Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

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

Results and discussion

Effect levels
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.