Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: Expert review and assessment of available data.
Adequacy of study:
key study
Study period:
Report Issued: 13 February 2019.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Not assignable as the result is from expert assessment.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report Date:
2019

Materials and methods

Objective of study:
other: Basic toxicokinetic assessment to support REACH Annex VIII registration.
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Expert review of available data at REACH Annex VIII tonnage level.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Results and discussion

Applicant's summary and conclusion

Conclusions:
It is not possible to draw conclusions about the toxicokinetic profile of Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester from either acute and repeated dose oral toxicity studies or ecotoxicity studies as apart from some body weight effects in an acute inhalation study, no effects of note were observed following treatment. As a result it is not possible to determine if either the substance is systemically absorbed, or absorbed but to such a low degree that it cannot exert toxicity, or it is of such low toxicity that it is unable to exert any adverse effects.

Based on its physicochemical profile it is expected that the substance will be soluble in lipids and fats and if it is absorbed it could partition into body fats; however, given its chemical composition it is likely it will undergo metabolism and hence it is unlikely to accumulate in the body.
Executive summary:

Introduction

An expert review of toxicokinetic data on Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester was undertaken to provide a basic toxicokinetic asessment as required for REACH Annex VIII registration. The assessment was based on available data from toxicological studies studies. No specific toxicokinetic studies were undertaken.

Conclusion

It is not possible to draw conclusions about the toxicokinetic profile of Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl esterfrom either acute and repeated dose oral toxicity studies or ecotoxicity studiesas apart from some body weight effects in an acute inhalation study, no effects of note were observed following treatment. As a result it is not possible to determine if either the substance is systemically absorbed, or absorbed but to such a low degree that it cannot exert toxicity, or it is of such low toxicity that it is unable to exert any adverse effects.

 

Based on its physicochemical profile it is expected that the substance will be soluble in lipids and fats and if it is absorbed it could partition into body fats; however, given its chemical composition it is likely it will undergo metabolism and hence it is unlikely to accumulate in the body.