Registration Dossier
Registration Dossier
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EC number: 202-509-5 | CAS number: 96-48-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Study in animals performed before Annex VII and VIII amendments.
- 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:
- 1 960
- Report date:
- 1960
Materials and methods
- Principles of method if other than guideline:
- BASF-Test. See details in remarks on material and methods
- GLP compliance:
- no
Test material
- Reference substance name:
- γ-butyrolactone
- EC Number:
- 202-509-5
- EC Name:
- γ-butyrolactone
- Cas Number:
- 96-48-0
- Molecular formula:
- C4H6O2
- IUPAC Name:
- dihydrofuran-2(3H)-one
- Details on test material:
- - Name of test material (as cited in study report): γ-Butyrolacton
- Physical state: colorless liquid
- Analytical purity: 99.5 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site of the same animal served as control
- Duration of treatment / exposure:
- 1 min, 5 min, 15 min or 20 h
- Observation period:
- 8 days
- Number of animals:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptoms
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptoms
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptoms
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptoms
Any other information on results incl. tables
Undiluted gamma-butyrolactone caused only very slight erythema on the day of application after a 1 min, 5 min, 15 min exposure. The 20 h exposure caused no observed effects.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
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