Amides, C16-18 (even numbered) saturated and C18 unsaturated, N,N'-[[(2-hydroxyethyl)imino]di-2,1-ethanediyl]bis-, ethoxylated (1-2.5 mol)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013 / 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 417 (Toxicokinetics)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Chemical Testing Methods - Health Effects Volume, Beijing: Cina Environmental Science press. 2013.09.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C16-18 and C18-unsatd., N,N'-[[(2-hydroxyethyl)imino]di-2,1-ethanediyl]bis-,ethoxylated, lactates (salts)

Cas Number:

1434133-00-2

Molecular formula:

C47H96N3O5+ C3H5O3-

IUPAC Name:

Amides, C16-18 and C18-unsatd., N,N'-[[(2-hydroxyethyl)imino]di-2,1-ethanediyl]bis-,ethoxylated, lactates (salts)

Test material form:

solid: bulk

Details on test material:

Batch ST02697671

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ST02697671
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, sealed

Radiolabelling:

no

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Experimental Animal Center of Zhejiang Province
- Age at study initiation: 6 - 8 weeks old
- Weight at study initiation: -
- Housing: stainless steel wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

physiological saline

Doses / concentrations

Dose / conc.:

450 mg/kg bw (total dose)

No. of animals per sex per dose / concentration:

3

Control animals:

not specified

Details on dosing and sampling:

TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): plasma
- Time and frequency of sampling: before exposure and after 5 min, 20 min, 40 min, 1 h, 2 h, 6 h, and 24 h.

Results and discussion

Preliminary studies:

The structure of REWOSOFT TE 19L was analyzed and found that there were three compounds which have a higher relative amount.

Main ADME results

Type:

distribution

Results:

the 3 compounds of Rewosoft TE 19L were not detected in plasma at the different time points.

Metabolite characterisation studies

Metabolites identified:

not specified

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:

The stability of these three compounds in rat whole blood, rat plasma, and rat blood cells was studied. It was found that these three compounds are very unstable incubated in rat whole blood at 37°C, suggesting that they are also not stable in vivo.

Applicant's summary and conclusion

Conclusions:

The stability of three compounds of Rewosoft TE 19L in rat whole blood, rat plasma and rat blood cells was studied. It was found, that the instability in vivo was too high to determine its distribution.