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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
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
Species:
rat
Strain:
Wistar
Sex:
male/female
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
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

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral exposure : A dose-range-finding toxicity study has been realized according OCDE 407. 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.

Cutaneaous exposure : The substance is essentially used as cosmetic ingredient for cutaneous application. Regard to his molecular structure and molecular weight, the substance will not cross the epidermal barrier.

Inhalation exposure : No inhalation exposure is expected.

Justification for selection of acute toxicity – oral endpoint

Recent study according OECD guideline and reliable without restriction, LDL0>1000 mg/kg

Justification for classification or non-classification

Regarding experimental results, squalane is considered as non toxic.