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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:
1999
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

Constituent 1
Reference substance name:
Isopropyl methyl-2-butyrate
IUPAC Name:
Isopropyl methyl-2-butyrate
Constituent 2
Chemical structure
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)

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