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Administrative data

Description of key information

The acute oral median lethal dose of 11-methyldodecyl laurate in Wistar rats was found to be > 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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.
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.
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Reason: study scientifically not necessary / other information available
Justification: dermal route was chosen as second route considering the nature of the substance and the likely route of human exposure. - According to REACH Regulation Annex VIII (second column): “In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 (that is inhalation route) to 8.5.3 (that is dermal route) shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure”. Since the substance has a low vapor pressure and considering the substance uses, dermal route has been chosen.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The justification for type of information is provided in attachment.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred (Table 1).
Clinical signs:
Piloerection and/or chromodacryorrhoea were noted in all males on Day 1 and/or 2. No clinical signs of systemic toxicity were noted in females.
Scales, scabs, focal erythema were seen in the treated skin-area of all females and three males during the observation period.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity (Table 2).
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals (Table 3).

Table 1 Mortality Data:

Test Day

1

1

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Hours After Treatment

0

2

4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Males 2000 mg/kg

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

Females 2000 mg/kg

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

- = Sign not observed.

Table 2. Body weight (grams)

Sex/ dose level

Animal

Day 1

Day 8

Day 15

Male 2000 mg/kg

 

 

 

 

 

1

284

290

322

 

2

286

293

315

 

3

282

293

313

 

4

269

274

291

 

5

273

279

295

 

Mean

279

286

307

 

St.Dev

7

9

13

 

N

5

5

5

Females 2000 mg/kg

6

190

192

197

 

7

191

201

214

 

8

181

183

194

 

9

194

190

207

 

10

186

188

194

 

Mean

188

191

201

 

St.Dev

5

7

9

 

N

5

5

5

 

Table 3. Macroscopic Findings:

Animal Organ

Finding

Day of Death

Male 2000 mg/kg

 

 

1

No findings noted

Scheduled necropsy

Day 15 after treatent

2

No findings noted

Scheduled necropsy

3

No findings noted

Day 15 after treatent

4

No findings noted

Scheduled necropsy

5

No findings noted

Day 15 after treatent

Female 2000 mg/kg

No findings noted

Scheduled necropsy

Day 15 after treatent

6

No findings noted

Scheduled necropsy

Day 15 after treatent

7

No findings noted

Scheduled necropsy

Day 15 after treatent

8

No findings noted

Scheduled necropsy

Day 15 after treatent

9

No findings noted

Scheduled necropsy

Day 15 after treatent

10

No findings noted

Scheduled necropsy

Day 15 after treatent

 

Interpretation of results:
not classified
Conclusions:
The experimental data obtained by testing decyl octadec-9-enoate can be reliably extrapolated (by read-across) to 11-methyldodecyl laurate and support the absence of acute dermal toxicity of the substance.
Overall, 11-methyldodecyl laurate should not be classified for the acute dermal toxicity in accordance with Regulation (EC) n. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Read-across from supporting substance (decyl octadec-9-enoate)

Additional information

The experimental data obtained by testing decyl octadec-9-enoate can be reliably extrapolated (by read-across) to 11-methyldodecyl laurate and support the absence of acute dermal toxicity of the substance.

Overall, 11-methyldodecyl laurate should not be classified for the acute dermal toxicity in accordance with Regulation (EC) n. 1272/2008.

Justification for classification or non-classification

Based on the test results, the substance should not be classified for the acute toxicity by oral and dermal route.

No information about the inhalation route is available (i.e. data lacking).