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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:
1996-03-25 to 1996-04-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Glyceryl Citrate/Lactate/Linoleate/Oleate
IUPAC Name:
Glyceryl Citrate/Lactate/Linoleate/Oleate
Constituent 2
Reference substance name:
Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts
EC Number:
294-585-1
EC Name:
Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts
Cas Number:
91744-23-9
IUPAC Name:
91744-23-9
Test material form:
liquid
Specific details on test material used for the study:
- Substance type: product
- Physical state: liquid
- Stability under test conditions: > 1 year
- Storage condition of test material: at room temperatures in the dark
- Manufacture date: May 1995
- Lot/batch No.: 505024
- Expiration date of the lot/batch: not earlier than May 1996

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 146 - 161 g (male); 130 - 142 g (female)
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet: R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.004 cm³/kg
Doses:
2000 mg/kg bw
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 and weighing: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
Statistics:
no statistics performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0/10 animals
Clinical signs:
none
Body weight:
normal body weight gain of all animals
Gross pathology:
no findings
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met