Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Slovak Academy of Sciences, Dobra Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 203-218g
- Fasting period before study: 10-12h prior to dosing
- Housing: plastic cages suspended on stainless steel racks, 3 rats per cage
- Diet (e.g. ad libitum): ssniff (ssniff Spezialdiäten GmbH, Germany) ad libitum
- Water (e.g. ad libitum): tap water for human consumption, ad libidum
- Acclimation period: 5 days prior to treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.2 mL/kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit dose
Doses:
2000 mg/kg bw/d
No. of animals per sex per dose:
3 + 3 females were dosed 2000 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: 0.5, 1, 2 and 4 hours after administration, thereafter daily.
- Weighing: immediately prior to administration and weekly thereafter.
- Necropsy of survivors performed: yes: external body surface and orifices, the appearance of tissues and organs in the thoracic cavity (trachea, esophagus, heart, aorta, lungs with main stem bronchi, thymus, tracheobronchial lymph node) and in the abdominal cavity (liver, spleen, adrenal glands, kidneys, ovaries, uterus including cervix, urinary bladder, small intestine, large intestine, pancreas, stomach, mesenteric lymph nodes).
- Other examinations performed: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behavioural pattern. Particular attention to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

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 observed.
Clinical signs:
No clinical signs of intoxication, change of health nor any other adverse reactions observed.
Body weight:
The body weights of all animals increased during the study. No body weight losses were observed between the first and second week after administration.
Gross pathology:
No macroscopic findings were observed during necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

The acute toxicity of the test item was examined by means of an OECD 423 Acute Toxic Class method in accordance with GLP. A limit dose of 2000 mg/kg body weight was used as a starting dose. The test item was administered to 6 female rats and was found to not cause death. During the observation period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction. The body weights of all animals increased during the study. No body weight losses were observed between the first and second week after administration. During necropsy, no macroscopic findings were observed.

The LD50 of the test item “Oligomerisation product obtained by plasma treatment of vegetable oil mono- and polyunsaturated C16 – C22 triglycerides”is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

The experimentally determined acute oral LD50 is > 2000 mg/kg bw. As a consequence, the substance does not need to be classified in accordance with the criteria of Regulation EC 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP).