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EC number: 446-560-3 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-08-28 to 2001-10-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 July 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 446-560-3
- EC Name:
- -
- Cas Number:
- 213265-83-9
- Molecular formula:
- C4HCl2FN2
- IUPAC Name:
- 4,6-dichloro-5-fluoropyrimidine
1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG D-24601 Lohndorf/Post Wankendorf
- Age at study initiation: approx 6-11 months
- Weight at study initiation: 2.3-2.9 kg
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Remarks:
- dermal application to the shaved intact dorsal skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL/patch
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx 6 cm²
- Type of wrap if used: The test substance was applied to the test site and then covered with a gauze patch. The patch was held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 60 min, 24, 48, 72 h and 4 to 14 days
SCORING SYSTEM: according to test guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days, area of application dark discoloured, swelling on left abdomen increasing to: induration of the skin and skin in area of application discoloured and indurated, skin around area of application red and warm
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days, area of application dark discoloured, swelling on left abdomen increasing to: induration of the skin and skin in area of application discoloured and indurated, skin around area of application red and warm
- Irritation parameter:
- edema score
- Basis:
- animal: #1 - #3
- Time point:
- other: 60 min
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: animals 1 and 3 died therafter
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 - #3
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: Animal 1 and 3 died thereafter
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Under the present test conditions all three animals showed an erythema (grade 1) 1 hour after patch removal.
All three animals showed an oedema (grade 2) 1 hour after patch removal, animal no. 2 (grade 1) in addition at the examination time-points 24 and 48 hours after patch removal.
Additionally, dark discolouration of skin of the area of application and a swelling on the left abdomen were noted in animal no. two 24 hours to 14 days after patch removal. Induration of skin was noted in animal no. two 72 hours to 7 days after patch removal. Furthermore, from 8 to 14 days after patch removal discolouration and induration of the area of application was noted while the skin around this area was red and warm.
Animal nos. 1 and 3 were found dead at the examination time point 24 hours after patch removal. - Executive summary:
In a primary dermal irritation study according to OECD guideline 404 (1992), young adult Himalayan rabbits (3/treatment) were dermally exposed to 0.5 mL/patch of 4,6-dichlor-5-fluorpyrimidine (100 % a.i.) for 4 hours to 6 cm² of shaved dorsal skin. Animals then were observed for 14 days. Irritation was scored as required by the test guideline.
Under the present test conditions all three animals showed an erythema (grade 1) 1 hour after patch removal.
All three animals showed an oedema (grade 2) 1 hour after patch removal, animal no. 2 (grade 1) in addition at the examination time-points 24 and 48 hours after patch removal.
Additionally, dark discolouration of skin of the area of application and a swelling on the left abdomen were noted in animal no. two 24 hours to 14 days after patch removal. Induration of skin was noted in animal no. two 72 hours to 7 days after patch removal. Furthermore, from 8 to 14 days after patch removal discolouration and induration of the area of application was noted while the skin around this area was red and warm.
Animal nos. 1 and 3 were found dead at the examination time point 24 hours after patch removal. In this study, 4,6-dichlor-5-fluorpyrimidine is extremely irritating to the skin based on the presented results. Based on these results the test item is classified according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) as corrosive Category 1 (Causes severe skin burns and eye damage).
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