Octanoic acid, mixed tetraesters with 2-ethylhexanoic acid, heptanoic acid and pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)

EC Number:

230-743-8

EC Name:

2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)

Cas Number:

7299-99-2

Molecular formula:

C37H68O8

IUPAC Name:

3-[(2-ethylhexanoyl)oxy]-2,2-bis{[(2-ethylhexanoyl)oxy]methyl}propyl 2-ethylhexanoate

Test material form:

other: Liquid, colorless and transparent

Details on test material:

- Name of test material (as cited in study report): Hexanoic acid, 2-ethyl, 2,2-bis[[(2-ethyl-l-oxohexyl)oxy]methyl]-1,3-propanediyl ester- Molecular formula (if other than submission substance): C37H68O8- Molecular weight (if other than submission substance): 640.94- Physical state: Liquid, colorless and transparent- Analytical purity: 98.4% (GC%)- Stability under test conditions: stable- Storage condition of test material: Room temperature, shade

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Atsugi breeding center
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 191-214 g
- Fasting period before study: yes
- Housing: 1-3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9-16 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.5-24.2°C
- Humidity (%): 48-81%
- Air changes (per h): 8/h
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.40%w/v
- Amount of vehicle (if gavage): 0.5 mL/100 g weight
- Justification for choice of vehicle: Stability and uniformity of concentration

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: everyday for observation and Days 0, 7, 14 for weighting
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No motarity

Clinical signs:

other: One animal at 300 mg/kg bw suffered from diarrhea after 1 h of dosing. But it recovered after 4 h of dosing. There were no abnormality in other animals.

Gross pathology:

There were not any abnormalities for gross pathology at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median dose (LD50) of the test substance in the female Crj:CD(SD) IGS rats was determined to be >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance in Crj:CD(SD) IGS rats according to OECD Guideline 423. Groups of rats were orally administered the test substance at dose levels of 300 and 2000 mg/kg bw as a solution in corn oil. Clinical signs and bodyweight development were monitored during the study period of 14 d. All animals were subjected to gross necropsy. No mortality was observed in either test group. No clinical signs were observed and there were no treatment-related effects on the body weight. No abnormalities were observed at necropsy. Under the study conditions, the acute oral LD50 of the substance in Crj:CD(SD)IGS rats was determined to be >2000 mg/kg bw (MHLW, 2005).