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

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

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Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022-2023

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December 2001

GLP compliance:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Route of administration:

oral: gavage

Vehicle:

other: cotton seed oil / Physiological saline 0.9% NaCl

No. of animals per sex per dose:

3

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.

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.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 July, 2011

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Skin preparation:
24 hours before the beginning of the test the back and the sides of the animals have been shaved on an area of about 20 cm2.
Application:
The test sample has been given, a ratio of 2000 mg/kg, with a square of gauze directly on animals' skin humidified with sodium chloride injection and fixed with a skin patch in a area of about 10% of the total body surface.
the square has been put on the back of animals and further fixed with hypo-allergenic occlusive adhesive tape.
The whole trunk of the animal has been protected with an elastic bandage. Bandage has been left in situ for 24 hours, during this period animals have been kept in single cages.
Removal:
24 hours after application bandage and adhesive tape have been remove.
Skin has been cleaned from sample excess by a tampon soaked in physiological solution.

Duration of exposure:

24 hours

Doses:

The test sample has been given, a ratio of 2000 mg/kg, with a square of gauze directly on animals' skin humidified with sodium chloride injection and fixed with a skin patch in a area of about 10% of the total body surface.

No. of animals per sex per dose:

10 (5 males and 5 females)

Control animals:

not specified

Details on study design:

Observations
The general status of all animals has been daily monitored after 1-3-5 hours from the start of treatment and daily (5 days per week) for 14 days.
All activies related to the study, as well as remarks and exams have been daily registered in dated and signed forms.
During the study the following observations have been done:
- Mortality
Animals have been observed in the morning of each working day (5 days/week).
- Clinical symptomatology
Every clinical symptom, including possible variations of somato-motory activity, was daily registered for each individual animal.
Clincial observations included a general objective exam (G.O.E.) above:
1.assessment of major organic functions;
2. assessment of the status of integumentary apparatus;
3. assessment of the status of mucosae;
4. assessment of somato-motory activity and of the sensory status.
- Body weight
Animals have been weighted before experiment, after 7 days and at the end of the experiment.
- Post mortem
At the end of the observation period, animals have been sacrificed and a post-mortem examination has been carried out.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

During the study no mortality was detected.

Clinical signs:

other: During the study neither symptoms nor signs of toxicity were recorded.

Other findings:

- Post mortem observations
At the autopsy no abnormalities have been detected.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance has a LD50 > 2000 mg/kg bw and can be considered NOT TOXIC - NOT HARMUFUL.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw