Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 06, 2021 to February 08, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Molecular formula:

not applicable - UVCB substance

IUPAC Name:

Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Specific details on test material used for the study:

Test item name: Finestar 2009
CAS Number: 2225876-48-0
Water solubility: soluble in water
Molecular formula: C12 H22 O8
Molecular weight: 294.30
Batch/Lot number: 3253082031
analyzed purity: 100% active
Saponification value: 45.87
Date of manufacture: August 27, 2020
Date of expiry: August 26, 2021
Appearance: Pale yellow viscous liquid
Storage temperature: Room temperature (15 to 30°C)
Storage condition: Keep away from light, moisture, and oxidizing - reducing chemicals
Storage container: Keep in original container

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Age/Weight at Dosing : 8 to 11 weeks, Weight (g) Minimum: 190.8, Maximum: 226.0
Source : Animal Breeding Facility, Jai Research Foundation
Total Number of Animals used : Six females (nulliparous and non-pregnant)

Acclimatisation
Acclimatisation Period : 6 to 19 days

Husbandry Practices
Caging : Polypropylene rat cages covered with stainless steel grid top were used.
Autoclaved clean rice husk was used as the bedding material. Wooden blocks
were provided as enrichment material.
Water Bottle : Each cage was supplied with a polypropylene water bottle with a stainless
steel nozzle.
Room sanitation : Daily: 1. Rack was: cleaned with cloth, 2. Floor of experimental procedure
room was swept, 3. All work tops and the floor were mopped with a
disinfectant solution.

Animal Identification
Each rat was uniquely numbered on the tail using a tattoo machine on day 1 of acclimatisation.
Appropriate labels were attached to the cages indicating the study number, study code, test itemcode, set number, sex, dose, type of study, cage number and animal number.

Feed and Water
The rats were provided with feed (with the exception of overnight fasting prior to dosing and three hours post-dosing) and water, ad libitum. The quality of feed and water is regularly monitored at Jai Research Foundation. There were no known contaminants in the feed and water at levels that would have interfered with the experimental results obtained.
Feed : Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA.
Water : UV sterilized water filtered through Reverse Osmosis water filtration system.

Environmental Conditions
Animal Room : BMR 27, Department of Toxicology
Temperature : 19 to 23 °C
Relative Humidity : 56 to 66%
Air Changes : Minimum 15 air changes/hour
Photoperiod : The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h (photoperiod was maintained through automatic timer)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test item was a liquid end-use product and was tested undiluted (at a constant concentration).

Doses:

Rat number 1- 175 mg Finester 2009/kg body weight
Rat number 2- 550 mg Finester 2009/kg body weight
Rat number 3- 1750 mg Finester 2009/kg body weight
Rat number 4- 5000 mg Finester 2009/kg body weight
Rat number 5- 5000 mg Finester 2009/kg body weight
Rat number 6- 5000 mg Finester 2009/kg body weight

No. of animals per sex per dose:

One female

Control animals:

no

Details on study design:

Justification for Selection of the Test System
The rat (Rattus norvegicus) was selected as a test system because it is a readily available rodent species. It has been historically shown to be a suitable model for acute oral toxicity assessment and is recommended by the OECD and other regulatory authorities. Female rats were used as they have been shown to be most sensitive for this test. The results of the study are expected to be of value in predicting the acute toxicity of the test item in humans and higher mammals.

Dose Administration
Individual dose volume was adjusted according to body weight, dose level and density (1243 mg/mL). All rats were dosed by oral gavage (day 0) using a metal cannula attached to a BD 1 mL disposable syringe and Hamilton syringe which were graduated up to 1 mL and 100 μL, respectively. Rats were fasted overnight prior to dosing until three hours post-dosing.

Observations
The rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 5 hours post-administration on the day of dosing. Subsequently, the rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. The clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.

Necropsy
At the end of the 14 days observation period, all rats were euthanised by carbon dioxide asphyxiation and were subjected to gross pathological examination, consisting of external examination and opening of the abdominal and thoracic cavities.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in rats treated with Finester 2009.

Clinical signs:

other: No clinical sign related to treatment was observed in rats treated with Finester 2009.

Gross pathology:

External
An external examination of the terminally sacrificed rats did not reveal any abnormality.
Internal
Then visceral examination of the terminally sacrificed rats did not reveal any lesion.
In the absence of any lesion in the terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose level used in this study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of Finester 2009 was estimated to be greater than 5000 mg/kg body weight.
Based on the results of this study, an indication of the classifications for Finester 2009 is as mentioned below:
Globally Harmonized System of Classification and
Labelling of Chemicals (GHS 2019) -Unclassified

Executive summary:

Study Guidelines
The present study was conducted according to:
OECD, 2008: The Organisation for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, OECD 425, Acute Oral Toxicity – Up-and-Down Procedure, adopted by the Council on October 03, 2008.

Results-

The LD50 was calculated using the Dixon’s maximum likelihood method using software (AOT 425 StatPgm) and found to be greater than 5000 mg/kg body weight.
Since the LD50 value of Finester 2009 was found to be greater than 5000 mg/kg body weight, Finester 2009 is being classified “Unclassified” as per the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2019).