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Diss Factsheets
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EC number: 941-319-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 009
- 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
- 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
1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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