11-methyldodecyl laurate

Endpoint summary

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

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system 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:

other: No clinical singns were observed in 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 N°	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 for cross-reference:

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 for cross-reference:

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:

other: 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 obs

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).