Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 07, 2018 - October 18, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 423

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
A total of 12 animals were used during this test, the rats used were female, nulliparous and non-pregnant of 8 to 10 weeks old, Weigt (g) Minimum: 177.3, Maximum: 195.6

The study was undertaken in compliance with the guidelines of the “Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), USA” and “Guidelines for Laboratory Animals Facility” issued by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), India.
Compliance of these guidelines ensures the humane care of animals used throughout the experiment. It further enhances the well-being of animals which subsequently promotes a quality outcome of the experiment, for the advancement of biological knowledge, relevant to human and animals.
Project proposal for the experimentation was approved by the “Institutional Animal Ethics Committee (IAEC)”, JRF.

Acclimatisation
An acclimatisation Period of 6 to 12 days was observed.

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 chew blocks were provided as enrichment material.
Water Bottle: Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle.
Housing: Three rat per cage
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.

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).
Individual dose volume was adjusted according to body weight, dose level and density (0.8626 g/mL). All rats were dosed by oral gavage (day 0) using a metal cannula attached to a BD 1 mL disposable syringe which was graduated up to 1 mL. Rats were fasted overnight prior to dosing until three hours post-dosing.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
As no information was available of test item, the first set (set I) of three female rats was given a single dose of 300 mg 11-methyldodecyl laurate/kg body weight. No mortality was observed at this dose level so a second set (set II) of three female rats was administered with same dose level of 300 mg 11-methyldodecyl laurate/kg body weight. No mortality was observed at this dose level so a third set (set III) of three female rats was administered with higher dose level of 2000 mg 11-methyldodecyl laurate/kg body weight. No mortality was observed at this dose level so a fourth set (set IV) of three female rats was administered with same dose level of 2000 mg 11-methyldodecyl laurate/kg body weight. No mortality was observed at this dose level hence the endpoint was achieved and further testing was not required.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality was observed in rats treated with 300 and 2000 mg 11-methyldodecyl laurate/kg body weight.
Clinical signs:
No clinical singns were observed in rats treated with 300 and 2000 mg 11-methyldodecyl laurate/kg body weight.
Body weight:
Normal gain in body weight was observed in all the rats treated with 300 and 2000 mg 11-methyldodecyl laurate/kg body weight.
Gross pathology:
External examination of terminally sacrificed rats did not reveal any abnormality.
Visceral examination of terminally sacrificed rats did not reveal any abnormality.

Any other information on results incl. tables

TABLE1:Mortality

 

                                                                                                                                        Sex: Female

Dose

(mg/kg body weight)

Set

Number of Rats Used

Mortality after Dosing

At Hour

(Day 0)

On Day

0.5 – 4

5

1

2

3

4 - 7

8 - 14

300

I

3

0

0

0

0

0

0

0

II

3

0

0

0

0

0

0

0

2000

III

3

0

0

0

0

0

0

0

IV

3

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral median lethal dose of 11-methyldodecyl laurate in Wistar rats was found to be 5000 mg/kg body weight.
Executive summary:

In an acute oral toxicity study, four sets of fasted Wistar rats (3 females/set) (8 to 10 weeks) were given a single oral dose of11-methyldodecyl laurateat 300(for set I and II) and 2000 (for set III and IV) mg/kg body weight and all rats were observed for 14 days.There were no treatment-related mortality, clinical sign and changes in body weight or necropsy findings observed.The acute oral median lethal dose (LD50) of 11-methyldodecyl laurateinWistar rats was found to be 5000 mg/kg body weight.