Isopropyl oleate

Acute Toxicity: oral

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 guideline

Test guideline 1

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

Test guideline 2

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

Test material information

Constituent 1

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:

other: 2 h after dosing hunched posture and uncoordinated movements were noted in two females.

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