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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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:
29 Apr - 13 May 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentaerythritol tetraoleate
EC Number:
242-960-5
EC Name:
Pentaerythritol tetraoleate
Cas Number:
19321-40-5
Molecular formula:
C77H140O8
IUPAC Name:
Fatty acids, C16-18 (even numbered) and C18-unsatd., tetraesters with 2,2-Bis(hydroxymethyl)1,3-propanediol
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Colour: yellow
- Analytical purity: no data (treated as 100% pure)
- Lot/batch No.: N558331
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Density (20 °C): 0.92 g/mL


Test animals

Species:
rat
Strain:
other: Wistar strain Crl:(WI) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 275 g ± 20 g, females: 188 g ± 12 g
- Fasting period before study: overnight before until 3-4 h after dosing
- Housing: 3 animals/sex/cage in polycarbonate cages, containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands)
- Diet: standard laboratory animal diet, Carfil Quality BVBA, Oud-Turnhout, Belgium, ad libitum
- Water: tap-water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes: approx. 15 (air conditioned room)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.17 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed twice daily for mortality. Individual body weights were determined weekly (Days 1 (pre-administration), 8 and 15). Animals were observed for clinicals signs at periodic intervals on Day 1 and once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No statistical analysis was performed (the method used is not intended to allow the calcuation of a precise LD50 value)

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 study period.
Clinical signs:
other: No clinical signs of toxicity were observed during the study period.
Gross pathology:
No abnormatlities were found at macroscopic post mortem examination of the animals.

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