Registration Dossier

Administrative data

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)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: gavage
Vehicle:
other: 0.5% methylcellulose aqueous solution
Doses:
Starting dose level : 2000 mg/kg (1874 mg/kg of active ingredient)
Treatment : 2000 mg/kg (2043 mg.kg of active ingredient based on a final purity of 93,7%)
No. of animals per sex per dose:
3
Control animals:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No unscheduled deaths occured during the study
Clinical signs:
No clinical signs were observed in any animals
Body weight:
The body weights and mean body weigh change recorded in test item treated animals during the observation period were similar to CiToxLAB historical data.

Pathology :

No test item related changes were seen at necroscopy, 14 days after a single oral administration of the test item at 2000 mg/kg.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimetal conditions of this study, the oral LD50 of the test item, Tocopheryl Glucoside, was higher than 2000 mg/kg in rats. Therefore, the test item should not be classified as toxic by oral route according the crieria of CLP regulation.
Executive summary:

The objective of the study was to evaluate the potential acute toxicity of the test item, Tocopheryl Glucoside, following a single oral administration (gavage) in rats. The study was conducted according the OECD guideline n°423.

The test item was administred once by oral route (gavage) to two groups of three fasted female Sprague-Dawley rats under a dosage volume of 10 mL/kg. The test item was prepared in a 0.5% methylcellulose aqueous solution at the dose level of 2000 mg/kg.

Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on day 1 and then on days 8 and 15. At the end of the study, the animals were sacrified and submitted for a macroscopic post-mortem examination.

Under the experimental conditions of the study, the oral LD50 of the test item aws higher than 2000 mg/kg in rats.

Therefore, the test item should not be classified as toxic by oral route according to the criteria of CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

Only acute oral toxicity study was conduced and show no adverse effects and no mortality after a single oral administration of 2000 mg/kg of test item in rats.