Registration Dossier
Registration Dossier
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EC number: 413-860-0 | CAS number: 1187-74-2 ACETONYLBERNSTEINSÄUREESTER; ASE
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted according to International test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diethyl 4-oxopentane-1,2-dicarboxylate
- EC Number:
- 413-860-0
- EC Name:
- Diethyl 4-oxopentane-1,2-dicarboxylate
- Cas Number:
- 1187-74-2
- Molecular formula:
- C11H18O5
- IUPAC Name:
- 1,4-diethyl 2-(2-oxopropyl)butanedioate
- Details on test material:
- - Name of test material (as cited in study report): Acetonylsuccinic acid diethylester
- Physical state: Liquid
- Analytical purity: 97.5%
- Lot/batch No.: W 71604
- Expiration date of the lot/batch: 1989-10-31
- Stability under test conditions: Stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Research Laboratories Ltd, CH-4414, Fullinsdorf
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.3-2.5 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1989-09-12 To: 1989-09-15
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Semi-occlusive dressing wrapped around adbdomen and secured with elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment site flushed with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale as described in test guidelines
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Other effects:
- None observed
Any other information on results incl. tables
Observation time |
Animal |
Erythema |
Oedema |
1 hour |
79 |
1 |
0 |
| 80 | 1 | 0 | |
| 81 | 1 | 0 | |
| 24 hours | 79 | 0 | 0 |
| 80 | 0 | 0 | |
| 81 | 0 | 0 | |
| 48 hours | 79 | 0 | 0 |
| 80 | 0 | 0 | |
| 81 | 0 | 0 | |
| 72 hours | 79 | 0 | 0 |
| 80 | 0 | 0 | |
| 81 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acetonyl succinic acid diethyl ester is not a skin irritant
- Executive summary:
Acetonyl succinic acid diethyl ester is not a skin irritant
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