Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-05-16 until 2005-06-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD test under GLP.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
not applicable
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: Charles River Deutschland, D-88353 Kisslegg
- Weight at study initiation: 2.1- 2.5 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The substance was not washed out.
Observation period (in vivo):
one animal: 72 h
two animals: 168 h
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: as stated in Guideline OECD 405


TOOL USED TO ASSESS SCORE: not given in the report except fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1-3
Time point:
other: anyoverall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: max. duration: h; max. value at the end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal: 1-3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: max. duration: h; max. value at the end of observation period: 0 (related to all animals)
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 144 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall 24, 48 and 72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 168 h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 168 h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall 24, 48 and 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days.
Other effects:
No corneal lesions were found upon fluorescein examination at the final reading. No clinical effects were observed. Throughout the 72 h observation period no significant weight loss was recorded in the test animals.

Any other information on results incl. tables

Comments:

Maximum duration of any effect (in hours):

conjunct./redness: > 72

conjunct./chemosis: > 72

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance has produced only slight irritation and therefore has not to be classified as irritant according to the EU regulations.
Executive summary:

An acute eye Irritation/Corrosion test according to OECD 405 was performed. The test item was applied to the lower conjunctival sac of one eye of 3 female New Zealand White Rabbits Crl:KBL (NZW) at a dose of 0.1 ml per application site. The untreated eye served as control. The test item showed slight irritant effects on the conjunctivae of all 3 animals (redness mean score 0.67 - 1.33; chemosis mean score 0.33 - 1). All changes were fully versible within 7 days.

The test item produced no corrosion and no corneal lesions were found upon fluorescein examination at the final reading in any of the animals. No other treatment related effects were observed. Throughout the 72 h observation period no significant weight loss was recorded. Therefore, the substance does not have to be classified and has no obligatory labelling requirement for eye irritation.