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Diss Factsheets
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EC number: 305-203-0 | CAS number: 94349-84-5
- 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 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 7
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Viability measured after 3 minutes
- Value:
- ca. 40.3
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue viability measured after 1 hour
- Value:
- ca. 28.1
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Notes from study report: "After 3 min and 1h exposure on the surface of EpiDermTM reconstructed human epidermis, the viability of the tissues was assessed and compared to a negative control.
The percentage of viability obtained was 40.3% after 3 min and 28.1% after 1h and therefore:
Potassium Iso-Alpha Resin was classified as Corrosive, optional sub-category 1B/1C to human skin." - Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 7
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 7.323
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Conclusions:
- After 60 ± 1 minute exposure on the surface of the EpiDermTM reconstructed human epidermis, and a 42 ± 4 hours post-exposure incubation time, viability of the tissues was assessed and compared to the negative control.
The percentage of viability obtained was 7.323 % and therefore:
Potassium Iso-Alpha Resin was classified as an Irritant to the skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 corrosion studies performed on this substance indicate that a preliminary classification of eye damage category 1 is appropriate, pending the results of the study planned.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 431: skin corrosion study used as supporting evidence for classification
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no. EXP 7
- Vehicle:
- unchanged (no vehicle)
- Irritation parameter:
- other: % tissue viability 3 minutes
- Value:
- ca. 40.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: % tissue viability 1 hour
- Value:
- ca. 28.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1 (irreversible effects on the eye) 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 corrosion studies performed on this substance indicate that a preliminary classification of eye damage category 1 is appropriate, pending the results of the study planned.
Notes from study report: "After 3 min and 1h exposure on the surface of EpiDermTM reconstructed human epidermis, the viability of the tissues was assessed and compared to a negative control.
The percentage of viability obtained was 40.3% after 3 min and 28.1% after 1h and therefore:
Potassium Iso-Alpha Resin was classified as Corrosive, optional sub-category 1B/1C to human skin." - Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- 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. DB EXP 9
- Irritation parameter:
- other: Percentage of viability
- Value:
- ca. 2.8
- 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 Potassium salt of hop iso-alpha acids, resin form was 2.831 %, therefore no prediction can be made.
During the study, the required preliminary test confirmed that the test item did not interfere with MTT or solvent.
During the study, it was observed that the resinous test item was not fully removed using the standard rinsing procedures. The outcome of this is that the test item remained on the surface of the tissues for more than the standard 6 hours application time. The total exposure time was 24 hours and this should be taken into account when regarding the data presented below. The potential effect of the prolonged exposure time could be reduced tissue viability. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Notes from study report: During the study, it was observed that the resinous test item was not fully removed using the standard rinsing procedures. The outcome of this is that the test item remained on the surface of the tissues for more than the standard 6 hours application time. The total exposure time was 24 hours and this should be taken into account when regarding the data presented below. The potential effect of the prolonged exposure time could be reduced tissue viability.
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 test gave a considerably lower viability than the positive control. Together with weight of evidence from skin irritation and skin corrosion studies, an eye damage category 1 classification is reasonable.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
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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