Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Feb 1988 - 09 Mar 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
adopted in 1984
Deviations:
yes
Remarks:
a limit dose level of 2000 mg/kg bw was applied.
Qualifier:
according to
Guideline:
other: Bewertung Wassergefährdender Stoffe, II Bestimmung der akuten, oralen Säugertiertoxizität, Ad hoc Arbeitsgruppe I, LTwS, nr. 10 September 1979
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
-Chemical name: Glycerol trioleate
- Physical state: liquid
- Analytical purity: approx. 100% ester
- Stability under test conditions: stable at storage conditions
- Storage condition of test material: at ambient temperature in the dark
- Specific gravity: 0.92 g/mL (20 °C)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 222 ± 3.6 g (males), 177 ± 7.5 g (females)
- Fasting period before study: animals were fasted overnight (prior to dosing) until approx. 3 h after administration of the test substance.
- Housing: individually housed in polycarbonate cages containing purified sawdust (Woody Clean supplied by Broekman Institute, Someren, The Netherlands) as bedding material.
- Diet: standard pelleted laboratory animal diet (RMH-B, Hope Frams, Woerde, The Netherlands), ad libitum.
- Water: tap-water (via automatic nozzles), ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 Feb 1988 To: 09 Mar 1988

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: the dose volume (mL/kg bw) used was calculated as follows:
dose (g/kg bw) / specific gravity (g/mL)
The specific gravity used was 0.92 g/mL. Thus the maximum dose volume applied was 2.174 mL/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on the day of dosing (approx. once every 2 h) and once daily thereafter for 14 days. Any signs of toxicity were recorded along with the time of onset and duration. Individual body weights were measured weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the 14-day observation period.
Clinical signs:
No signs of systemic toxicity were observed during the 14-day observation period.
Body weight:
All animals showed body weight gain.
Gross pathology:
Macroscopic examination of animals at termination did not reveal any abnormalities that were considered to be treatment-related.

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