Fatty acids, C18-unsatd., diesters and triesters with trimethylolpropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 04th, 1992 - June 18th, 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation. Only basic data on test material given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Only basic data on test material given

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate

EC Number:

260-895-0

EC Name:

2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate

Cas Number:

57675-44-2

Molecular formula:

C60H110O6

IUPAC Name:

2,2-bis[(oleoyloxy)methyl]butyl octadec-9-enoate (non-preferred name)

Details on test material:

- Physical state: yellow, liquid
- Lot/batch No.: 2035/406
- Storage condition of test material: room temeprature

Test animals

Species:

rat

Strain:

other: ICO: OFA-SD (IOPS Caw)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, France
- Age at study initiation: 6 weeks
- Weight at study initiation: 187 ± 6 g (males), 153 ± 6 g (females)
- Housing: 5 animals per polycarbonate cage (48x27x20 cm)
- Fasting period before study: 18 h before until 4 h after dosing
- Diet: ad libitum (Rats - Mice substance ref. A04 C)
- Water: tap-water ad libitum
- Acclimation period: 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- 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: 2.20 mL/kg

Doses:

2000 mg/kg bw (taking into account the specific gravity of 0.912 g/mL)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily, weighing: Days 1, 5, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology

Statistics:

Not applicable

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No clinical signs at any time point

Gross pathology:

No apparent abnormalities

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