Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
Toxicokinetic assessment of the substance based on the available data
Type of information:
other: expert statement
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: since this is a theoretical assessment, the Klimisch value cannot be 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Objective of study:
other: Toxicokinetic assessment of the substance based on the available data
Test guideline
Qualifier:
according to
Guideline:
other: Guidance for the implementation of REACH. Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. European Chemical Agency.
Version / remarks:
Version 2.0; November 2014
Deviations:
not applicable
GLP compliance:
no

Results and discussion

Any other information on results incl. tables

Toxicokinetic assessment

 

A toxicant can enter the body via the gastrointestinal tract, the lungs and the skin.

 

In general, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract after oral administration. POEMA is good water soluble and, in combination with the partition coefficient (≤ 3.6), the absorption of POEMA is considered to be good. For risk assessment purposes oral absorption of POEMA is set at 100%. The oral toxicity data do not provide reasons to deviate from the proposed oral absorption factor.

For inhaled substances the processes of deposition of the substance on the surface of the respiratory tract and the actual absorption have to be differentiated. A vapor pressure of less than 0.5 kPa (< 1.5 × 10-3 Pa) and a boiling point above 150°C (reaction and/or decomposition of the test substance was observed starting at 175°C) indicate a low volatility. If POEMA reaches the tracheobronchial region, it is likely to diffuse/dissolve into the mucus lining of the respiratory tract due to its water solubility and subsequently will be absorbed due to its partition coefficient.

Based on the above data, for risk assessment purposes the inhalation absorption of POEMA is set at 100%. The oral toxicity data do not provide reasons to deviate from the proposed inhaled absorption factor.

POEMA is a liquid which is taken up when it comes in contact with the skin. According to the criteria given in the REACH Guidance, a default value of 100% dermal absorption should be used unless MW >500 and log Pow <-1 or >4, in which case a value of 10% skin absorption should be chosen. The log Pow of POEMA indicates that absorption is to be expected. In addition, POEMA has skin corrosive properties, resulting in destruction of the skin barrier function. Based on these considerations, for risk assessment purposes the dermal absorption of POEMA is set at 100%.

Once absorbed, distribution of the substance throughout the body is expected based on its water solubility and partition coefficient. Absorbed POEMA might undergo biotransformation. The biotransformation products will either be excreted via the bile (high molecular weight compounds) or excreted via urine (low molecular weight compounds). Based on its partition coefficient and water solubility POEMA is not expected to accumulate significantly in adipose tissue.

Applicant's summary and conclusion

Conclusions:
For risk assessment purposes, 100% is used for oral, dermal and inhalation absorption.
Based on the available information POEMA is considered to have no significant bioaccumulation potential.