Registration Dossier
Registration Dossier
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EC number: 202-603-6 | CAS number: 97-72-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: according to an acceptable internal BASF method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Internal method (BASF test): Two animals were treated for 5 and 15 min, 2 and 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. In addition skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time the skin was washed. The animals were observed 8 days and the skin changes were recorded on working days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Isobutyric anhydride
- EC Number:
- 202-603-6
- EC Name:
- Isobutyric anhydride
- Cas Number:
- 97-72-3
- Molecular formula:
- C8H14O3
- IUPAC Name:
- isobutyric anhydride
- Details on test material:
- - Physical state: liquid
no further information provided
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: 2.82 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 5 and 15, 2 and 20 hours
- Observation period:
- 24 and 48 hours and 8 days
- Number of animals:
- 2 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm of the back per treating time point
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 5 and 15 min, 2 and 20 hours, respectively
SCORING SYSTEM: Draize (data were re-evaluated according to the scoring system of Draize, as recommended by the actual guideline requirements)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 48 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: after 2 hours of treatment
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 48 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: after 2 hours of treatment
Any other information on results incl. tables
|
|
Exposure period: 5 min |
Exposure period: 15 min |
Exposure period: 2 h |
Exposure period: 20 h |
||||||||
Readings |
Animal |
Erythema |
Edema |
Additional findings |
Erythema |
Edema |
Additional findings |
Erythema |
Edema |
Additional findings |
Erythema |
Edema |
Additional findings |
24 h |
1 |
2 |
0 |
c |
2 |
2 |
c |
3 |
3 |
c |
3 |
3 |
|
2 |
2 |
0 |
c |
2 |
2 |
c |
3 |
3 |
c |
3 |
3 |
|
|
48 h |
1 |
1 |
0 |
|
1 |
0 |
|
3 |
3 |
c |
3 |
3 |
c |
2 |
2 |
1 |
c |
2 |
1 |
c |
3 |
3 |
c |
3 |
3 |
|
|
8 d |
1 |
0 |
0 |
d |
0 |
0 |
d |
2 |
1 |
d |
4 |
2 |
Np |
2 |
0 |
0 |
d |
0 |
0 |
d |
2 |
2 |
d |
4 |
2 |
Np |
|
Mean 24 - 48 h |
1 |
1.5 |
0.0 |
|
1.5 |
1.0 |
|
3.0 |
3.0 |
|
3.0 |
3.0 |
|
2 |
2.0 |
0.5 |
|
2.0 |
1.5 |
|
3.0 |
3.0 |
|
3.0 |
3.0 |
|
|
Mean |
1.8 |
0.3 |
|
1.8 |
1.3 |
|
3.0 |
3.0 |
|
3.0 |
3.0 |
|
|
c: comprehensive; d: desquamation; N: necrosis; p: parchmenty
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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