Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
14 Jan 2008 - 21 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 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeding farm BioTest, s r.o., Konárovice, 281 25 Czech Republic, RČH CZ 21760152
- Age at study initiation: 4-5 months
- Weight at study initiation: 3.0-3.5 kg
- Housing: individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs (made by Bergman, Mill Kocanda, Jesenice u Prahy) ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 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: 21 Jan 2008

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48 , 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with water.
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize scores


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Clinical examination of eye

Rabbit No. 1:
1 hour: Conjunctivae - some blood vessels hyperaemic (injected)
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations

Rabbit No. 2:
1 hour: Conjunctivae - some blood vessels hyperaemic (injected), Chemosis - some swelling above normal
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations

Rabbit No. 3
1 hour: Conjunctivae - some blood vessels hyperaemic (injected)
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations
Other effects:
No signs of systemic intoxication were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The following changes were observed in the treated eyes at 1 h post-application: some blood vessels were hyperaemic (injected) in all animals, and in one animal, some swelling above normal was noted. At 24, 48 and 72 h after application no signs of eye irritation were observed. No clinical signs of systemic intoxication were detected. It was concluded that the test substance is not irritating to the eye of rabbits.
The test substance does not fufil the requirements to be classified according to DSD and CLP criteria.