Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Expert assessment
Adequacy of study:
key study
Study period:
2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Expert assessment

Data source

Reference
Reference Type:
other: Expert assessment
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Expert assessment

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

The substance is a dark yellow solid and the molecular weight is 699.25 g/mol. The predicted negative explosive properties shows that the substance is non volatile therefore inhalation is unlikely to be a significant route of exposure. The substance has a low log octanol/water partition coefficient value (Log10 Pow -3.3) and high water solubility (100g/L at 23°C). The available repeated dose reproductive screening study showed evidence of absorption, metabolism and excretion. The test item is not a skin or eye irritant but was shown to be sensitising to the guinea pig skin with the possibility of also causing respiratory sensitisation. The acute oral toxicity study (LD50 >5000 mg/kg bw) and available reproductive and developmental study showed no convincing evidence of systemic toxicity and no maternal or developmental toxicity up to dose a dose level of 1000 mg/kg/day

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
The available information suggests that absorption of the test substance will primarily take place in the gastrointestinal tract following oral ingestion. Some absorption may also take place via damaged skin. Once absorbed, the substance would be distributed in the serum and excretion via the urine and faeces.
Executive summary:

The absorption, distribution, metabolism and excretion of FAT 40061/F TE have been predicted based on the following information:

FAT 40061/F TE absorption was indicated via the gastro-intestinal tract following oral gavage administration.

FAT 40061/F TE no absorption was indicated via intact skin or ocular routes of exposure. However, available data confirmed the test item was a sensitizer to Guinea pig skin and also indicated to potentially cause respiratory sensitisation.

FAT 40061/F TE no uptake via inhalation is anticipated on the basis that the inhalable fraction was shown from the Particle size test to be ~99% at <100 μm indicating almost all inhaled particles will be cleared in the oral/nasal region and subsequently swallowed with the mucus.

FAT 40061/F TE based on the available evidence including single oral dose and repeated oral dose reproductive screening studies that the test item and/or its predicted metabolites to have limited toxic potential whether absorbed through the skin or gastro-intestinal tract.

Excretion of FAT 40061/F TE and any of its predicted metabolites is expected to be from urine and faeces.