Registration Dossier

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:
05 February - 12 February 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
Charles River, Kißlegg
- Age at study initiation:
about 22 weeks
- Weight at study initiation:
2.95 - 3.48 kg
- Housing:
separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm2
- Diet: ad libitum (Altromin Standard Diet TPF® 2113, pellets)
- Water: ad libitum (tap water)
- Acclimation period:
at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
19 to 22
- Humidity (%):
54 to 75
- Photoperiod (hrs dark / hrs light):
12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
1 hour, 24, 48, 72 hours after treatment and then daily up to day 8
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing:
none

SCORING SYSTEM:
according to OECD Guideline

TOOL USED TO ASSESS SCORE: 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
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not considered to be irritating to eye.
Executive summary:

A Study according to OECD Guideline 405 was performed to investigate the test item regarding its eye irritation potential. To test for primary eye irritation, 0.1 g of the test material powder was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for another 7 days. No signs of irritation were observed in cornea and iris. The conjunctivae showed redness (score 1) and discharge (score 1) in all animals at the first reading. This is a common finding in the case of powder application. The untreated eyes were unchanged. Thus, the test item is not considered to be irritating to eye.