Dodecanoic acid, monoester with oxybis[propanediol]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data given. Lack of details on test material.

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:

lack of details on test material

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol tristearate

EC Number:

209-097-6

EC Name:

Glycerol tristearate

Cas Number:

555-43-1

Molecular formula:

C57H110O6

IUPAC Name:

propane-1,2,3-triyl trioctadecanoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. Tuck and Sons Limited, Battlesbridge, Essex, UK.
- Weight at study initiation: 220-265 g (males), 180-265 (females).
- Fasting period before study: animals were fasted 16-20 h prior to administration.
- Housing: by sex in suspended metal cages (370 x 360 x 180 mm) with mesh floors. A maximum of 5 animals were housed in each cage.
- Diet: Rat Diet (Nottingham University, School of Agriculture, Sutton Bonington, Near Loughborough, Leicestershire, UK), ad libitum.
- Water: tap water, ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Air changes (per hr): min. 20
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage):
Range finder study: 2, 4, 10, 20 and 40 mL/kg bw
Main study: 40 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw

Doses:

Range finder study: 1000, 2000, 5000, 10000 and 20000 mg/kg bw
Main study: 20000 mg/kg bw

No. of animals per sex per dose:

Range finder study: 1
Main study: 5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Range finder study: after dosing, animals were observed daily for 5 days, or until any evidence of toxicity had subsided, whichever was the longer, and any mortalities were recorded.
Main study: animals were observed 30 min, 1, and 4 h after dosing and once daily thereafter for 14 days. Any mortalities or evidence of overt toxicity were recorded. Body weights of all animals were recorded at Day 0 and at Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Preliminary study:

No mortality occurred in the range finder study at any of the tested dose levels (1, 2, 5, 10 and 20 mg/kg bw). Clinical signs of toxicity were not reported.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

Evidence of overt toxicity was confined to subdued activity and pilar erection within 1 h of dosing. Animals had recovered at 4 h. No further symptoms of toxicity were observed throughout the 14-day observation period, in any of the test animals.

Body weight:

No significant effect on body weight increase was apparent.

Gross pathology:

Gross necropsy of all survivors at termination of the study revealed no abnormal macroscopic lesions.

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

Conclusions:

CLP: not classified