Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-20 to 2009-04-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): L173
- Substance type: inorganic
- Physical state: solid
- Analytical purity: presumably > 99.9 %
- Lot/batch No.: DP/SL 040c/09
- Expiration date of the lot/batch: not applicable
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 3.1 kg, 4.1 kg, 3.3 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- acclimatisation: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light):12 h light, 12 h dark

IN-LIFE DATES: From: 2009-04-15 To: 2009-04-25

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No rinsing after application.
- Time after start of exposure: 72 h

SCORING SYSTEM: Grading of ocular lesion
Cornea: Degree of density (opacity, densest are taken for reading. Score 0 - 4
Iris: Score 0 - 2
Conjunctiva: Redness (refers to palpebral and bulbar conjunctiva; excluding cornea and iris. Score 0 - 3
Conjunctiva: Chemosis, swelling (refers to lids and/or nictitating membranes). Score 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: all 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
other: all 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: all 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: all 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
other: all 3 animals
Time point:
other: 24 h
Score:
0
Irritation parameter:
iris score
Basis:
other: all 3 animals
Time point:
other: 24 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: all 3 animals
Time point:
other: 24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
other: all 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
iris score
Basis:
other: all 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: all 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: all 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
other: all 3 animals
Time point:
other: 72 h
Score:
0
Irritation parameter:
iris score
Basis:
other: all 3 animals
Time point:
other: 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: all 3 animals
Time point:
other: 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: all 3 animals
Time point:
other: 72 h
Score:
0

Any other information on results incl. tables

Control negative in all animals 1 h, 24 h, 48 h and 72 h after application.

No individual systemic and local findings (clinical signs of toxicity) were found in any of the 3 animals 1 h, 24 h, 48 h and 72 h after application of the test item.

The body weights of 2 animals remained constant throughout the observation period. The 3rd animal gained 0.1 kg body weight during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not irritating
Executive summary:

The eye irritating potential of L173 was examined in a GLP guideline study according to OECD 405.

Under the conditions of the present study, single ocular application of the test item L173 to rabbits at a dose of 0.1 g produced no irritant effects. Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the EC criteria of DSD (Directive 2001/59/EC) and the CLP-Regulation (EC) 1272/2008, the test item L173 does not have to be classified for eye irritation.