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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:
weight of evidence
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Secondary source

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972
Reference Type:
secondary source
Title:
Final Report on the Safety Assessment of Squalane and Squalene
Author:
CIR Expert panel
Year:
1982
Bibliographic source:
International Journal of Toxicology 1982 1: 37

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
No data

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5.0, 12.5, 25.0, 50.0 ml/kg
No. of animals per sex per dose:
groups with 5, 5, 10 and 10 mice
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 50 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 50 mL/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
no clinical signs observed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the seven-day observation period, no toxic effects were observed and no deaths occurred. The single dose oral LD50 was determined to be greater than 50 ml/kg in mice.
Executive summary:

Squalene has been tested for acute oral toxicity on mice. The single dose oral LD50 was determined to be greater than 50 ml/kg.