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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
May 20th, 1988 - June 3rd, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Purity of test substance not given.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Glycerides, C12-18
EC Number:
266-944-2
EC Name:
Glycerides, C12-18
Cas Number:
67701-26-2
IUPAC Name:
67701-26-2
Details on test material:
- Name of test material (as cited in study report): C10-18 Triglyceride;
- Name of test material: Hydrogenated Coco-Glycerides
- Physical state: white, waxy solid
- Analytical purity: no data
- Storage condition of test material: room temperature
- Stability under test conditions: not determined

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CFY strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna Ltd., Cambridgeshire, U.K.
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 120-137 g; females 120-136 g.
- Fasting period before study: yes
- Housing: goups of up to five in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Ltd., Essex, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: min 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 50 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION:
The test material was ground to a waxy paste and freshly prepared, as required, as a suspension in arachis oil B.P.

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: Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy
- Other examinations performed: body weights were recorded on days 0, 7 and 14

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:
No deaths occured during the study period.
Clinical signs:
No evidence of systemic toxicity were noted during the study period.
Body weight:
All animals showed normal gains in bodyweight during the study period.
Gross pathology:
No abnormalities occured.

Applicant's summary and conclusion

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