Heavy wax residue fraction, waste plastic derived, hydrothermal conversion

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 10 March 2022 to 7 April 2022

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Heavy wax residue fraction, waste plastic derived, hydrothermal conversion

Molecular formula:

Not applicable - UVCB

IUPAC Name:

Heavy wax residue fraction, waste plastic derived, hydrothermal conversion

Test material form:

other: solid - lumps

Details on test material:

- Stability: stable under storage conditions
- Storage: room temperature (20 ± 5 °C)
- Appearance: large, brown, solid lumps
- Purity: not applicable, UVCB
- Homogeneity: homogeneous
- EC no.: 950-445-8

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute of Experimental Pharmacology and Toxicology, Center of Experimental Medicine of the Slovak Academy of Sciences, Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Fasting period before study: Overnight + 3-4 h after administration of test item
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, in a room equipped with central air-conditioning.
- Diet: A laboratory food (Altromin 1324 Spezialfutter GmbH & Co. KG, Germany) were offered in recommended doses each day, approximately at the same time
- Water: The animals received tap water for human consumption (the production and distribution managed by Turčianska vodárenská spoločnosť a.s., Martin, SR). The supply of drinking water was unlimited.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55±10 %.
- Photoperiod (hrs dark / hrs light): 12-hour light / 12-hour dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Remarks:

The test item is poorly soluble in water and adheres to the tube's walls after mixing in water.

Details on oral exposure:

The test substance was administered in a single dose by gavage using a stomach tube. The volume of oil suspension administered at one dose was 1mL/100g body weight.
A group of 3 female rats was dosed in each step. The number of animals depends on the number of dosage steps, defined by the animals' absence or presence of test item-related mortality. Two dosing steps were necessary to achieve the study objectives. The total number of animals used in the study was 6.
Available information indicated that the test item is likely to be less toxic regarding acute toxicity. Therefore, a limit dose of 2000 mg/kg body weight of Heavy wax residue fraction, waste plastic derived, hydrothermal conversion was used as a starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females per step

Control animals:

no

Details on study design:

The animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days.
Observations included: changes in the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural patterns. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Individual weights of animals were recorded shortly before test item administration (Initial weight), weekly after that or at the time of death or sacrifice.
All test animals were subjected to gross necropsy.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died after the test item administration in the dose of 2000 mg/kg body weight.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

Changes in animal weight before administration, 1 and 2 weeks after administration were within the normal physiological range.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item Heavy wax residue fraction, waste plastic derived, hydrothermal conversion 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, the test item Heavy wax residue fraction, waste plastic derived, hydrothermal conversion is classified in GHS Category 5/Unclassified. LD50 cut off value is 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 Heavy wax residue fraction, waste plastic derived, hydrothermal conversion when administered as a single oral dose to female Wistar rats, followed by 14 days observation period.
The procedure, according to OECD Guideline 423 Acute Toxic Class (ATC) method, was used. All animals received a single dose of the test item as olive oil suspension by the oral route of administration.
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.
The first group of 3 female Wistar rats was dosed with 2000 mg/kg body weight. Test item-related mortality was not observed during 48 hours, and therefore in the next step, 3 female rats were treated with the same dose. All 6/6 animals survived the limit dose.
The administration of the test item in the dose of 2000 mg/kg body weight to female Wistar rats caused the signs of systemic toxicity in 6/6 animals. Symptoms of test item toxicity occurred only within the first 3 hours after administration and were reversible. Piloerection was observed in 2 animals after 0.5 hours and after 1 hour of test item administration, and in the case of 3 animals after 2 hours. Another recorded symptom was mild sleepiness, which occurred after 0.5 hours in 4 animals. During the subsequent 14-day observation period, we did not report any other symptoms indicating the toxicity of the test item.
The body weights of all surviving animals increased in a normal range during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.