Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

EC Number:

271-516-3

EC Name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

Cas Number:

68583-51-7

Molecular formula:

C21H44O6

IUPAC Name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

Test animals

Species:

mouse

Strain:

other: White mice of Tylers original strain

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 20 ± 2 g
- Fasting period before study: overnight
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
no details available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

No details available

Doses:

5 mL/kg, which is correspondent to 4.6 mg/kg bw

No. of animals per sex per dose:

10 animals

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: after 1, 2, 3, 4, 7 and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: no

Results and discussion

Preliminary study:

Pretest: Concentrations: 1, 2, 3, 4 and 5 mL/kg, 2 animals each, observed for 7 days, no deaths observed

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 4 600 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of the test item in mice was established as exceeding 4600 mg/kg body weight.

Executive summary:

In an acute oral toxicity study, conducted similar to OECD 401, groups of fasted white mice were given a single oral dose of the test item at a dose of 5 mL/kg bw and observed for 14 days. No animals died during the study. No clinical signs were observed during the study period. The oral LD50 was determined to be > 5 mL/kg bw, which is correspondent to 4600 mg/kg bw.