Registration Dossier
Registration Dossier
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EC number: 201-744-0 | CAS number: 87-41-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- BASF-Test, see details in remarks on matrial and methods.
- GLP compliance:
- no
Test material
- Reference substance name:
- Phthalide
- EC Number:
- 201-744-0
- EC Name:
- Phthalide
- Cas Number:
- 87-41-2
- Molecular formula:
- C8H6O2
- IUPAC Name:
- 1(3H)-Isobenzofuranone
- Details on test material:
- - Name of test material (as cited in study report): Phthalid
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: 2.9 - 3.2 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animal served as control
- Amount / concentration applied:
- 80 % in water
- Duration of treatment / exposure:
- 1, 5, 15 min, 20 h
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol concentrated and Lutrol diluted to 50 % with warm water
- Time after start of exposure: 1, 5, 15 min and 20 h, respectively
SCORING SYSTEM:
The original scoring system was converted into Draize scores.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
Readings |
Animal |
Exposure period: 20 h |
||
Erythema |
Edema |
Additional findings |
||
1 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
24 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
Mean 24, 48, 72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
Mean 24, 48, 72 h |
1-2 |
0 |
0 |
|
No erythema and no edema were observed (score 0 according to the OECD/Draize scheme).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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