Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
07 Jan 2008 - 14 Jan 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ashes (residues)
- Substance type: technical product
- Physical state: solid
- Significant impurities:
Metals with content lower than 0.1%: Cr, Cu, Zn
Metals with content lower than 0.01%: As, Pb, Cd, Hg
- Composition of test material, percentage of components:
Main components: SiO2 (42.12%), Al2O3 (32.16%) and Fe2O3 (10.88%)
Components with content lower than 10%: TiO2, MnO, MgO, CaO, Na2O, K2O, SO3
- Lot/batch No.: 30.08.2007_ENERGETIKA
- Expiration date of the lot/batch: unlimited
- Stability under test conditions: stable
- Storage condition of test material: labotatory conditions
- Appearance: greyish black powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding farm BioTest s.r.o., Konárovice, 281 25, Czech Republic
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.8-3.2 kg
- Housing: individually in cages without bedding in a conventional animal room
- Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum, made by Bergman, Kocanda Mill, 252 42 Jesenice u Prahy
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%):30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 07 Jan 2008 To: 14 Jan 2008

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied:0.5 g
Duration of treatment / exposure:
Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h
Observation period:
Following initial and confirmatory tests: 1, 24 , 48, 72 h
Number of animals:
3 animals (1 female and 2 males)
Details on study design:
TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 10
- Type of wrap if used: The test substance was covered by gauze patch, foil and cellulose cotton and held in place with non-irritating tape (Spofaplast)


REMOVAL OF TEST SUBSTANCE
- Washing: At the end of each exposure period the patch was removed and remaining sample was washed off with water.
- Time after start of exposure: 3 min, 1 and 4 h


SCORING SYSTEM: Draize scores

INITIAL TEST:
- Test substance was applied to one animal (rabbit No. 1). Skin reaction was evaluated after 3 min, 1 and 4 h. At 4 h exposure, very slight erythema was observed. After 4-hour exposure, rabbit No. 1 was evaluated for skin reactions according to standard time schedule (24, 48 and 72 h).

CONFIRMATORY TEST:
- Because in the initial test no skin irritation was observed, two additional animals (rabbits No. 2 and 3) were used to confirm the negative response. One patch was applied to each of 2 animals for an exposure period of 4 hours. Skin reactions were evaluated after patch removal at 1, 24, 48 and 72 h post-application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In the initial test with one animal, very slight erythema and no edema were observed immediately after a 4 h exposure. No irritant reponses were observed in any animal at any other reading time point.
Other effects:
No symptoms of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was tested for acute dermal irritation/corrosion. Three rabbits were exposed to 0.5 g of the test substance, applied onto the clipped skin for 4 h using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure. No symptoms of systemic toxicity were observed in the animals during the test period. No skin irritation was caused by a 4-hour exposure to the test substance.
The test substance does not fufil the requirements to be classified according to DSD and CLP criteria.