Registration Dossier
Registration Dossier
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EC number: 266-411-4 | CAS number: 66576-71-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 May to 08 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- 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: March 25, 2000
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: : in a refrigerator (2 - 6°C)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division
- Age at study initiation: Females: 10 weeks, Males: 8 weeks
- Weight at study initiation:
- Fasting period before study: approximately 16.5 to 18.5 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
- Housing: Groups of three in Makrolon type-4 cages with standard softwood bedding
- Diet: Pelleted standard Kliba 3433, rat maintenance diet (Provimi Kliba AG,) available ad libitum (except for the overnight fasting period prior to intubation).
- Water: Community tap water, available ad libitum.
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 70% (relative humidity)
- Air changes (per hr): 10 - 15 (air-conditioned)
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PEG 300
- Doses:
- Dose: 2000mg/kg bw
Application volume: 10ml/kg bw - No. of animals per sex per dose:
- 3 females, 3 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability and Clinical Signs: Four times during test day 1 and once daily during days 2-15; Body weights: On test day 1 (pre-administration), 8 and 15; Room environment was monitored continuously with hourly recordings
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- No statistical analysis was used as no deaths occurred.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study.
- Clinical signs:
- No clinical signs were observed during the study period.
- Body weight:
- Sex Animal No. Day of Treatment Day 8 Day 15
Female 1 187.1 205.5 217.1
2 184.9 207.6 226.8
3 188.9 216.6 227.4
Male 4 205.9 270.8 293.4
5 218.5 274.8 301.8
6 212.4 258.5 273.9 - Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of Isopropyl methyl-2-butyrate after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred.
LD50 rat: greater than 2000 mg/kg body weight
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