Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.