[No public or meaningful name is available]

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Materials and methods

Objective of study:

other: to determine the rate of hydrolysis of the test substance and the rate of formation of a hydrolysis product in a simulated gastric fluid.

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

A simulated gastric fluid was prepared, treated with the test substance and incubated in the dark at constant temperature. After 15 minutes, the solution was analysed for the test substance and the expected hydrolysis product.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty alcohols C13-15 (odd numbered, linear and branched), reaction products with ethylene oxide, sodium chloroacetate and ethanolamine

Molecular formula:

R-O-(CH2CH2O)nCH2CO-NH-CH2CH2OH

IUPAC Name:

Fatty alcohols C13-15 (odd numbered, linear and branched), reaction products with ethylene oxide, sodium chloroacetate and ethanolamine

Test material form:

liquid

Details on test material:

- appearance: clear yellowish viscous liquid
- Manufacturing/expiry date: 13Dec.2018/13Dec.2019
- storage conditions at test facility: Ambient temperature (range 18-25°C), in original plastic container (PEHD) protected from direct sunlight.
- thermal stability: maximum 35°C (recommended storage 15-35°C)

Specific details on test material used for the study:

Storage condition of test material: refrigerated (1 - 5°C)

Radiolabelling:

no

Test animals

Details on test animals or test system and environmental conditions:

Not applicable.

Administration / exposure

Details on exposure:

Not applicable.

Duration and frequency of treatment / exposure:

15 minutes.

Doses / concentrations

Dose / conc.:

10.3 other: mg/L

Details on study design:

- Test solutions preparation: A stock solution of the test item was prepared at a concentration of 10.3 g/L in acetonitrile by adding 106.3 mg of the test item to 10 mL of acetonitrile. A solution at 10.3 mg/L of the test item was prepared by mixing 50 µL of the stock solution with 50 mL of SGF pre-heated at 37°C. After that, the solution was divided in 2 replicates in 10 mL flasks filled to the brim. A control solution was also prepared by filling a flask with SGF (without test item).
- Other:
- The test flasks were protected from light and incubated at 37 °C for 15 minutes without shaking.
- The temperature of the test was monitored using a thermometer

Details on dosing and sampling:

- Sampling and analysis:
The concentrations of the test substance and ETHANOLAMINE were determined twice in the test solution at 10.3 mg/L immediately after preparation and immediately after the incubation. After the 15 minutes of incubation, the concentrations of the test substance and ETHANOLAMINE in the two replicates and in the control solution were determined. Final pH of the test solutions was monitored with special indicator strips.

Statistics:

None

Results and discussion

Main ADME results

Type:

other: Hydrolysis

Results:

- The rate of hydrolysis RH determined for the main constituent of the registered substance is 5 %. The rate of formation of ETHANOLAMINE RFEA is 0 %.

Any other information on results incl. tables

 

Table 7.1.1/1: the measured concentrations of the test substance and ETHANOLAMINE (in mg/L):

	Test substance		ETHANOLAMINE
	T0	T15	T0	T15
Control	-	< 0.3	< 0.03	< 0.03
Replicate 1	13.3	10.7	< 0.03	< 0.03
Replicate 2	10.7	12.0	< 0.03	< 0.03
Mean	12.0	11.4	< 0.03	< 0.03

Applicant's summary and conclusion

Conclusions:

Under the test conditions, After 15 minutes of incubation in a simulated gastric fluid at 37 °C, the test substance did not decompose into ETHANOLAMINE. However, some weak evidence of hydrolysis of the test substance was observed.

Executive summary:

The purpose of this study was to determine the rate of hydrolysis of the test substance in a simulated gastric fluid. A simulated gastric fluid was prepared, treated with the test substance and incubated at 37 °C in the dark at constant temperature. After 15 minutes, the solution was analysed for the test substance and the expected hydrolysis product. The test item concentrations were monitored by UPLC-MS/MS.

The rate of hydrolysis calculated for the test item is to 5.0 %. The variations observed in the test item concentrations between T0 and T15 may also be due to the uncertainty of the analytical method. Besides, no formation of ETHANOLAMINE (a suspected hydrolysis product) was observed.

Therefore, after 15 minutes of incubation in a simulated gastric fluid at 37 °C, the test item did not decompose into ETHANOLAMINE.