Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented, according to OECD guidelines and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

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 animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 3-4 months
- Weight at study initiation: 2.34 kg – 3.20 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/ - 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
reading 1, 24, 48 and 72 h after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
About (but not less than) 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.

SCORING SYSTEM: according to OECD guideline and Commission Directive 67/548/EEC

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24h

Applicant's summary and conclusion

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