Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

The following remarks on the toxicokinetics of ITC 288/S are based on physico-chemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed

Absorption
The low toxicity of the substance when administered orally compared with the greater toxicity when administered by the
intraperitoneal route in the micronucleus study suggests that the substance is poorly absorbed from the gastro-
intestinal tract. The poor lipid solubility of the substance indicates that dermal absorption will be low.

Distribution
There is no experimental evidence to indicate distribution of any absorbed substance but the low fat solubility and log
Pow value suggest that bioaccumulation is unlikely. The substance was shown to induce contact sensitisation in a
guinea-pig study so it, presumably, can become bound to proteins.

Metabolism
An in-vitro chromosome aberration study showed some evidence of increased cytotoxicity in the presence of S9 (an hepatic
metabolising enzyme broth). This may indicate that the substance has potential to be biotransformed by microsomal
enzymes but there is no other experimental evidence to support this.

Excretion
Again, there is no evidence to indicate a route of excretion for this substance but it's water solubility is such that
excretion of unchanged parent substance could occur by biliary or renal routes. Presumably, any metabolites would
be similarly water soluble. In view of the possible potential of the substance to become protein bound,
excretion in the bile might be anticipated. The parent substance could not be eliminated via the lungs in expired

air because it is non-volatile.