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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Apr - 13 May 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions (analytical purity of test substance not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
analytical purity of test substance not specified
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl oleate
EC Number:
203-935-4
EC Name:
Isopropyl oleate
Cas Number:
112-11-8
Molecular formula:
C17H34O2 to C21H40O2
IUPAC Name:
isopropyl oleate
Details on test material:
- Name of test material (as cited in study report): isopropyl oleate
- Physical state: Liquid, yellow
- Analytical purity: Not indicated, treated as 100% pure
- Lot/batch No.: N558331
- Storage condition of test material: RT in the dark

Test animals

Species:
rat
Strain:
other: Wistar Crl:(WI) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: Males: 261 g; Females 187 g;
- Housing: 3 animals per sex housed in polycarbonate cages
- Fasting period before study: over night until approximately 3 - 4 h after administration of the test substance
- Diet: standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium, ad libitum
- Water: tap water, ad libitum
- Acclimatisation: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- air changes per hour: 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.3 mL/kg bw; dose volume calculated based on a density of 0.87 g/mL
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Toxicity: at periodic intervalls on the day of dosing (day 1) and once daily thereafter, until day 15. Body weight were measured weekly (day 1 (pre-administration), day 8 and 15)
- Necropsy of survivors performed: yes, after terminal sacrifice by asphyxiation using a oxygen/carbon dioxide procedure (day 15)
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
2 h after dosing hunched posture and uncoordinated movements were noted in two females.
Body weight:
Normal body weight gain was observed.
Gross pathology:
No findings considered to be related to treatment were found.

Any other information on results incl. tables

The LD50 for the test substance when admistered orally as a single dose to rats is considered to be >2000 mg/kg bw. According to DSD and CLP the test substance has not to be classified.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified