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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:
1999-09-06 to 1999-09-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kißlegg
- Weight at study initiation: 1.8 to 1.9 kg
- Housing: individually in PPO cages
- Diet (e.g. ad libitum): pelleted complete rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3°c
- Humidity (%): 55%+-15%
- Air changes (per hr): 10 air changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml per application
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h and 7 d
Number of animals or in vitro replicates:
4 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 20 ml 0.9% sodium chloride solution
- Time after start of exposure: 24 h after exposure

SCORING SYSTEM:
- According to OECD guideline.

TOOL USED TO ASSESS SCORE: fluorescein / UV-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
0.33
Reversibility:
fully reversible

Any other information on results incl. tables

Scores for ocular lesions

 Rabbit No.    Individual mean score from readings after 24, 48 and 72 hours
 1623  Cornea opacity, degree  0.00
   Iris  0.00
   Conjunctiva Redness  0.67
   Chemosis  0.00
     
 1624  Cornea opacity, degree  0.00
   Iris  0.00
   Conjunctiva Redness  1.00
   Chemosis  0.33
     
 1625  Cornea opacity, degree  0.00
   Iris  0.00
   Conjunctiva Redness  0.67
   Chemosis  0.00
     
 1626  Cornea opacity, degree  0.00
   Iris  0.00
   Conjunctiva  0.00
   Chemosis  0.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is non irritating to the eye according to GHS criteria.
Executive summary:

The test item was tested for eye irritation in an in-vivo test in rabbits (according to OECD 405 and GLP). Four rabbits had the test item instilled in the left eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as day 7 after dosing. Slight signs of irritation were observed on the treated eyes. By 7 days, 4 of 4 treated eyes had returned to normal. It is concluded that the substance is not irritating to the eyes of rabbits under the conditions of the study.