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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 April 2018 to 25 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

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
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, tall-oil mono-
EC Number:
263-034-7
EC Name:
Glycerides, tall-oil mono-
Cas Number:
61789-12-6
Molecular formula:
C19H38O4 to C21H42O4 * (mono-glycerides) # C37H66O5 to C39H76O4 * (di-glycerides) # C55H96O6 to C57H108O4 * (tri-glycerides) # * in H2 increments (i,e, decreasing # of double bonds)
IUPAC Name:
Glycerides, tall-oil mono-
Test material form:
liquid
Details on test material:
Name: LUMULSE GMT-K
Batch no.: 385932
Appearance: opaque amber liquid
Purity: 100%
Homogeneity: homogeneous
Expiry date: 26. Oct. 2019
Storage: Room Temperature: (20 ± 5°C)
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: 8-9 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, 3 animals per cage in a room equipped with central airconditioning. The average room temperature was maintained within the range of 22.85 ± 0.59 °C, relative humidity within 54.53 ± 3.30 %. 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. The certificate of analysis is included in the raw data.
Water: The animals received tap water for human consumption. Supply of drinking was unlimited. The quality of drinking water is periodically analysed and recorded; certificate of analysis is included in the raw data.
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification: The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study code, ID of animals and date of administration of the test item.
Justification for the Choice of Species: Normally females are used for testing according to 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:
Vehicle: Olive oil
Lot Number: L71143
Expiry Date: 10/2018
Manufacturer: Oleificio Luca, Italy
Storage: 20 ± 5 °C
Justification for the Choice of Vehicle: Olive oil is a common vehicle in toxicity studies like OECD TG 423

Dose Preparation
The required amount of the test item (according to the body weight and dose) was mixed with vehicle (Olive oil) shortly before administration. The dose of 2000 mg/kg was administered in a volume of 5 mL/kg body weight.

Dose Levels
The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose.
Doses:
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.
No. of animals per sex per dose:
3 animals per group (6 in total).
Control animals:
no
Details on study design:
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 administration of the test item 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.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.
Clinical signs:
other: No mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.
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

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Respiratory System

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Circulatory System

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

CNS

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Somatomotoric Activity

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Tremor

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Spasms

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Salivation

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Diarrhea

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

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

193

214

218

21

25

4

2

191

189

200

-2

9

11

3

195

210

219

15

24

9

4

180

196

196

16

16

0

5

189

204

208

15

19

4

6

189

211

227

22

38

16

 

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:
Category 5 based on GHS criteria
Conclusions:
The LD50 of the test item LUMULSE GMT-K 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 LUMULSE GMT-K is according to GHS criteria 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 LUMULSE GMTK when administered as a single oral dose to Wistar rats.

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

A limit dose of 2000 mg/kg body weight was used as a starting dose. The test item administered to 6 females at a limit dose did not cause death. The body weight of all animals increased during the study.

A slight decrease of body weight in one animal within the 1st week was observed. A stagnation of body weight in another one animal was observed between the first and second week after administration of the test item. During necropsy, no macroscopic findings were observed.

The LD50 of the test item LUMULSE GMT-K 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 LUMULSE GMT-K is according to GHS criteria 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.