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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
Study period:
2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline for the Testing of Chemicals, Guideline 407 Repeated Dose 28-Day Oral Toxicity Study in Rodents
Deviations:
yes
Remarks:
Food consumption was not recorded on day 14 by mistake
Principles of method if other than guideline:
Dose-range-finding study
GLP compliance:
yes (incl. certificate)
Test type:
other: Dose-Range-Finding Toxicity Study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
vegetal squalan

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
the test item was pure
Doses:
For groups tested :
Group 1 : 0 mg/kg/day (control group, vehicule = corn oil
Group 2 = 100 mg/kg/day
Group 3 = 500 mg/kg/day
Group 4 = 1000 mg/kg/day
No. of animals per sex per dose:
3 females
3 males
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LDLo
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and no clinical sign observed

Any other information on results incl. tables

No mortality, neither no clinical sign were observed after oral administration of 1000 mg/kg/day during 14 consecutive days.

Applicant's summary and conclusion

Interpretation of results:
other: non toxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In the test condition, the substance is considered as nontoxic after oral administration of 1000 mg/kg/day during 14 consecutive days.
Executive summary:

The dose-range-finding toxicity study has been realized according OCDE 407 method on 24 animals (wistar rats - 12 females and 12 males). The test item was administrated by oral gavage at 100, 500 or 1000 mg/kg/day during 14 consecutive days. Animals were observed twice daily from J0 (oral administration) to J14.

Repeated oral (gavage) administration of Phytosqualan to Wistar Hannover rats at doses up to 1000 mg/kg/day for 14 days resulted in no mortality or relevant clinical signs.

The effects observed on clinical biochemistry analysis such as slightly lower protein count, lower calcium values and increased ALP values (in females) with respect to the Control group are considered non-adverse effects.

The relevance of the effects on thyroid, liver and kidney weights of males treated at 1000 mg/kg remains unclear in the absence of a microscopic examination. In any case, they should not be considered toxicologically relevant because there was no evidence of liver or kidney impairment in the clinical laboratory investigations.