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EC number: 222-148-7 | CAS number: 3371-33-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 November 1999 to 03 December
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive 92/69
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1996
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-(3,5-dihydroxyphenyl)-2-[[2-(4-hydroxyphenyl)-1-methylethyl]amino]ethan-1-one hydrobromide
- EC Number:
- 222-148-7
- EC Name:
- 1-(3,5-dihydroxyphenyl)-2-[[2-(4-hydroxyphenyl)-1-methylethyl]amino]ethan-1-one hydrobromide
- Cas Number:
- 3371-33-3
- Molecular formula:
- C17H19NO4.BrH
- IUPAC Name:
- 1-(3,5-dihydroxyphenyl)-2-{[1-(4-hydroxyphenyl)propan-2-yl]amino}ethan-1-one hydrobromide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No details on the source of the test material were provided. Batch number: 206.
- Expiration date of the lot/batch: No details reported.
- Purity test date: 15 June 1999.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, protected from light.
- Stability under test conditions:Not reported
- Solubility and stability of the test substance in the solvent/vehicle: No details reported.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was moistened with water to ensure good contact with the site of administration.
- Preliminary purification step (if any):No details reported.
- Final dilution of a dissolved solid, stock liquid or gel:No details reported.
- Final preparation of a solid:No details reported.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Animals: 3 female New Zealand White rabbits
- Housing: individually housed in ABS - plastic rabbit cages, floor 4200 cm2, Semi-barrier in air conditioned rooms.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate acclimatization period. No further details reported.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3°C
- Humidity: 55 +/- 10%
- Air changes: at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dak/12 hours artificial light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A dose of 0.5 g of the test item was applied to each test site.
- Duration of treatment / exposure:
- 4 hour
- Observation period:
- 1, 24, 48, 72 hours after patch removal
- Number of animals:
- 3 (female)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of skin on one side of the dorsal area of the animals.
- Type of wrap if used: gauze patch, non-irritating tape
Evaluation of results
- according to the relevant OECD test guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The test substance showed no irritant/corrosive effects.
Any other information on results incl. tables
The test substance showed no irritant effects on the intact skin after a contact time of 4 hours.
No skin reactions (erythema, oedema) were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance showed no irritant effects on the intact skin after a contact time of 4 hours. Based on the results of this study, the test substance is classified as not skin irritating according to CLP criteria.
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