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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no analytical purity of test substance given; deficiencies in reporting;
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C16-18, 2-ethylhexyl esters
EC Number:
292-951-5
EC Name:
Fatty acids, C16-18, 2-ethylhexyl esters
Cas Number:
91031-48-0
Molecular formula:
C24H48O2 to C26H52O2
IUPAC Name:
91031-48-0
Details on test material:
- Name of test material (as cited in study report): stearate d´ethyl2 hexyle
- Analytical purity: no data given

Test animals

Species:
mouse
Strain:
other: NMRI EOPS
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 22 and 20 g, respectively

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5 mL/kg bw, equivalent to a dose of 4.3 g/kg bw (calculated with a density of 860 g/L at 20 °C).
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
The method was adapted from the French Pharmacopoeia IXth edition, dose fixed taking account of the OECD guideline 401.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 300 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No abnormal reactions were seen during the observation period.
Body weight:
No data.
Gross pathology:
No data.

Applicant's summary and conclusion

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