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Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method

Data source

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

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment based on toxicity data presented for BPA EO and BPA PO.
Limited toxicity findings.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-isopropylidenebis(p-phenyleneoxy)diethanol
EC Number:
212-985-6
EC Name:
2,2'-isopropylidenebis(p-phenyleneoxy)diethanol
Cas Number:
901-44-0
Molecular formula:
C19H24O4
IUPAC Name:
2,2'-[propane-2,2-diylbis(4,1-phenyleneoxy)]diethanol

Results and discussion

Preliminary studies:
Substance appears to be absorbed orally, with metabolic activity based on transitory changes in liver function
Main ADME resultsopen allclose all
Type:
absorption
Results:
Orally, but no evidence of dermal or inhalation absorption
Type:
distribution
Results:
Effects seen in liver suggesting distribution
Type:
metabolism
Results:
Increased liver function suggesting metabolism
Type:
excretion
Results:
No evidence

Toxicokinetic / pharmacokinetic studies

Details on absorption:
There was no evidence of systemic effects reported in the data provided on the acute oral or dermal toxicity studies, but blood parameter changes observed in the repeat dose oral toxicity study would suggest that absorption does take place orally.

The low water solubility and potential high fat solubility suggests that it is likely that a significant proportion is excreted without being absorbed.

Details on distribution in tissues:
Systemic effects were observed in the subacute oral toxicity study with changes in blood chemistry and minor findings in the liver and kidneys. It is therefore possible to conclude that the substance, or the metabolites, are transported.
Details on excretion:
There is no evidence from testing performed that there is subsequent excretion of the absorbed substance or any metabolites formed. Slight transient effects in the kidney suggest some exposure to the kidney to the substance of metabolites.

Metabolite characterisation studies

Metabolites identified:
not measured

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
Assessed that some absorption occurs and there is evidence of metabolism.
Executive summary:

The absence of specific toxicokinetic data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion of the substance. However, there is sufficient evidence from other testing to show that some oral absorption takes place and there is likely to be adaptive changes to the animals following transportation and metabolism.

It is not considered appropriate to perform further animal studies on this substance.