Registration Dossier

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

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.