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EC number: 807-702-3 | CAS number: 3225-26-1
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-03-16 to 1995-07-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD 406)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The non-LLNA study was performed in 1992 and adequately demonstrates no skin sensitising properties in the test substance. As this study meets the endpoint requirements, it was considered no necessary to perform a further in vivo study.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
conditions:
- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Gartenstrasse 27, 33174 Borchen, Germany
- Age at study initiation: young adults
- Weight at study initiation: < 500 g
- Housing: conventional, groups of 5 at maximum in Macrolon cages type IV
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity:30 - 70 %
- Air changes: 15 per h
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: Main test from: 1995-05-01 to 1995-06-01 - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
0.5 g, applied as a paste at 50% (w/w)- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.5 g, applied as a paste at 50% (w/w)
- No. of animals per dose:
- 20
plus 9 for negative control (from n=10, one Guinea pig excluded from study during in life phase due to presumed pregnancy) - Details on study design:
RANGE FINDING PRE-TESTS:
- IN-LIFE dates: 1995-03-21 to 1995-03-24
- Concentrations: 0.5 g, applied as a paste at 2.5, 10 25 or 50% (w/w)
- No. of animals: 3
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (day 0, 7, 14)
- Exposure period: 6 hrs each
- Site: left flank (sheared 2 to 3 hrs prior to application)
- Concentrations: 0.5 g, applied as a paste at 50% (w/w)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 28
- Exposure period: 6 hrs
- Site: right caudal flank (sheared 2 to 3 hrs prior to application)
- Concentrations: 0.5 g, applied as a paste at 50% (w/w)
- Evaluation: 30 and 54 hrs after challenge
OTHER: Application sites were swiped with cotton pads soaked in corn oil 6 hrs after each application.- Challenge controls:
on apical flank of the same animals- Positive control substance(s):
- no
- Positive control results:
Last in house test on this animal strain with 2-Mercaptobenzothiazol from 1994-11-07 to 1994-12-02, animals were sensitive to pos. control item.- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none reported.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
The test substance 4-Hydroxy TEMPO did not induce delayed contact hypersensitivity in the Bühler test and is thus not regarded as a skin sensitiser.
Reference
0 of 20 animals showed erythema or edema after induction and challenge, at either 30 or 54 hours post application.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a skin sensitisation assay (Bühler test: 95-0258-DGT), 20 female Guinea pigs received three dermal doses (day 0, 7 and 14) of 0.5 g 4-Hydroxy-TEMPO as a paste in petrolatum at a 50 % (w/w) concentration onto their left caudal flank, while nine female negative control animals received the vehicle alone. The maximum concentration feasible was determined in a pre-test. The animals were challenged on day 28, using the same vehicle and test item concentration, applied onto the right flank. No signs of skin sensitisation where detected. The latest positive control using 2-Mercaptobenzothiazol was positive. The study was performed according to GLP and it satisfies the requirements of OECD test guideline 406. The study is considered acceptable (key study).
Migrated from Short description of key information:
The test substance 4-Hydroxy TEMPO did not induce delayed contact hypersensitivity in the Bühler test and is thus not regarded as a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
Adequate assay to address endpoint
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The test item has no structural alert indicative for respiratory sensitisation. In addition, no human data on respiratory sensitisation have been reported. The test item is considered not to induce respiratory sensitisation.
Migrated from Short description of key information:
Considered not to induce respiratory sensitisation.
Justification for classification or non-classification
Skin sensitisation
Based on the results of an in vivo skin sensitisation test, the test item should not be classified with regard to skin sensitisation according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (GHS, CLP).
Respiratory sensitisation
Considered not to induce respiratory sensitisation.
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