Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

1

Reference substance name:

Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride

EC Number:

941-319-3

Molecular formula:

Unknown (Substance of Unknown or Variable Composition)

IUPAC Name:

Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

The trade name of the test item Palmitoyl grape seed extract is BERKEMYOL PEPIN DE RAISIN (the name mentioned in acute toxicity study report).

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Six Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle - France), were used after an acclimatization period of at least five days. At the beginning of the study, the animals of the treated group weighed between 181 g and 205 g and were 8 weeks old.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

In each step of the study, 2 g of the test item was weighed and olive oil was added in a 10 ml volumetric flask. The preparation was magnetically agitated to optain a slight brown homogeneous suspension, just before being administered.
The preparation was administered by gavage under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

The animals of the treated group, received an effective dose of 2000 mg/kg body weight of the test item BERKEMYOL PEPIN DE RAISIN / 09.508.

No. of animals per sex per dose:

6 animals were treated.

Control animals:

yes

Remarks:

Systematic examinations were carried out to identify any behavioural or toxic effects on the major phyisiological functions 14 days after administration of the test item.

Details on study design:

The experimental protocol was established according to the OECD guideline n°423 dated 17 December 2001 concerning acute oral toxicity and the test method B.1 ter of the Council regulation N°440/2008.

Results and discussion

Effect levels

Key result

Sex:

female

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

The LD50 of the test item BERKEMYOL PEPIN DE RAISIN /09.508 is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline n°423, the LD50 cut-off of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.

Mortality:

No mortality occured during the study.

Clinical signs:

No clinical signs related to the administration of the test item were observed.

Body weight:

The body weight of the animals remained normal throughout the study.

Other findings:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Conclusions:

According to attached study report, the product BERKEMYOL PEPIN DE RAISIN must not be classified. No symbol and risk phrase are required.

Executive summary:

The LD50 of the test item BERKEMYOL PEPIN DE RAISIN /09.508 is higher than 2000 mg/kg body weight by oral route in the rat.

In accordance with the OECD guideline n°423, the LD50 cut-off of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directive 67/548, 2001/59 and 99/45, the test item BERKEMYOL PEPIN DE RAISIN /09.508 must not be classified. No symbol and risk phrase are required.

In accordance with the Globally Harmonised System (Regulation (EC) No 1272/2008), the test item must not be classified. No signal word and hazard statement are required.