Ethane-1,2-diyl palmitate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

12 Jun 1991 - 26 Jun 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Lack of test material details, no necropsy performed.

Justification for type of information:

Refer to category justification provided in the category object.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of test material details, no necropsy performed

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FHSA/CPSC: Federal Hazardous Substances Control Act, 16 CFR 1500.3

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethylene distearate

EC Number:

211-014-3

EC Name:

Ethylene distearate

Cas Number:

627-83-8

Molecular formula:

C38H74O4

IUPAC Name:

ethane-1,2-diyl dioctadecanoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA, USA
- Age at study initiation: young adult, not further specified
- Weight at study initiation: 184-205 g
- Fasting period before study: 18 h
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet: pelleted Purina Rat Chow #5012, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2.5%

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/w
- Amount of vehicle (if gavage): 2.0-2.3 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2.3 mL/kg bw

Doses:

5000 mg/kg bw administered as two doses due to the volume of test material of 2.0-2.3 mL each within 24h.

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the rats were observed for signs of gross toxicity and mortality at 1, 2, 3, 4, 5 and 24 h post-dosing, and at least once daily thereafter for 14 days. Body weights were recorded initially and at termination (Day 14).
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

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: administered as two doses within 24 h.

Mortality:

No mortalities occurred.

Clinical signs:

other: No abnormal clinical signs were observed.

Gross pathology:

Not examined.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.