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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Hartley strain albino
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid paraffin (intradermal induction); see also under concentration (next box)
- Concentration / amount:
- Intradermal induction: 0.1 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item)
Topical induction: 0.2 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item) --> exposure for 48 hrs
Challenge: a. 0.1 ml of the test formulations at two concentrations (100% and 50 w/w% in polyethylene glycol 300) --> exposure for 24 hrs
Intradermal dosing: Day 1
Induction dosing: Day 1 + 6
Challenge dosing: Day 1 + 20
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid paraffin (intradermal induction); see also under concentration (next box)
- Concentration / amount:
- Intradermal induction: 0.1 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item)
Topical induction: 0.2 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item) --> exposure for 48 hrs
Challenge: a. 0.1 ml of the test formulations at two concentrations (100% and 50 w/w% in polyethylene glycol 300) --> exposure for 24 hrs
Intradermal dosing: Day 1
Induction dosing: Day 1 + 6
Challenge dosing: Day 1 + 20
- No. of animals per dose:
- 5 (control group) and 10 (test item sensitization group)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% and 50 w/w%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormal clinical signs in any animal in any group
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% and 50 w/w%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormal clinical signs in any animal in any group.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% and 50 w/w-%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormal clinical signs in any animal in any group
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% and 50 w/w-%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormal clinical signs in any animal in any group.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 100% and 50 w/w-%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no abnormal clinical signs in any animal in any group
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 100% and 50 w/w-%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no abnormal clinical signs in any animal in any group.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group
- Dose level:
- 100% and 50 w/w-%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no abnormal clinical signs in any animal in any group
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 100% and 50 w/w-%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no abnormal clinical signs in any animal in any group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item was judged to have no sensitization potential.
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