Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 March 2004 to 18 March 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Annex V
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 2 December 2002 Date of Signature: 13 February 2003

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TIPX
- Substance type: Colourless liquid.
- Physical state: Liquid.
- Lot/batch No.: 042028.
- Storage condition of test material: Approximately 4ºC in the dark.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, United Kingdom.
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322, supplied by BCM IPS Limited, London, United Kingdom) ad libitum throughout the study.
- Water (e.g. ad libitum): Mains drinking water ad libitum throughout the study.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eyes in the exposured animals were used for control.
Amount / concentration applied:
0.1 ml (as supplied).
Duration of treatment / exposure:
72 hours.
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.

SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the grading in the test guideline. The result was classified according to EU classification system.

TOOL USED TO ASSESS SCORE: The light source from a standard ophthalmoscope.

OTHERS
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used. Initially, a single rabbit was treated. Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Table 1. After consideration of the ocular responses produced in the first animal, two additional animals were treated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
114 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The highest score of 1 was observed at 24 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
7 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The highest score of 1 was observed at 24 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
80 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The highest score of 1 was observed at 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
114 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
7 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
80 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
114 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
71 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
80 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
114 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
71 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
80 Male
Time point:
other: mean at 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritant / corrosive response data:
See Table 2. The application of the test material to eyes of three rabbits produced minimal conjunctival irritation which were fully reversible within 2 days.

Other effects:
Not reported.

Any other information on results incl. tables

Table 2 Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex 114 Male 71 Male 80 Male
IPR= 1 IPR= 1 IPR= 1
Time After Treatment 1 Hour 24 Hours 48 Hours 72 Hours 1 Hour 24 Hours 48 Hours 72 Hours 1 Hour 24 Hours 48 Hours 72 Hours
CORNEA                        
Degree of Opacity 0 0 0 0 0 0 0 0 0 0 0 0
Area of Cornea Involved 0 0 0 0 0 0 0 0 0 0 0 0
IRIS 0 0 0 0 0 0 0 0 0 0 0 0
CONJUNCTIVA                        
Redness 1 1 0 0 1 1 0 0 1 1 0 0
Chemosis 0 0 0 0 0 0 0 0 0 0 0 0
Discharge 0 0 0 0 0 0 0 0 1 0 0 0

IPR= Initial pain reaction     

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)

§        Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

 

Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour aboservation.

 

Conclusion. The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).