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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 11th, 1999 - March 12th, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, C16-18 mono- and di-
EC Number:
286-490-9
EC Name:
Glycerides, C16-18 mono- and di-
Cas Number:
85251-77-0
Molecular formula:
C19H38O4, C21H42O4, C35H68O5, C39H76O5
IUPAC Name:
Glycerides, C16-18 mono- and di-
Details on test material:
- Name of test material (as cited in study report): Glyceryl Palmitostearate
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: August 1st, 2000

Test animals

Species:
rat
Strain:
other: Rat Ico: OFA.SD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IFFA-CREDO, Cedex, France.
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: males: 163 - 172 g, females 138 - 149 g
- Fasting period before study: overnight
- Housing: up to 5 in polycarbonate cages
- Diet (e.g. ad libitum): pelleted complete diet, Usine d'Alimentation Rationnelle, France.
- Water (e.g. ad libitum): yes
- Acclimation period: 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): min 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % (w/w)
- Lot/batch no. (if required): A28557/1
- Purity: pure
Test substance preparation was administered within 4 hours of preparation.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 15 min, 1 h, 2 h and 4 h after administration. Thereafter daily.
- Frequeny of weighing: day -1, immediately before administration and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: rat
Mortality:
None.
Clinical signs:
None.
Body weight:
No treatment related effects.
Gross pathology:
No macroscopic abnormalities observed.

Applicant's summary and conclusion

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