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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Modern, high quality investigative study; non-GLP and non-guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Objective of study:
absorption
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The study investigated the absorption of the submission sustance in an in vitro everted rodent intestinal sac model.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Penta
IUPAC Name:
Penta
Constituent 2
Chemical structure
Reference substance name:
Pentaerythritol
EC Number:
204-104-9
EC Name:
Pentaerythritol
Cas Number:
115-77-5
Molecular formula:
C5H12O4
IUPAC Name:
2,2-bis(hydroxymethyl)propane-1,3-diol
Test material form:
other: liquid
Details on test material:
Pentaerythritol (Penta), supplied by Perstorp Holdings
Specific details on test material used for the study:
Pentaerythritol (Penta),supplied by Perstorp Holdings
Molecular formula : C5H12O4
Molecular weight : 136.15
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Intestinal sacs were prepared from male Han Wistar Rats, approximately 8-12 weeks of age. Rats were obtained from Harlan, Bicester, UK.

Administration / exposure

Route of administration:
other: in vitro
Vehicle:
other: 'Fed State' Simulated Intestinal Fluid (FeSSIF)
Details on exposure:
The sacs from two rats were incubated in triplicate at 37°C for 1 hour.
Duration and frequency of treatment / exposure:
Absorption was assessed over a period of one hour
Doses / concentrations
Dose / conc.:
50 other: mM
No. of animals per sex per dose / concentration:
The sacs from two rats were used
Control animals:
no
Positive control reference chemical:
Not required
Details on study design:
The everted intestinal sacs were prepared by gently everting a freshly excised rat proximal small intestine over a glass stirring rod, rinsing with TC-199 media and filling the everted intestine with oxygenated FeSSIF medium at 37°C and dividing it into sacs approximately 2.5 cm in length using braided suture silk.
Details on dosing and sampling:
After 1 hour the individual sacs were removed, washed with running water and blotted dry. The sacs were cut open and the serosal fluid drained into small tubes. Each tube was weighed before and after collection of the serosal fluid to accurately calculate the volume of medium collected from inside the sac.
Statistics:
Calculation of mean and standard deviation: no further statistical analyses required.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The calculated concentrations of Penta in the serosal fluid from the intestinal sac incubations were 38.233mM (±0.626) from Rat 1 and 38.331mM (±0.501) from Rat 2.

Metabolite characterisation studies

Metabolites identified:
not measured

Any other information on results incl. tables

Calculated concentration of Penta in serosal fluid

 

Sample

Calculated concentration of Penta in serosal fluid (mM)

Mean (mM)

±SD

 

 

 

 

Serosal fluid 1 Rat 1

38.382

 

 

Serosal fluid 2 Rat 1

38.770

 

 

Serosal fluid 3 Rat 1

37.545

38.233

0.626

 

 

 

 

Serosal fluid 1 Rat 2

37.770

 

 

Serosal fluid 2 Rat 2

38.492

 

 

Serosal fluid 3 Rat 2

38.731

38.331

0.501

 

 

 

 

External media 60 min

45.617

 

 

 

Calculated amount of Penta absorbed into serosal fluid

 

Sample

Calculated amount of Penta absorbed into serosal fluid (µmoles/400µL)

Mean (µmoles)

±SD

 

 

 

 

Serosal fluid 1 Rat 1

15.353

 

 

Serosal fluid 2 Rat 1

15.508

 

 

Serosal fluid 3 Rat 1

15.018

15.293

0.250

 

 

 

 

Serosal fluid 1 Rat 2

15.108

 

 

Serosal fluid 2 Rat 2

15.397

 

 

Serosal fluid 3 Rat 2

15.493

15.332

0.200

 

 

 

 

External media 60 min

18.247

 

 


 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: The results of the study indicate that Penta is extensively absorbed in the everted rodent intestinal sac model
The results of the study indicate that Penta is extensively absorbed in the everted rodent intestinal sac model.
Executive summary:

The potential gastro-intestinal absorption of Penta was assessed in vitro, in the everted rodent gut sac model. The results of the study indicate that Penta is extensively absorbed in the everted rodent intestinal sac model.