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Diss Factsheets
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EC number: 695-757-2 | CAS number: 897381-19-0
- 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:
- 3/07/2013-12/07/2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted at a GLP accredited laboratory
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study has been performed according to a scientifically and regulatorily valid OECD TG at the time of the performance of the study.
Test material
- Reference substance name:
- Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)
- IUPAC Name:
- Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)
- Reference substance name:
- 1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol
- EC Number:
- 695-757-2
- Cas Number:
- 897381-19-0
- Molecular formula:
- UVCB
- IUPAC Name:
- 1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol
- Details on test material:
- Light yellow liquid. It stored at room temprature in dark.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Age: 4 weeks
BW: 328-337 gr (dose range), 313-442 g (main study)
Housing: Animals were individually housed in compliance with USDA Guidelines. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
Lighting: 12 hours light/12 hours dark
Room Temperature: 16-27 C degrees
Relative Humidity: 25to 96%
Food: All animals had access to HArlan Tekland Guinea Pig Diet ad libitum. The lot number(s) and specifications of each lot used are archived at Calvert. No contaminants were known to be present in the certified diet at levels that would be expected to interfere with the results of this study. Analysis of the diet was limited to that performed by the manufacturer records of which are maintained in the Calvert archives.
Water: Water was available ad libitum to each animal via an automatic watering device. The water is routinely analyzed for contaminants as per Calvert SOP's. No contaminants were known to be present in the water at levels that would be expected to interfere with the results of this study.
Acclimation: Study animals were acclimated to their housing for a minimum of 5-7 days prior to dosing.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: Dermal induction with patch
- Vehicle:
- physiological saline
- Concentration / amount:
- Initially, a dose range was performed in four na'ive animals with the test article, PD 206, at 5%, 25%, 50% and 100% (as received). Based on these results, an induction dose and challenge dose of 100% (as received) was chosen for this study.
Challengeopen allclose all
- Route:
- other: Dermal induction with patch
- Vehicle:
- physiological saline
- Concentration / amount:
- Initially, a dose range was performed in four na'ive animals with the test article, PD 206, at 5%, 25%, 50% and 100% (as received). Based on these results, an induction dose and challenge dose of 100% (as received) was chosen for this study.
- No. of animals per dose:
- Four primary irritation
Twenty test article group (10/sex)
Ten vehicle control (5/sex)
Six positive control (3/sex) - Details on study design:
- Article group were induced with two six-hour occluded dermal applications of PD 206 (as received) (second and third inductions). For the first induction, it is documented that the dental dam and patch were removed ~4 hours after test article application . A vehicle group of ten animals (5/sex) was induced in the same manner with 0.9% saline.
Fifteen days after the last induction, all animals were dermally challenged with occluded applications at naiive test sites. Animals in the test article and vehicle control group were challenged with PD 206 (as received) and 0.9% saline. Animals in the positive control group were challenged with DNCB (0.2°.4> in acetone). On the day following the challenge, animals were depilated and approximately three hours later were scored for dermal irritation (24 hour). Scoring was repeated at 48 hours. - Challenge controls:
- A positive control group of six animals (3/sex) was induced with a known dermal sensitizer: 1-chloro-2,4-dinitrobenzene (DNCB).
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- The positive control group, induced and challenged with DNCB, exhibited the anticipated positive responses at challenge indicating that the methods
employed in this study were valid. All dermal irritation scores at the 24- and 48-hour observations were zero for the vehicle control animals challenged with the test article and the vehicle (saline).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% and in saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- incidence and severity
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% and in saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- incidence and severity
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2% DNCB
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- incidence and severity
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.2% DNCB
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- incidence and severity
Any other information on results incl. tables
All dermal irritation scores at the 24- and 48-hour observations were zero for the test article group animals challenged with the test article and the vehicle (saline).
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study induction with Precursor PD 206 did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged.
- Executive summary:
The purpose of this study was to determine if a test article elicits a delayed dermal contact hypersensitivity response in guinea pigs by the measurement of skin reactivity.
The positive control group, induced and challenged with DNCB, exhibited the anticipated positive responses at challenge indicating that the methods employed in this study were valid. Under the conditions of this study induction with Precursor PD 206 did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged.
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