Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Lack of details on the test material and limited documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

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 the test material and limited documentation
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Propane-1,2,3-triyl trisheptanoate
EC Number:
210-647-2
EC Name:
Propane-1,2,3-triyl trisheptanoate
Cas Number:
620-67-7
IUPAC Name:
propane-1,2,3-triyl triheptanoate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 ± 20 g
- Fasting period before study: overnight
- Housing: through the observation period of the test, animals were segregated in cages according to sex and dosage group.
- Diet: normal diet (not further specified)
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
Doses:
First experiment (range-finder): 0.5, 1, 2.5 and 5 mL/kg bw
Second experiment: 5 mL/kg bw
No. of animals per sex per dose:
First experiment (range-finder): 1
Second experiment: 5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 7 and 14 days in the first and second experiment, respectively.
- Frequency of observations: animals were observed immediately after dosing and daily thereafter. Any deaths or signs of toxicity were recorded.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, mortality

Results and discussion

Preliminary study:
No mortality occurred in rats (2 per dose level) administered the test substance at 0.5, 1, 2.5 and 5 mL/kg bw and observed for 7 days.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 820 mg/kg bw
Based on:
test mat.
Remarks on result:
other: converted from mL/kg bw based on a density of 0.964 g/mL (Spilker, 2011)
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

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