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Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: expert statement
Adequacy of study:
key study
Study period:
2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Theoretical assessment taking all currrently available relevant information into account, based on the REACH Guidance: Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c Endpoint specific guidance. Since this is a theoretical assessment, the Klimisch value cannot be 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

GLP compliance:
no

Results and discussion

Main ADME results
Type:
absorption
Results:
For risk assessment purposes, 10% is used for oral and dermal absorption. For inhalation absorption 100% should be used.

Applicant's summary and conclusion

Conclusions:
For risk assessment purposes, 10% is used for oral and dermal absorption. For inhalation absorption 100% should be used. Distribution and bioaccumulation of P 1920C is expected to be limited.
Executive summary:

Based on a theoretical assessment of all available data, P 1920C is expected to absorb to a limited extent by the oral and dermal route. A value of 10% is proposed for both routes for risk assessment. Exposure via the respiratory route is expected for a minor part of the particulates. A value of 100% is proposed as worst case for the respiratory route for risk assessment.

Distribution and bioaccumulation of P 1920C is expected to be limited. Cytochrome P450 metabolism is predicted to consist mainly of O-dealkylation or epoxidation of the vinylether, and N-dealkylation, which are expected to be converted to less toxic substances rapidly as all genotoxicity tests performed were negative.

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