Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Based on available physico-chemical properties and toxicological data of the substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP assessment based on physico-chemical properties and toxicological data of the substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Objective of study:
other: Toxicokinetic assessment
Principles of method if other than guideline:
An expert assessment was made based on all data available.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Esterification products of acrylic acid and 2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol
EC Number:
800-838-4
Cas Number:
1384855-91-7
Molecular formula:
Molecular formula not available for this UVCB.
IUPAC Name:
Esterification products of acrylic acid and 2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol
Details on test material:
- Name of test material (as cited in study report): DPHA
- Physical state: Colourless to slightly yellow viscous liquid
- Analytical purity: 100%

Administration / exposure

Details on study design:
A toxicokinetic assessment has been performed based on available physico-chemical properties and toxicological data of the substance.

Results and discussion

Main ADME results
Type:
absorption
Results:
Based on available physico-chemical properties and toxicological data of the substance, the oral absorption of DPHA is 100%.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
Based on available physico-chemical properties and toxicological data of DPHA, the oral absorption is 100% while the dermal absorption is 50%.
Executive summary:

The toxicokinetic assessment is based on the available physico-chemical properties and toxicological data of the substance.

According to REACH Guidance R.7C, the molecular weights around 500 of the main constituents DPHA and DPPA (578 and 524) are favourable for absorption in the gastrointestinal tract. Also, the log partition coefficients of these constituents (3.44 – 2.43) suggest that they will dissolve into the gastrointestinal fluid and be absorbed by passive diffusion. Only their water solubility (6 - 80 mg/L) is a limiting factor for absorption. On this basis, oral absorption was set at 100% for risk assessment purposes. In the gastro-intestinal tract, absorbed substance will be metabolized. Excretion of the substance and its metabolites will occur via bile (high molecular weight) or urine (low molecular weight).

Based on its low vapour pressure (4.28 x 10-8Pa at 25°C),exposure via inhalation will not be significant under ambient conditions but may occur in situations where the substance is aerosolized during use or handling (e.g. spraying).

According to the criteria given in the REACH Guidance, 10% dermal absorption will be considered in the case of a molecular weight > 500 g/mol and a log Kow < -1 or > 4, otherwise 50% dermal absorption should be proposed. Given the physico-chemical characteristics of the main constituents DPHA and DPPA, a dermal absorption of 50% was therefore considered for risk assessment purposes.

Given the presently available data, no additional conclusions can be drawn on the distribution, metabolism and excretion of DPHA after dermal and inhalation absorption.