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Administrative data

Link to relevant study record(s)

Reference
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.
Objective of study:
other: Basic toxicokinetic assessment to support REACH Annex VIII registration.
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
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. 

Description of key information

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

Key value for chemical safety assessment

Additional information

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.