[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Ether diicosylique

IUPAC Name:

Ether diicosylique

Constituent 2

Reference substance name:

Ethanesulphonic acid

EC Number:

209-843-0

EC Name:

Ethanesulphonic acid

Cas Number:

594-45-6

Molecular formula:

C2H6O3S

IUPAC Name:

ethanesulfonic acid

Constituent 3

Reference substance name:

Icosanol

IUPAC Name:

Icosanol

Constituent 4

Reference substance name:

Esylate de glycine bétaïne

IUPAC Name:

Esylate de glycine bétaïne

Constituent 5

Reference substance name:

Eicosyl betainate esylate

Molecular formula:

C27NSO4

IUPAC Name:

Eicosyl betainate esylate

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species : Wistar rats

Source: Institue of Experimental Pharmacology and Toxicology, Center of Experimental Medicine of the Slovak Academy of Sciences, Dobrá Voda, Slovak Republic

Number and Sex of Animals 6 – 9 females

Age at First Dose: At least 8 – 12 weeks; female animals will be non-pregnant and nulliparous.

Animal Health The health condition of animals will be examined by a veterinarian before initiation of the study.

Acclimation: The animals will be acclimated to the condition identical to the condition during the experiment at least 5 days prior to the start of treatment. The acclimation will be according to standard operation procedures.

Housing Condition : The animals will be housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, in a room equipped with central air-conditioning. The room temperature will be within the range of 22±2°C. The relative humidity will be 55±10%. The light regime will be set to a 12-hour light /12-hour dark cycle. The sanitation will be performed according to standard operation procedures.

Diet : A standard laboratory food KKZ-P/M (UEFT CEM SAS) will be available ad libitum. The certificate of analysis will be included in the raw data.

Water: The animals will receive tap water for human consumption. Supply of drinking water will be unlimited. The quality of drinking water is periodical monitored (including microbiological control) and recorded; certificate of analysis will be included in raw data.

Bedding: AlpenSpan Eco, Johann Pabst Holzindustrie GmbH, Zeltweg, Austria

Animals Identification: Each animal will be marked with an ID number. Each cage will be affixed with a cage card containing pertinent animal and study information. The animals in cages will be marked by a line on the tail with an ink marker.

Justification for the Choice of Species: Female rats will be used as recommended by the OECD TG 423 guideline.

Administration / exposure

Route of administration:

oral: gavage

Details on oral exposure:

The test item will be administered in a single dose by gavage using an oral gavage. Animals will be fasted prior to dosing (food but not water will be withheld over-night). Following the period of fasting, the animals will be weighed and the test item will be administered. After the test item has been administered, food will be withheld for further 3 – 4 hours.

Doses:

The starting dose can be selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight. Available information indicated that the test item was likely to be non-toxic regarding acute toxicity therefore we chose a dose of 2000 mg GBE C20 Reaction mass between glycine betaine, ethanesulphonic acid and eicosan-1-ol /kg body weight to be used as a starting dose.

No. of animals per sex per dose:

A group of 3 females will be dosed.

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period at limit dose of 2000 mg/kg body weight was observed. Animal No 5 exhibited slight piloerection after ½ an hour from administration and went to normal behavior in 1 hour.

Other findings:

Necropsy
All animals were necropsied. No visible pathological findings were observed in animals dosed with 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item “GBE C20 Reaction mass between glycine betaine, ethanesulphonic acid and eicosan-1-ol” when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.
A limit dose of 2000 mg/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose.
In the first step, one group of 3 females was dosed. The test item at this dose did not cause death in the next 48 hours and therefore another 3 females were treated at the same dose level. The test item GBE C20 Reaction mass between glycine betaine, ethanesulphonic acid and eicosan-1-ol administered to 6 females Wistar rats at a limit dose of 2000 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. During necropsy we did not observe any macroscopic findings in all Animals at this dose level. The LD50 of the test item “GBE C20 Reaction mass between glycine betaine, ethanesulphonic acid and eicosan-1-ol” is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item GBE C20 Reaction mass between glycine betaine, ethanesulphonic acid and eicosan-1-ol is classified in GHS Category 5 – Unclassified. Limit test with dose of 5000 mg/kg body weight was not conducted.