Fatty acids, coco, 2-ethylhexyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 Apr - 05 May 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, coco, 2-ethylhexyl esters

EC Number:

295-366-3

EC Name:

Fatty acids, coco, 2-ethylhexyl esters

Cas Number:

92044-87-6

Molecular formula:

Substance is UVCB

IUPAC Name:

Fatty acids, coco, 2-ethylhexyl esters

Details on test material:

- Name of test material (as cited in study report): Only trade name given
- Physical state: liquid
- Analytical purity: approximately 100%
- Lot/batch No.: 77742
- Stability under test conditions: stable at storage conditions
- Storage condition of test material: at ambient temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 243 - 275 g; females: 176 - 205 g
- Fasting period before study: yes, overnight until approximately 3 hours after administration of the test substance
- Housing: 6 days prior to dosing the animals were individually housed in polycarbonate cages
- Diet: RMH-B, pellet diameter 10 mm, Hope Farms, Woerden, ad libitum
- Water: tap-water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23. On one occasion the temperature ranged from 18 - 19 °C for a period of 2 hours.
- Humidity (%): 43 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Dose range finding:
560, 1400, 1800, 3200 and 5600 mg/kg bw

Main study:
5000 mg/kg bw

No. of animals per sex per dose:

Dose range finding: 1 animal

Main study: 5 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cage-side observations were performed on the day of dosing every 2 hours and daily thereafter. With exceptions of weekends and holidays a mortality check was performed at the end of the day. Individual body weights were measured weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

In order to establish an appropriate dose range 5 groups of each animal/group/sex, were dosed with a single oral administration of the test substance at 560, 1400, 1800, 3200 and 5600 mg/kg bw, repsectively. No mortalities occured and no signs of systematic toxicity were observed during the 14-day observation period.
Based on these result, one group of animals, comprising 5 males and 5 females, was dosed with a single oral administration of the test substance at 5000 mg/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: No signs of systemic toxicity were observed during the 14-day observation period.

Gross pathology:

No findings considered to be related to treatment.

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