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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008, L 142, Annex Part B, 30 May 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3/3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
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.