Registration Dossier
Registration Dossier
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EC number: 606-629-2 | CAS number: 20761-68-6
Eye irritation
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:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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.
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