Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 17, 2010 - January 19, 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed in accordance with OECD 405 (2002), EU Method B.5 (2008), EPA OPPTS 870.2400 (1998) and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): L579
- Physical state: colourless 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 Deutsschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 11 weeks old
- Weight at study initiation: >2 kg
- Housing: individually housed in ABS - plastic rabbit cages, floor 4200 cm^2
- Diet: autoclaved hay and Altromin 2123 maintenance diet (lot no. 0955), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: December 12, 2010 To: December 17, 2010

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Not applicable (the treated eyes were not rinsed)
Observation period (in vivo):
Not applicable (after 72 hours no ocular lesions were found in any animal)
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE: Not applicable
SCORING SYSTEM: in accordance with OECD 405
TOOL USED TO ASSESS SCORE: fluorescein (only 72 hours after installation)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: Mean for animals #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Remarks on result:
other: Individual mean scores: 0-0-0
Irritation parameter:
iris score
Basis:
other: Mean for animals #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
2
Remarks on result:
other: Individual mean scores: 0-0-0
Irritation parameter:
conjunctivae score
Basis:
other: Mean for animals #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 72 hours (in all animals)
Remarks on result:
other: Individual mean scores: 0.7-0.7-0.3
Irritation parameter:
chemosis score
Basis:
other: Mean for animals #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Remarks on result:
other: Individual mean scores: 0-0-0
Irritant / corrosive response data:
- In none of the animals, any effects on the cornea were observed
- In all animals, an iris score of 1 was observed after 1 hour
- In all animals, conjunctival redness (score: 1) was observed after 1 and 24 hours and in animals #1 and #2 also after 48 hours
- In animal # 1 and #2 chemosis (score: 1) was observed after 1 hour
- In animal #3, chemosis (score: 2) was observed after 1 hour
Other effects:
- Animal #2 and #3 had a slight discharge after 1 hour

Any other information on results incl. tables

- No mortalities nor significant clinical signs of toxicity were observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute eye irritation study in 3 rabbits, conducted in accordance with OECD 405 (2002), EU Method B.5 (2008), EPA OPPTS 870.2400 (1998) and according to GLP principles, irritant effects were observed which were fully reversible within 72 hours. Based on the results of this study, the substance does not need to be classified for eye irritation.
Executive summary:

An acute eye irritation study was conducted in 3 rabbits in accordance with OECD 405 (2002), EU Method B.5 (2008), EPA OPPTS 870.2400 (1998) and according to GLP principles. In none of the animals, any effects on the cornea were observed. In all animals, an iris score of 1 was observed after 1 hour. Conjunctival redness (score: 1) was observed in all animals after 1 and 24 hours and in two animals also after 48 hours. In these two animals, chemosis (score: 1) was observed after 1 hour and in the other animal chemosis (score: 2). All ocular effects fully reversed within 72 hours. Based on the results of this study, the substance does not need to be classified for eye irritation.