.beta.-D-Glucopyranoside, (2R)-3,4-dihydro-2,8-dimethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-2H-1-benzopyran-6-yl

Endpoint summary

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

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:

other: No clinical signs were observed in any animals

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

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.