Neodecanoic acid, iron salt

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Preliminary studies:

No additional data.

Details on absorption:

Not applicable.

Details on distribution in tissues:

Not applicable.

Details on excretion:

Bulk activity was found in the feces and urine. Expired air contained less that 0.5% of the dose. The rate of excretion pattern seems consistent in all cases. Activity in both urine and feces falls off rapidly and indicate that further significant activity will not be forthcoming. The expired air samples indicate a peak rate of excretion around 12 hours and probably before. Representative fat, muscle, and blood samples showed specific activities near the measurable limit of 0.003% of the dose per gram. Of all tissues examined, the gastrointestinal tract showed the greatest specific activity. Total retained by the stomach was 0.02% of dose.

Metabolites identified:

not measured

Details on metabolites:

Not applicable.

Conclusions:

In conclusion, no bioaccumulation potential based on study results.

Executive summary:

In this study, rats were fed 100 mg/kg bw/day of neodecanoic acid for 5 days and followed by a pulse of C-14 labeled neodecanoic acid and assessed every 24 hours for 3 days to determine the distribution and excretion. It was found that under the conditions of the experiment, 70-80% of the administered activity could be accounted for. Excretion in the urine may expect to range from 50-60% while that in the feces will vary from 40-50%. In any case, the total of these two will be at least 98%. The excretion rate falls off rapidly such that less than 1% of dose is expected past 72 hours. Expired air reaches a peak rate somewhere around 12 hours or earlier.  The total carcass, exclusive of organs, retains less than 1% of the recovered dose. Intestines had the greatest specific activity and contribute as much as 1% of total dose. Analysis by thin layer chromatography shows that the bulk of excreted activity is either the original free acid or a material which is readily converted to the acid upon mild hydrolysis.  

Description of key information

No data on the toxicokinetic behavior of the target substance, Neodecanoic acid, iron salt, were available. Therefore, toxicokinetic data from the dissociation product Neodecanoic acid is described. For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

Based on the study results, Neodecanoic acid was bioavailable and was equally excreted via urine and feces. There were no signs for a bioaccumulation potential.

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Additional information

No data on the toxicokinetic behavior of the target substance, Neodecanoic acid, iron salt, were available. Therefore, toxicokinetic data from the dissociation product Neodecanoic acid is described. For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

In a toxicokinetik study, rats were fed 100 mg/kg bw/day of neodecanoic acid for 5 days and followed by a pulse of C-14 labeled Neodecanoic acid and assessed every 24 hours for 3 days to determine the distribution and excretion. It was found that under the conditions of the experiment, 70-80% of the administered activity could be accounted for. Excretion in the urine may expect to range from 50-60% while that in the feces will vary from 40-50%. In any case, the total of these two will be at least 98%. The excretion rate falls off rapidly such that less than 1% of dose is expected past 72 hours. Expired air reaches a peak rate somewhere around 12 hours or earlier. The total carcass, exclusive of organs, retains less than 1% of the recovered dose.  Intestines had the greatest specific activity and contribute as much as 1% of total dose. Analysis by thin layer chromatography shows that the bulk of excreted activity is either the original free acid or a material which is readily converted to the acid upon mild hydrolysis.