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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:
weight of evidence
Study period:
January 15, 2001 - July 5, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
Name of the test material (as cited in the report): Miranol H2M CONC

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A., Como, Italy
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.4 - 2.8 kg
- Housing:
The animals were individually housed in stainless steel cages measuring 48x63x41 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary.
- Diet (e.g. ad libitum): ad libitum (pelleted laboratory diet from Altromin MSK, Altromin,  D-32770 Lage, Postfach 1120, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum period of 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 21 °C
- Humidity (%): 45 to 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye of each animal remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable, the aqueous solution was tested as such
Duration of treatment / exposure:
Not applicable (the eyes were not rinsed)
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE: not applicable
SCORING SYSTEM: in accordance with OECD 405
TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: Mean for animals #1, #2 and #3
Time point:
24/48/72 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 14 days (in all animals)
Remarks on result:
other: Individual mean scores: 1-1.3-1.3; Note: solid content of the test material: 50%
Irritation parameter:
iris score
Basis:
other: Mean for animals #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours (in all animals)
Remarks on result:
other: Individual mean scores: 0-0-0; Note: solid content of the test material: 50%
Irritation parameter:
conjunctivae score
Basis:
other: Mean for animals #1, #2 and #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days (in all animals)
Remarks on result:
other: Individual mean scores: 1.3-1.7-2; Note: solid content of the test material: 50%
Irritation parameter:
chemosis score
Basis:
other: Mean for animals #1, #2 and #3
Time point:
24/48/72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 7 days (in all animals)
Remarks on result:
other: Individual mean scores: 1-1.3-1; Note: solid content of the test material: 50%
Irritant / corrosive response data:
See section "Any other information on results incl. tables"

Any other information on results incl. tables

 Scores for corneal opacity  
CORNEA 1h 24h 48h 72h Individual mean scores
 (24, 48 and 72h)
Rabbit 1 1 1 1 1 1.0
Rabbit 2 0 1 1 2 1.3
Rabbit 3 0 1 1 2 1.3

 Scores for iris lesion  
IRIS 1h 24h 48h 72h Individual mean scores
 (24, 48 and 72h)
Rabbit 1 1 0 0 0 0.0
Rabbit 2 1 0 0 0 0.0
Rabbit 3 1 0 0 0 0.0

 Scores for Redness and Chemosis of conjunctivae  
CONJUNCTIVAE 1h 24h 48h 72h Individual mean scores
 (24, 48 and 72h)
Rabbit 1 Redness 3 1 1 2 1.3
Chemosis 2 1 1 1 1.0
Rabbit 2 Redness 2 2 2 1 1.7
Chemosis 2 1 2 1 1.3
Rabbit 3 Redness 3 2 2 2 2.0
Chemosis 3 1 1 1 1.0

Other information:

- The animals had a normal weight gain during the 14 days(0.1 -0.3 kg)

- No indication of systemic effects


Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the results of this study, conducted in accordance with OECD 405 and GLP, the aqueous solution of the test material (solid content 50%) is classified as Irritating to eyes (Category 2) according to the criteria of the CLP Regulation.
Executive summary:

The test material was tested as an aqueous solution at 50% solids for acute ocular irritation in 3 female New-Zealand White rabbits, according to OECD 405 / EC method B.5, and in compliance with Good Laboratory Practice. The test material, was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of each animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed 1, 24, 48 and 72 hours after the instillation. Slight corneal opacity (grade 1) was observed at 1 hour after instillation in one animal, then between day 1 and 7 in all animals (grade 1 or 2). Iris inflammation (grade 1) was only noted at 1 hour. The mean scores (24-48-72 hours) calculated for each animal were 1.0 - 1.3 - 1.3 for corneal opacity, and 0.0 - 0.0 - 0.0 for iritis. Conjunctival redness and chemosis (grades 2 or 3) was observed in all three animals at 1 hour after instillation, and persisted until 72 hours (grade 1 or 2). These reactions were no longer present at day 7. The mean scores (24-48-72 hours) calculated for each animal were 1.3 - 1.7 - 2.0 for conjunctival redness, and 1.0 - 1.3 - 1.0 for chemosis.

The test material (solid content 50%) is classified as irritating to eyes (Category 2) according to the criteria of the CLP Regulation.