Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Toxicokinetic assessment
Adequacy of study:
key study
Study period:
April 2012 to May 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Toxicokinetic assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2012

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Toxicokinetic assessment, based on
- Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance
- ECB EU Technical Guidance Document on Risk Assessment, 2003
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Main ADME results
Type:
absorption
Results:
Oral route: 100%. Dermal route: 10 %. Inhalation route: 100 %

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: The absorption factors for risk assessment purposes have been set as follows: absorption oral 100%, absorption dermal 10% and absorption inhalation 100 %
For risk assessment purposes:
Absorption oral: 100%,
Absorption dermal: 10%
Absorption inhalation: 100 %