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
Study period:
12 - 18 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Principles of method if other than guideline:
To determine the LD50 of the test substance, 5000 mg/kg bw was administered to 5 female mice orally. The mice were observed for mortality and signs of toxicity for 6 days after dosing. The body weights were recorded on day 0 prior to dosing and on day 6.
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C8-10, C12-18-alkyl esters
EC Number:
306-082-7
EC Name:
Fatty acids, C8-10, C12-18-alkyl esters
Cas Number:
95912-86-0
Molecular formula:
Unspecified
IUPAC Name:
Fatty acids, C8-10, C12-18 (even numbered)-alkyl esters
Details on test material:
- Name of test material (as cited in study report): coco caprylate/caprate
- Analytical purity: no data
- Physical state: clear liquid
- Lot/batch No.: 0907 D
- Density: 0.828 g/mL

Test animals

Species:
mouse
Strain:
other: NMRI EOPS
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 19-20 g
- Fasting period before study: 4 h

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 6 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: the animals were observed for mortality and signs of toxicity daily; the body weight was recorded on day 0 prior to dosing and on day 6
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, mortality, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified