Registration Dossier
Registration Dossier
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EC number: 606-629-2 | CAS number: 20761-68-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5ml
- Duration of treatment / exposure:
- 3 min, 1 hour, 4 hours
- Observation period:
- 7 days
- Number of animals:
- One rabbit each for 3min and 1 hour treatment.
Three rattbis for 4 hour treatment
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- observation in three rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- observation in three rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Individual Skin Reactions Following 3-Minute and 1-Hour Exposures |
|||
Skin Reaction |
Observation Time |
Individual Scores |
|
3-Minutes Exposure |
1-Hour Exposure |
||
Erythema/Eschar Formation |
1 Hour |
0 |
0 |
24 Hours |
0 |
0 |
|
48 Hours |
0 |
0 |
|
72 Hours |
0 |
0 |
|
7 Days |
0 |
0 |
|
Oedema Formation |
1 Hour |
0 |
0 |
24 Hours |
0 |
0 |
|
48 Hours |
0 |
0 |
|
72 Hours |
0 |
0 |
|
7 Days |
0 |
0 |
|
Individual Skin Reactions Following 4-Hour Exposure |
||||
Skin Reaction |
Observation Time |
Animal 1 |
Animal 2 |
Animal 3 |
Erythema/Eschar Formation |
1 Hour |
1 |
0 |
0 |
24 Hours |
1 |
0 |
0 |
|
48 Hours |
1 |
0 |
0 |
|
72 Hours |
1 |
0 |
0 |
|
7 Days |
0 |
0 |
0 |
|
Oedema Formation |
1 Hour |
0 |
0 |
0 |
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
|
72 Hours |
0 |
0 |
0 |
|
7 Days |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritating property of TMP-Ketal was investigated according to the Guideline OECD 404. TMP-Ketal is not irritating to skin.
- Executive summary:
The skin irritating property of TMP-Ketal was investigated according to the Guideline OECD 404. TMP-Ketal is not irritating to skin.
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