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:
October 21, 2015 - March 15, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted on October 02, 2012
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Before application, the test item was grounded in a mortar using a pestle.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, France
- Age at study initiation: 19 - 21 weeks
- Weight at study initiation: 3.32 - 3.96 kg
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.8 to 18.4 °C
- Humidity (%): 44.7 to 71.9 %.
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12h dark : 12h light

IN-LIFE DATES: From: day 1 To: day 4

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The solid test item was administered at a volume of 0.1 ml. The volume of the solid test item was measured after gently compacting it.
Observation period (in vivo):
Any clinical alterations were recorded 1 hour and 6 hours after treatment and then twice daily up to experimental day 4.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: The grades of ocular reaction were evaluated according to Draize (1944), OECD and EC recommendations.

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
other: discharge
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
other: discharge
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
other: discharge
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No clinical symptoms and no signs of eye irritation were observed.
Other effects:
none

Any other information on results incl. tables

Objective

The objective of the present study was to investigate the eye irritation potential of the test item in rabbits.

Study design

The test item was applied into the conjunctival sac of the left eye of rabbits, the untreated right eye served as control. The degree of eye irritation was evaluated by scoring lesions of conjunctiva, cornea and iris at specific intervals. The first examinations of the eyes followed 1 and 6 hours after treatment. Subsequently, the eyes were investigated twice daily for a further 3 days. In addition, potential systemic effects and the body weight development was determined.The study was performed initially with one animal, followed by the confirmatory test with two further animals.


Results

No mortality occurred during the experimental phase of the study.

The body weight development of the treated rabbits was inconspicuous.

No clinical symptoms and no signs of eye irritation were observed.


Conclusion

Under the conditions of the present study, no eye irritation potential was detected for the test item.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, no eye irritation potential was detected for the test item.
Executive summary:

The study was performed according to OECD 405 under GLP conditions. Under the conditions of the present study, no eye irritation potential was detected for the test item.