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EC number: 922-676-4 | CAS number: 286426-31-1
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3-[(1S)-2-[benzyl(methyl)amino]-1-hydroxyethyl]phenol
- Cas Number:
- 286426-31-1
- Molecular formula:
- C17 H20 O2
- IUPAC Name:
- 3-[(1S)-2-[benzyl(methyl)amino]-1-hydroxyethyl]phenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: solid
- Analytical purity: 99.7 %
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH; D-33178 Borchen
- Weight at study initiation: 302 - 312 g
- Housing: The animals were kept in groups in Terluran-cages on Altromin saw fiber bedding. Max. gruop size 10 animals.
- Diet : Feeding ad libitum Altromin 3112 maintenance diet for guinea pigs, rich in crude fiber, totally-pathogen-free-TPF
- Water : Free access to tap water ( drinking water, municipalresidue control, microbiol. controlled periodically )
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 45 - 65
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12:12 , light 6:30 -18:30
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 500 mg ( industion first stage )
50 % ( induction second stage and challenge )
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 500 mg ( industion first stage )
50 % ( induction second stage and challenge )
- No. of animals per dose:
- 10 animals per dose
- Details on study design:
- RANGE FINDING TESTS: Three animals were topically treated with 10 % / 25 % / 50 % concentration of the test item. No signs of irritation and systemic toxicity were recorded after a contact period of 48 h after application on 50 % concentration.
Therefore a 50 % concentration was chosen for the topical induction and for the challenge as well.
For the first stage of the induction the highest concentration ( 5 % ) applicable as interdermal injection, was chosen.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: Prepared test item in Freund`s Adjuvant complete
- Control group: NaCl in Freund`s Adjuvant complete
- Site: shoulder region
- Duration: 0- 20 d
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 h
- Test groups: 1.0 ml test item ( 50 % ) / 1.0 ml CMC 1 %
- Control group: 1.0 ml test item ( 50 % ) / 1.0 ml CMC 1 %
- Site: left and right flank
- Evaluation (hr after challenge ) : 24,48, 72 h - Challenge controls:
- 5 female animals
1.0 ml test item / 50 % concentration - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazol
Results and discussion
- Positive control results:
- The recent reliability checks were performed in November 1999. The raw data and summary of the study are kept in the BSL archives (BSL Project ID 991298). The test was performed in accordance with BSL Standard Operating Procedures and was audited by the QA-unit.
Positiv control substance : Mercaptobenzothiazol, Purity >98 %, CAS No. 149-30-4, Lot 117H3487, Sigma Chemicals Co.
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test substance concentration
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no observation
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% test substance concentration. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no observation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data of this sensitization test it can be stated that the test item L-Benzyladrianol Base caused no reaction identified as
sensitization.
According to the EEC criteria for classification (93/21/EEC) no labelling is necessary as the sensitization rate was below 30 %. - Executive summary:
During the induction phase the guinea pigs (10 test group, 5 control group all female, strains: Hsd Poc:DH ) were interdermally injected with 5 % L-Benzyladrianol Base and, after treatment with sodium laurly sulfate, topically treated with 50 % L-Benzyladrianol Base. After a latencyof 14 days - to allow a pontential reaction of the immune system - the animals were challenged with 50 % L-Benzyladrianol Base on the flank. The grade of skin reaction was compared to control animals, which were treated with 0.9 % NaCl or CMC 1 % during the induction phase and, duing challenges phasewith the test item, respectively.
The sensitization rate after application of L-Benzyladrianol Base was 0%. Under the conditions described the test item showed no sensitizing properties. Animals of the test group showed normal weight gain as compared to historical data and the of the control group.
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