Reaction mass of ethyl dodecanoate and ethyl hexadecanoate and ethyl tetradecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliable study, similar to OECD TG 401, without GLP, with minor restrictions in design and/or reporting but sufficiently reliable for assessment.

Justification for type of information:

The information is used to read across to Oenanthic ether.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Range finding test yielded four doses: 3.18; 3.96; 5.0; 6.3 ml/kg;
Appraisal of the safety of foods, drugs and cosmetics (FDA) rules applied

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

1,4-dioxacyclohexadecane-5,16-dione

EC Number:

259-423-6

EC Name:

1,4-dioxacyclohexadecane-5,16-dione

Cas Number:

54982-83-1

Molecular formula:

C14H24O4

IUPAC Name:

1,4-dioxacyclohexadecane-5,16-dione

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Winkelmann, Paderborn
Weight: ca. 140 g; fasting period before study:ND
Diet: Standard laboratory diet (Ssniff/Intermast)
Water: ad libitum
Acclimation period: 22°C ± 1°C, humidity of the air: 45- 55%, Light period: 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

After 16 hour starvation period, different doses were administered in groups of 10 rats each existing of 5 males and 5 females

Doses:

3.18; 3.96; 5.00; 6.30 ml/kg

No. of animals per sex per dose:

five

Control animals:

no

Details on study design:

Mortality and behaviour were observed for seven days. Animals that died were dissected to observe any changes in the physiological structures

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4.21 other: mL/kg bw (4500 mg/kg bw)

Based on:

test mat.

Remarks on result:

other: 24 hours and 7 days average following Litchfield and Wilcoxon with Gaussian approximation

Mortality:

Mortality:

24 hours           7 days
3.18 ml/kg      0/10                     0/10
3.96 ml/kg      4/10                     4/10
5.00 ml/kg      9/10                     9/10
6.30 ml/kg    10/10

Clinical signs:

In the doses applied the substance did not show any toxic symptoms other than apathy of the animals.

Body weight:

An increase of the average body weight from 135 to 156 g after 7 days was detected.

Gross pathology:

No abnormalities were found after necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful

Remarks:

according to EU CLP (EC No. 1272/2008 and its amendments).

Conclusions:

The oral LD50 in rats was determined to be 4500 mg/kg bw.

Executive summary:

In an acute oral toxicity study conducted using a protocol similar to OECD guideline 401 (performed before GLP principles were implemented), undiluted test substance was administered via oral gavage to fasted Wistar rats (five males + five females/dose) at dose levels of 3.18, 3.96, 5 and 6.30 mL/kg. The animals were sluggish soon after administration. In the higher dose groups mortality was observed within 24 hours of dosing, while no mortality was observed after 7 days. Necropsy did not reveal any pathological effects. The LD50 was 4.21±1 mL/kg bw (4500 mg/kg bw) both for the 24 hour and 7 day observation period.