Registration Dossier
Registration Dossier
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EC number: 203-299-8 | CAS number: 105-45-3
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: Study meets scientific standards with acceptable restrictions (limited documentation; pre-GLP study)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and two other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl acetoacetate
- EC Number:
- 203-299-8
- EC Name:
- Methyl acetoacetate
- Cas Number:
- 105-45-3
- Molecular formula:
- C5H8O3
- IUPAC Name:
- methyl 3-oxobutanoate
- Details on test material:
- - Name of test material (as cited in study report): Acetessigsaeuremethylester (methyl acetoacetate); no further information given in the summary report
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder
- Weight at study initiation: females: 2.71 kg and 3.13 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml
- Duration of treatment / exposure:
- Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h - Observation period:
- Experiment 1: up to 8 days
Experiment 2: up to 8 days - Number of animals:
- 2
- Details on study design:
- Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.
TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (37°C; approx. 1 ml)
REMOVAL OF TEST SUBSTANCE
- Washing:
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50% (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.
SCORING
Descriptive scores of the raw data have been converted to Draize numerical scores.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 20 hours treatment
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Remarks:
- 20 hours treatment
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- 20 hours treatment
- Basis:
- mean
- Remarks:
- 2 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Remarks:
- 1; 5 and 15 minutes treatment
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Remarks:
- 1; 5 and 15 minutes treatment
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Findings after 24 hours: No effects were seen after application to the dorsal skin for 15 minutes or less.
Following application to the dorsal skin for 20 hours, slight, spotted redness was observed.
Findings after 8 days: No signs of irritation were seen at any skin site. - Other effects:
- No other effects.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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