Oil shale, thermal processing waste

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-03-09 - 2010-07-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No 440/2008, L 142, Annex Part B, 30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Burnt Oil Shale (BOS)

IUPAC Name:

Burnt Oil Shale (BOS)

Constituent 2

Reference substance name:

Oil shale, thermal processing waste

EC Number:

297-648-1

EC Name:

Oil shale, thermal processing waste

Cas Number:

93685-99-5

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

tricalcium oxo[(oxoalumanyl)oxy]alumane oxo[(oxoferrio)oxy]iron silanedione carbonate oxidandiide sulfate

Details on test material:

- Name of test material (as cited in study report): Oil shale, thermal processing waste
- Physical state: greyish-reddish, fine powder
- Analytical purity: no data
- Lot/batch No.: P.1082
- Expiration date of the lot/batch: not applicable
- Storage condition of test material: room temperature, avoid moisture
- Density: ca. 2.8 [g/cm³]

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld
- Age at study initiation: approximately 15 weeks old
- Weight at study initiation: > 2 kg
- Housing: Semi-barrier in an air-conditioned room, housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Free access to autoclaved hay and toAltromin 2123 maintenance diet for rabbits (lot no. 0748), rich in crude fibre
- Water: Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: test item was moistened with aqua ad injectionem (B. Braun Melsungen, lot no. 7494A191, expiry date: 11/2010)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A dose of 0.5 g of the test item was applied to each test site.

Duration of treatment / exposure:

The test item was held in contact with the skin throughout a 4-hour period.

Observation period:

All animals were observed for 72 hours after the patch removal.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: small skin area (approx. 6 cm²) on the left side of the dorsal area
- Type of wrap if used: gauze was held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3/3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3/3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test item showed neither irritant nor corrosive effects on the intact skin of 3 female rabbits (strain NZW) after a contact time of 4 hours.
Neither mortalities nor significant clinical signs of toxicity were observed.

Any other information on results incl. tables

Absolute body weights in kg

Animal number	Start of study (weight kg)	End of study (weight kg)
1	2.9	3.0
2	3.1	3.2
3	3.3	3.2

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

A GLP - guideline study according to OECD 404 was performed. Under the conditions of the present study, single dermal application of the test item Oil shale, thermal processing waste to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects. Neither mortalities nor significant clinical signs of toxicity were observed. In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item Oil shale, thermal processing waste does not have to be classified and has no obligatory labelling requirement for skin irritation.