Oleic acid, monoester with oxybis(propanediol)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)"

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3-dihydroxypropyl oleate

EC Number:

203-827-7

EC Name:

2,3-dihydroxypropyl oleate

Cas Number:

111-03-5

IUPAC Name:

2,3-dihydroxypropyl octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): Chemical substance name: Glyceryl oleate, IUPAC name: 9-Octadecenoic acid, (9Z)-, 2,3-dihydroxypropyl ester
- Physical state: light yellow pellet with slight characteristic odour
- Analytical purity: 99.93%
- Stability under test conditions: verified after exposure
- Storage condition of test material: at room temperature (17-28 °C)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 6 weeks
- Weight at study initiation: 123-125 g
- Fasting period before study: 16 h
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 42-51
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): CER5860

DOSAGE PREPARATION:
After the test substance was heated and melted at 37 °C, it was diluted in the vehicle. This preparation was performed two days before administration and stored in the dark.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Because the acute oral toxicity of the test substance was expected to be very low, a dose level of 2000 mg/kg bw was chosen. No mortality was observed during step 1. Therefore, the dose level in step 2 was also 2000 mg/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed once a day. Animals were weighed on Days 0, 1, 2, 3, 7, 10 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs were reported.

Gross pathology:

There were no abnormalities during test period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified