2-ethylhexyl oleate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 to 18 Mar 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study with acceptable restrictions (analytical purity of test substance not specified, only female animals evaluated, only 6-day observation period in the absence of any sign of adverse toxicity, no necropsy, limited information on test animals/test animal husbandry).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

analytical purity of test substance not specified, only female animals evaluated, only 6-day observation period in the absence of any sign of adverse toxicity, no necropsy, limited information on test animals/test animal husbandry

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl oleate

EC Number:

247-655-0

EC Name:

2-ethylhexyl oleate

Cas Number:

26399-02-0

Molecular formula:

C26H50O2

IUPAC Name:

2-ethylhexyl octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): oleate ethyl 2 hexyle
- Physical state: liquid, clear
- Batch/Lot Nr.: 2903 DL

Test animals

Species:

mouse

Strain:

NMRI

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- NMRI EOPS mice were used in the study
- Weight at study initiation: 19 - 20 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
> 5 mL/kg, calculated from 5000 mg/kg bw, assuming test substance density of 870 mg/mL from chapter 4.4

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 (female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: daily, body weight before and at the end of the study.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities or clinical signs of adverse toxicity observed at this unique dose level

Mortality:

No mortality occured during the study period.

Clinical signs:

other: No abnormality were observed up to the end of the observation period.

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