Ashes (residues), coal

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 Jan 2008 - 29 Jan 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted February 24, 1987

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ashes (residues), coal

EC Number:

931-322-8

Cas Number:

68131-74-8

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Ashes (residues), coal

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)
- Housing: single
- Diet (e.g. ad libitum): ST 1 BERGMAN complete pelleted diet ad libitum, (producer: Mill Kocanda, Jesenice u Prahy) ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 Jan 2008 To: 29 Jan 2008

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6x6 cm
- % coverage: 10
- 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 (if done): 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
- For solids, paste formed: yes. The test substance was moistened with a small amount of water and applied onto the depilated area of the skin.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed on day 1 at the start of the study (prior to application), on day 8 and on day 15 at the end of the study. After application, animals were observed individually: twice on day 1 (30 min and 3 h post-application), twice on day 2 (in the morning and in the afternoon) and daily thereafter up to day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities occurred.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

No macroscopic changes were observed.

Applicant's summary and conclusion

Interpretation of results:

other: The test substance does not fufil the requirements to be classified according to CLP (EU-GHS) criteria.

Conclusions:

The test substance applied to the rat skin at 2000 mg/kg bw caused no death of animals. No clinical signs of intoxication were observed. No pathologic macroscopic changes were diagnosed.