological properties of the test material and the read across substance there is no / low bioaccumulation potential.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The substance is a non-volatile solid block.



In an acute oral toxicity study, the test material showed no treatment- related effects (LD50 >2,000 mg/kg bw. In addition, in a suitable repeated dose (oral) study with the read-across substance there were no treatment-related effects (NOAEL 1,000 mg/kg bw/day. Based on these results, absorption of the test material via the gastro-intestinal tract is not expected to occur.  

In a read across acute dermal toxicity study, showed no treatment related effects (LD50 >2,000 mg/kg bw.  In addition, the substance is poorly water soluble (less than 0.0506 mg/l at 20 ± 5 ºC). Based on these results the test material is unlikely to be absorbed via the skin.  

The log Pow of the test material is considered high (greater than 6.5), which according to ECHA’s Guidance on information requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance indicates ready diffusion across skin membrane. In light of the other physico-chemical properties, absorption potential is low.



Data from a suitable repeated dose (oral) study with the read-across substance, there were no effects in the organs or hematological effects observed. This does not, however, rule out the potential for distribution within the body. 



There are no experimental data on metabolism.  Data from a suitable repeated dose (oral) study with the read-across substance showed no effects in the organs, with no changes in organ weight.

In vitro mutagenicity studies on the test material and the read-across substance showed no differences in cell toxicity in the presence or absence of S9.



No observations on excretion were noted in the results from a suitable repeated dose (oral) study with the read-across substance. It is therefore not possible to determine the main route of excretion.