Registration Dossier
Registration Dossier
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EC number: 266-411-4 | CAS number: 66576-71-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 to 28 June 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isopropyl methyl-2-butyrate
- IUPAC Name:
- Isopropyl methyl-2-butyrate
- Reference substance name:
- Isopropyl 2-methylbutyrate
- EC Number:
- 266-411-4
- EC Name:
- Isopropyl 2-methylbutyrate
- Cas Number:
- 66576-71-4
- Molecular formula:
- C8H16O2
- IUPAC Name:
- isopropyl 2-methylbutyrate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Isopropyl methyl-2-butyrate
- Substance type: organic
- Physical state: colourless liquid
- Analytical purity: 98.6%
- Lot/batch No.: Batch number: 9000322674
- Expiration date of the lot/batch: 25 March 2000
- Stability under test conditions: Stable at storage conditions
- Storage condition of test material: In a refrigerator (2 - 8°C)
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes
- Age at study initiation: : Age at start of treatment: 13 weeks (not specified but considered to be weeks)
- Weight at study initiation:
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum.
- Water: Community tap water ad libitum, in water bowls.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40 - 70% (relative humidity)
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mI/animal (left side only) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Viability/mortality: Daily
Clinical signs: Daily during the observation period
Body weights: At start of acclimatization, on the day of application and at termination of observation
Room environment: Monitored continuously with hourly recordings - Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm2
- % coverage: no data
- Type of wrap if used: The semi-occlusive dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
- Time after start of exposure: The duration of treatment was 4 hours
SCORING SYSTEM: The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then divided by the number of data points.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: both female rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal: male
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal: male
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: both female rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: Male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal: male
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria, Isopropyl methyl-2-butyrate is considered to be “not irritating” to rabbit skin.
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