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EC number: 214-772-3 | CAS number: 1193-24-4
- 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:
- 1995-08-21 to 1995-12-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea pig Buehler test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- 6-hydroxy-1-H-pyrimidin-4-one
- IUPAC Name:
- 6-hydroxy-1-H-pyrimidin-4-one
- Reference substance name:
- 6-hydroxy-1H-pyrimidin-4-one
- EC Number:
- 214-772-3
- EC Name:
- 6-hydroxy-1H-pyrimidin-4-one
- Cas Number:
- 1193-24-4
- Molecular formula:
- C4H4N2O2
- IUPAC Name:
- 6-hydroxypyrimidin-4(3H)-one
- Details on test material:
- - Substance type: pure active substance
- Physical state: solid, homogeneous brownish-yellow powder
- Impurities (identity and concentrations): water 1.78%
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: Dunkin Hartley, Pirbright White HSD/Win:DH (SPF)
- Age at study initiation: young adult
- Weight at study initiation: 310 - 381 g
- Housing: conventional, up to 5 animals/Macrolon cage type IV
- Diet: ad libitum, Ssniff G 4 Alleindiaet fuer Meerschweinchen
- Water: communal drinking water ad libitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 1995-08-21 To: 1995-12-29
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- vaseline
- Concentration / amount:
- Pretest: 2.5, 10, 25, 50 % (w/w)
Induction phases I-III: 50 % (w/w)
Challenge: 50 % (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- vaseline
- Concentration / amount:
- Pretest: 2.5, 10, 25, 50 % (w/w)
Induction phases I-III: 50 % (w/w)
Challenge: 50 % (w/w)
- No. of animals per dose:
- Pretest: 3 animals
Main test: 20 animals
Determination of challenge concentration: 3 animals each, pretest and week 4
Control to main test: 10 animals - Details on study design:
- RANGE FINDING TESTS:
Formulation of the solid test material: Concentrations of 10, 50, and 70% (w/w) of the finely ground powder in petrolatum (vaseline) were tested, and 50% was determined to be the highest concentration that ensured a good skin contact.
Tolerability: Application of the test substance in petrolatum (0.5 g of mixture, concentrations 2.5, 10, 25, 50 %) to the shaved flanks of 3 animals, (4 gauze patches per animal, area 2x2cm each), with occlusive dressing, for 6 hours. Recording of skin reactions at 30 and 54 hours after the start of the application.
Similar Range finder during the 4th week of the experiment, with 3 untreated animals, to account for changes in skin sensitivity due to increased weight and age.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: days 0, 7, and 14
- Duration: 28 days
- Concentrations: 50% test substance in petrolatum, 0.5 g of the mixture
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals
- Control group: 10 animals
- Site: right flank, posterior
- Vehicle patch site: right flank, anterior
- Concentrations: 50% test substance in petrolatum, 0.5 g of the mixture
- Evaluation (hr after challenge): 30 and 54
OTHER: - Challenge controls:
- 10 animals exposed to the pure vehicle 3 times during the induction period, challenged in the same way as the exposure group (50% w/w test material in petrolatum)
- Positive control substance(s):
- yes
- Remarks:
- Strain sensitivity to 2-mercaptobenzothiazole tested 1995-06-22
Results and discussion
- Positive control results:
- Sensitivity test HS-95/MCPT of the guinea pig strain Dunkin Hartley, Pirbright White (DHPW), performed 1995-05-22 to 1995-06-22, with 2-mercaptobenzothiazole (50% in petrolatum) in a Buehler test: 40% (4/10) of the test animals exhibited erythema, 30% also edema of the challenge test region. The sensitivity of the strain is considered positive.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 50% 2-mercaptobenzothiazole
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- 4/10 exhibited erythema, 3/10 also edema
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is considered to be not sensitising. The study is considered to be relevant and reliable.
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