Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-08-26 to 2002-09-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid, fine scales

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 GmbH, D-97633 Sulzfeld
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen,79 cm x 59 cm bottom area, 38 cm height, with a wooden rest shelf, 15 cm x 59 cm.
- Diet: Altromin 2023 diet, Hay-briquettes (supplied by SSNIFF, D-59494 Soest) were offered additionally as a dietary supplement.
- Water: Tap water from an automatic watering system
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19.9 °C
- Humidity: 71.0 %
- Air changes: 12 per hour
- Photoperiod: Artificial light from 6 a.m. to 6 p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: approximately 60 mg = 0.1 mL of the test item was applied into the right eye. The test item was firstly ground in a mortar and afterwards administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent a loss of test substance. The left eye remained untreated and served as control.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Eyes were examined over at 1, 24, 48 and 72 hours post application.
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: A fluorescein solution was instilled onto the cornea of 1 animal after 24 hours post application. The whole eyes, especially the corneae, the irises and the conjunctivae were examined using an otoscope lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
Reversibility of slight irritation effects were fully reversible within 72 hours observation period.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the eye irritation study the test item is not subjected to classification and labelling for eye irritation/corrosion effects according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (CLP).
Executive summary:

The irritation/ corrosion potential of the test item was evaluated in the eyes of New Zealand White rabbits, according to OECD 405, adopted in 1992. Each of three rabbits received 0.1 mL weight equivalent dose of the test item in the conjunctival sac of the right eye. The left eye remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours after application. 2/3 animals showed very light redness and 1/3 showed slight cornea opacity. All signs of toxicity were fully reversible within the 72- hour observation period. The mean (conjuctivae or chemosis or cornea or iris) score that each animal obtained was 0 or between 0 to 1. Therefore, under the selected test conditions the test item was considered to be "not irritating" to eye.