Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Specific details on test material used for the study:
Identification: TMP-Ketal
Description: clear colourless liquid
Bach number: DEG 1003554

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
three
Details on study design:
In order to minimise pain on applicaiton of the test material, one drop of local anaesthetic, tetracaine hydrolchloride 0.5%, was instilled into eyes of animals 1 to 2 minutes before treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
three rabbits
Time point:
24/48/72 h
Score:
0.6
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
three rabbits
Time point:
24/48/72 h
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
three rabbits
Time point:
24/48/72 h
Score:
1.9
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
three rabbits
Time point:
24/48/72 h
Score:
0.9
Max. score:
1
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Individual Scores and Individual Total Scores for Ocular Irritation

 

Animal 1

Animal 2

Animal 3

 

24h

48h

72h

7d

14d

24h

48h

72h

7d

14d

24h

48h

72h

7d

14d

Cornea

0

1

0

0

0

0

1

1

0

0

0

1

1

0

0

Iris

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

Conjunctivae Redness

2

2

1

0

0

2

2

2

1

0

2

2

2

1

0

Chemosis

2

2

1

0

0

2

2

0

0

0

2

2

2

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The eye irritation property of TMP-Ketal was investigated according to the Guideline OECD 405. TMP-Ketal is not irritating to eyes.
Executive summary:

The eye irritation property of TMP-Ketal was investigated according to the Guideline OECD 405. TMP-Ketal is not irritating to eyes.