Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to internationally accepted test guidelines and is considered relevant, adequate and reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

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:

Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine

EC Number:

270-279-3

EC Name:

Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine

Cas Number:

68424-19-1

Molecular formula:

Not applicable as the substance is a UVCB

IUPAC Name:

Fatty acids, C16-18 (even numbered) and C18-unsatd., compds. with triethanolamine.

Test material form:

semi-solid (amorphous): gel

Remarks:

paste

Details on test material:

- Name of test material (as cited in study report): Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine.
- Physical state: Viscous, translucent yellowish waxy paste
- Analytical purity: >95%
- Impurities (identity and concentrations):See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: 01/2013
- Lot/batch No.: DDR02/91
- Expiration date of the lot/batch: October 2014
- Storage condition of test material: At +10° to +25°C
- Other: Manufacturer/Supplier: OLEON NV, Assenedestraat 2, 9940 Ertvelde, Belgium

Test animals

Species:

rat

Strain:

other: CD / Cri: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Germany GmbH, Research Models and Services, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at start of administration: Approx. 8 weeks
- Weight at start of administration: 164-180 g
- Fasting period before study: Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus). Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food and was offered ad libitum.
- Water (e.g. ad libitum): Drinking water was offered in bottles ad libitum.
- Acclimation period: At least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C (maximum range)
- Humidity (%): 55% ± 15% (maximum range)
- Air changes (per hr): 12-18 fold air change per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 11, 2013 To: April 2, 2013

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
The ATC- test method permits the identification of the 'acute-toxic-class' (ATC), a measurement of the acute toxicity by the oral route.
The test item is administered orally by gavage at a single dose level to a group of experimental animals. The dose used is selected from a series of defined dose levels. Due to the small number of animals used with this method, there is no need to perform a range finding test.
The test item is tested using a stepwise procedure, each step uses three female animals. The results of each step determine if:
- no further testing is needed,
- the next step will be performed with the same dose,
- the next step will be performed at the next higher or next lower dose level.

At 2000 mg/kg bw
- Testing at 2000 mg/kg bw:
Three animals of one sex (preferably females) are treated at 2000 mg/kg bw (first step). If two to three animals die, testing at 300 mg/kg bw should be performed.
If no to one animal dies, the test item should be retested (second step) with 2000 mg/kg bw, using three animals of the same sex.
If, in this second step, two to three animals die, testing at 300 mg/kg bw should be performed. If, in this second step, no to one animal dies, no further testing is necessary.

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

6 (3 in the first step, 3 in the second step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed.
During the follow-up period of 2 weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms had subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on deaths were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes.
At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. Autopsy and macroscopic inspection of animals which died prematurely would have been carried out as soon as possible after exitus.
No histopathology was carried out as no macroscopical findings were noted at autopsy.
- Other examinations performed: The LD50 value was ranked exceeding 2000 mg/kg body weight.

Statistics:

No statistical analysis could be performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death was recorded within the test period.

Clinical signs:

other: No clinical signs were recorded within the test period.

Gross pathology:

No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg

Executive summary:

Acute oral toxicity, was tested in rats according to OECD guideline 423 and EC method B.1 tris (ATC method). A first group of three females were dosed at 2000 mg active ingredient/kg bw, followed by a second group of 3 females at same dose. The test item, Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine was suspended in sesame oil and administered by oral gavage at a volume of 10 mL/kg bw.

No-observed-effect level by oral administration was 2000 mg/kg bw. Dose level with first intolerance reactions by oral administration was >2000 mg/kg bw. Lowest lethal dose level by oral administration was >2000 mg/kg bw. LD₅₀was above 2000 mg/kg bw, p.o.

Under the present test conditions, a single oral administration of 2000 mg/kg bw did not reveal any signs of toxicity. No death was recorded within the test period. All animals gained the expected weight throughout the whole study period. No signs or abnormalities were noted at necropsy.