Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-05-27 until 2003-10-08
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:
2003
Report Date:
2003

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: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: > 2 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): 12 h dark, 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):
The animals were observed for 14 days after dosing.
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: 1-2 (mean score)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal: 1-3
Time point:
other: over all 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: 1-3 (mean score)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal: 1-2 (mean score)
Time point:
other: overall at 24, 48 and 72 h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: overall 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
The test item produced corrosion and irreversible effects in all animals tested.
Other effects:
No other toxic effects were observed. Throughout the observation period no weight loss was recorded.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item produced irritation and corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive
93/21 EEC) the test item has to be classified and has obligatory labelling requirement for eye irritation.
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 HsdIf:NZW at a dose of 0.1 ml per application site. The untreated eye served as control. The test item produced corrosion and irreversible effects in all animals tested. No corneal lesions were found upon fluorescein examination at the final reading. No other toxic effects were observed. Throughout the observation period no weight loss was recorded .

The mean scores of the 24, 48 and 72 hour readings exceeded the limit values according to Directive 93/21 EEC in any case. Therefore, the substance has to be classified and has obligatory labelling requirement for eye irritation.