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EC number: 700-854-0 | CAS number: 256473-04-8
- 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)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP compliant study with good documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- 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:
- EU Method B.6 (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:
- 2-chloro-3-(2,2,2-trifluoroethoxy)pyridine
- EC Number:
- 700-854-0
- Cas Number:
- 256473-04-8
- Molecular formula:
- C7H5ClF3NO
- IUPAC Name:
- 2-chloro-3-(2,2,2-trifluoroethoxy)pyridine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibn: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:RCC Ltd.; Biotechnology & Animal Breeding Division; 4414 Füllingsdorf; Switzerland
- Age at study initiation: 5-7 weeks
- Weight at study initiation: The weight at the start of the one week acclimation period was 298-410 g (males) and 297 - 347 g (females).
- Housing: individually at standard laboratory conditions.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0 - 22.5°C
- Humidity (%): 52 - 75.5%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- Music was played during the light period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 5 % for intradermal induction
50% for epidermal induction (highest attainable concentration)
50 % for epidermal challenge (highest attainable concentration and highest non-irritating concentration)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 5 % for intradermal induction
50% for epidermal induction (highest attainable concentration)
50 % for epidermal challenge (highest attainable concentration and highest non-irritating concentration)
- No. of animals per dose:
- 5 males and 5 females (control group)
10 males and 10 females (test group) - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal, epidermal application: 48 h
- Test groups: test item in Freuds Complete Adjuvant (FCA) and in vehicle.
- Control group: FCA and vehicle
- Site: left flanks
- Frequency of applications: intradermal injections Day 1, SLS treatment Day 7, epidermal applications Day 8
- Duration: epidermal: 48 h
- Concentrations: 5 % intradermal and 50% epidermal
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
- Test groups: 50 % in PEG
- Control group: vehicle only
- Site:shaved area, over the injection sites
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h after removal of bandages - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The contact sensitization of CTFEP (purity 91.4%) to guinea pigs (Ibn: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)) was determined in a GLP compliant test according to OECD 406, EU Method B.2, and OPPTS 870.2600. Since the study from Acrelin (2001) was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1.
For the contact sensitization test 10 males and 10 females were first intradermally inducted (Day 1), then epidermally inducted (day 8) and epidermally challenged for 24 hours on day 22. Readings were performed 24 and 48 hours after removing the dressings. FCA was used in combination with PEG as vehicle. Concentrations were 5% for intradermal and 50% for epidermal applications.
After the intradermal induction one male and one female died. The mortality was not considered test item related. There were no clinical findings during the study.
In none of the readings any unusual sensitization findings other than in the controls were found.
It can be concluded that under the experimental conditions the test substance is not a skin sensitizer for guinea pigs according to the testing scheme from Magnuson and Kligman.
According to the classification criteria set out in Directive 67/548/EEC and Regulation (EC) No. 1272/2008 the substance does not fulfil the criteria for classification as skin sensitizer.
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