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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-11-15 to 2006-11-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
04-2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Official Journal of the European Communities L383 A, Vol. 15, 29. December 1992.
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 18 weeks
- Weight at study initiation: 3.34 KG
- Housing: separately in special rabbit cages (manufacturer: Becker, type K99/30 KU)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 47 - 63
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: Days 1 to 15

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single application into the conjunctival sac of the left eye, the right eye remained untreated and served as control. The eyelids were closed for 30 sec after installation.
Observation period (in vivo):
24, 48, and 72 hours, then daily up to day 15 of the experimental part
Number of animals or in vitro replicates:
1 f
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according OECD GL 405

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 9 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
The cornea developed diffuse areas of opacity from the first reading up to day 3 of the experimental part. At the iris signs of irritation were observed from the first reading up to day 4. The conjunctivae showed redness and chemosis from the first reading up to experimental day 8. Thereafter no signs of irritation were observed. The untreated eye was unchanged.
Other effects:
none

Any other information on results incl. tables

Study design

The test item was tested for its eye irritating potential with one rabbit in a GLP study according to OECD GL 405. Prior to testing, a hen's egg test on the chorioallantoic membrane was performed and no irritating potential could be detected. For the test of primary eye irritation, 100 mg of the test material was applied into the conjunctival sac. The first examination of the eyes followed 1 hour after instillation and the other examinations were performed daily for a further 14 days.

Results

There were no signs of pain immediately after instillation. The cornea developed diffuse areas of opacity (scores 1) from the first reading up to day 3 of the experimental part. At the iris signs of irritation were observed (score 1) from the first reading up to day 4. The conjunctivae showed redness (scores 1 and 2) and chemosis (score 1) from the first reading up to experimental day 8. Thereafter no signs of irritation were observed. The untreated eye was unchanged.

Conclusion

Based on the observed results the test item should be regarded as an irritant to the eyes.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
The test item possess an irritating potential to eye.
Executive summary:

This GLP study was performed according to OECD GL 405. A eye irritating potential was noted and the test item should be regarded as an irritant to the eyes.