Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Type of information:

other: Assessment based upon available information.

Adequacy of study:

key study

Study period:

March 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Information selected for the toxicokinetic assessment is primarily study data. Studies were conducted inaccordance with recognised testing guidelines.

Data source

Reference

Reference Type:

other: Assessment

Title:

Unnamed

Year:

2018

Results and discussion

Any other information on results incl. tables

The physical state of the substance, molybdenum, bis(dibutylcarbamodithioato)di-mu-oxodioxodi-, sulfurizedis, yellow powder with 38.6% of particles less than 100 μm and 0.012% of particles less than 10 μm in size.  The particle size of the substance indicates that the majority of the substance particles are not respirable and, therefore, the substance is unlikely to be absorbed via the inhalation route.

 

The water solubility and partition coefficient (Log Pow)of the substance are 0.0528 mg/L and 6.24 -7.28, respectively.  The typical molecular mass of the substance (C₁₈H₃₆N₂Mo₂O₄S₄) is 664.63 daltons.  These data indicate that the substance is relatively large (> 500 daltons), has very low water solubility (<0.1 mg/L), and is a highly lipophilic (Log Pow > 5.6) molecule, and thus is not expected to be absorbed via the oral route, in accordance with Lipinski's rule of five.  Furthermore, acute and repeated dose oral toxicity studies in rats did not show any systemic effects up to the highest doses tested (2000 mg/kg in the acute oral toxicity study and 1000 mg/kg/day in the combined repeated dose oral toxicity study with the reproductive/developmental toxicity screening test).  No information is currently available on possible degradation products produced in the gastrointestinal tract.  The very low water solubility, high lipophilicity, and relatively large molecular mass of the substance also indicate that it is not expected to be absorbed via the dermal route.  Thelocal lymph node assay in mouse and skin irritation test in vitroshowed that the substance is neither a skin sensitizer nor a skin irritant.

 

Additionally, the ready biodegradability test of the substance showed that it was not readily biodegradable. Although the Log Pow of the substance exceeds 5, its water solubility is very low, and thus, the substance is expected to have low potential for bioaccumulation in aquatic organisms.

 

In conclusion, based upon the available data,the substance, molybdenum, bis(dibutylcarbamodithioato)di-mu-oxodioxodi-, sulfurizedis not expected to be bioavailable and has low or no systemic toxicity.

Applicant's summary and conclusion

Conclusions:

In conclusion, based upon the available data,the substance, molybdenum, bis(dibutylcarbamodithioato)di-mu-oxodioxodi-, sulfurizedis not expected to be bioavailable and has low or no systemic toxicity.