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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
20 May - 03 Jun 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
Report date:
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
Chemical structure
Reference substance name:
Glycerides, C12-18
EC Number:
266-944-2
EC Name:
Glycerides, C12-18
Cas Number:
67701-26-2
Molecular formula:
C39H74O6 to C57H110O6
IUPAC Name:
Glycerides, C12-18
Details on test material:
- Name of test material (as cited in study report): [trade name] C10-18 Triglyceride;
- 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: 120-137 g (males), 120-136 g (females)
- Fasting period before study: overnight
- Housing: goups of up to five in solid-floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diet Services Ltd., Essex, UK), ad libitum
- Water: ad libitum
- Acclimation period: at least 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:
other: not required
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.
Mortality:
No deaths occured during the study period.
Clinical signs:
other: No evidence of systemic toxicity were noted 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
Conclusions:
CLP: not classified
DSD: not classified