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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:
13 November 2006 - 25 December 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
white powder
Details on test material:
- Name of test material (as cited in study report): ucb108628-1
- Stability under test conditions: not indicated
- Storage condition of test material: room temperature, in the dark
Specific details on test material used for the study:
The pH of the test material was determined prior to commencement of the study and found to be 4.7 (10% aqueous solution). According to the Certificate of Analysis (dated 28th July 2008) the purity was re-tested (19th January 2007) and analysed to be 99.54% .

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: an accredited supplier
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended cages
- Diet: certified rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS (set conditions)
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other (untreated) eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml i.e. approximately 0.06 mg (volume measured by gently compacting the required volume into an adapted syringe)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. In addition, the eyes were inspected on day 7, 14 and 21 after instillation.
Immediately after administration of the test material, an assessment of the initial pain reaction was made.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
Numerical evaluation according to Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).

TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks:
At the 14-day observation, vascularisation with a localised ingrowth of vessels for approximately 3 mm around half of the cornea was noted.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Scattered or diffuse corneal opacity was noted in all treated eyes at the 24, 48 and 72-hour and 7-day observations and in one treated eye at the 14-day observation. Vascularisation, with a localised ingrowth of vessels for approximately 3 mm, around half of the cornea was noted in one treated eye at the 14-day observation. On day 21, this effect was reversed. Iridial inflammation was noted in all treated eyes one hour after treatment and at the 24-hour observation and in two treated eyes at the 48 and 72-hour observations.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24, 48 and 72-hour observations. Minimal conjunctival irritation noted in all treated eyes at the 7-day observation and persisted in one treated eye at the 14-day observation.
Two treated eyes appeared normal at the 14-day observation and the remaining treated eye appeared normal at the 21-day observation.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
An in vivo eye irritation study was performed according to OECD/ EC guidelines and GLP principles with 3 male rabbits. In summary, the test substance produced corneal opacity = 1 in all three animals, iritis = 1 in 2/3 animals, conjuctival redness = 2 in all three animals, which reversed in 14 days for 2 animals and in 21 days for one animal (mean of values at 24, 48 and 72 hours). Based on these results, the substance is classified Category 2 for eye irritation.