Ashes (residues), nonhazardous municipal solid waste

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14.1.2008-29.1.2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ashes (residues)

EC Number:

268-627-4

EC Name:

Ashes (residues)

Cas Number:

68131-74-8

Test material form:

solid: bulk

Details on test material:

- Name of test material (as cited in study report): Ashes (residues)
- Substance type: technical product
- Physical state: solid
- Main components: SiO2 (42.12%), Al2O3 (32.16%), Fe2O3 (10.88%), TiO2, MnO, MgO, CaO, Na2O, K2O, SO3 - constituents with content less than 10%
- Expiration date of the lot/batch: unlimited
- Appearance: greyish black powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding farm BioTest s.r.o., Konárovice, 281 25 CZ, RČH CZ 21760152
- Weight at study initiation: 264-287 g (males), 207-242 g (females) - see table No.1 and No.2
- Housing: Animal room with monitoring conditions– one animal in one plastic cage
- Diet: ST 1 BERGMAN – complete pelleted diet ad libitum, (producer: Mill Kocanda, Jesenice u Prahy)
- Water: drinking tap water ad libitum (quality corresponding to the Regulation No. 252/2004 of Czech Coll. of Law)
- Acclimation period: 12 days
- Bedding: Sterilized shavings of soft wood
- Identification of animals: Colour marks on tail, each cage was marked with the number of study, number of animal, sex, name and dose of the test substance.
- Randomisation: According to the internal rule, at the start of the study the weight variation of animals was minimal and did not exceed + 20 % of the mean weight for each sex.
- Health condition: Certificate of good health condition – from breeding farm; no signs of diseases were observed at clinical check-in, during the acclimatisation period and before the start of study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22 +/- 3 °C, permanently monitored
- Humidity (%): relative humidity 30 – 70 %, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): light: 12 hour light/12 hour dark


STUDY TIME SCHEDULE
Animal supply: 02. 01. 2008
Experimental part of study: 14 .01. – 29. 01. 2008

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6x6 cm
- % coverage: 10 % body
- Type of wrap if used: The application site was covered by mull, plastic foil and held in contact by plaster (strapping).


REMOVAL OF TEST SUBSTANCE
- Washing: After 24 hours the occlusive dressing and remains of the test substance were removed with water.
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- The test substance in delivered form (moistened with the smallest amount of water) was applied on the depilated area of skin.

VEHICLE
- No vehicle was used.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of o weighing: The animals were weighed at the start of the study (before application), at 8th day and in the end of experiment (15th day. Average body weight in-group was counted from individual body weights. See table No.1.
- Frequency of observation: After application the animals were observed individually – the first day: twice (30 minutes and 3 hours after application), the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days.
- Necropsy of survivors performed: yes, gross necropsy
- Clinical signs: After application the animals were observed individually – the first day: twice (30 minutes and 3 hours after application), the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days.
Observations included changes in skin and fur, eyes, visible mucous membranes, nutritive condition, autonomic and central nervous systems, psychic activity, somatomotor activity, reactions to stimuli, function of respiratory, circulatory, digestive and urogenital system. Also presence of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma was carefully observed.
- Pathological examination: All test animals survived to the end of study were sacrificed on the 15th day by injection of veterinary preparation T61 (1 ml iv.) and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.
The animals were weighed at the start of the study (before application), at 8th day and in the end of experiment (15th day). Average body weight in-group was counted from individual body weights.
- Body weight: Body weight increments were calculated from body weight at the start of the study and in the end of the study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No death of animals was observed during 14 days observation period.

Clinical signs:

other: No clinical signs of toxicity were observed during the study in all animals.

Gross pathology:

Macroscopic changes were not diagnosed during pathological examination.

Any other information on results incl. tables

Table No. 7: Summary table of toxic effects

Dose	Number and sex of animals	Mortality	Clinical signs of intoxication	Pathological findings
2000 mg/kg	5 males	0	0	0
2000 mg/kg	5 females	0	0	0

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance toxicity was evaluated on the basis of mortality, body weight changes, and clinical signs of toxicity during the observation period and necropsy findings in the end of study.
The test substance applied on skin in dose the 2000 mg/kg of animal weight did not cause death of animals.
No clinical signs of intoxication of animals were observed in all animals. Macroscopic changes were not diagnosed during pathological examination in all animals.
According to the results of dermal toxicity study the value of LD50 dermal of Ashes (residues) for rats is higher than 2000 mg/kg of animal weight.

Executive summary:

The study was performed as limit test: two groups of animals – 5 males and 5 females and the dose of 2000 mg/kg. The test substance was applied on the shaved skin of the test animals in delivered form (moistened with the smallest amount of water) for 24 hours.

The test animals were observed 14 days after application, afterwards were sacrificed and the necropsy for macroscopic examination of the organs was performed.

The test substance applied in the dose 2000 mg/kg of animal weight did not cause the death of animals.No clinical signs of toxicity were observed during the study in all animals. Macroscopic changes were not diagnosed during pathological examination in all animals.

According to the results of study the value of LD₅₀dermal of the test substance, Ashes (residues), for rats of both sexes is higher than 2000 mg/kg of animal weight.