Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test item was administered at a single dose by gavage using a feeding tube.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
Doses:
The test item was administered at a dose volume of 10 mL/kg body weight.
3 Female per 300 mg/kg body weight.
6 Female per 2000 mg/kg body weight.
No. of animals per sex per dose:
3 Female per 300 mg/kg body weight.
6 Female per 2000 mg/kg body weight.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: once daily
- Frequency of weighing: on day 1 (prior to the administration) and on day 8 and 15.
- Necropsy performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, mortality

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50 cut-off
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality.
Clinical signs:
No signs of toxicity.
Body weight:
None of the animals showed weight loss during the observation period.
Gross pathology:
No specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, a single oral application of the test item TEA Trioleate to rats at a dose of 300 mg/kg body weight was associated with no signs of toxicity or mortality.
Under the conditions of the present study, a single oral application of the test item TEA Trioleate to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.
The median lethal dose of TEA Trioleate after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): ∞ mg/ kg bw
Executive summary:

One group of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 300 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.03 g/mL and administered at a dose volume of 10 mL/kg.

Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.

All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study without showing any test-item related signs of toxicity.

Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.

At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.

LD50 cut-off: ∞ mg/kg bw

Species/strain: WISTAR Crl: WI(Han) rats

Vehicle: Corn Oil

Number of animals: 3 per step / 3 steps performed