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Diss Factsheets
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EC number: 207-405-3 | CAS number: 468-28-0
- 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:
- The study performed on hop extract is relevant for beta acids, since hop extract may contain up to ca. 64% beta acids, and the extract tested here contained 38% beta acids. 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:
- Batch no. EXP 5
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 27.1
- 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 beta acids, potassium resin, is classfied as irritant to human skin.
- Endpoint:
- skin corrosion: 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no. EXP 5
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue viability measured after 1 hour
- Value:
- ca. 85.4
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Notes from study report: "The test item did not reduce the viability below 50% after 3 min nor below 15% after 1h and should be considered as non-corrosive."
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:
- The study performed on hop extract is relevant for beta acids, since hop extract may contain up to ca. 64% beta acids, and the extract tested here contained 38% beta acids. 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 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
- Value:
- ca. 5.65
- 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:
- 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 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)
- Specific details on test material used for the study:
- Batch no. EXP 5
- Irritation parameter:
- other: % tissue viability
- Remarks:
- Weight of evidence supporting study
- Value:
- ca. 27.1
- 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 indicate that a preliminary classification of eye irritation category 2 is appropriate, pending the results of the study planned.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Note this was performed in the US and would not have been permitted on three rabbits in Europe. Also, even if with only one animal, the test shouold have been terminated as soon as it becam apparant that corneal opacity was not improving.
The results have been disregarded as there was no record made of the pH of this product. New in-vitro tests have been initiated in 2018. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no. RD11-627. Purity: 44.0% beta acids
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL dose in the conjunctival sac of right eye. The contralateral eye remained untreated and served as the control.
- Duration of treatment / exposure:
- Up to 21 days
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- The classification was based on the corneal opacity.
Iris score was 1 throughout, but was difficult to assess once the cornea became damaged
There was slight improvement of conjunctival scores during the 21 day observation period.
The test laboratory made observations that suggested that the animals were not distressed, although UK law would not have permitted this study. The registrant was not responsible for the conduct of this test. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Notes from the study report: "According to the Kay and Calandra Evaluation Criteria, KBR is considered to be a very severe irritant to the ocular tissue of the rabbit."
IMPORTANT QUALIFIER: These results were made available by J I Haas for the purpose of supporting the REACH regitsration. The tests themselves were commissioned for a separate USA regulatory submission. It was considered that much of the severe irritation may have been due to excess KOH present in the KBR resin. Accordingly, new resins were carefullly prepared for REACH, avoiding any excess KOH, and were tested for skin irritation (see endpoint skin irritation / corrosion.002 and .003). They will also be tested in an in vitro eye irritation test (study planned), with results added as an update to this dossier. The skin irritation / corrosion results indicate that the substance should be provisionally classfied as eye irritant category 2, to be updated once the new in vitro tests are completed. - 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. EXP 5
- Irritation parameter:
- other: Percentage of viability
- Value:
- ca. -11.78
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Notes from the study report:
Prior to the study, the required preliminary test confirmed that the test item interfered with MTT or solvent and so parallel tests using freeze-killed tissues were also performed to allow for data correction.
Due to the high MTT-reducing activity of the test item, no conclusive classification of the eye irritancy potential of Potassium Beta Resin could be determined and therefore the outcome is Inconclusive. - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The substance interfered with the detection system and so no prediction was possible. Given that the substance is a moderate skin irritant, Category 2 classification as a precaution 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.
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