2-ethylhexyl palmitate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Start: 25 Jul 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (test substance purity not specified).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

test substance purity not specified; body weight gain not recorded

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl palmitate

EC Number:

249-862-1

EC Name:

2-ethylhexyl palmitate

Cas Number:

29806-73-3

Molecular formula:

C24H48O2

IUPAC Name:

2-ethylhexyl palmitate

Details on test material:

- Name of test material (as cited in study report): Ethylhexyl Palmitate
- Physical state: Liquid, colorless
- Lot/batch No.: B216
- Analytical purity: no data

Test animals

Species:

rat

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Kent, U.K.
- Weight at study initiation: 169 - 250 g
- Housing: animals were housed in single sex groups in polypropylene cages
- Fasting period before study: overnight
- Diet: modified 41B diet, Pilsbury's Limited, Birminham, UK, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Details on oral exposure:

DOSAGE PREPARATION: The required dose level per kilogram bodyweight was suspended in vegetable oil on a weight/volume basis to a total volume of 10 mL.

Doses:

5000 mg/kg bw

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: Animal were weighed prior to dosing. Mortality/Toxicity: immediately after dosiung, 4 h after dosing and the daily for 14 days.
- 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 mortality, adverse clinical signs observed at this unique dose level

Mortality:

No mortality occured during the observation period.

Clinical signs:

other: No overt signs of toxicity 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:

DSD: not classified
CLP: not classified