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Diss Factsheets

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:
29 Apr - 13 May 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

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:
3-(oleoyloxy)-2,2-bis[(oleoyloxy)methyl]propyl octadec-9-enoate (non-preferred name)
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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

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