4,4'-Isopropylidenediphenol, ethoxylated

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

calculation (if not (Q)SAR)

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

Test material information

Constituent 1

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 results

Main ADME results 1

Type:

absorption

Results:

Orally, but no evidence of dermal or inhalation absorption

Main ADME results 2

Type:

distribution

Results:

Effects seen in liver suggesting distribution

Main ADME results 3

Type:

metabolism

Results:

Increased liver function suggesting metabolism

Main ADME results 4

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:

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.