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EC number: 212-506-0 | CAS number: 822-89-9
- 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:
- March 31- May 6, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no data on reliability check of the test
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no data on reliability check of the test
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA FIFRA Pesticide Assessment Guidelines (1984)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this reliable guinea pig maximisation test was performed before entry into force of the REACH Regulation.
Test material
- Reference substance name:
- Hydroxyl-2-pyridone
- EC Number:
- 212-506-0
- EC Name:
- Hydroxyl-2-pyridone
- Cas Number:
- 822-89-9
- Molecular formula:
- C5H5NO2
- IUPAC Name:
- 1-hydroxy-1,2-dihydropyridin-2-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): Oxy PYRION
- Physical state: solid (powder)
- Appearance: white speckled gold powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 93100020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature in a glass jar
- Stability under test conditions: Stable
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall, Darley Oaks, Newchurch, Burton on Trent, Staffordshire, England
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 361-442 g for controls, 359-438 g for test animals
- Housing: Stainless steel cages with grid floors and tops, suspended in mobile racks. 5 same sex animals per cage.
- Diet (e.g. ad libitum): Commercially available pelleted guinea pig diet, ad libitum
- Water (e.g. ad libitum): Public tap water, ad libitum
- Acclimation period: at least 6 but not more than 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C (15-23 °C)
- Humidity (%): 55% (40-70% range)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 dark/12 light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% w/v oxypyrion in propylene glycol/0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% w/v oxypyrion in propylene glycol in FCA/0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- other: Purified water
- Concentration / amount:
- FCA 1:1 mixture of the adjuvant concentrate with purified water/0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- other: according to OECD Guideline 406
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 50% w/v oxypyrion in propylene glycol/0.6 mL
- Day(s)/duration:
- Day 8/48 hours (secondary induction)
- Adequacy of induction:
- other: was to cause at most, a weak or moderate inflammatory response and the concentration used at challenge was to be at the highest sub-irritant level; maximum practicable concentration of the test material and three lower concentrations in vehicle
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10% w/v oxypyrion in propylene glycol/0.03 mL
- Day(s)/duration:
- Day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 3% w/v oxypyrion in propylene glycol/0.03 mL
- Day(s)/duration:
- Day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Screening test: 4 animals
Main test: The test group consisted of twenty animals and the control group ten animals, evenly divided by sex. - Details on study design:
- RANGE FINDING TESTS:
The study design included a primary skin irritation screen which imposed limits on the concentration of the test material used during the main study.
Pre-treatment formulation trials indicated that 10% w/v oxypyrion in propylene glycol was the maximum concentration that would pass through a hypodermic needle. The maximum practicable concentration of the test material in the chosen vehicle was taken as 50% w/v for topical administration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of injections per animal, anterior-FCA; middle-test substance in propylene glycol; posterior-test substance in propylene glycol in FCA
- Exposure period: Day 1 injection
- Test groups: 20 animals
- Control group: 10 animals
- Site: primary induction: dorsal median line; secondary induction: dermal site overlying the scapulae
- Frequency of applications: Once
- Duration: primary induction: single injection; secondary induction: 48 hours
- Concentrations: primary induction: 5% w/v oxypyrion in propylene glycol or 5% w/v oxypyrion in propoylene glycol in FCA; secondary induction: 50% w/v oxypyrion in propylene glycol
B. CHALLENGE EXPOSURE
- No. of exposures: 1 per animal and vehicle
- Day(s) of challenge: Day 22
- Exposure period: 1 h
- Test groups: 20 animals
- Control group: 10 animals
- Site: Both flanks of animals, left side-0.03 mL vehicle, right side-0.03 mL of 2 concentrations of test substance, occluded
- Concentrations: 3% and 10%
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Controls were untreated sites on the left flank of each challenged animal.
- 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:
- propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v oxypyrion in propylene glycol
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- eschar formation in one animal and slight erythema in one test animal
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% w/v oxypyrion in propylene glycol
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- eschar formation in one animal and slight erythema in one animal
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% w/v oxypyrion in propylene glycol
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- slight erythema in 2 control animals
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% w/v oxypyrion in propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% w/v oxypyrion in propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% w/v oxypyrion in propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3% w/v oxypyrion in propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3% w/v oxypyrion in propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: all groups
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Induction:
Intradermal injection of 5% w/v oxypyrion in propylene glycol, alone or in Freund's Complete Adjuvant caused slight or moderate erythema, eschar formation and pallor, and a low incidence of discoloration.
Occluded topical application of 50% w/v oxypyrion in propylene glycol gave rise to slight erythema, eschar formation, and a single case of oedema and exfoliation.
Challenge:
Application of 10% w/v oxypyrion in propylene glycol caused eschar formation in 1 test animal, and slight erythema in 1 test and 2 control animals. Barely perceptible erythema was observed in 3 test animals and 1 control animal.
Application of 3% w/v oxypyrion in propylene glycol caused barely perceptible erythema in 1 test and 1 control animal.
Application of propylene glycol alone gave rise to a single case of barely perceptible erythema amongst the test animals, as the only reaction to treatment.
General health and bodyweight:
The animals remained in overt good health and achieved anticipated overall body weight gains. On day 25, the body weight range of the control animals was 521 -726 g and of the test animals 522 -652 g.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The incidence of response was below the EEC limit value (30%) to classify the test material as a dermal sensitizer. It is concluded that under the conditions of the study, repeated application of the test substance did not cause delayed contact hypersensitivity in the guinea pig.
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