Solid Recovered Fuel (Municipal Solid Waste and similar wastes, processed)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022-2023

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2023

Report date:

2023

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December 2001

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Solid Recovered Fuel (Municipal Solid Waste and similar wastes, processed)

EC Number:

700-869-2

Molecular formula:

Not applicable

IUPAC Name:

Solid Recovered Fuel (Municipal Solid Waste and similar wastes, processed)

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: cotton seed oil / Physiological saline 0.9% NaCl

No. of animals per sex per dose:

3

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

Under the conditions of the present study, a single oral application of the polar and non-polar extract of the test item Solid Recovered Fuel showed no acute toxic characteristics.

Mortality:

0

Clinical signs:

other: none

Body weight:

other body weight observations

Remarks:

The body weight development of the animals was within the expected range

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Conclusions:

Under the conditions of the present study, a single oral application of the polar and non-polar extract of the test item Solid Recovered Fuel showed no acute toxic characteristics.

Executive summary:

Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item extract by oral gavage administration. The test item was extracted according to ISO 10993-12 using polar and nonpolar extraction medium and the test item extracts (100% concentration) were administered according to the body weight at a volume of 10 mL/kg bw.
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.
The piloerection observed on day 1 in one animal (no. 8) of step 2 was not considered to be related to the test item but to the administration procedure and the possible stress induced. No further clinical signs were observed in this animals until the end of the observation period.
With regard to the data reported it can be stated that the administration of two test item extracts produced no signs of acute toxicity. Administration of extracts was performed under the following conditions:
Species/strain: healthy rats rat / WISTAR Crl: WI(Han) (full barrier)
Number of animals: 12 (3 per step/extract, 2 steps per extracts were performed)
Extraction media: physiological saline 0.9% NaCl (polar test item extract) cottonseed oil (nonpolar test item extract)
Extraction ratio: 0.2 g/mL
Extraction conditions: 37 ± 1 °C for 72 ± 2 h, under agitation
Dose level: 10 mL/kg body weight
Route of administration: oral (single exposure)
Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step.
Therefore, according to ISO 10993-11, a sufficient estimation of the acute toxicity of the test item is provided.