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Diss Factsheets
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EC number: 232-504-3 | CAS number: 8060-28-4
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Oil-rich hop extract batch no. BI/YYF/1701
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 5.65
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Hop extract (Oil rich) is classfied as irritant to human skin
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Low oil hop extract batch no. 871008
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 3.39
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- An eye irritation study according to OECD test guideline 492 has been commissioned and an update will be made once results are available. The skin irritation studies performed on this substance, together with a long history of use as a food ingredient, indicate that a preliminary classification of eye irritation category 2 is appropriate, pending the results of the study planned.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 439
- Version / remarks:
- Weight of evidence to support study planned
- GLP compliance:
- yes (incl. QA statement)
- Irritation parameter:
- other: % tissue viability
- Remarks:
- Weight of evidence supporting study
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- An eye irritation study according to OECD test guideline 492 has been commissioned and an update will be made once results are available. The skin irritation studies performed on this substance, together with a long history of use as a food ingredient, indicate that a preliminary classification of eye irritation category 2 is appropriate, pending the results of the study planned.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no. 871 008
- Irritation parameter:
- other: Percentage of viability
- Value:
- ca. 28.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Notes from study report:
Provided that the assay acceptance criteria are met:
• A test item is considered as “No Category”, i.e. not requiring a warning label in the European chemical classification systems for eye irritation or serious eye damage (UN GHS No Category), if the eye model viability after exposure and post-treatment incubation is >60%.
• If the mean percent tissue viability after exposure and post-exposure incubation is ≤60%, no prediction can be made.
The percentage of viability obtained with test item Hop Extract (Low Oil) was 28.432 %, therefore no prediction can be made. However, as described above (section 13), the tissues were exposed to the test item for 24 hours, and not the standard 6 hours, because of the difficulties faced when removing the test item from the tissue surfaces and this should be considered when reviewing the data presented in this report. - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test item was very sticky and so following the standard rinsing procedures, the testing lab was unable to fully remove the test item from the surfaces of the tissues at the end of the incubation time, meaning that the tissues were exposed to the tissue surfaces for longer than the time period stipulated in the test guideline procedure, and so this could potentially lead to a lower tissue viability result. This has been documented in the reports.
The test item is a naturally sticky resin and so the laboratory issues were reasonable. Inspection of the results, especially Graph 1 (see the attached results under "Attached background material") show that the positive control gave quite a low viability, and hop extract (test material) was in line with the positive control (neat methyl acetate; eye irritation Category 2). Together with weight of evidence from skin irritation studies, an eye irritation category 2 classification is reasonable.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.