Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January 2017 to 15 February 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Acute Oral Toxicity-Acute Toxic Class Method, OECD Guideline for Testing of Chemicals No 423, Adopted: 17th December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol

EC Number:

270-471-7

EC Name:

Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol

Cas Number:

68441-67-8

Molecular formula:

Not applicable - UVCB

IUPAC Name:

Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol

Test material form:

liquid

Details on test material:

Designation in Test Facility: 16102602G
Date of Receipt: 26. Oct. 2016
Condition at Receipt: Room temperature, in proper conditions

Specification
Name Hatcol 3178
Batch no. 2011280182
Appearance: Clear liquid
CAS No.: 68441-67-8
EINECS-No.: 270-471-7
Molecular formula: C33H60O8 to C41H76O8 (in CH2 unit increments)
Molecular weight: 692 daltons
Purity: 99.6 %
Homogeneity: homogeneous liquid
Stability: H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility: H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Production date: 18. Jul. 2011
Expiry date: 01. Nov. 2019
Storage: Room Temperature (20 ± 5°C)

Storage in Test Facility
The test item was stored in a closed flask at 15.8 – 22.0 °C, protected from humidity.

Specific details on test material used for the study:

No further details specified in the study report.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species: Wistar rats
Source: Dobrá Voda, Slovak Republic
Number and Sex of Animals: 6 females
Age at First Dose: 8-12 weeks; female animals were non-pregnant and nulliparous
Animal Health: Health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central airconditioning.
The average room temperature was maintained within the range of 22.1 ± 0.5° C, relative humidity within 54.0 ± 3.5 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.
Diet: The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time.
Water: The animals received tap water for human consumption. Supply of drinking was unlimited.
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification: Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in the cages were marked by a line on the tail with an ink marker.
Justification for the Choice of Species: Normally females are used for testing OECD TG 423 because females are typically the more sensitive gender.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The required amount of the test item (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration.

Doses:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose.

No. of animals per sex per dose:

One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose.

Control animals:

no

Details on study design:

Dose Administration
The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the test item administered. After test article administration, food was withheld for further 3-4 hours.

Clinical Observation
Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Body Weight
Individual weights of animals were measured immediately prior to test item was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.

Necropsy
All test animals were subjected to gross necropsy and the results were recorded for each animal.

Statistics:

Not specified

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 was observed during the study.

Clinical signs:

During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction negative reactions.

Body weight:

The body weights of all animals increasing slightly during the study. Stagnation of body weight increases was observed in 2 animals (rat No 3 and No 5) and a slight increase in the body weight of the rest animals was observed during the first and second week follow up.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Any other information on results incl. tables

Administration Results

Sex	Dose	ID	Result	Sex	Dose	ID	Result
Female	2000 mg/kg	1	Alive	Female	2000 mg/kg	4	Alive
		2	Alive			5	Alive
		3	Alive			6	Alive

 

Clinical Observation

Observation	Time After Administration
	Hour					Day
	Immediately	0.5	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
Skin and Hair	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Eyes	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Mucosa	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Respirator System	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Circulatory System	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
CNS	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Somatomotric Activity	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Tremor	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Spasms	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Salivation	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Diarrhoea	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Lethargy	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Sleep	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Coma	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Death	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-

- No observed signs

 

Body Weight

Sex	Dose	ID	Body Weight (g)			Body Weight Difference (g)
			Initial	Week 1	Week 2	Week 1 – Initial	Week 2 – Initial	Week 2 – Week 1
Female	2000 mg/kg	1	200	220	225	20	25	5
		2	200	225	230	25	30	5
		3	180	200	200	20	20	0
		4	185	185	190	0	5	5
		5	205	210	210	5	5	0
		6	205	205	210	0	5	5

 

Necropsy Results

Sex	Dose	ID	Result	Sex	Dose	ID	Result
Female	2000 mg/kg	1	No finding	Female	2000 mg/kg	4	No finding
		2	No finding			5	No finding
		3	No finding			6	No finding

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item Hatcol 3178 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 Hatcol 3178 is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item Hatcol 3178 when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item related mortality was not observed during 24 hours and therefore in a next steps 3 females were treated with the same dose. All 6 females survived the limit dose. The limit dose of 2000 mg/kg body weight did not cause death, evident signs of toxicity or body weight loss during the 14-day long observation period.

The LD50 of the test item Hatcol 3178 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 Hatcol 3178 is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.